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FDA Consumer magazine
VOL. 30 No. 5 JUNE 1996
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Features

Seven Steps to Safer Sunning 
Practices that once went into getting a tan are fading into the sunset.
In their place are safer habits that preserve natural skin color and
condition and protect against skin cancer.

Organ Transplants from Animals: Examining the Possibilities 
Organs from pigs, baboons, and possibly other animals may save human
lives in the years ahead. For now, however, their use is experimental,
and at times controversial.

Infant Formula: Second Best but Good Enough 
When breast-feeding isn't possible, babies can thrive on today's infant
formulas, prepared under strict quality control procedures to ensure
healthfulness and safety.

Health Information On-Line 
Easy access to health information on the Internet and from on-line
services can be convenient and empowering, but it also has its pitfalls.

Evening Out the Ups and Downs of Manic-Depressive Illness 
Only about a third of the estimated 2 million Americans who have bipolar
disorder receive treatment, often because it hasn't been diagnosed. A
number of drugs are available to even out the manic and depressive
phases of this psychiatric condition. 


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Departments


Updates 

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


Consumer Forum 

Letters to the editor of FDA Consumer. 


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.


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Seven Steps to Safer Sunning

by Paula Kurtzweil 

Put away the baby oil. Toss out that old metal sun reflector. Cancel
your next appointment to the local tanning salon.

These are new days with new ways of sunning, and the practices that
traditionally have gone into obtaining the so-called "healthy tanned"
look are on the verge of fading into history.

In their place: safer sun practices that preserve people's natural skin
color and condition.

That's what health experts are hoping for as the evidence against
exposure to the sun and sunlamps continues to mount. Both emit harmful
ultraviolet (UV) radiation that in the short term can cause painful
sunburn and in the long term may lead to unsightly skin blemishes,
premature aging of the skin, cataracts and other eye problems, skin
cancer, and a weakened immune system.

The problems may become more prevalent, too, if, as some scientists
predict, the Earth's ozone layer continues to be depleted. According to
the Environmental Protection Agency, scientists began accumulating
evidence in the 1980s that the ozone layer--a thin shield in the
stratosphere that protects life from UV radiation--is being depleted by
certain chemicals used on Earth. According to the most recent estimates
from the National Aeronautics and Space Administration, the ozone layer
is being depleted at a rate of 4 to 6 percent each decade. This means
additional UV radiation reaching Earth's surface--and our bodies.

Although people with light skin are more susceptible to sun damage,
darker skinned people, including African Americans and Hispanic
Americans, also can be affected.

You may have already started to take precautions. But are you doing all
you can?

The following recommendations come from various expert organizations,
including the American Academy of Dermatology, American Cancer Society,
American Academy of Ophthalmology, Skin Cancer Foundation, American
Academy of Pediatrics, National Cancer Institute, National Weather
Service, and Food and Drug Administration. FDA regulates many items
related to sun safety, including sunscreens and sunblocks, sunglasses,
and sun-protective clothing that makes medical claims. The agency also
sets performance standard s for sunlamps.

Here are seven steps to safer sunning:

1. Avoid the sun. 

This is especially important between 10 a.m. and 3 p.m., when the sun's
rays are strongest. Also avoid the sun when the UV Index is high in your
area.

The UV Index is a number from 0 to 10+ that indicates the amount of UV
radiation reaching the Earth's surface during the hour around noon. The
higher the number, the greater your exposure to UV radiation if you go
outdoors. The National Weather Service forecasts the UV Index daily in
58 U.S. cities, based on local predicted conditions. The index covers
about a 30-mile radius from each city. Check the local newspaper or TV
and radio news broadcasts to learn the UV Index in your area. It also
may be available through your local phone company and is available on
the Internet at the National Weather Service Climate Prediction Center's
home page (http://nic.fb4.noaa.gov).

Don't be fooled by cloudy skies. Clouds block only as much as 20 percent
of UV radiation. UV radiation also can pass through water, so don't
assume you're safe from UV radiation if you're in the water and feeling
cool. Also, be especially careful on the beach and in the snow because
sand and snow reflect sunlight and increase the amount of UV radiation
you receive.

