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FDA Consumer Magazine
VOL. 32 NO. 1
JANUARY-FEBRUARY 1998
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Features

Direct to You: TV Drug Ads That Make Sense
Clueless. That's how consumers felt about prescription drug ads on TV.
Then FDA changed the rules.

Living Day-to-Day with Kidney Dialysis
New requirements for dialysis devices and quality guidelines for clinics
hold the promise of better care for people who have lost their kidneys
to disease or injury.

Dangers of Lead Still Linger
Many battles have been fought to get rid of lead products that can
poison people. But the lead war isn't over yet.

Skimming the Milk Label
Your favorite milk isn't changing; the labels are just coming in line
with the rest of the products on your grocer's shelves.

Air Aid: When Medical Care Is Sky-High
If you suffer a medical emergency at 40,000 feet, your survival may hang
on whether the plane is carrying the right medical equipment.

Drugs of the Deep
Medical researchers are beginning to discover that fish and other sea
life have more to offer us than sustenance.


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Departments



Updates

The latest information on FDA-related issues, gathered from FDA Press
Releases, Talk Papers, and other sources.



Notebook

A potpourri of items of interest gathered from the Federal Register and
other sources.



Investigators' Reports

Selected cases illustrating regulatory and administrative actions--such
as inspections, recalls, seizures, and court proceedings--by FDA's
regional and district offices across the country



Summaries of Court Actions

Cases involving seizure, criminal and injunction proceedings.



Statement of Ownership

Extent and nature of circulation of FDA Consumer.




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Direct to You: TV Drug Ads That Make Sense

by Tamar Nordenberg

The secret's out. The prescription drug Claritin is an antihistamine for
seasonal allergies, new TV commercials reveal. Before August 1997, the
Claritin television ads said little beyond, "At last, a clear day is
here" and "It's time to see your doctor."

Not much to go on in those earlier ads, and the commercials for
Claritin's main competitor, Allegra, were equally unrevealing. Why the
secrecy? Because, by stating the drug's name but not what it was used
for, the ads were exempt from a Food and Drug Administration regulation
that generally requires prescription drug advertisements to disclose the
risks of the medication as well as its benefits. From the drug
companies' perspective, it was impractical to include detailed risk
information in a 30- or 60-second TV spot.

But the so-called "reminder ads" for Claritin and other drugs left
consumers puzzled. "We used to get a tremendous amount of phone calls
saying, 'What is Claritin? What is it for?'" says Alex Giaquinto, senior
vice president for worldwide regulatory affairs for Schering-Plough
Corp., the drug's manufacturer. "You'd be surprised. We got calls from
gynecologists saying patients were asking if they were candidates for
Claritin."

In part because of the consumer confusion and concerns that some TV and
radio advertisements might be misleading, FDA reviewed its policies on
broadcast ads and, in August 1997, issued a draft guidance for public
comment. The new guidance describes how prescription drug companies can
advertise a product directly to consumers on TV or radio, including the
product's use, without scrolling the type of detailed risk information
that accompanies magazine and other print advertisements.

The makers of Claritin and Allegra soon began airing revised ads. "Only
one tablet means 24-hour, nondrowsy seasonal allergy relief," announced
the new Schering-Plough commercial.

Not everyone agrees that these "direct-to-consumer" ads are beneficial.
At a 1995 public hearing on consumer-directed advertising, FDA heard
from scientists, drug companies, patient advocates, and medical
professionals. Some objected to direct-to-consumer ads, saying that they
mislead consumers because they don't provide a complete picture of the
drug. Others favored the ads, telling the agency that a
consumer-directed ad can be an important educational tool in an era when
patients want to be more involved in their own health care.

But, says Nancy Ostrove, a public health analyst in FDA's division of
drug marketing, advertising, and communications, "Direct-to-consumer
advertising is not inherently bad or good. It can be useful or harmful,
depending on how it's done."

Truth in Advertising

FDA has regulated the advertising of prescription drug products since
1962, under the Federal Food, Drug, and Cosmetic Act and related
regulations. Most other advertising, including the advertising of
over-the-counter drugs, is regulated by the Federal Trade Commission,
under a different set of rules.

FDA generally interprets the term "advertisement" to cover information
other than labeling that promotes a product. The term includes
promotions broadcast on television or radio, conducted by telephone, or
printed in magazines or newspapers. (Also see "Drug Promotion in
Cyberspace.")

For many years, prescription drug makers promoted their products
exclusively to health-care professionals. But about 15 years ago, some
manufacturers began to produce ads targeted to consumers.

<Picture omitted: Graph showing Direct-to-Consumer Advertising of
Prescription Medications 1993-1996>

Since then, direct-to-consumer advertising has become a popular
promotional tool. In 1996 alone, prescription drug manufacturers spent
almost $600 million on this type of advertising, according to
Competitive Media Reporting, which projects 1997 spending to be at least
twice that.

And consumer-directed ads seem to be capturing consumers' attention. In
a 1996 study by drug industry consultant Scott-Levin, three-quarters of
the doctors surveyed said their patients have talked about drug ads they
heard or saw.

FDA regulates consumer-directed ads under the same regulations as
professional-directed ones. Like promotions directed to health-care
providers, consumer ads may only make claims that are supported by
scientific evidence and that are not inconsistent with the FDA-approved
product labeling. And, like professional-directed advertisements, they
may not be false or misleading.

FDA oversight helps ensure that consumers understand both the benefits
and limitations of an advertised drug. (See "In Trouble with FDA.") The
agency monitors ads to make sure they are tailored for the target
audience. For example, a consumer-directed ad may be considered
misleading unless it explains the drug's benefits and risks in words
that people who aren't medical professionals can understand.

FDA regulations call for "fair balance" in every ad. FDA reviewers look
at the entire advertisement to see if it is balanced. The risks as well
as the benefits must be clearly identified, with the risks presented
prominently and readably so that the benefits are not unfairly
emphasized.

Under the Federal Food, Drug, and Cosmetic Act, most ads must include a
"brief summary" describing the effectiveness of the drug and its risks.
In print ads, drug companies usually meet the requirement by including
entire risk-related sections of the approved labeling. Many people have
expressed concern to FDA that, because drug labeling is primarily
written for doctors, much of it cannot be understood by consumers.

"The brief summary might be fine for someone who went through medical
school," says Linda Golodner, president of the National Consumers
League. Even then, she says, "you have to get out a magnifying glass to
try and sort out the information."

FDA is considering what steps can be taken toward a more
consumer-friendly format. In the meantime, says Ostrove, "We encourage
manufacturers to write the brief summary information to be more
understandable to consumers."

TV Reality

In a short television or radio ad, manufacturers have found it difficult
to meet the brief summary requirement. "Scrolling a long, detailed brief
summary on a television screen is not practical on commercial
television," writes drug law expert Wayne Pines in the Thompson
Publishing Group's Advertising and Promotion Manual.

So, for television commercials and sometimes print ads, companies have
historically opted for two types of ads--"reminder" ads and
"help-seeking" ads--that are exempt from the brief summary requirement.

Reminder ads, like the original version of the Claritin commercial, call
attention to a drug's name, but don't state the condition it is used to
treat.

Help-seeking ads tell consumers only that there are treatments available
for a particular condition and encourage them to talk to a health-care
professional. To be considered a help-seeking advertisement, an ad may
not state or imply the name of a particular product, although it can
mention the manufacturer's name. One such magazine ad said simply, "Life
without ulcers. It is now possible. See your doctor."

The reminder and help-seeking ad "each has only part of the information
a consumer wants, which can create a lot of confusion," Ostrove says.

Completing the Puzzle

FDA regulations have always permitted sponsors of television and radio
ads to present a brief summary. Or, instead, they could make "adequate
provision" for interested people to get the approved labeling.

Before August 1997, FDA had not described "adequate provision" for
consumer-directed ads, so drug companies were not taking advantage of
the option because they were uncertain about whether their ads would
meet FDA's standards.

The draft guidance doesn't change the regulation, but rather describes
one way to meet the requirement. Under the approach described in the
guidance, "adequate provision" is accomplished if the ad contains the
following:

 * a toll-free telephone number so consumers can request the approved
   package labeling by mail, fax, or prerecorded telephone message

 * a reference to print ads about the product in consumer magazines so
   consumers can read more detailed drug information, or to brochures
   containing the package labeling that a consumer can find conveniently
   in public places such as libraries, pharmacies, doctors' offices, and
   grocery stores

 * a statement that additional product information is available from a
   doctor or pharmacist

 * an Internet address where package labeling can be found.

Whether the brief summary or "adequate provision" is used, however, the
most important risk information must always be included in the ad
itself. This information is often referred to as the "major statement."

Joint Responsibility

Some consumer-directed ads can raise awareness that drugs are available
to treat certain conditions, including diseases such as seasonal
allergies that might not require a doctor's care, and undertreated
conditions such as depression and impotence. "We have a huge patient
population for which there are drugs available to help them live longer
and better lives," says John Kamp of the American Association of
Advertising Agencies. He adds that government agencies and medical
professionals "can use their tools until they're blue in the face and
not reach the people who will be reached through television."

While a doctor's prescription is necessary to get these medications,
some at the 1995 public hearing expressed a concern that this
alternative source of drug information would interfere with the
doctor-patient relationship. The National Consumers League's Golodner
and others, however, feel that consumers will communicate with their
physicians more, not less, if they are aware that a drug exists for
their condition.

"In health care," Golodner says, "there is a general trend toward having
consumers more responsible for their own health. Now, consumers can go
to their physicians with a little more information."

A related issue raised at the 1995 public hearing is whether such ads
would lead to patients pressuring doctors to prescribe unneeded
medications. Many speakers emphasized the doctors' duty to advise their
patients responsibly. Mary Jane Sheffet, from Michigan State
University's marketing department, told FDA, "The doctor needs to be
there as a gatekeeper."

With the health concerns of both supporters and opponents in mind, the
agency continues to review its policies on direct-to-consumer promotion.
FDA will finalize the draft guidance on consumer-directed broadcast
advertising, the first step of the review, after considering all
comments received during the 60-day comment period, which ended last
Oct. 14.

As more ads have been reviewed by FDA, Ostrove says, the agency "has
become more and more confident that the appropriate information,
including risk information, can reach consumers and be helpful to them."

But the foremost goal of advertisers will always remain the same: to get
people to use their products. So Ostrove urges consumers to regard
prescription drug ads with thoughtfulness.

"These are prescription drugs with real potential downsides," she says.
"We don't want people going to their doctor and saying, 'I want this
drug.' The message should be, 'I saw this ad. Is it right for me?'"

Tamar Nordenberg is a staff writer for FDA Consumer.


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In Trouble with FDA

Generally, FDA does not require pre-clearance of promotional materials.
But the agency often reviews drug companies' draft promotional materials
at their request.

If FDA finds that an advertisement a company is using is false or
misleading, the agency may take enforcement action against the company.
The agency regulates all of a drug company's prescription drug
promotions, including the promotional tactics of its salespeople.

For the least serious violations of advertising regulations, FDA will
send the drug company an "untitled letter" outlining FDA's findings.

For more serious violations, FDA may issue a "warning letter" requesting
that the company immediately stop the violative advertising and, in many
cases, take other corrective steps.

For example, the company may be asked to send a "Dear Doctor" letter to
alert those who prescribe the medication to FDA's finding. The company
may also be asked to run corrective advertisements setting forth FDA's
concerns and bringing the ad's language into compliance. Finally, a
warning letter may request that a company send its future promotional
materials to FDA for clearance before they are used.

Beyond sending untitled letters and warning letters, FDA may stop
violative promotions by seizing affected products or enjoining the use
of promotions that make the same or similar claims. These actions and
the most serious remedy, criminal prosecution of the company or the
individuals involved, are used rarely--generally when intentional and
serious misstatements are involved.

The threat of agency action isn't the only thing that keeps companies
honest, says John Kamp of the American Association of Advertising
Agencies. "A drug company won't play fast and loose with the rules
because its most important asset is its reputation with the American
people."

--T.N.


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Drug Promotion in Cyberspace

Like many other companies, prescription drug marketers are beginning to
take advantage of the extensive reach of the Internet to promote their
products. FDA monitors the Internet to check the quality of the
information provided, and encourages consumers to remain vigilant to
separate the good information from the bad. (See "Health Information
On-Line" in the June 1996 FDA Consumer.)

"Generally, FDA is treating Internet promotion like it does other forms
of promotion," says Melissa Moncavage, a public health advisor with
FDA's division of drug marketing, advertising, and communications.
"Although the Internet is brand new, the promotion content issues are
largely the same as print, broadcast, and other traditional media."

To address those issues that are unique to the Internet, FDA held a
public meeting in October 1996 to hear from consumers, patient groups,
health professionals, manufacturers of FDA-regulated products, and
others.

The questions discussed at the meeting included:


 * Where should promotional product information be located on a
   company's Website?

 * How can promotional information on the Internet be clearly
   distinguished from other information?

 * How can Internet users be ensured access to a balanced presentation
   of risks and benefits?

 * Should Websites distinguish between Internet promotions directed to
   health professionals and consumers? How?

 * How should the promotional materials of multinational companies be
   addressed to ensure compliance with U.S. drug laws and regulations?

Also, in a Sept. 16, 1996, Federal Register notice, FDA requested
written comments on some of these same Internet-related drug promotion
issues. The agency is considering the written comments, suggestions of
meeting participants, and information received since the meeting, and
plans to publish a draft guidance to clarify its policies.

--T.N.

FDA Consumer magazine (January-February 1998)
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Living Day-to-Day with Kidney Dialysis

Quality Improvements Continue for Devices and Clinics

by Rebecca D. Williams

As he has for the last seven years, Tony Robinson, 47, heads straight
from work on Monday, Wednesday and Friday afternoons to a nearby
hemodialysis center in Orlando, Fla.

A nurse gives him a checkup, then Robinson settles into one of the
recliners circling the room. Propping his left arm up, he allows a
technician to slip two needles into blood vessels near his wrist. The
needles--one to capture the blood and the other to return it--are
attached to plastic tubes leading to a dialysis machine beside the
chair.

For the next three hours, this device, which looks like a tall, narrow,
automated teller machine, removes wastes and extra fluid from Robinson's
blood. He passes the hours by reading, watching the evening news, and
sometimes dozing.

Robinson was born with only one kidney. It failed when he was in his
30s, as did a kidney transplant. For now, dialysis keeps him alive.

Except for the initial needle stick, the procedure doesn't hurt. "You
never get used to the needles, you just learn to handle them," he says
with a laugh. "Sometimes I feel sick on my stomach if my blood pressure
drops, but other than that, it's not bad."