People with darker skin will resist the sun's rays by tanning, which is
actually an indication that the skin has been injured. Tanning occurs
when ultraviolet radiation is absorbed by the skin, causing an increase
in the activity and number of melanocytes, the cells that produce the
pigment melanin. Melanin helps to block out damaging rays up to a point.

Those with lighter skin are more likely to burn. Too much sun exposure
in a short period causes blood vessels to dilate, resulting in sunburn.
A sunburn causes skin redness, tenderness, pain, swelling, and
blistering. Although there is no quick cure, the American Academy of
Dermatology recommends using wet compresses, cool baths, bland
moisturizers, and over-the-counter hydrocortisone creams.

Sunburn becomes a more serious problem with fever, chills, upset
stomach, and confusion. If these symptoms develop, see a doctor.

2. Use sunscreen. 

With labels stating "sunscreen" or "sunblock," these lotions, creams,
ointments, gels, or wax sticks, when applied to the skin, absorb,
reflect or scatter some or all of the sun's rays.

Some sunscreen products, labeled "broad-spectrum," protect against two
types of radiation: UVA and UVB. Scientists now believe that both UVA
and UVB can cause sunburn, damage the skin, and lead to skin cancer.

Other products protect only against UVB, previously thought to be the
only damaging type.

Some cosmetics, such as some lipsticks, also are considered sunscreen
products if they contain sunscreen and their labels state they do.

Sunblock products block a large percentage of UV radiation.

FDA requires the labels of all sunscreen and sunblock products to state
the product's sun protection factor, or "SPF," from 2 on up. The higher
the number, the longer a person can stay in the sun before burning. In a
1993 tentative final monograph, FDA suggested 30 as the upper SPF limit
because it was felt that anything above this offers little additional
benefit and might expose people to dangerous levels of chemicals.

FDA also advised manufacturers that "water-resistant" or
"sweat-resistant" products must list an SPF for both before and after
being exposed to water or sweat. FDA also proposed that products
claiming to be sunblocks have an SPF of at least 12 and contain titanium
dioxide, the only opaque agent that blocks light. Also, any tanning
product that doesn't contain a sunscreen would have to state on the
label that the product does not contain a sunscreen, according to the
tentative final monograph.

Manufacturers may already be following these recommendations.

Experts recommend broad-spectrum products with SPFs of at least 15. They
also suggest applying the product liberally--about 30 milliliters (1
ounce) per application for the average-size person, according to The
Skin Cancer Foundation--15 to 30 minutes every time before going
outdoors. It should be applied evenly on all exposed skin, including
lips, nose, ears, neck, scalp (if hair is thinning), hands, feet, and
eyelids, although care should be taken not to get it in the eyes because
it can irritate them. If contact occurs, rinse eyes thoroughly with
water.

Sunscreens should not be used on babies younger than 6 months because
their bodies may not be developed enough to handle sunscreen chemicals.
If you think your baby may need a sunscreen, check with your
pediatrician.

For children 6 months to 2 years, use a sunscreen with at least an SPF
of 4, although 15 or higher is best.

Use sunscreen products regularly on children, advises Stephen Katz,
M.D., Ph.D., director of the National Institute of Arthritis and
Musculoskeletal and Skin Diseases and chief of the National Cancer
Institute's dermatology branch. "Get them used to it, so they can use it
regularly like toothpaste," Katz says.

3. Wear a hat. 

A hat with at least a 3-inch brim all around is ideal because it can
protect areas often exposed to the sun, such as the neck, ears, eyes,
and scalp. A shade cap (which looks like a baseball cap with about 7
inches of material draping down the sides and back) also is good. These
are often sold in sports and outdoor clothing and supply stores.

A baseball cap or visor provides only limited protection but is better
than nothing.

4. Wear sunglasses. 

Sunglasses can help protect your eyes from sun damage.

The ideal sunglasses don't have to be expensive, but they should block
99 to 100 percent of UVA and UVB radiation. Check the label to see that
they do. If there's no label, don't buy the glasses. And, don't go by
how dark the glasses are because UV protection comes from an invisible
chemical applied to the lenses, not from the color or darkness of the
lenses.

Large-framed wraparound sunglasses are best because they can protect
your eyes from all angles.

Children should wear sunglasses, too, starting as young as 1, advises
Gerhard Cibis, a pediatric ophthalmologist in Kansas City, Mo. They need
smaller versions of real, protective adult sunglasses--not toy
sunglasses. Kids' sunglasses are available at many optical stores, Cibis
says.

Ideally, says the American Academy of Ophthalmology, all types of
eyewear, including prescription glasses, contact lenses, and intraocular
lens implants used in cataract surgery, should absorb the entire UV
spectrum.

You may want to put sunscreen on the eyelids and around the eyes, too,
even if you're wearing sunglasses. According to Cibis, sunglasses
prevent UV rays from getting into the eyes; they won't help protect the
skin around them.


5. Cover up. 

Wear lightweight, loose-fitting, long-sleeved shirts, pants or long
skirts as much as possible when in the sun. Most materials and colors
absorb or reflect UV rays. Tightly weaved cloth is best. 

Avoid wearing wet clothes, such as a wet T-shirt, because when clothes
get wet, the sun's rays can more easily pass through. If you see light
through a fabric, UV rays can get through, too.

This year, FDA will adopt a policy in which so-called "sun-protective"
clothing will be regulated by the agency only if the clothing's label
makes a medical claim, such as that it prevents skin cancer. In March,
FDA was working on a proposed rule to address this new policy. Under the
new policy and as of March, no products on the market would qualify as
sun-protective clothing.

6. Avoid artificial tanning. 

Many people believe that the UV rays of tanning beds are harmless
because sunlamps in tanning beds emit primarily UVA and little, if any,
UVB, the rays once thought to be the most serious. However, UVA can
cause serious skin damage, too. According to some scientists, UVA may be
linked to the most serious form of skin cancer, melanoma. A 1996
unpublished risk analysis by FDA scientists Sharon Miller, Scott
Hamilton and Howard Cyr, Ph.D., concluded that people who use sunlamps
about 100 times a year may be in creasing their exposure to
"melanoma-inducing" radiation by up to 24 times compared with the amount
they would receive from the sun. This would depend on the type of
sunlamp used and whether sunscreen is used regularly. The authors note
that home users are a major concern because they may use their sunlamps
as often as every day. But, Miller said, "This analysis was based on
data from a nonmammalian animal model, and thus the conclusions must be
regarded with caution."

Because of sunlamps' dangers, health experts advise people to avoid them
for tanning.

Sunlamps remain on the market because, according to George Jan, Ph.D., a
physicist in FDA's Center for Devices and Radiological Health, they
represent an alternative to the sun, and unlike the sun, can be
regulated to promote greater safety.

Under FDA regulations, sunlamp products must:


 * have a timer to limit the amount of exposure a person can receive

 * have a control that can turn off the sunlamp

 * have a label with recommended exposure position or distance from the
   sunlamp to reduce the risk of overexposure, even when the timer is
   set at its maximum limit

 * limit the amount of short-wave UV radiation emitted from the product

 * come with UV-blocking goggles, which the user should always wear

 * carry a prominent warning about the dangers of overexposure,
   especially to those who are sensitive t o UV radiation

 * provide information on proper use.

Several products that claim to give a tan without UV radiation carry
safety risks, too. These include so-called "tanning pills" containing
carotenoid color additives derived from substances similar to
beta-carotene, which gives carrots their orange color. The additives are
distributed throughout the body, especially in skin, making it orange.
Although FDA has approved some of these additives for coloring food, it
has not approved them for use in tanning agents. And, at the high levels
that are consumed in tanning pills, they may be harmful. According to
John Bailey, Ph.D., acting director of FDA's Office of Cosmetics and
Colors, the main ingredient in tanning pills, canthaxanthin, can deposit
in the eyes as crystals, which may cause injury and impaired vision.
There also has been one reported case of a woman who died from aplastic
anemia, which her doctor attributed to her use of tanning pills.