Robinson is one of approximately 217,000 Americans who receive ongoing
dialysis, at an annual cost of $11.1 billion nationwide. Since the late
1960s, the procedure has been used in place of kidneys lost to disease,
birth defects, or injury. It can be used temporarily until the kidneys
resume function or the patient receives a transplant, or for years if
those options are not available.

With dialysis, Robinson and many others like him can live full and
active lives. In fact, Robinson works full-time as an investigator with
the Food and Drug Administration's Orlando office. His job requires him
to walk distances through production plants, climb ladders, and lift
boxes to inspect products. He travels to cities all over Florida to
conduct inspections. The overnight trips are not a problem as long as he
schedules dialysis ahead of time in the cities he visits.

"If a dialysis patient is otherwise healthy, they should be afforded the
opportunity to work," says Robinson. "No one should say you're disabled
or restricted to certain areas. I travel, go to training, do
inspections--and I have since 1990. I've gotten adjusted to arranging
things around the treatments."

Dialysis Under Scrutiny

Since the 1960s, surveillance studies have consistently shown that
American dialysis patients do not live as long as those in other
countries--the U.S. mortality rate for dialysis patients is about 23
percent, twice the rate of patients in Western Europe or Japan.

A number of factors seem to be the cause. As a whole, American clinics
perform hemodialysis treatments for a shorter length of time than in
other countries, both because reimbursement doesn't increase for
lengthier treatments and patients don't want to sit for five or six
hours, according to Dr. Garabed Eknoyan, president of the National
Kidney Foundation and professor of medicine at Baylor College of
Medicine in Houston, Texas. "If you talk to any of the patients, you'll
find it's hard to convince them to stay five hours. They come in late
and want to leave early."

In addition, says Barbara McCool, a nurse and senior scientist in FDA's
Office of Device Evaluation, we dialyze older and sicker patients than
do other countries, including AIDS patients, who do not withstand the
rigors of dialysis very well. And because of the need to cut costs,
American dialysis clinics reuse much of the dialysis equipment and
employ staff who have minimal technical training. Many experts say this
may be a risk to patient care.

The quality between clinics within the United States varies as well.
Most clinics operate for profit; others don't. Some are located in
teaching hospitals, while some are in more remote rural areas. Some have
doctors on site every day, while others only have them on call. These
factors result in a wide range of quality of care. "We may all read the
same books and have the same science, but we're using it differently,"
says Eknoyan.

In response to these concerns, many scientific and medical groups,
including the National Kidney Foundation and FDA, are working to improve
the quality of dialysis care nationwide.

FDA has increased its involvement in regulating the reuse of dialysis
equipment. The agency does not inspect dialysis clinics--that is the
responsibility of each state health department. FDA approves the
equipment used in dialysis, and the agency has begun requiring that
hemodialyzer filters and tubes be tested and approved in realistic
clinical situations. For example, in about 80 percent of hemodialysis
treatments, the equipment is reused to cut costs, although it was
originally tested, labeled and approved for one-time use only. FDA is
now requiring manufacturers to prove that filters and tubes are safe and
effective when reused. FDA is also taking a closer look at water
purifying equipment used in dialysis. Pure water is crucial to
hemodialysis, since impurities can kill a patient. FDA has recently
begun enforcing regulations that require the manufacturers of water
purifiers to prove their devices are safe and effective.

FDA has produced numerous training videos and documents to inform
dialysis clinicians about the importance of making sure their equipment
is used properly and meets FDA requirements. In addition, the agency has
met with many manufacturers of dialysis equipment to help them meet
requirements for marketing their devices in the United States. FDA also
maintains MedWatch, an adverse events reporting hot line that helps the
agency track medical device problems.

"We're hoping to enhance communications with dialysis providers and
consumers," says Marie Reid, a nephrology nurse in FDA's Office of
Surveillance and Biometrics. "Whenever there's an adverse event, we look
at it to identify the problem and learn how we can help prevent it from
happening again."

The National Kidney Foundation, as well as others in the renal (kidney)
care community, has been trying to improve quality in dialysis clinics
nationwide. The foundation led an extensive project for the last two
years to develop quality guidelines for dialysis treatment nationwide.
If dialysis providers adopt the voluntary guidelines, experts say
patients will benefit because the latest information on quality
treatment will be available in even the smallest dialysis clinics.

How Dialysis Works

Dialysis acts as an artificial kidney. There are two types of treatment:
hemodialysis and peritoneal dialysis. About 90 percent of dialysis
patients receive hemodialysis, in which the blood is circulated outside
the body and cleaned inside a machine before returning to the patient.

Before hemodialysis can be done, a doctor must make an entrance, called
an access, into the patient's blood vessels. This is done by minor
surgery in the leg, arm or sometimes neck. The best access for most
patients is called a fistula. Minor surgery is performed to join an
artery to a vein under the skin to make a larger vessel.

If no vessels are suitable for a fistula, the doctor might use a soft
plastic tube called a vascular graft to join an artery and vein under
the skin. For temporary dialysis in the hospital, a patient might need a
catheter implanted into a large vein in the neck. Once the access is
made and healed, two needles are inserted in the fistula or graft, one
on the artery side and one on the vein side.

Blood drains into the dialysis machine to be cleaned. The machine has
two parts, one side for blood and one for a fluid called dialysate. A
thin, semipermeable membrane separates the two parts. As dialysate
passes on one side of the membrane, and blood on the other, particles of
waste from the blood pass through microscopic holes in the membrane and
are washed away in the dialysate. Blood cells are too large to go
through the membrane and are returned to the body.

The benefits of hemodialysis are that the patient requires no special
training, and he or she is monitored regularly by someone trained in
providing dialysis.

The other type of treatment, peritoneal dialysis, uses the patient's own
peritoneal membrane as a filter. The peritoneal membrane is a sac around
the abdominal organs. This membrane (like the dialysis machine membrane)
is semipermeable. Waste particles can get through it, but larger blood
cells cannot.

The patient has a plastic tube called a peritoneal catheter surgically
implanted into the belly. He or she slowly empties about two quarts of
dialysate fluid through the catheter into the abdomen. As the patient's
blood gets exposed to the dialysate through the peritoneal membrane,
impurities in the blood are drawn through the membrane walls and into
the dialysate. The patient drains out the dialysate after three or four
hours and pours in fresh fluid. The draining takes about half an hour
and must be repeated about five times a day. This is called Continuous
Ambulatory Peritoneal Dialysis (CAPD).

The main benefit of CAPD is freedom--the patient doesn't have to stay at
a dialysis clinic several hours a day, three times a week. The dialysate
can be exchanged in any well-lit, clean place, and the process is not
painful. The drawback to this treatment is that some people get an
infection of their peritoneal lining, and the process may not work well
enough on very large people.

Children often do a similar type of dialysis called Continuous Cycling
Peritoneal Dialysis (CCPD). Their treatments can be done at night while
they sleep. A machine warms and meters dialysate in and out of their
abdomens for 10 hours continuously. Then they are free from treatments
during the day.

As a college student in the spring of 1985, Kris Robinson chose CAPD
when her kidney (she was born with only one) began to fail.

Doctors quickly determined Robinson would need dialysis until a kidney
transplant could be done. Robinson's father was willing and able to give
her one of his kidneys, and for several months before the operation was
arranged, she drained dialysate in and out of her abdomen five times a
day. She became adept at draining it out in the shower, putting fresh
fluid in during breakfast, and so on throughout the day.

"I'm extremely independent," Robinson says. "This let me be in charge of
my own dialysis. I knew I could do it, and I wanted to be responsible
for my own care. I didn't like to have to sit for four hours, three
times a week, and I didn't like the idea of dealing with my own blood in
such an open way as in hemodialysis."

The transplant from her father was successful and today Robinson, now
32, still has her kidney transplant and is the executive director of the
American Association of Kidney Patients in Tampa, Fla., a nonprofit
organization dedicated to patient education about dialysis and kidney
disease.

One thing all dialysis patients must know a great deal about is diet.
They need a good amount of protein and lower amounts of potassium and
phosphate, which tend to accumulate in the blood and cannot be removed
very well with treatment. French fries, for example, are off-limits, and
ice cream and cheese must be eaten with caution. Dialysis patients also
must limit fluids because the treatment removes only a certain amount of
water. Excess fluids make body tissues swell.

Dialysis in the Future

The first successful artificial kidney was developed in the 1940s by a
Dutch physician, Willem J. Kolff. Because of World War II and the Nazi
occupation of his country, he improvised many materials. For example, he
used sausage-link casing for the semipermeable membrane. Since then, the
process of dialysis has been fine-tuned over the years, and
semipermeable membranes and dialysate have improved.

Still, dialysis is not a cure. If a person's kidneys are temporarily
damaged, dialysis can give them a rest and a chance to recover. But for
chronic, end-stage renal disease, a kidney transplant is the only
long-term solution that frees a patient from dialysis.

Living relatives can donate a kidney if their remaining organ is
healthy. Even with a kidney from a close relative, however, a transplant
recipient must take drugs to suppress the immune system from rejecting
the organ. There are about three times as many people waiting for
transplants as there are kidneys available.

Some dialysis patients are not well enough for the rigors of a
transplant operation and the drugs that follow, according to Robinson of
the American Association of Kidney Patients. In fact, 20 percent of
dialysis patients are over 65. More than half suffer from other
illnesses, such as diabetes and high blood pressure. Some patients
receive transplants only to have them rejected by their immune system
later. Some patients refuse transplants. For them, says Robinson,
dialysis may be something of a social gathering and a way to be
monitored and cared for by a group of health-care providers that become
like friends.

Dialysis survival in the United States after one year is 77 percent,
according to the National Center for Health Statistics. After five years
it is 28 percent, and after 10 years it is about 10 percent. Transplant
survival rates are higher: 77 percent of patients survive 10 years after
a living-relative donor. Many experts point out there is room for
improvement in the survival rate and quality of life for American
dialysis patients.

"I think everything will be different in the future," predicts Eknoyan
of the National Kidney Foundation. "People are working on fine-tuning
dialysis and improving the technology. For instance, they are trying to
develop ways to put essential substances back into the blood while
taking the impurities out."

Perhaps kidney transplants, always in shortage, will become easier to
get if animals such as pigs are used as donors, Eknoyan adds. But the
best treatment, of course, is to protect healthy kidneys in the first
place. Diabetes and high blood pressure account for more than half of
all cases of end-stage renal disease. Both of these conditions usually
can be managed with proper medical care (see article below, "Take Care
of Your Kidneys").

Says Eknoyan, "Prevention is going to be a big part of the answer."

Rebecca D. Williams is a writer in Oak Ridge, Tenn.


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To report a problem with dialysis equipment, call MedWatch at
1-800-FDA-1088.


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Take Care of Your Kidneys

<Picture omitted: illustration of the urinary system>

Healthy kidneys are the body's cleaning crew. Located under the rib cage
in the lower back, these twin bean-shaped organs, each the size of a
fist, filter out extra water, minerals, and toxins dumped into the blood
by the body's other organs.

Kidneys process 18 gallons of blood each hour with a sophisticated
method of excretion, absorption and re-absorption. By the end of each
day, they can produce as much as 7 gallons of urine.

The kidneys are reddish-brown, their concave sides facing each other.
They are cushioned in fat, with only the tops of them protected by the
rib cage. Perched on top of each kidney is an adrenal gland, which
produces many hormones vital to life. The right kidney is a little lower
than the left because it must squeeze under the liver, a large organ
that occupies a large section of the upper right abdominal cavity.

In the concave section of the kidney is a depression containing blood
vessels, nerves and the ureter, a small tube that carries urine away
from the organ and down to the bladder. The blood-filtering units of the
kidney are microscopic tubes called nephrons.

The leading causes of end-stage renal (kidney) disease are diabetes and
high blood pressure. These two conditions take a toll on blood vessels,
and the kidneys are rich with blood vessels. Managing these diseases can
go a long way toward preventing kidney failure and the need for
dialysis. (See "Diabetes Demands a Triad of Treatments" in the May-June
1997 FDA Consumer.)

If your kidneys are normal, they don't need special care. A healthy,
balanced diet and enough water to quench thirst are adequate to keep
kidneys working fine. Fad diets, such as those very high in protein,
however, can hurt your kidneys. Drinking very little water, or an
overabundance of water (more than 8 quarts a day), may also damage these
organs.

Other than illnesses, the real kidney killers are drugs--they must pass
through the kidney to be filtered out of the bloodstream. Some
antibiotics, anesthesia medications, and antipsychotic drugs may damage
kidneys. Even over-the-counter painkillers, if taken in large doses, may
lead to kidney failure.

Common household chemicals can also hurt your kidneys. Chemical
solvents, wood alcohol, toluene, carbon tetrachloride (a cleaning
fluid), and ethylene glycol (antifreeze) can damage kidneys if ingested
or inhaled. Be very careful handling any chemical and use it according
to directions.

--R.D.W.

FDA Consumer magazine (January-February 1998)
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Dangers of Lead Still Linger

by Dixie Farley

The hazardous substance lead was banned from house paint in 1978. U.S.
food canners quit using lead solder in 1991. And a 25-year phaseout of
lead in gasoline reached its goal in 1995.

<Picture omitted: chart showing percentage of Americans with elevated
blood lead levels>

As a result of such efforts, the number of young children with
potentially harmful blood lead levels has dropped 85 percent in the last
20 years, as shown in National Health and Nutrition Examination Surveys
conducted by the National Center for Health Statistics. Interested in
measuring the impact of lead solder's removal from food cans, the Food
and Drug Administration funded collection of the data during the
1976-1980 period and has continued to support the survey efforts.

Similarly, FDA's 1994-1996 Total Diet Studies showed that, since
1982-1984, daily intakes of lead from food dropped 96 percent in 2- to
5-year-olds (from 30 micrograms a day to 1.3) and nearly 93 percent in
adults (from 38 micrograms a day to 2.5).

Yet in 1997, FDA approved a new, portable blood lead screening test kit
for health professionals to use. In the face of so much success, why is
another screening tool even necessary?

The answer: Lead is still around.

Lead paint abounds in older housing. The deteriorating paint exposes
youngsters indoors to lead-laden dust and paint chips and outdoors to
exterior paint lead residues in nearby soil--residues that remain unless
removed. Lead particles emitted by the past use of leaded gasoline are
also in the soil, especially near major highways. Lead persists at some
work sites and, occasionally, in drinking water, ceramicware, and a
number of other products.