Tanning accelerators, such as those formulated with the amino acid
tyrosine or tyrosine derivatives, are ineffective and also may be
dangerous. Marketers promote these products as substances that stimulate
the body's own tanning process, although the evidence suggests they
don't work, Bailey says. FDA considers them unapproved new drugs that
have not been proved safe and effective.

Two other tanning products, bronzers and extenders, are considered
cosmetics for external use. Bronzers, made from color additives approved
by FDA for cosmetic use, stain the skin when applied and can be washed
off with soap and water. Extenders, when applied to the skin, interact
with protein on the surface of the skin to produce color. The color
tends to wear off after a few days. The only color additive approved for
extenders is dihydroxyacetone.

Although they give skin a golden color, these products do not offer
sunscreen protection. Also, the chemicals in bronzers may react
differently on various areas of your body, producing a tan of many
shades.

7. Check skin regularly. 

You can improve your chances of finding precancerous skin conditions,
such as actinic keratosis--a dry, scaly, reddish, and slightly raised
lesion--and skin cancer by performing simple skin self-exams regularly.
The earlier you identify signs and see a doctor, the greater the chances
for successful treatment.

The best time to do skin exams is after a shower or bath. Get used to
your birthmarks, moles and blemishes so that you know what they usually
look like and then can easily identify any changes they undergo. Signs
to look for are changes in size, texture, shape, and color of blemishes
or a sore that does not heal.

If you find any changes, see your doctor. Also, during regular checkups,
ask your doctor to check your skin.

The more of these practices you can incorporate into your life, the
greater your chances of reducing the damage sun can cause. And by
teaching these same practices to your children, you can help them get
off to a lifetime of safer sun practices.

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


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What's Your Risk of Skin Damage?

Take extra care to protect babies and children from the sun. Studies
show that one or more severe, blistering sunburns as a child or teenager
could increase the risk for melanoma, an often fatal form of skin
cancer.

You need to be especially careful to play it safe in the sun if you:


 * have fair skin; blond, red, or light brown hair; and blue green, or
   gray eyes

 * have freckles and burn before tanning

 * spend a lot of time outdoors

 * were previously treated for skin cancer

 * have a family history of skin cancer, especially melanoma

 * work indoors all week and then try to catch up on your tan on
   weekends

 * live or vacation at high altitudes (ultraviolet radiation from the
   sun increases 4 to 5 percent for every 1,000 feet above sea level)

 * live or vacation close to the equator

 * have certain diseases, such as lupus erythematosus

 * take certain medicines, including:

    * acne medicines
    * antibiotics, such as tetracyclines
    * antihistamines
    * oral contraceptives containing estrogen
    * nonsteroidal anti-inflammatory drugs, such as naproxen sodium
    * phenothiazines (major tranquilizers and anti-nausea drugs)
    * sulfa drugs
    * tricyclic antidepressants
    * thiazide diuretics
    * sulfonylureas, such as oral anti-diabetics.


Ask your doctor about the risk of any medicines you may be taking that
could be harmful to you when you are in the sun. (See "Chemical
Photosensitivity: Another Reason to Be Careful in the Sun" in the May
1996 FDA Consumer.)

--P.K.


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Which Sunscreen Product for You?


Sunburn and Tanning History and Recommended SPF*

Always burns easily; rarely tans: 20 to 30

Always burns easily; tans minimally: 2 to under 20

Burns moderately; tans gradually: 8 to under 12

Burns minimally; always tans well: 4 to under 8

Rarely burns, tans profusely: 2 to under 4

*Sun protection factor

(Source: FDA's 1993 tentative final monograph on sunscreen drug products)


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Monthly Skin Self-Examination

[graphic illustrating examination steps omitted]

1.Examine your body, front and back, in the mirror, then the right and
left sides with arms raised.