"The risk of lead exposure remains disproportionately high for some
groups, including children who are poor, non-Hispanic black, Mexican
American, living in large metropolitan areas, or living in older
housing," the national Centers for Disease Control and Prevention noted
in its Feb. 21, 1997, Morbidity and Mortality Weekly Report. Indeed, CDC
reports that nearly a million children under 6 still have blood lead
levels high enough to damage their health. While CDC considers the blood
lead level of concern in adults to be 25 micrograms per deciliter
(mcg/dL) of blood, this level in young children is only 10 mcg/dL.

Based on CDC's levels, FDA's "tolerable" daily diet lead intakes are 6
mcg for children under age 6, 25 mcg for pregnant women, and 75 mcg for
other adults. However, some risk exists with any level of lead exposure,
says toxicologist Michael Bolger, Ph.D., chief of FDA's contaminants
branch in the Office of Plant and Dairy Foods and Beverages.

And harmful levels need never occur, according to Sheryl Rosenthal,
M.S.P.H., R.D., a lead educator at FDA's Center for Food Safety and
Applied Nutrition. "Lead poisoning is preventable and just should not
happen today," she says.

Lead Absorption

While adults absorb about 11 percent of lead reaching the digestive
tract, children may absorb 30 to 75 percent. When lead is inhaled, up to
50 percent is absorbed, but less than 1 percent of lead is absorbed when
it comes in contact with the skin. The body stores lead mainly in bone,
where it can accumulate for decades.

"Anyone in poor nutritional status absorbs lead more easily," adds
Cecilia Davoli, M.D., a pediatrician with Kennedy Krieger Institute's
Lead Poisoning Prevention Program, in Baltimore. Calcium deficiency
especially increases lead absorption, as does iron deficiency, which can
also increase lead damage to blood cells. A high-fat diet increases lead
absorption, and so does an empty stomach.

The Risks of Lead

Lead disrupts the functioning of almost every brain neurotransmitter,
says David Bellinger, Ph.D., a psychologist and epidemiologist at
Children's Hospital in Boston. Neurotransmitters are chemical messengers
between the body's nerve cells. The messenger calcium, for example, is
essential to nerve impulse transmission, heart activity, and blood
clotting, but if it doesn't work right, affected systems may also be
askew.

"Lead fits into binding sites that calcium should," Bellinger says, "so
it can disturb cellular processes that depend on calcium. But there's no
unifying theory that explains in detail what lead does to the central
nervous system, which is where lead typically affects children."

Bellinger estimates that each 10 mcg/dL increase in blood lead lowers a
child's IQ about 1 to 3 points.

"Evidence is less clear," he says, "on whether mild blood lead
elevations in pregnancy cause permanent effects on the fetus. Studies
have tended not to find that early developmental delays related to minor
fetal exposure carry through to school age, when IQ is measured."
Studying middle- and upper-middle-class children exposed before birth to
mild lead levels, Bellinger and colleagues found delays in early
sensory-motor development, such as grasping objects, but did not find
such effects by school age.

However, he adds, "When lead exposure in the uterus is quite high, the
impact can be devastating on the fetus, causing serious neurological
problems."

High lead exposures can cause a baby to have low birth weight or be born
prematurely, or can result in miscarriage or stillbirth.

"Symptoms of lead poisoning can be highly variable depending, in part,
on the age of the child, the amount of lead to which the child is
exposed, and how long the exposure goes on," says pediatrician Randolph
Wykoff, M.D., FDA associate commissioner for operations. Children
exposed to lead may have no symptoms, he says, or may report sometimes
vague symptoms, including headache, irritability or abdominal pain.

While a child's chronic exposure to relatively low lead levels may
result in learning or behavioral problems, Wykoff says that "higher
levels of exposure can be associated with anemia and changes in kidney
function, as well as significant changes in the nervous system that may,
at extreme exposures, include seizures, coma and death."

In adults, lead poisoning can contribute to high blood pressure and
damage to the reproductive organs. Severe lead poisoning can cause
subtle loss of recently acquired skills, listlessness, bizarre behavior,
incoordination, vomiting, altered consciousness, and--as with
children--seizures, coma and death. Poisoning without severe brain
effects can cause lethargy, appetite loss, sporadic vomiting, abdominal
pain, and constipation.

By the time symptoms appear, damage is often already irreversible.

"The most important thing for families to do," says Baltimore's Davoli,
"is to learn what steps they can take to prevent lead poisoning. We
don't want to get to treatment. And they should take their children to
the doctor regularly for checkups and, if the children are at risk, get
blood lead tests done."

Critical to prevention is focusing on the important lead sources. FDA's
Rosenthal says, "Dealing with sources of lead means recognizing them in
your family's environment, knowing which ones contribute significant
exposures, and eliminating or avoiding those exposures."

Top Contaminator: Lead Paint

America's No. 1 source of lead exposure in children is deteriorating
lead paint in older housing. Because young children frequently put their
thumbs and fingers and objects they handle in their mouths, they are
easily poisoned from chronic ingestion of lead paint chips and house
dust or soil that may have lead particles in it.

The Consumer Product Safety Commission (CPSC) banned house paint having
more than 0.06 percent lead in 1978. But housing built before then,
particularly before 1950, may contain lead paint. The Environmental
Protection Agency and Department of Housing and Urban Development
require owners of pre-1978 housing to give prospective buyers or renters
federally approved information on the risk. Buyers must have 10 days to
inspect for lead-based paint before being obligated by a contract.

Improper housing renovation increases exposure. The riskiest practices
are sanding, scraping or removing lead paint with a heat gun, which
taint the air with lead paint dust. CPSC warns: There is no completely
safe method for do-it-yourself removal of lead paint. Only experts
should remove lead paint.

Occupational Hazards

Clark Carrington, Ph.D., of FDA's dairy foods and beverages contaminants
branch, names workplace exposure as the next major potential source of
lead. Besides their own exposures, workers may bring lead dust home on
clothes, hands or hair, exposing children in the household.

Occupations that may expose workers to lead include painting, smelters,
firearms instruction, automotive repair, brass or copper foundries, and
bridge, tunnel and elevated highway construction.

To help protect workers from such exposure, the Occupational Safety and
Health Administration calls for removal of workers from the workplace if
their blood lead levels reach 50 mcg/dL. EPA limits lead emissions from
certain industries.

Keeping Drinking Water Safe

Certain drinking water systems can also pose a lead risk.

Under EPA rules, if lead exceeds 15 parts per billion (ppb) in more than
10 percent of public water taps sampled, the system must undergo a
series of corrosion control treatments. The main culprits are corroded
lead plumbing, lead solder on copper plumbing, and brass faucets. Lead
is highest in water left in pipes for a long time--for example, when the
faucet isn't used overnight.

FDA's quality standard for bottled water requires that lead not be
present at 5 ppb, the lowest concentration that generally available
methods for water analysis can reliably measure. If bottled water
contains lead above this level, it is subject to regulatory action,
including removal from the marketplace.

Lead in Ceramicware

Some ceramicware has lead in the glaze and may introduce small amounts
of lead in the diet, which the body can tolerate, says Carrington. "The
major problem with ceramicware is the rare poorly made piece with very
high levels of leaching lead."

Bolger adds that even with these pieces, risk varies. "A plate coming in
brief contact with food is not an issue," he says, "but storage of food
in such a bowl or pitcher is a risk." It's especially wise to avoid
storing acidic foods like juice and vinegar in ceramicware, as acids
promote lead leaching.

FDA has established maximum levels for leachable lead in ceramicware,
and pieces that exceed these levels are subject to recall or other
agency enforcement action. The levels are based on how frequently a
piece of ceramicware is used, the type and temperature of the food it
holds, and how long the food stays in contact with the piece. For
example, cups, mugs and pitchers have the most stringent action level,
0.5 parts per million, because they can be expected to hold food longer,
allowing more time for lead to leach. Also, a pitcher may be used to
hold fruit juice. And a coffee mug is generally used every day to hold a
hot acidic beverage, often several times a day.

Michael Kashtock, Ph.D., chief of FDA's Office of Plant and Dairy Foods
and Beverages enforcement branch, says, "FDA allows use of lead glazes
because they're the most durable. But we regulate them tightly to ensure
their safety. Commercial manufacturers ... employ extremely strict and
effective manufacturing controls that keep the lead from leaching during
use." Small potters often can't control the firing of lead glazes as
well, he warns, so their ceramics are more likely to leach illegal lead
levels, although many do use lead-free glazes. "The best advice is to
stick to commercially made products. If you are going to buy something
hand-made or hand-painted, get assurance that lead-free glazes were
used," he says.

Antique ceramicware may leach high levels of lead. Consumers can use a
lead test kit from a hardware store on such pieces and on other
hand-painted ceramicware they may already own. Avoid using such
items--particularly cups, mugs or pitchers--if the glaze develops a
chalky gray residue after washing.

"And you want to make sure," says Rosenthal, "that you know whether an
item is for food use, or if it's for decorative use only." FDA requires
high-lead-leaching decorative ceramicware to be permanently labeled that
it's not for food use and may poison food. Such items bought outside the
United States may not be so labeled, potentially posing serious risk if
used for food.

Other Lead Sources

Tin-coated lead foil capsules on wine bottles:

FDA banned these capsules in 1996 after a study by the Bureau of
Alcohol, Tobacco and Firearms found that 3 to 4 percent of wines
examined could become contaminated during pouring from lead residues
deposited on the mouth of the bottle by the foil capsule.

U.S. winemakers stopped using lead foils before the ban, but older
bottles with the foils may still be around. "Remove the entire foil
before using such wines," says attorney Martin Stutsman, a consumer
safety officer in FDA's dairy foods and beverages enforcement branch.
"Then before uncorking the bottle, wipe its neck and rim and the top of
the cork with a clean wet cloth."

Lead-soldered food cans:

Despite U.S. food canners' voluntary elimination of lead solder and a
1995 FDA ban on lead-soldered cans, requiring their removal from shelves
by June 1996, this source of lead in the diet hasn't been fully
eliminated. Some countries still use lead-soldered cans for food, and
these food items may still occasionally be imported, albeit illegally,
into the United States. Also, some small vendors may still stock old
inventories of food in lead-soldered cans. In fact, a 1997 FDA
investigation found more than 100 such cans in ethnic grocery stores in
California alone.

Glassware:

Lead crystal glassware may leach lead. "The crystalware industry has
established voluntary lead-leaching limits for crystalware," says
Kashtock, "that most foreign and domestic manufacturers follow." As a
precaution, children and pregnant women should avoid frequent use of
crystal glassware. Lead crystal baby bottles should never be used.

Also, FDA intends to issue industry guidance in 1998 to prohibit use of
lead-based (and cadmium-based) pigments for decorating the lip rim area
of glassware, says Kashtock. "Use of the pigments may pose only a
negligible risk, but it is avoidable."

Calcium products:

Some people have expressed concern about lead in calcium supplements.
Lead is a common contaminant in calcium from such natural sources as
dolomitic limestone and oyster shells, but levels vary considerably from
trace amounts to higher levels. However, FDA's Carrington says, "Since
calcium intakes decrease lead absorption, supplements that correct low
calcium intakes may reduce lead absorption, even though they contain
small amounts of lead."

Lead is also found in other calcium sources. For example, lead in milk
is usually too low to measure, but FDA's yearly Total Diet Study of
foods in grocery stores sometimes detects lead in milk, says Carrington.

FDA has been petitioned to establish a tolerance level for lead in
calcium sources used in dietary supplements. According to Robert Moore,
Ph.D., of the agency's Office of Special Nutritionals regulatory branch,
two petitions propose different tolerance levels--one similar to current
industry standards and one considerably lower. FDA is reviewing the
issues raised in the two documents.

Progressive hair dyes:

Applied over time to gradually color the hair, these dyes contain lead
acetate. After studying information on their safety, FDA found that lead
exposure from these dyes was insignificant and that the dyes could be
used safely, says John Bailey, Ph.D., director of FDA's Office of
Cosmetics and Colors. "But we restricted how much could be in the
product, and we required specific labeling instructions, including a
warning to keep it out of the reach of children."

Kajal and surma, or kohl:

These unapproved dyes in certain eye cosmetics from the Middle East
contain potentially harmful amounts of lead. A 7-month-old in 1992 had a
39 mcg/dL blood lead level due to surma applied to the lower inner
eyelid. Bailey says, "They are sold in stores specializing in Middle
East products or brought into the country in personal luggage." He
stresses that people using these cosmetics "need to understand the
potentially serious health risk."

Foreign digestive remedies:

Certain unapproved foreign digestive remedies containing lead include
Alarcon, Azarcon, Coral, Greta, Liga, Maria Luisa, or Rueda. Greta, for
example, is 99 percent lead oxide.

FDA orders the detention at U.S. borders of items known to possibly
contain potential harmful levels of lead, including the Middle East eye
cosmetics, the foreign digestive remedies, lead crystal baby bottles,
and many other prohibited items. Lead sources outside FDA's purview
include lead-based artists' paints, lead solder used in electronics work
and stained glass, fishing weights, lead toy soldiers, and old painted
toys and furniture.

Reflecting that these many lead sources are not all in every family's
environment, new CDC screening guidance calls for state lead-poisoning
prevention programs to identify communities at risk of high exposure and
recommend appropriate screening. (See the accompanying article,
"Screening and Treatment.") To this end, CDC funded 30 state and 10
local programs in 1996.

When announcing the new guidance, Health and Human Services Secretary
Donna E. Shalala said, "Lower lead levels for America's children
constitute a public health achievement of the first importance. But a
significant number of children are still at risk for high lead exposure,
and we have to finish the job on their behalf."

For a quick reference guide, see our one-page summary of some sources of
lead poisoning (a 77K PDF file).

Dixie Farley is a staff writer for FDA Consumer.

(Source for the graphic at the beginning of the article: National Health
and Nutrition Examination Surveys, National Center for Health
Statistics)


------------------------------------------------------------------------


Screening and Treatment

Decisions about who needs lead screening should be made by individual
doctors as well as state health departments, who can examine local lead
hazards and conditions to determine which children are at risk of lead
exposure, according to 1997 guidance issued by the national Centers for
Disease Control and Prevention.

A new screening test is especially suited for use in isolated U.S. rural
areas and in developing countries. In September 1997, FDA approved the
LEADCARE In Office Test System, a portable blood lead screening kit for
health professionals' use in areas lacking refrigeration and other
complex equipment needed with previously approved tests. Manufacturers
developed the quick, easy and reliable kit in conjunction with CDC.

FDA has approved three drugs that bind to, or chelate, lead molecules so
the body can remove them in urine and stool. Calcium Disodium Versenate
(edetate calcium disodium) requires injections or intravenous infusion
in the hospital. Along with this drug, BAL (dimercaprol), also injected,
may be used. The pediatric oral drug Chemet (succimer) may be taken at
home, but it's important to eliminate the lead sources. Like other
chelator drugs, Chemet should not substitute for effective environmental
assessment and removal of the source of lead exposure.

These drugs may have side effects, however, so doctors closely monitor
their patients during treatment.

--D.F.


------------------------------------------------------------------------


Want More Information?

Centers for Disease Control and Prevention
1-888-232-6789
http://www.cdc.gov/nceh/programs/lead/lead.htm

Consumer Product Safety Commission
1-800-638-CPSC
TDD: 1-800-638-8270
http://www.cpsc.gov/

Environmental Protection Agency's Safe Drinking Water Hotline
1-800-426-4791
http://www.epa.gov/opptintr/lead/index.html

National Lead Information Center
1-800-LEAD-FYI
clearinghouse: 1-800-424-LEAD
TDD: 1-800-526-5456
http://www.nsc.org/ehc/lead.htm

FDA Consumer magazine (January-February 1998)
------------------------------------------------------------------------

------------------------------------------------------------------------


Skimming the Milk Label

Fat-Reduced Milk Products Join the Food Labeling Fold

by Paula Kurtzweil

Milk, that all-American food, is taking on some all-American names--like
"fat free," "reduced fat" and "light."

Starting Jan. 1, 1998, the labeling of fat-reduced milk products will
have to follow the same requirements the Food and Drug Administration
established almost five years ago for the labeling of just about every
other food reduced in fat. From now on: <Picture omitted: table of new
names for milk products>


 * 2 percent milk will become known, for example, as "reduced fat" or
   "less fat" instead of "low fat"

 * 1 percent milk will remain "low fat" or become, for example, "little
   fat"

 * skim will retain its name or be called, for example, fat-free,
   zero-fat, or no-fat milk.

Also, the regulations that implement the labeling changes give dairy
processors more leeway to devise new formulations. As a result,
consumers may see a broader range of milk and other dairy products,
including "light" milk with at least 50 percent less fat than whole, or
full-fat, milk and other reformulated milks with reduced fat contents
but greater consumer appeal.

"I expect that there are going to be many more milk products for
consumers to choose from" says Michelle Smith, a food technologist in
FDA's Office of Food Labeling. "This is positive for milk consumption in
general, and it's likely that consumers will be able to find a lower fat
milk product that they like." (See accompanying article.)

FDA issued a final rule in November 1996 that revoked the standards of
identity--the prescribed recipes that manufacturers of a particular food
must follow--for many fat-reduced milk and other dairy products. This
allowed the agency to bring milk labeling in line with existing labeling
requirements for nutrient content claims, such as "fat free," "low fat,"
"high protein," and others.

Lower fat milk products will still need to be nutritionally equivalent
to full-fat milk and provide at least the same amounts of the
fat-soluble vitamins A and D as full-fat milk. Vitamins A and D are lost
when milk fat is reduced or removed.

"[Milk] is just as nutritional as before," says LeGrande "Shot" Hudson,
dairy plant manager for the Landover, Md.-based Giant Food Inc. "[The
milk industry] just changed the name[s] a little."

Joint Effort

FDA's final rule was prompted in part by a petition filed jointly by the
Milk Industry Foundation and the Center for Science in the Public
Interest (CSPI), a consumer advocacy group, and a separate petition
filed by the American Dairy Products Institute. The petitions asked FDA
to lift the labeling exemption provided for in the Nutrition Labeling
and Education Act of 1990 for lower fat dairy products.

FDA agreed to revoke the standards of identity for low-fat milk and 11
other lower fat dairy products, including low-fat cottage cheese,
sweetened condensed skimmed milk, sour half-and-half, evaporated skimmed
milk, and low-fat dry milk. These products are now bound by the "general
standard" for nutritionally modified standardized foods. This means the
nutrients that lower fat milk products provide, other than fat, must be
at least equal to full-fat milk before vitamins A and D are added.

FDA also agreed to allow manufacturers to use "skim" as a synonym for
"fat free" in the labeling of dairy products because, the agency
concluded, most consumers realize that skim milk means no fat.

The changes do not affect lower fat yogurt products. FDA decided to keep
the standards of identity for the time being to further consider
manufacturers' concerns about fortifying yogurt with vitamin A, a
nutrient found in full-fat yogurt.

FDA, along with the milk industry and nutrition educators, believes the
label changes will give consumers more accurate, useful information
about milk. Because claims on milk labels will be consistent with claims
on other foods, consumers will know, for example, that "low-fat" milk
(formerly known as 1 percent milk) will be similar in fat content to
"low-fat" cookies. (Both can provide no more than 3 grams of fat per
serving. The serving size for each is listed on their label's Nutrition
Facts panel.)

The improved accuracy of milk labeling is particularly important for
skim milk, experts say, because "skim" carries a negative connotation
for many consumers. "They think it is skimmed of all its good
nutrients," says Brad Legreid, executive director of the Wisconsin Dairy
Products Association. "That it's flat and tasteless. But that's not it
at all."

Or, they view it in the same negative light as dry powdered milk, says
Margo Wootan, a senior scientist with CSPI. She coordinates the group's
public health campaign to encourage consumers to use milk that provides
4 percent or less of the Daily Value for fat--that is, low-fat or skim
milk. She prefers the term "fat-free" to describe skim milk because she
says: "It is more recognizable to the public. And "fat-free" better
describes the benefits of skim milk."

Dietary Significance

The goal of the labeling changes, as many nutrition experts see it, is
to help consumers select milk products that can help them lower their
fat and saturated fat intakes to recommended levels. The Dietary
Guidelines for Americans recommends limiting fat to no more than 30
percent of calories and saturated fat to less than 10 percent of
calories. There is substantial scientific evidence to show that low fat
intakes may help reduce the risk of some cancers, and diets low in
saturated fat and cholesterol may reduce the risk of heart disease.

Switching from higher fat to lower fat milk products can have a
particularly significant impact on lowering fat and saturated fat
intakes because milk plays such an important role in the American diet,
CSPI's Wootan says. She says that milk is a major contributor of
saturated fat to the American adult's diet. Only cheese and beef
contribute more.

Considering that 240 milliliters (one cup) of full-fat milk provides 26
percent of the Daily Value for saturated fat, while fat-free milk
provides none, switching from full-fat to fat-free milk can drop
saturated fat intake considerably, she says.

"It's an easy way to lower fat intake," she says. "It doesn't take a lot
of time. No preparation skills are needed. It takes only five seconds at
the dairy case to move your hand to the fat-free [skim] or low-fat
[formerly 1 percent] milk. It's a good first step towards healthy
eating."

Wootan believes that the revised milk labeling will make especially
clear to consumers the difference between reduced-fat (formerly 2
percent low-fat milk) and low-fat (1 percent low-fat milk). "A lot of
people use 2 percent milk thinking it is the same as 1 percent," she
says, because the previous labels referred to both as "low fat."
However, reduced-fat milk provides almost twice the amount of fat and
saturated fat as low-fat milk.

The new labels will "show a difference," she says, "and, [I think,] more
people will go to drinking 1 percent or skim milk."

New Names in the Dairy Case

But first, they'll need to get used to milk's new names. Joan Taylor,
consumer affairs manager for Schnuck Markets Inc., of St. Louis, recalls
the confusion that arose when manufacturers began relabeling ice milk as
"low-fat" ice cream in 1994, under another FDA rule. The company
received a number of calls from shoppers wanting to know why they had
stopped selling ice milk, she says. "We hadn't," she says. "We only
changed the name."

Some groceries and milk processors plan to educate consumers about the
label changes. Schnuck Markets, for example, was planning at press time
to post signs at their stores' dairy cases explaining what the new names
mean. And its dairy plant planned to label, at least at first, lower fat
milk with both the new name, followed by its former name or the milk's
fat content. An example might be "reduced-fat milk, contains 2 percent
milk fat."

Efforts such as these should help consumers catch on quickly to the new
names, but nutrition and industry experts hope the new labels' potential
benefits will be longer lasting.

"This is not just a cosmetic change," CSPI's Wootan says. "This is an
important strategy to healthier eating."

Paula Kurtzweil is a member of FDA's public affairs staff.


------------------------------------------------------------------------


Raising Milk Consumption

<Picture omitted: graph of milk sales since 1976>While the new labels
may promote greater consumption of the lower fat milk products, some
nutrition experts--and industry members in particular--hope the changes
will increase milk consumption overall.

LeGrande "Shot" Hudson, dairy plant manager for Giant Food Inc., in
Landover, Md., notes that the industry already has taken steps to entice
consumers, especially teens and young adults, to drink more milk. It's
undertaken major advertising campaigns and, in an effort to make milk
more palatable to people who dislike the taste of plain milk, has begun
marketing novel flavored products, such as banana, blueberry, raspberry,
strawberry, and mocha milk products.

"We don't all wear the moustache," he says, alluding to the industry's
current milk advertisements in which celebrities tout their preference
for plain milk.

Michelle Smith, a food technologist in FDA's Office of Food Labeling,
believes that milk processors will have even more flexibility to develop
products with greater consumer appeal, now that the standards of
identity for lower fat milks have been revoked. For example, processors
will be able to add fat substitutes, stabilizers or thickeners to give
lower fat milks a creamier texture and better sensation in the mouth or
coloring to make the products whiter. When added, these ingredients must
be listed on the label.

"There are many ways to modify a food," she says. "So, if you come
across a reduced-fat product, and you want to know how they did it, look
at the ingredient list."

With greater product development comes greater product choices for
consumers, she says, and that will allow consumers to make better, lower
fat choices that they can enjoy.

--P.K.

FDA Consumer magazine (January-February 1998)
------------------------------------------------------------------------


------------------------------------------------------------------------


Air Aid: Medical Kits Reach New Heights

by Tamar Nordenberg

"Is there a doctor on board?" Not one, but two doctors responded to the
plea when, on April 23, 1995, Benjamin Talit suffered sudden cardiac
arrest in flight. Despite the medical expertise of a heart-lung surgeon
and the other doctor who came forward, the 43-year-old Talit died en
route to Los Angeles aboard Northwest Airlines flight 339.

Ben--"a thoughtful, loving husband of 20 years, exemplary father, valued
professional, and truly good citizen"--died needlessly before reaching
medical help on the ground, his wife Lynn told Congress at a May 1997
hearing about airplane medical kits, because the plane did not carry a
device called a defibrillator to restart his heart. It is a "bitter
irony," she said, that Ben, himself a volunteer firefighter and
emergency medical technician, died "for the lack of exactly the
preparedness he supported and practiced every day of his life."

Based on Federal Aviation Administration surveys, an average of 15
medical emergencies may occur daily on U.S. airlines. Medical
emergencies have more than doubled in the last decade, according to FAA,
which says the increase may be due at least in part to improved airline
accommodations for medically-at-risk disabled and elderly passengers.

"The number of emergencies is small in the statistical sense," says
Jerry Hordinsky, M.D., head of FAA's aeromedical research division. "But
when an event does occur, with a person potentially dying in flight
because of a lack of medical equipment, it is very dramatic and attracts
a great deal of public attention."

Lynn Talit disagrees. Because airlines are not required to report
medical emergencies, people underestimate their scope, she told
Congress, pointing out that the number of people who die in flight each
year "far exceeds" airline crash deaths.

Cardiac Care Aloft

Along with neurological problems such as strokes and seizures,
heart-related problems rank among the most common types of emergencies.
In sudden cardiac arrest, the heart stops pumping blood, often without
warning in people like Ben Talit with no known heart problems.

According to the American Heart Association, more than 250,000 Americans
die each year from sudden cardiac arrest. "And not all of them happen to
suffer their cardiac emergency in a hospital waiting room," Lynn Talit
says.

Fewer than 7 percent of those suffering cardiac arrest outside a
hospital survive, a statistic which the association attributes to the
unavailability of a defibrillator, a device that restarts the heart by
delivering an electric shock.

As David McKenas, M.D., American Airlines corporate medical director
testified before Congress, a person's chance of survival drops 7 to 10
percent with each passing minute. Even if someone's heart stopped right
after the plane left its gate, McKenas said, it would be too late to
save the person by the time the plane returned to the gate. An on-board
defibrillator would offer the best chance of survival.

In September 1996, the Food and Drug Administration cleared an
"automatic external defibrillator" (commonly called "AED") for in-flight
use and has since cleared another. While defibrillators have been used
in ambulances and other nonhospital settings since the 1960s, the unique
environment of a plane in flight prompted FDA to require additional
testing.

According to Carole Carey, a scientific reviewer in FDA's division of
cardiovascular and respiratory devices, the maker of a defibrillator for
airplane use must show FDA that:


 * the defibrillator can physically withstand in-flight environmental
   demands, such as vibration and variations in temperature and altitude

 * the device will not electronically interfere with the airplane's
   instruments

 * the airplane's instruments will not electronically interfere with the
   functioning of the device.

Based on this evidence, a defibrillator's labeling was permitted to
state that the device was environmentally tested for use in planes. Only
after FAA added its approval could the device actually be used in
flight.

In July 1997, American Airlines became the first U.S. airline to carry
automatic external defibrillators and the third internationally, after
Britain's Virgin Atlantic and Australia's Qantas airlines. American put
defibrillators on its planes that fly over-water routes to Europe,
Japan, the Caribbean, Central and South America, and some domestic
destinations.

Manufactured by Seattle-based Heartstream Inc. and sold under the brand
name ForeRunner, the new model purchased by American weighs about 4
pounds, half the weight of most defibrillators. And the ForeRunner has a
longer-lasting battery and requires much less maintenance than older
models, according to Carey.

It's also easier to use, she says, making it possible for trained flight
attendants to deal with some cardiac emergencies. "Flight attendants
obviously aren't physicians, nurses or paramedics. But to use this
prescription device, they must receive training in emergency care and
use of the defibrillator."

Flight attendants can use the ForeRunner with minimal training because,
unlike most defibrillators, it comes with simple pictures and a digital
voice to guide a rescuer through the steps. The rescuer simply puts two
pads on the victim's chest and rib area. The device measures the heart's
rhythm to check for ventricular fibrillation, which requires a shock to
the heart, then directs the user to push a button if a shock is needed.

American has trained 2,300 lead flight attendants in use of the
defibrillator and plans to train its other flight attendants, according
to Nestor Kowalsky, M.D., American Airlines' Chicago area medical
director. At least one trained person will be on each flight that
carries the device, he says.

American has not decided whether to add the device to the medical kit on
all its domestic aircraft. "Right now, the airline is following this
first phase of the program to see how successful it is," Kowalsky says.
"Then a decision will be made about expanding it to other airplanes."