2.Examine back of neck and scalp with the help of a hand mirror--part
hair or use blow dryer to lift hair and give you a close look.

3.Check back and buttocks with hand mirror.

4.Bend elbows and look carefully at forearms, upper underarms, and
palms.

5.Look at backs of the legs and feet, including the soles and spaces
between toes.

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Organ Transplants from Animals:
Examining the Possibilities

by Rebecca D. Williams 

"You'll need a liver transplant," Dr. Zeno says. She scribbles quickly
on her prescription pad and dates it: April 17, 2025. "Take this to the
hospital pharmacy and we'll schedule the surgery for Friday morning."

The patient sighs--he's visibly relieved that his body will be rid of
hepatitis forever.

"What kind of liver will it be?" he asks.

"Well, it's from a pig," Zeno replies. "But it will be genetically
altered with your DNA. Your body won't even know the difference."

Obviously, this is science fiction. But according to some scientists, it
could be a reality someday. An animal organ, probably from a pig, could
be genetically altered with human genes to trick a patient's immune
system into accepting it as its own flesh and blood.

Called "xenotransplants," such animal-to-human procedures would be
lifesaving for the thousands of people waiting for organ donations.
There have been about 30 experimental xenotransplants since the turn of
the century.



Rebuilding Bodies 

Xenotransplants are on the cutting edge of medical science, and some
scientists think they hold the key not only to replacing organs, but to
curing other deadly diseases as well.

Last December, for example, after getting permission from the Food and
Drug Administration, researchers at the University of California, San
Francisco, injected an AIDS patient with baboon bone marrow. The hope
was that the baboon bone marrow, which is resistant to HIV and a source
of immune cells, could provide a replacement for the patient's damaged
immune system.

In April 1995, also with FDA permission, doctors at Lahey Hitchcock
Medical Center in Burlington, Mass., injected fetal pig brain cells into
the brains of patients with advanced Parkinson's disease. The hope was
that the fetal tissue would produce dopamine, which the patients' brains
lack. Both experiments were primarily to test the safety of such
procedures, not whether they are effective.

Other xenotransplant experiments have involved implanting animal hearts,
livers and kidneys into humans.

According to Scott McCartney's book on transplantation, Defying the
Gods: Inside the New Frontiers of Organ Transplants, the first organ
transplant was performed in the early twentieth century by Alexis
Carrel, a French physician practicing in Chicago. He had developed a
technique to sew blood vessels together, and in 1906 he transplanted a
new heart into a dog and a new kidney into a cat.

The first animal-to-human transplant was in the same year, when the
French surgeon Mathieu Jaboulay implanted a pig's kidney into one woman
and a goat's liver into another. Neither survived.

Today, human organ transplants are commonplace. For example, more than
10,000 Americans received kidney transplants last year, with a
three-year life expectancy of more than 85 percent, according to the
United Network for Organ Sharing (UNOS), an organization of transplant
programs and laboratories in the United States. Under contract to the
U.S. Department of Health and Human Services, UNOS administers a
national organ network, and its members set policies for equitable organ
allocation.

Surgeons have made great strides in perfecting transplant techniques,
but two problems endure. First, there are never enough organs to go
around (see "Transplant Organs: Too Little, Too Late"). Second, once
patients receive organs, it is a constant battle to keep their immune
systems from rejecting them. Both problems may be eventually solved by
xenotransplants and the genetic engineering techniques developed from
such experiments.

Of all animals, baboons and pigs are the favored xenotransplant donors.
Baboons are genetically close to humans, so they're most often used for
initial experiments. Six baboon kidneys were transplanted into humans in
1964, a baboon heart into a baby in 1984, and two baboon livers into
patients in 1992.

Although all the patients died within weeks after their operations, they
did not die of organ rejection. Rather, they died of infections common
to patients on immunosuppressive drugs.