Several other U.S. airlines have said they are considering carrying
defibrillators on their aircraft.

Medical Minimum

Most U.S. airlines carry little more than the medical equipment
currently required by FAA: one to four first-aid kits, depending on the
number of passengers, and one medical kit per aircraft.

Each first-aid kit must be accessible to the flight attendants and
include:


 * bandages
 * compresses for applying pressure, moisture, heat, or cold
 * antiseptic swabs
 * arm and leg splints
 * tape
 * scissors.

An airplane's medical kit must be accessible to the flight crew, but is
for use only by medical professionals. It must include:


 * blood pressure cuff
 * stethoscope
 * plastic airways to deliver oxygen to help with breathing
 * nitroglycerin tablets for chest pain
 * dextrose solution for hypoglycemia
 * epinephrine for asthma or allergic reactions
 * injectable diphenhydramine HCl for serious allergic reactions
 * hypodermic needles
 * protective latex gloves.

The goal during serious in-flight medical emergencies is to stabilize
the patient while further emergency care is sought. The pilot may decide
to make an emergency landing, called "diverting" the plane, depending on
factors such as the passenger's apparent medical condition, weather
conditions, turbulence, air traffic, and the distance from adequate
ground medical facilities.

To help with medical decisions, most airlines have 24-hour access to a
physician on the ground. In the future, airlines may decide to use a
computerized system developed by a Michigan surgeon for air-to-ground
transmission of passengers' vital signs.

But "there is nothing the people on the ground could tell the doctor on
board if the right equipment doesn't exist," says Talit, who wants
Congress to require enhanced medical kits that would include
defibrillators.

One airline voluntarily carrying defibrillators on its overseas flights
is not enough, according to Talit. The automated defibrillator, she
says, "should be as commonplace as fire extinguishers, and as accessible
in case of emergency. Not every public building catches fire--few
do--but do we not have a fire extinguisher in these public places?"

Joan Sullivan Garrett, who is president of MedAire Inc., a firm that
provides emergency medical guidance to commercial airlines, is also in
favor of updating the federal regulations. "Emergency physicians and
flight crews," she told Congress, "are using first-aid kits circa 1924
to deal with 1997 realities."

In addition to the automated defibrillator, her recommendations include
an automated blood pressure cuff and stethoscope so laypersons can check
a person's pulse and an albuterol metered-dose inhaler in case someone
suffers an asthmatic attack.

At press time, Congress was still exploring whether to require
additional on-board medical equipment, including defibrillators. FAA is
working with the airline industry to evaluate the costs and health
benefits of additional medical tools on board. But, Hordinsky says,
until FAA gets more information, the agency cannot impose additional
rules.

So, for now, it is up to the airlines if they want to upgrade their
medical kits beyond legal requirements. Regardless of what medical
equipment is on board, people with medical conditions that put them at
risk should consult their doctors before flying. They should also bring
their own medications on board. Even the best-equipped airlines have
limited medical capabilities. As MedAire's Garrett testified at the
congressional hearing, "It's important to remember that an aircraft
cannot be a flying hospital."

Tamar Nordenberg is a staff writer for FDA Consumer.


------------------------------------------------------------------------


Sick at Sea

More than 4 million passengers took a cruise in 1996, according to the
Cruise Line Industry Association. The organization estimates that by the
year 2000, cruises will attract as many as 7 million passengers each
year.

Based on the sheer volume of travelers, some are bound to get sick. "In
addition to seasickness and sunburn, which are the big leaders, we see
all the things you would normally see in an emergency department on
land," says Theodore Harrison, M.D., who heads the cruise ship and
maritime medicine section of the American College of Emergency
Physicians.

While Coast Guard regulations cover the safe navigation and design of a
cruise ship, the government does not regulate the quality of on-board
medical treatment. In 1996, the American College of Emergency Physicians
and a major industry group, the International Council of Cruise Lines,
developed the first meaningful standards for cruise ship medical
facilities.

Under the ICCL guidelines, a ship should have:


 * licensed medical staff qualified to administer cardiac care and life
   support, who are fluent in the language spoken by most of the
   passengers and crew

 * adequate infirmary space based on the ship's size

 * wheelchairs, stretchers, cardiac monitor, portable defibrillator, and
   other important equipment and emergency medications.

Harrison says that most cruise ships already meet the voluntary
guidelines, and he expects that virtually all the ships will meet them
in time. "Before the guidelines, everybody was pretty much on their own
in determining what medical capabilities were needed. The guidelines
leveled the playing field for everybody."

The guidelines may help cruise medical staff address the day-to-day
medical needs of passengers, but for complicated cases, many cruise
lines are associated with a hospital that can provide emergency
consultation 24 hours a day. "We help the ship's medical staff make a
decision when they call us about an unusual condition," says Abdul
Memon, M.D., the associate director of the emergency department of
Florida's Jackson Memorial Hospital, which provides medical emergency
advice to Royal Caribbean Cruise Lines.

"The medical care will be pretty good on most cruise ships, under the
circumstances," Harrison says. But he cautions travelers to not expect
the level of medical care they could get in a New York City hospital. "A
cruise ship is just a one or two thousand person little town out there.
And people should expect the same medical care as they would expect in a
little town in the middle of nowhere."

To help ensure a safe cruise, passengers may want to take some
precautions. If you have medical concerns and are considering going on a
cruise, Memon recommends:


 * discussing your travel plans with a doctor

 * carrying adequate supplies of medications you may need

 * calling the cruise line's medical department to make sure the ship
   can accommodate your special medical needs.

--T.N.

FDA Consumer magazine (January-February 1998)
------------------------------------------------------------------------

------------------------------------------------------------------------

Drugs of the Deep

Treasures of the Sea Yield Some Medical Answers and Hint at Others

by John Henkel

Don Hochstein raises a thin glass tube up to his eye level and flicks it
with a fingernail. Inside the pencil-width vessel, a substance with the
texture of gelatin shimmies and wobbles but doesn't move from the tube's
bottom.

"There's endotoxin in there, you can bet on it," he says, slipping the
tube back into a rack.

Hochstein, former deputy director of product quality control (he retired
last Sept. 3) in the Food and Drug Administration's Center for Biologics
Evaluation and Research, is demonstrating a simple analytical test. It's
one that medical professionals, drug companies, pharmacies, and others
use worldwide to detect the presence of endotoxins--dangerous toxic
byproducts of "gram-negative" bacteria such as Salmonella and E. coli.

The test is the limulus amebocyte lysate assay and is, Hochstein says,
"remarkable" for its origin: the horseshoe crab. The limulus test, along
with an osteoporosis treatment derived from salmon and a bone filler
made from coral, are approved medical products that come from the sea.

Until recently, virtually all medical products had terrestrial sources.
For example, organisms found in soil have yielded products such as
penicillin, amoxicillin, and other antibiotic compounds responsible for
saving millions of Americans from suffering and death.

Sea-based products are rare, but some experts say the world's oceans and
waterways may harbor the next generation of drugs, biologics, and even a
few medical devices. Dozens of promising products, including a cancer
therapy made from algae and a painkiller taken from snails, are in
development at research laboratories right now. Other products, such as
an anti-inflammatory drug extracted from an organism called the
Caribbean sea whip, are under FDA review. Three approved products
already have brought the healing power of the sea successfully into the
world of public health.

A Lucky Horseshoe

Along the Eastern Seaboard of the United States, it's not unusual when
strolling on the shore to find horseshoe crabs that have "beached" or
shed their shells. These crabs, the limulus species, are important
players in the ecology and marine life of shore areas from Maine to
Florida. Their importance increased when, more than two decades ago,
researchers discovered that, due to some unique properties, the crabs'
blood could be used to detect dangerous endotoxins in drugs, medical
devices, and even water.

Endotoxins are produced when E. coli and other gram-negative bacteria
break down. The effect on humans exposed to the toxins ranges from fever
to hemorrhagic stroke. "This underscores the importance of the test in
finding these toxins before they can do any damage," says Hochstein.

Before the limulus amebocyte lysate (LAL) test was marketed, medical
professionals gauged endotoxin presence by injecting the substance being
analyzed into a rabbit's ear. If the animal developed a fever,
endotoxins were present. Rabbit tests still are done but are "falling
out of favor," says Hochstein, because "they are just too complicated."
The tests take four to five hours, and labs must keep caged rabbits on
hand.

By contrast, the LAL test uses a glass tube and takes only one hour.
Drawing blood from horseshoe crabs causes the animals no harm, and they
can be returned to their habitat within 48 hours.

By many accounts, the discovery of the LAL test was serendipitous. In
1971, National Institutes of Health researcher Jack Levin was studying
various marine animals when he discovered that blood in horseshoe crabs
exposed to E. coli bacteria had clotted. He then drew fresh blood from
some horseshoe crabs and exposed it to E. coli in the laboratory. The
blood clotted to a gel-like consistency. Further experiments in the NIH
Bureau of Biologics, which later became part of FDA, confirmed that if
any endotoxins are present, the blood will clot.

Hochstein was a major participant in those early tests, and he recalls
setting up shop at a NASA facility on the Eastern Shore of Virginia to
catch and draw blood from 1,000 horseshoe crabs at a time. He and his
colleagues also kept as many as 200 crabs in tanks filled with ocean
water in labs outside Washington, D.C., to ensure an available blood
supply.

The team ultimately developed a method for separating amebocytes, which
are similar to human white blood cells, from the rest of the crab's
blood. These cells then were spun in a centrifuge to intentionally
rupture them and create a "lysate," the essence of the LAL test, which
is freeze-dried and looks like grains of salt.

In 1973, FDA published regulatory guidelines for producing the LAL test,
and in 1977, the agency licensed the first LAL product to
Massachusetts-based Associates of Cape Cod. Five other companies have
developed their own LAL products since then. Hochstein says FDA's LAL
work is an excellent example of transferring technology from the public
to the private sectors.

The test has a large market in drug companies that use LAL to detect
endotoxin contamination in injectable products, says Melissa Juntunen,
marketing coordinator for Associates of Cape Cod. "Probably every major
pharmaceutical company uses it," she says. Medical device firms also use
the test to ensure that catheters, pacemakers, and other invasive
devices are endotoxin-free.

From Fish to Pharmacies

Osteoporosis, a crippling disease marked by a wasting away of bone mass,
affects as many as 25 million Americans, 90 percent of them women, at an
expense of $10 billion a year, according to the National Osteoporosis
Foundation. The disease may be responsible for 1.5 million fractures of
the hip, wrist and spine in people over 50, the foundation says, and may
cause 50,000 deaths. Given the pervasiveness of osteoporosis and its
cost to society, experts say it is crucial to have therapy alternatives
if, for example, a patient can't tolerate estrogen, the first-line
treatment.

Enter the salmon, which, like humans, produces a hormone called
calcitonin that helps regulate calcium and decreases bone loss. For
osteoporosis patients, taking salmon calcitonin, which is 30 times more
potent than that secreted by the human thyroid gland, inhibits the
activity of specialized bone cells called osteoclasts that absorb bone
tissue. This enables bone to retain more bone mass.

Though the calcitonin in drugs is based chemically on salmon calcitonin,
it is now made synthetically in the lab in a form that copies the
molecular structure of the fish gland extract. Synthetic calcitonin
offers a simpler, more economical way to create large quantities of the
product.

FDA approved the first drug based on salmon calcitonin, Calcimar, an
injectable form marketed by Rhone-Poulenc Rorer, in 1975. Since then,
two drugs made by Novartis and marketed under the trade name
Miacalcin--one injectable form and one administered through a nasal
spray--were approved. An oral version of salmon calcitonin is in
clinical trials now. Salmon calcitonin is approved only for
postmenopausal women who cannot tolerate estrogen, or for whom estrogen
is not an option.

A Coral Performance

Scuba divers and snorklers have long marveled at the intricate patterns
of coral reefs in the Pacific, Caribbean, and other exotic locations.
These patterns are now a marvel for people with certain kinds of bone
injuries. A product made from the rigid exoskeletons of marine coral can
fill voids caused by fractures or other trauma in the upper, flared-out
portions of long bones.

Called hydroxyapatite (HA), the material is similar in structure to
human bone. FDA approved the HA product Pro Osteon Implant 500, made by
Interpore International, in 1992. When HA is implanted into a bone void,
its web-like structure allows surrounding bone and fibrous tissue to
infiltrate the implant and make it biologically part of the body.

The implants, which are either blocks in pre-cut sizes or granules used
to fill in the spaces not covered by the blocks, must be used with
reinforcement devices such as steel rods to ensure that the fracture
remains stable until it heals. "Otherwise," says Nadine Sloan,
biomedical engineer in FDA's restorative devices branch, "the implant
may crack when you walk or put any weight on it. It wouldn't have
sufficient strength to support the weight until bone grows into it or
the fracture heals."

Although it is possible for patients to donate bone from other sites on
their body to repair a fracture, this causes extra trauma, says Sloan.
"One of the real advantages of using [coral-based] implants is that they
avoid a second surgery that would be necessary if a donor site is used."

FDA also has approved coral-derived implants for applications such as
bone loss around the root of a tooth and in certain areas of the skull.

On the Horizon

Research into new products from the sea, including medical products, is
in "high gear" in labs across the United States, says Linda Kupfer,
program officer for the National Sea Grant College Program. A unit of
the Commerce Department's National Oceanic and Atmospheric
Administration, Sea Grant is a network of 29 university-based programs
in coastal and Great Lakes areas that involves more than 300
institutions. Though research into medical products is only part of the
program's focus, some "very promising work" with medical potential is
under way in Sea Grant-supported labs, Kupfer says.

For example, researchers at the University of Hawaii have created what
may be a novel cancer treatment from blue-green algae. Using compounds
called cryptophycins extracted from the algae, researchers have treated
mice implanted with cells that cause prostate and breast cancer. The
compounds appear to affect the cancer cells' internal structure,
possibly keeping the disease from spreading. Much work remains before a
drug treatment could be created, but at least one major pharmaceutical
company has shown interest in developing the compounds as an anti-cancer
therapy.

At the University of Rhode Island, professor Yuzuru Shimizu is
developing a culturing system that will ensure an adequate supply of
sea-based organisms that show anti-tumor properties. Shimizu is
examining metabolites of single-celled plankton called dinoflagellates,
which National Cancer Institute tests have shown to have cancer-fighting
potential.

Scientists at the University of California's Santa Barbara and San Diego
campuses are researching compounds called pseudopterosins. Extracted
from the Caribbean sea whip, a type of coral that resembles shrubbery on
the sea floor, the compounds are being investigated for use in skin-care
products. They also appear to have anti-inflammatory properties and
could see use someday as treatment for skin irritations resulting from
injury or infection. One pseudopterosin-based product, licensed from the
university, is in clinical trials now. The researchers hope to take
their work even further: "Our next attempt will be to develop drugs for
inflammatory diseases such as arthritis and asthma, among others," says
William Fenical, an organic chemist at UC San Diego.

Other important sea-based medical product work is in progress outside
the Sea Grant program. For instance, the National Cancer Institute is
sponsoring clinical trials of five substances derived from marine
invertebrates such as sea hares and bryozoans that may have use in the
future as cancer treatments. Elsewhere, one drug company is testing a
neurotoxin obtained from a seagoing snail common in the Pacific as a
potent painkiller. Early clinical trials have shown that the substance
relieves some of the worst kind of chronic pain and could someday be an
alternative to morphine.

For the time being, the sea's potential as a medicine cabinet remains
largely in the realm of experimentation. But science is moving quickly,
and many experts say the world's waterways may soon yield some effective
medical treatments, if not some miracle cures.

John Henkel is a staff writer for FDA Consumer.

FDA Consumer magazine (January-February 1998)
------------------------------------------------------------------------

------------------------------------------------------------------------


Updates

Warning About Herbal Fen-Phen

Because so-called "herbal fen-phen" products have not been shown to be
safe or effective and may contain ingredients associated with injuries,
FDA is taking action to remove these products from the market.

The agency considers the products to be drugs because their names
reflect that they are intended for the same use as the anti-obesity
drugs fenfluramine and phentermine, which in combination are commonly
referred to as "fen-phen."

FDA warned consumers last November about "herbal fen-phen." The agency
believed that an increase in use of these alternative products might
follow from the September withdrawal based on safety concerns about
fenfluramine (Pondimin) and another prescription anti-obesity drug,
dexfenfluramine (Redux). In addition, promotion of these products over
the Internet and through weight-loss clinics, print ads, and retail
outlets is on the rise.

The main ingredient in most herbal fen-phen products is ephedra, also
called Ma Huang. Ephedra is an amphetamine-like compound with
potentially powerful stimulant effects on the nervous system and heart.
Since 1994, FDA has received more than 800 reports of adverse events
associated with ephedrine alkaloid-containing products, ranging from
high blood pressure and headaches to heart attacks and death.

Many ephedra-containing herbal fen-phen products also contain Hypericum
perforatum, often called St. John's Wort or "herbal Prozac," which has
not been studied under carefully controlled trials.

Other herbal fen-phen products contain 5-hydroxy-tryptophan. This
compound is closely related to L-tryptophan, which was pulled from the
market after being linked to 1,500 cases, including about 38 deaths, of
a rare blood disorder.

New FDA Labeling Rules
For Dietary Supplements

A Supplement Facts panel, modeled after food labeling's Nutrition Facts
panel, is among new FDA labeling requirements for vitamins, minerals,
herbs, amino acids, and other dietary supplements.

Labels also must identify these products as dietary supplements (for
example, "Vitamin C Supplement") and when products have botanical
ingredients, the part of the plant used must be identified, according to
final FDA rules in the Sept. 23, 1997, Federal Register.

The rules, which take effect March 23, 1999, will implement several key
provisions of the Dietary Supplement Health and Education Act of 1994.

The Supplement Facts panel must provide information about:


 * the appropriate serving

 * 14 nutrients, such as vitamins A and C, calcium, iron, and sodium,
   when present in more than insignificant amounts

 * other vitamins and minerals, if they are added or referred to in a
   label claim

 * other dietary ingredients for which there are no FDA-established
   Reference Daily Intakes.

Also, products must meet certain criteria to be labeled with the terms
"high potency" and "antioxidant."

"High potency" will be allowed to describe both individual vitamins and
minerals or multinutrient products. When describing an individual
vitamin or mineral, it will mean that 100 percent or more of the Daily
Value for the nutrient is present in each serving. For multinutrient
products, it will mean that one serving provides more than 100 percent
of the Daily Value for two-thirds of the vitamins and minerals present.

"Antioxidant" may be used with the already defined claims "good source
of" and "high" to describe a nutrient for which a Reference Daily Intake
value has been established (for example, vitamin C) and the nutrient is
shown by scientific evidence to inactivate free radicals or to prevent
free-radical-initiated chemical reactions in the body after a sufficient
quantity of the nutrient has been absorbed.

Warnings Added
To Seldane Labels

People taking a new hypertension drug or several other drugs should not
take the antihistamine Seldane or the antihistamine/decongestant
Seldane-D, according to new warnings on Seldane's labeling.

The hypertension drug, Posicor (mibefradil dihydrochloride), joins
antibiotics such as erythromycin and antifungals such as ketoconazole,
which have long been associated with severe risks when taken with
Seldane, Seldane-D, or generic versions containing the antihistamine
terfenadine.

The new labeling also warns against taking the antihistamine at the same
time as these drugs:

LI>HIV protease inhibitors such as Crixivan (indinavir), Norvir
(ritonavir), Invirase (saquinavir), and Viracept (nelfinavir)

 * serotonin re-uptake inhibitors such as Luvox (fluvoxamine), Zoloft
   (sertaline), and Serzone (nefazodone)

 * Zyflo (zileuton)

 * Propulsid (cisapride)

 * Zagam (sparfloxacin).

In addition, no one should take Seldane, Seldane-D, or the generics with
grapefruit juice, and patients with kidney difficulties should not take
more than one tablet daily.

FDA is in the process of removing all terfenadine products from the
market because of the approval of a safer alternative, Allegra
(fexofenadine hydrochloride). (See "Antihistamine Poses Possible Safety
Risk" in the Updates section of the April 1997 FDA Consumer.) Both
Allegra and Seldane are manufactured by Hoechst Marion Roussel Inc.

FDA urges health-care providers to report any terfenadine-related
adverse events to the manufacturer by calling 1-800-633-1610 or to FDA's
MedWatch program by calling 1-800-FDA-1088.

Final Rules Will Improve
Mammography Quality

Final FDA rules on mammography facilities will lead to further
improvements in the quality of mammography in the United States.

Under the Mammography Quality Standards Act of 1992, FDA has
strengthened the interim rules by which it has certified and inspected
almost all 10,000 U.S. mammography facilities. According to the final
rules:

 * Medical records and reports of mammography results must meet standards
for contents and wording. Facilities must provide the reports to
patients, including patients who have not designated a health-care
provider. Facilities must make reasonable attempts to notify both
patients and health-care providers as soon as possible of reports when
results are "suspicious" or "highly suggestive of malignancy."

 * Doctors who interpret mammograms must have 60 hours of training in
   mammography.

 * Technologists must average 200 mammograms every two years to keep
   their skills current.

 * Medical physicists who survey the equipment and facilities must meet
   initial and ongoing training requirements.

 * Better defined equipment requirements include specifications for
   motion of the tube-image receptor assembly, magnification,
   compression, automatic exposure control, and x-ray film.

 * Mobile mammography units must follow quality controls that are more
   stringent than before.

 * At the patient's request, original mammograms must be made available
   to other medical facilities, allowing comparison with new mammograms.

 * Facilities must provide for consumer complaints, so that patients or
   their representatives (such as family members or referring doctors)
   have an opportunity to be heard, and serious complaints investigated
   and resolved.

FDA published its final rules in the Oct. 28, 1997, Federal Register.

To obtain names and locations of FDA-certified facilities, call the
Cancer Information Service at 1-800-4-CANCER or visit
http://www.fda.gov/cdrh/dmqrp.html on FDA's Web site.

Liver Injuries Prompt
Warning for Diabetes Drug

Following reports of liver injury associated with a new diabetes drug,
the manufacturer changed the prescribing information and added a warning
to the labeling.

Rezulin (troglitazone), approved by FDA in January 1997, is used in
combination with insulin or sulfonylurea in patients with adult-onset
diabetes mellitus whose blood glucose levels are not adequately
controlled by these other therapies alone. (See "Diabetes Demands a
Triad of Treatments" in the May-June 1997 FDA Consumer.)

The 35 reports of liver injury, as of Oct. 21, 1997, ranged from mildly
elevated blood levels of the liver transaminase enzymes to liver failure
leading to one liver transplant and one death. It is not yet known if
the drug alone caused the liver injury or if other medical factors
contributed.

FDA and the drug's manufacturer, Parke-Davis, recommend checking
patients' serum transaminase levels routinely for the first one to two
months of Rezulin treatment, every three months for the rest of the
first year, and periodically after that. Liver function tests should be
done if a patient develops symptoms of liver dysfunction, such as
nausea, vomiting, abdominal pain, fatigue, loss of appetite, or dark
urine.

Patients should stop taking Rezulin if they develop jaundice or their
laboratory tests indicate liver injury.

About 2 percent of patients are expected to have to stop taking Rezulin
because of elevated liver enzymes. If the drug is stopped, few, if any,
of these patients will develop permanent liver damage.

Health-care providers should report any Rezulin-related adverse events,
especially those that suggest liver injury, to Parke-Davis by calling
1-800-223-0432, or to FDA's MedWatch program by calling 1-800-FDA-1088.

New Labels for Children's
Tylenol, Motrin Stress Safety

The manufacturer of Children's Tylenol (acetaminophen) and Children's
Motrin (ibuprofen) is modifying the labeling of these over-the-counter
analgesics to ensure their safe and effective use. Overdoses of Tylenol
have been associated with liver damage and deaths in children.

McNeil Consumer Products Co., of Fort Washington, Pa., announced
recently it would:

Add the warning "Read the instructions carefully" to the front panel of
all Children's Tylenol dosage forms. Change the language to emphasize
the importance of using the specific dosing device--for example, dropper
or cup--that comes with the product. Add the statement "Taking more
than the recommended dose (overdose) will not provide more pain or fever
relief and could cause serious health risks" to ensure that parents and
other caregivers understand that there is no advantage to exceeding
recommended doses. Change the front panel of Infants' Tylenol drops to
read "Concentrated Drops" instead of "Suspension Drops."

(For more information on children and drug dosing, see "How to Give
Medicine to Children" in the January-February 1996 FDA Consumer.)

Don't Buy Unapproved
Home Test Kits, FDA Warns

Two home-use kits distributed by Lei-Home Access Care of Sunnyvale,
Calif.--one intended to test for the AIDS virus and the other for the
hepatitis A virus--are unapproved, unreliable, and should not be used,
FDA warns.

The agency asked pharmacies last September to remove these two kits from
their shelves: the "Lei-Home Access HIV Test," advertised on the
Internet as the "Personal HIV Test Kit," and the "In-home Hepatitis A
Test Kit."

The only HIV home test approved by FDA is the Home Access HIV-1 Test
System, made by Home Access Health Corp., Hoffman Estates, Ill. Users
send a blood sample obtained from a finger prick to a laboratory for
testing. Confidential results are given over the phone, with a trained
counselor available.

FDA has not approved a hepatitis A test kit for use in the home.
Hepatitis A, usually transmitted by food, causes a mild, rarely serious,
liver disease.

Consumers who used either of the unapproved kits should consult their
doctors for retesting.

First Combination Drug
Approved for AIDS and HIV

Approval by FDA of the first combination drug for treating AIDS and HIV
infection would decrease the number of pills patients need to take each
day.

The new drug, Combivir, combines AZT (zidovudine) and 3TC (lamivudine),
two drugs commonly prescribed with one another in "drug cocktails" as
treatment.

Patients take one pill twice a day. Patients may need to take up to
eight pills a day when taken separately.

AZT and 3TC are members of the nucleoside analog class of drug
compounds, and both interfere with the replication of HIV, the virus
that causes AIDS. Side effects of these drugs include: nausea, diarrhea,
anemia, low white blood cells, pancreatitis, and neuropathy. Combivir
was approved on Sept. 26, 1997, and is manufactured and marketed by
Glaxo Wellcome of Research Triangle Park, N.C.

Final Rule Adds Warning
On Devices Containing Latex

Surgical gloves, adhesive bandages, intravenous catheters, and other
medical devices containing latex will have to start carrying a warning
for people allergic to the rubber substance, according to an FDA final
rule.

Beginning Sept. 30, 1998, labels of latex-containing medical devices
will have to state, "Caution: This Product Contains Natural Rubber Latex
Which May Cause Allergic Reactions." Similar labeling will be required
on medical devices containing dry natural rubber and medical device
packaging that contains latex.

Also, the rule will prohibit use of the claim "hypoallergenic" on labels
of latex-containing medical devices. As now used on devices with reduced
latex levels, the claim implies that such products are safe for
latex-sensitive people. But even reduced amounts of latex can cause
allergic reactions in susceptible people.

During the past decade, FDA received more than 1,700 reports of severe
allergic reactions, including 16 deaths in children with spina bifida,
related to medical devices containing latex. Health-care workers and
children with spina bifida and other conditions requiring multiple
surgeries are at greatest risk of allergic reaction because of their
constant exposure to latex-containing devices. For the general public,
the risk of allergic reaction is less than 1 percent.

FDA published the rule in the Sept. 30, 1997, Federal Register.

Devices Have Record Year

Increased approvals, quicker reviews, and no backlogs made 1997 a record
year for medical devices at FDA.

The agency's Center for Devices and Radiological Health approved 48
premarket approval applications in fiscal year 1997, five more than in
1996 and 18 more than in 1995. Key approvals included the first implant
to restore partial hand movement in quadriplegics, a deep brain
stimulator to help control tremors from Parkinson's disease, a nerve
stimulator to reduce severe epileptic seizures, a temporary skin
substitute for severe burns, and two fetal bladder stents to treat
urinary tract obstruction in unborn babies. The center also cleared the
first laser system for treating tooth decay.

Average review time for premarket approval applications was 16.6 months,
down from 25.9 months in 1996, with 17 applications approved within 180
days or less. Average review time to clear 510(k) devices--those similar
to existing products--was 97 days, down from 110 days in 1996, with 98
percent having an initial review decision within 90 days or less during
the first three quarters of the fiscal year.

The center eliminated its approval application backlogs and continued,
for the second year, a "zero" backlog of 510(k) clearances. Approval
time for 70 percent of investigational device exemptions was 30 days or
less, the quickest ever.

Unapproved Lasers Seized

To ensure that only approved excimer lasers are used to treat
nearsightedness and other eye conditions, FDA initiated the seizure of
unapproved lasers worth millions of dollars.

Consumers should make sure any laser surgery they undergo is done only
with approved lasers or in an FDA-monitored clinical study. Unapproved
lasers pose a risk of serious eye injury.

FDA has approved only two lasers as safe and effective for eye surgery.
One is manufactured by Summit Technology Inc., of Waltham, Mass., the
other by VISX Inc., of Santa Clara, Calif. Several others are in
FDA-sanctioned clinical trials.

The lasers treat nearsightedness with photorefractive keratectomy (PRK),
a procedure in which the surgeon reshapes the cornea with ultraviolet
light bursts from the laser.

At press time, U.S. marshals, on behalf of FDA, had seized unapproved
lasers from these sites:

 * Photon Data Inc., Winter Park, Fla.--nine lasers and components
   valued at more than $3 million seized June 9

 * Woodhams Eye Clinic, Atlanta, office of J. Trevor Woodhams, M.D.--one
   laser seized July 1

 * Neumann Eye Institute, Deland, Fla., office of Albert C. Neumann,
   M.D.--one laser seized Aug. 28

 * Pro Cargo, Miami, a private freight firm--one additional

Photon Data laser seized Aug. 28

 * St. George Corrective Vision Center, Chicago, office of Nicholas
   Caro, M.D.--one laser seized Sept. 2.

FDA continues to investigate unapproved lasers.

Proposal: Don't Exclude Women from Drug Studies

A rule proposed by FDA aims to ensure that women of reproductive age are
not automatically excluded from studies of drugs and biologics for
treating life-threatening diseases such as AIDS.

If made final, the rule would permit FDA to stop a company from
conducting or continuing a study if women or men were being
inappropriately excluded based only on the risk of damage to their
reproductive organs or to the health of potential offspring. It would
not apply to certain studies, such as those designed to look only at
healthy volunteers or to test drugs for use exclusively by one gender,
such as prostate cancer drugs.

FDA wants to expand access to new treatments for life-threatening
diseases, believing that patients and their doctors can themselves weigh
the risks and benefits of such treatments when given complete
information during the informed consent process.

The agency hopes that diversity in drug studies will provide better
information about how the drug will affect the people who will use it.

The proposed rule, published in the Sept. 24, 1997, Federal Register,
provided a public comment period that ended Dec. 23.

Free Report on Women's Health

FDA Consumer subscribers may order one free copy of the FDA Consumer
Special Report: Your Guide to Women's Health, Third Edition. Write to
FDA, HFI-40, Rockville, MD 20857, or fax your order to 301-443-9057.
Include the publication number, (FDA) 97-1181.

Incontinence Implant Approved

Adults who suffer a serious type of urinary incontinence have a new
treatment option: an implantable nerve stimulator.

FDA approved the Sacral Nerve Stimulation System last Sept. 29 to treat
urge incontinence. This sudden, uncontrollable loss of urine is due to
involuntary bladder wall contractions, which may result from such nerve
conditions as spinal cord injury, stroke, and multiple sclerosis, or
from other bladder problems. The device requires major surgery and is
for use only when less invasive treatments, such as drugs and diet
changes, fail. Of the 5 million adults, mainly women, who experience
urge incontinence, 20 percent may benefit from the new treatment.

The battery-operated device consists of a pacemaker-size generator for
implanting in the abdominal wall and a wire lead for attaching to the
nerves near the sacrum, the large bone at the bottom of the spine. The
generator sends electric impulses along the lead to the sacral nerves to
help control bladder contractions.

After six months into clinical studies of 86 implanted patients, 47
percent of patients were dry, and an additional 28 percent had 50
percent fewer leakage episodes. Results were similar after 12 months and
18 months. In safety studies of 157 implanted patients, about a third
had problems requiring at least a second surgery. Doctors could usually
resolve the most common problem, pain, by repositioning the device.

The manufacturer, Medtronic Inc., of Spring Lake Park, Minn., must do a
five-year study of the device to determine long-term effects.

FOI Reading Room Added
To Remodeled www.fda.gov

A new electronic Freedom of Information Act "reading room" is part of
FDA's expanded and redesigned Website.

Internet users can now directly access such documents as warning
letters, inspection operation manuals, monthly import detention lists,
medical device reports, and other often-requested materials without
having to go through the time and paperwork of filing a traditional FOI
request. Users can reach the Electronic Freedom of Information Reading
Room directly from the FDA homepage.

FDA has also revised its homepage to include a greatly expanded index
and special menus for such groups as consumers, health professionals,
and industry.

Drug Approval Process,
Food Label Win Accolades

Quicker and more new drug approvals and the design of food labeling's
Nutrition Facts panel garnered two recent awards for FDA.

The Innovations in American Government Awards Program, sponsored by the
Ford Foundation and Harvard University's John F. Kennedy School of
Government, recognized the agency for its efforts to speed the review
of, and access to, new medicines. In addition to cutting approval times
nearly in half, the agency has doubled the number of new drugs approved
in a year.

The Nutrition Facts panel, now found on virtually all food labels, was
tapped for the Presidential Design Achievement Award because of its
useful, consumer-friendly design. The award recognizes exemplary
achievements in federal design in such areas as architecture, interior
design, urban planning, and graphic design.

Correction

The article "Bone Builders," in the September-October 1997 FDA Consumer,
included an incorrect TDD number for the Osteoporosis and Related Bone
Diseases National Resources Center. The correct TDD number is
202-466-4315.

FDA Consumer magazine (January-February 1998)
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Notebook

The Notebook: a potpourri of items of interest gathered from FDA news
releases, other news sources, and the Federal Register (designated FR,
with date of publication). The Federal Register is available in many
public libraries. It is also available electronically through GPO Access
at the Government Printing Office.

A new test that can detect the potentially deadly E. coli O157:H7
bacterium in less than an hour is in development by FDA scientists. The
Anti-body direct epifluorescent filter test improves on many current
methods such as culturing, which can take four to five days for results.

Americans of all ages may be at risk for pneumococcal diseases, the
leading cause of 40,000 vaccine-preventable deaths that occur each year.
These diseases include pneumonia, bacteremia (blood infection), and
meningitis (infection of the brain lining). The national Centers for
Disease Control and Prevention urges vaccination for everyone over 65.
Others should ask their doctors if they need the vaccine.

Home-monitored blood pressure readings tend to be more accurate than
those taken in a doctor's office, report researchers at the Katholieke
Universiteit Leuven in Belgium. Many patients experience a rise in blood
pressure caused by office visit stress. The falsely elevated readings
can lead to unnecessary treatment for high blood pressure. (Journal of
the American Medical Association, Sept. 30)

Twenty percent of Americans over age 12 carry the genital herpes virus,
report researchers at the national Centers for Disease Control and
Prevention. The alarming occurrence of the virus--a 30 percent increase
over a 1970s' study--is partly the result of young people not practicing
safe sex, the report states. Herpes can be transmitted through sexual
activity and also by touching and kissing. The disease cannot be cured.
(New England Journal of Medicine, Oct. 16)

A reduced-fat mozzarella cheese that retains "meltability" and
"springiness" is now being used on pizzas and other foods for school
lunch programs nationwide. Developed by the U.S. Department of
Agriculture, the new cheese contains less than half the fat found in
whole-fat mozzarella.

A series of drug education materials for students in grades five through
nine is available free from the National Institute on Drug Abuse. NIDA's
"Mind Over Matter" campaign offers six glossy magazines that unfold into
posters and explore the effects of drugs on the brain. The campaign aims
to encourage interest in the neuroscience profession and includes a
teacher's guide. For copies, call NIDA at 1-800-729-6686.

Tuberculosis can be transmitted by contaminated bronchoscopes, which are
devices used to examine the lungs, according to a study by the national
Centers for Disease Control and Prevention. CDC says medical facilities
can reduce or eliminate this threat by adhering to sterilization
standards established by the Association for Practitioners in Infection
Control. (Journal of the American Medical Association, Sept. 30)

Unattended bathtub seats caused 29 infant drownings between 1983 and
1995, according to the Consumer Product Safety Commission. More than a
million of the seats are sold yearly. CPSC warns consumers to never
leave a child alone in the tub. (Pediatrics, October 1997; the article
is available in the October issue on the Pediatrics Electronic Pages at
www.pediatrics.org/content/vol100/issue4)

Senior citizens may keep their weight in check by eating more frequent,
but smaller, meals. A study sponsored by the U.S. Department of
Agriculture found that both women in their 20s and women in their 60s
and 70s burned about the same amount of fat after eating 250- and
500-calorie meals. But the older group burned about 30 percent less fat
after a 1,000-calorie meal. (American Journal of Clinical Nutrition,
October 1997)

The antidepressant Zyban (bupropion), which FDA approved last May, may
double smokers' chances of quitting smoking, according to a study at the
Mayo Clinic and elsewhere. In the study, 615 volunteers who were not
depressed but wanted to give up smoking took either Zyban or a placebo
for six weeks. After a year, 23 percent of the Zyban group had not
smoked, but only 12 percent of the placebo group had not smoked again.
(New England Journal of Medicine, Oct. 23)

FDA Consumer magazine (January-February 1998)
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Investigators' Reports

Manufacturer Sentenced for Selling
Unsterilized Surgical Instruments

by Dixie Farley

A manufacturer of gynecological surgical devices was sentenced to a
15-month prison term after pleading guilty to intentionally selling
unsterilized instruments labeled as "sterile" and providing FDA false
information.

The manufacturer and the company also were ordered to pay &37,004 each
to the hospitals and clinics that had returned the instruments. All the
unsafe devices were recalled, seized and destroyed under FDA
supervision.

After hearing testimony at the Sept. 17, 1997, presentencing hearing,
Judge Frederick Scullin, of the U.S. District Court for the Northern
District of New York, also placed International Medical Technologies
Group Inc. (IMTG) on five years' organizational probation and ordered
its president, John Sturgeon, to withdraw his device marketing
clearances and avoid involvement in the manufacture of drugs and devices
for one year after serving his sentence.

IMTG sold syringes, aspiration catheters, surgical tubing, cervical
dilators, curettes for sampling tissue, and tissue collection sets for
use in surgical gynecological procedures such as abortion, treatment of
abnormal uterine bleeding, and uterine sampling for diagnosing cancer.
These are considered sterile surgical procedures, and doctors have
traditionally demanded sterile instruments for performing them. The risk
of infection is one of the major hazards of these procedures because
infection may lead to blood poisoning, infertility and death.

At the hearing, Eugene Williams, M.D., an obstetrician-gynecologist now
retired from FDA's Center for Devices and Radiological Health, testified
that the unsterilized devices created a serious risk of harm from
infection and that data gathered by the agency's Buffalo, N.Y., district
office indicated that a fourfold increase in infections at one clinic
was likely due to the use of unsterilized IMTG devices the clinic had
received.

The company's poor practices came to FDA's attention in January 1993,
when three former IMTG employees complained to the agency's Albany,
N.Y., resident post that the company was shipping unsterilized products
labeled as "sterile."

Early in 1993, Nancy Saxenian and Michael Sinkevich, investigators with
FDA's Buffalo district office, inspected IMTG.

Initially, Sturgeon gave the investigators company records showing that
surgical devices labeled as sterile and distributed to hospitals and
clinics had been sterilized by Medical Device Sterilization Inc., of
Saratoga, N.Y. But when Saxenian and Sinkevich tried to locate the
company, they could find no evidence of its existence. Confronted with
this finding, Sturgeon admitted that he'd fabricated the records,
intentionally giving false information and knowingly labeling the
unsterilized devices as sterile. FDA's approvals of the devices called
for them to be sterilized with ethylene oxide, but Sturgeon said
sterilization was too costly.

The investigators examined Sturgeon's records, noting that one load of
curettes had been sent to a Northborough, Mass., company for
sterilization. But the records also showed that, of a batch of 1,825
curettes, only 1,500 had been sterilized. When FDA asked Sturgeon to
identify which instruments had been sterilized and which were in
commercial distribution, Sturgeon was unable to do so. As a result, FDA
urged Sturgeon to recall from the market all curettes made by the
company.

As the inspection progressed, the investigators found other problems,
including:

 * no records of production, quality control, packaging, and labeling
   specifications

 * inadequate records of product specification testing and dates and
   number of products made

 * no written procedures for inspecting finished devices

 * failure to receive FDA marketing clearance for tissue collection and
   uterine injector sets.

Sinkevich recalls that Sturgeon appeared "vague, evasive, inconsistent
and uncertain" in answering questions and providing records. Eventually,
Sturgeon admitted that the company had distributed other unsterilized
products labeled as sterile. At FDA's urging, he recalled from the
market all remaining products made by the company.

At the end of the inspection, the investigators reported their findings
to Sturgeon, who gave them copies of written manufacturing procedures he
said he intended to put in place to meet FDA requirements.

However, FDA found the procedures to be inadequate and decided to take
further action.

"In light of the extensive manufacturing problems and Sturgeon's history
of falsifying records and shipping potentially hazardous unsterilized
devices as sterile, particularly when faced with economic incentives, we
decided to go for seizure," says James Kewley, a compliance officer with
FDA's Buffalo district office.

Accompanied by Saxenian and Sinkevich, a U.S. deputy marshal seized the
devices in August 1993. Saxenian witnessed destruction of the devices,
valued at &100,000, in February 1994.

FDA continued to investigate Sturgeon and IMTG through a federal grand
jury in New York. "We interviewed many current and former employees,"
says John Thompson, a team leader in FDA's Buffalo district. "From the
interviews, we learned that Sturgeon had engaged in a coverup involving
not only false sterilization records but also false manuals on standard
operating procedures."

Sturgeon and IMTG were indicted in August 1996. They pleaded guilty four
months later.



Dixie Farley is a staff writer for FDA Consumer.


------------------------------------------------------------------------


Probe Proves Effective Against
Antibiotic Smuggling Scheme

A scheme to make money by smuggling counterfeit antibiotics into the
United States from China backfired on a New Jersey-based company and
four of its principals and key employees when they were fined sums
totaling more than &1 million. They also were given prison sentences or
probation.

An FDA investigation begun in 1990 revealed that the company's illegal
activities cost end-user companies more than &1.7 million in product
losses.

Judge Joseph E. Stevens Jr., of the U.S. District Court for the Western
District of Missouri, imposed the most recent fines last April. He
ordered the company, Flavine International Inc., Closter, N.J., to pay
&925,000; its owner, Gerd Weithase, &75,000; and vice president, Wolf
Vogel, &10,000. He also sentenced Weithase to two years in prison and
Vogel to home detention for six months and gave both probations of as
much as three years.

The men were part of a scheme in which Flavine bought bulk amounts of a
veterinary antibiotic ingredient, oxytetracycline (OTC) base, and the
human antibiotic gentamicin sulfate from unapproved sources in China for
subtantially less than the price of legitimate products. The company
then resold them to U.S. drug companies at inflated rates.

Besides constituting economic fraud, the scheme posed a risk to food
animals and humans because these counterfeit drugs are of unknown
quality and potency.

The case began in May 1990, when an industry source contacted FDA's
Omaha, Neb., resident post with information linking Flavine to the
counterfeit OTC base. The source stated that Flavine had imported about
310 metric tons of OTC base from China in 1989. But the company's
legitimate Chinese manufacturer, Long March Pharmaceutical Plant, which
is approved by FDA, had made only 100 metric tons of the chemical that
year. Thus, officials say, at least part of the shipments likely came
from unknown, unapproved sources.

In June 1991, FDA investigator Michael Spangenberg visited the Long
March plant in China and took pictures of legitimate bulk OTC
containers. After he returned to the United States, he inspected
SmithKline Beecham Animal Health, in Omaha and determined that the bulk
materials there were counterfeit because the containers were different
from those in China.

Over the next three years, FDA and U.S. Customs officials seized
suspected counterfeit materials from five end users and warehouses. The
material came from Flavine and other possible suppliers. Among the
seizure sites were the Port of Baltimore; Fermenta Animal Health,
Elwood, Kan.; and Sanofi Animal Health, Le Sueu, Minn. Much of the
material was later destroyed after being proven counterfeit.

In May 1993, after establishing probable criminal activity, special
agents from FDA's Office of Criminal Investigations (OCI) and the U.S.
Customs Service executed a search warrant at Flavine's New Jersey
headquarters. At the same time, agents executed searches at the
company's Kansas City, Mo., offices and at the residence of company vice
president Ira "Rip" Siegel in Parkville, Mo.

In reviewing records seized during the search, OCI and Customs agents
learned that Flavine was using a North Carolina company to repackage
some of the 20-kilogram drums of counterfeit OTC base into 25-kg drums.
The agents concluded that the company used this maneuver to hide its
sale of counterfeit products by repackaging materials to look like they
were from Long March, the legitimate Chinese manufacturer, which packs
its OTC materials only in 25-kg drums.

Between December 1993 and February 1994, OCI also analyzed import
information, determining that out of all the company's OTC base
shipments, almost half--277,325 kg--of the shipments came from Chinese
sources other than the legitimate supplier and were likely counterfeit.

These suspicions were backed up in May 1994, during an OCI and Customs
interview with Long March official Dejun Meng. He confirmed that
numerous shipments of OTC base, sold by Flavine under the Long March
name, were not made by Long March. He outlined for agents several ways
they could distinguish Long March materials from counterfeit by
examining the products' certificates of analysis.

In December 1994, OCI, Customs, and the Justice Department's Office of
Consumer Litigation interviewed former Flavine employee W. Mark
Paradise. He verified that numerous shipments of OTC base had not been
produced by Long March but were sold in the United States as such.

Agents also reviewed Flavine's shipment record of other bulk drugs it
bought from overseas. They found that Flavine had counterfeited several
other drugs, including gentamicin sulfate, an antibiotic used to treat
bacterial infections, such as those caused by Streptococcus pneumoniae,
in humans and animals. Long March also makes gentamicin sulfate, and,
again, Meng verified for agents that some of the bulk gentamicin sulfate
sold by Flavine under the Long March name was not made by his company.

On Jan. 24, 1995, a federal grand jury returned an 11-count indictment
charging Flavine International, Weithase, and several of his associates
with conspiracy, smuggling, misbranding, and other federal drug
violations.

In September 1995, French police arrested Weithase in Paris, where he
had fled after escaping to Germany to avoid prosecution. Accompanied by
U.S. marshals, Weithase returned to the United States in January 1996
after being turned over to U.S. authorities by the Justice Ministry of
France.

Initially, Weithase pleaded not guilty to the charges. But on March 20,
1996, he, along with his company and associates Vogel and John Milhard,
Flavine's traffic manager, admitted guilt to charges of conspiracy,
money laundering, and counterfeiting. They were sentenced last April 9.
Milhard was placed on probation for one year and fined &5,000. Two days
earlier, Flavine employee W. Mark Paradise was sentenced for his part in
the counterfeiting scheme to six months' home detention, a &25,000 fine,
and five years' supervised probation.

Flavine International Inc. is still in business and now deals in
legitimate products, FDA officials say.

--John Henkel


------------------------------------------------------------------------


FDA Takes Dim View of Glow-in-the-Dark Makeup

If the scary monsters that came trick-or-treating last Halloween glowed
in the dark, they may have unknowingly painted their faces with an
illegally marketed makeup.

The Face Colours Glow-in-the-Dark Cream Makeup, manufactured by Zauder
Brothers Inc. of Freeport, N.Y., contained an unapproved color additive,
zinc sulfide, added to the makeup to achieve a glowing appearance.

While FDA has not received any reports of injuries from the makeup, the
agency considers zinc sulfide unsafe until it concludes that studies
have been submitted to prove its safety.

Zauder Brothers recently sought approval of zinc sulfide by submitting a
color additive petition, as stated in an Oct. 6, 1997, Federal Register
notice.

FDA has been aware of these glow-in-the-dark makeups since the 1970s and
has cited eight manufacturers for violations. Most of the manufacturers
stopped making the products after FDA contacted them.

FDA first inspected the Zauder Brothers' facility in October 1993, after
an informant complained to the agency about the sale of the illegal
makeup. Investigators with FDA's New York district office collected
product samples, and FDA lab tests confirmed that the product contained
zinc sulfide.

In a March 4, 1994, warning letter, FDA cautioned Zauder Brothers that
the agency might take further action if the company continued to
manufacture and sell the illegal product.

But the company didn't stop making and selling it, as evidenced by
continuing tips from informants and an FDA re-inspection of the Zauder
facility in October 1996.

In April 1997, FDA filed a complaint against the glow makeup in the U.S.
District Court for the Eastern District of New York, and U.S. marshals,
accompanied by FDA investigators, seized 185 cartons of the makeup,
valued at &3,800.

In September 1997, Zauder Brothers entered into a consent decree under
which the U.S. Marshals Service will destroy the seized glow makeup. At
press time, the makeup had not yet been destroyed.

William Friedrich, an investigator with FDA's New York district office,
anticipates that his office will inspect the company's facility again as
the next Halloween season approaches.

--Tamar Nordenberg

FDA Consumer magazine (January-February 1998)
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Summaries of Court Actions

Summaries of Court Actions are given pursuant to Section 705 of the
Federal Food, Drug, and Cosmetic Act. Summaries of Court Actions report
cases involving seizure proceedings, criminal proceedings, and
injunction proceedings. Seizure proceedings are civil actions taken
against goods alleged to be in violation, and criminal and injunction
proceedings are against firms or individuals charged to be responsible
for violations. The cases generally involve foods, drugs, devices, or
cosmetics alleged to be adulterated or misbranded or otherwise violative
of the law when introduced into and while in interstate commerce.

Summaries of Court Actions are prepared by Food and Drug Division,
Office of the General Counsel, HHS, and are published by direction of
the Secretary of Health and Human Services.





SEIZURE ACTIONS

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Honey, at New Munster, Wis. (E.D. Wis.); Civil Action No.
97-C-0536.
CHARGED 5-5-97: While held for sale after shipment in interstate
commerce at Best Bargains, Inc., in New Munster, Wis., the article was
adulterated in that another substance, cane or corn sugar syrup, had
been substituted in whole or in part for honey--402(b)(2). The article
was misbranded in that the name on its labeling, honey, was false and
misleading as applied to an article of food which was not pure honey and
which consisted largely of another substance--403(a)(1).
DISPOSITION: The article was destroyed. (F.D.C. No. 67186; S. No.
97-562-238; S.J. No. 1)

PRODUCT: Infant Formula, at Wampum, Pa. (W.D. Pa.); Civil Action No. 95
1814 and 95 1991.
CHARGED 12-8-95: While held for sale after shipment in interstate
commerce at Gateway Commerce Center, in Wampum, Pa., the articles were
misbranded in that their labeling was false and misleading--403(a)(1).
DISPOSITION: The articles were either destroyed or reconditioned.
(F.D.C. No. 67110; S. No. 96-787-061; S.J. No. 2)

PRODUCT: Peppers, at Brooklyn, New York (E.D. N.Y.); Civil Action No.
CV-96-1230.
CHARGED 3-18-96: While held for sale after shipment in interstate
commerce at Adamba Imports International, in Brooklyn, N.Y., the
articles were adulterated in that they had been shipped and held under
insanitary conditions whereby they might have been rendered injurious to
health--402(a)(4).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67124; S. No.
95-752-931; S.J. No. 3)

PRODUCT: Sodium Citrate, at Springfield, Mo. (W.D. Mo.); Civil Action
No. 94-3152-CV-S-4.
CHARGED 4-12-94: While held for sale after shipment in interstate
commerce at G.S. Robins and Company, in Springfield, Mo., the article
was adulterated in that it was unfit for food because of the presence of
foreign material, including plant matter and a rubber-like material
visible to the naked eye--402(a)(3).
DISPOSITION: The article was reconditioned for nonfood use. (F.D.C. No.
66954; S. No. 94-688-047; S.J. No. 4)



Drugs/Human Use

PRODUCT: An article of drug, at Eau Claire, Wis. (W.D. Wis.); Civil
Action No. 96 C 1016 S.
CHARGED 12-17-96: While held for sale after shipment of one or more of
their components in interstate commerce at Radix Laboratories, Inc., in
Eau Claire, Wis., the article was adulterated in that it was a new
animal drug within the meaning of 201(v)(1) and was unsafe within the
meaning of 512(a)(1)(A) because no approval of an application filed
pursuant to 512(b) was in effect with respect to its intended use.
DISPOSITION: The article was destroyed. (F.D.C. No. 67158; S. No.
96-718-764; S.J. No. 5)



Medical Devices

PRODUCT: Test Kits, at Irvine, Calif. (C.D. Calif.); Civil Action No. CV
97-0524-ABC (VAP).
CHARGED 1-27-97: While held for sale after shipment in interstate
commerce at IBEX Medical Group, in Irvine, Calif., the articles were
adulterated in that they were a class III device without an application
for premarket approval--501(f)(1)(B). The articles were misbranded in
that the label failed to contain the name and place of business of the
manufacturer, packer or distributor--502(b)(1), and failed to bear the
established name of the device--502(e)(2). Also, notice or other
information respecting the device was not provided to the Food and Drug
Administration at least 90 days prior to its introduction into
interstate commerce--502(o).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67161; S. No.
97-683-594; S.J. No. 6)

PRODUCT: Test Kits, at Beverly Hills, Calif. (C.D. Calif.); Civil Action
No. CV 97-1751-GHK (RCx).
CHARGED 3-18-97: While held for sale after shipment in interstate
commerce at the residence of David Rudich, in Beverly Hills, Calif., the
articles were adulterated in that they were a class III device without
an application for premarket approval--501(f)(1)(B). The articles were
misbranded in that the label failed to contain the name and place of
business of the manufacturer, packer or distributor--502(b)(1), and the
label failed to bear the established name of the device--502(e)(2).
Also, notice or other information respecting the device was not provided
to the Food and Drug Administration at least 90 days prior to its
introduction into interstate commerce--502(o).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67173; S. No.
97-789-608; S.J. No. 7)



INJUNCTION ACTIONS

DEFENDANT: Central Grocers Cooperative, Inc., Robert J. Wagner, Joseph
Caccamo, and individuals, at Franklin Park, Ill. (N.D. Ill.); Civil No.
97-C-2052.
CHARGED 3-25-97: While held for sale after shipment in interstate
commerce at Central Grocers Cooperative, Inc., in Franklin Park, Ill.,
the articles were adulterated in that they had been shipped and held
under insanitary conditions whereby they might have been contaminated
with filth--402(a)(4).
DISPOSITION: A consent decree of permanent injunction was granted.
Central Grocers Cooperative, Inc., was ordered to pay all civil
penalties in this action. (Inj. No. 1411; S. No. 97-759-321; S.J. No. 8)

DEFENDANTS: MinXray, Inc., and Keith R. Kretchmer, at Northbrook, Ill.,
(N.D. Ill.); Civil Action No. 96 C 1062.
CHARGED 2-23-96: While held for sale after shipment in interstate
commerce at MinXray, Inc., in Northbrook, Ill., the defendants
manufactured and distributed x-ray units that did not comply with the
applicable performance standards--538oo(a)(1); they also issued
certificates that were false and misleading--538oo(a)(5)(B); and they
failed to notify the purchasers that the units did not comply with
applicable performance standards, failed to bring the units into
compliance without charge, and failed to replace them or to refund the
cost of the units--538oo(a)(2).
DISPOSITION: A consent order and judgment of permanent injunction was
granted. And MinXray, Inc., was ordered to pay civil penalties in this
action. (Inj. No. 1384; S. No. 95-741-232; S.J. No. 9)

FDA Consumer magazine (January-February 1998)
------------------------------------------------------------------------

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Statement of Ownership, Management, and Circulation

(Required by 39 U.S.C. 3685)

FDA Consumer, ISSN 0362-1332; owner and publisher: Food and Drug
Administration (HFI-40), 5600 Fishers Lane, Rockville, MD 20857; editor:
Isadora B. Stehlin.

Date of filing: Sept. 29, 1997; issued bimonthly; annual subscription
price $10 ($12.50 foreign).

Extent and Nature     Average No. Copies Each     Actual No. Copies
of Circulation:       Issue During Preceding      of Single Issue
                            12 Months             Published Nearest
                                                  to Filing Date

a. Total number of copies
  (net press run)            24,060                     23,858

b. Paid and/or requested circulation:

1. Sales through dealers
   and carriers, street
   vendors, and counter
   sales (not mailed)           -                         -

2. Paid or requested
   mail subscriptions         21,000                    21,000

c. Total paid and/or
   requested circulation
   (sum of b1 and b2)         21,000                    21,000

d. Free distribution by
   mail (samples,
   complimentary,
   and other free)             2,315                     2,113

e. Free distribution
   outside the mail
   (carriers or other means)     600                       600

f. Total free distribution
   (sum of d and e)             2,915                    2,713

g. Total distribution
  (sum of c and f)             23,915                   23,713

h. Copies not distributed:

1. Office use, leftovers,
   spoiled                        145                      145

2. Returns from news agents        -                        -

i. Total
   (sum of g, h1, and h2)       24,060                  23,858

Percent paid and/or requested
circulation (c / g x 100)       87 percent              88 percent


I certify that the statements made by me above are correct and complete.

Isadora B. Stehlin, editor FDA Consumer magazine (January-February 1998)
------------------------------------------------------------------------


------------------------------------------------------------------------
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