One drawback to using baboons is that they harbor many viruses. They
also reproduce slowly, carrying only one offspring at a time. Some
people have raised ethical objections, especially since baboons are so
similar to humans. They have human-like faces and hands and a highly
developed social structure. Although it's conceivable that baboons could
donate bone marrow without being killed, recent experiments have
required extensive tissue studies, and the animals have been sacrificed.

<Picture: [comparison of human and pig hearts and kidneys]>

For long-term use, pigs may be a better choice. Pigs have anatomies
strikingly similar to that of humans. Pigs are generally healthier than
most primates and they're extremely easy to breed, producing a whole
litter of piglets at a time. Moral objections to killing pigs are fewer
since they're slaughtered for food.

Pig organs have been transplanted to humans several times in the last
few years. In 1992, two women received pig liver transplants as
"bridges" to hold them over until human transplants were found. In one
patient, the liver was kept outside the body in a plastic bag and hooked
up to her main liver arteries. She survived long enough to receive a
human liver. In the other patient, the pig liver was implanted alongside
the old diseased liver, to spare the patient the rigors of removing it.
Although that patient died before a human transplant could be found,
there was some evidence that the pig liver had functioned for her.

By genetically altering pig livers, some scientists believe they can
make a pig liver bridge more successful. In July 1995, FDA permitted the
Duke University Medical Center to test genetically altered pig livers in
a small number of patients with end-stage liver disease. The pig livers
contained three human genes that will produce human proteins to counter
the rejection process.

Safe or Disastrous? 

Xenotransplantation could be very good news for patients with end-stage
organ diseases. There would be no more anxious months of waiting for an
organ donor. Disease-free pigs would provide most of the organs. Raised
in sterile environments, they would be genetically altered with human
DNA so that the chance of rejection is greatly reduced.

Transplant surgery would be scheduled at the patient's convenience, as
opposed to emergency surgery performed whenever a human donor is found.
Patients wouldn't have to wait until their diseases were at a critical
stage, so they would be stronger for recovery.

Today, however, xenotransplantation is still experimental, and there are
serious risks to the procedures.

Although many researchers believe it is slight, one legitimate concern
is that animal diseases will be transmitted into the human population.
Baboons and swine both carry myriad transmittable agents that we know
about--and perhaps many more we cannot yet detect. These bacteria,
viruses and fungi may be fairly harmless in their natural host, a baboon
or pig, yet extremely toxic--even deadly--in humans.

The two types of animal viruses that are especially troublesome are
herpes viruses and retroviruses. Both types have already been proven to
be rather harmless in monkeys, but fatal to humans. HIV, for example, is
a retrovirus that many researchers believe was transmitted to humans
from monkeys. The problem occurs in reverse as well. Measles, for
example, a serious but manageable disease in humans, can destroy a whole
colony of monkeys quickly.

By regulating xenotransplants, FDA will provide a framework for
collecting safety data and tracking patients' health. The process should
involve open and public discussion by scientists about their
experiments, allowing their peers to evaluate and critique them, and
their patients to understand the risks and make informed decisions.

"Will [xenotransplants] cause an outbreak of a new infectious disease?
We don't know," says Phil Nogouchi, M.D., a pathologist and director of
FDA's division of cellular and gene therapies. "But we want all these
procedures discussed in public. We need to make people aware of the
hazards."

Nogouchi emphasizes the importance of monitoring and tracking all
recipients of xenotransplants so that if any new diseases do develop,
they will be detected quickly and the threat to public health will be
minimized.

"We cannot say that's not a possibility," says Nogouchi. "But we do feel
the potential benefits are great and that efforts can be made to make
everyone responsible. There are ways to deal with problems should they
arise."

At press time, FDA, the national Centers for Disease Control and
Prevention, and the National Institutes of Health were working on
recommendations for researchers doing xenotransplant experiments.

Although the new recommendations will be for researchers, patients will
likely also recognize their importance.

"Our biggest allies are the patients," says Nogouchi. "They should be
asking, 'Where'd you get that pig?'" Xenotransplants cannot be "fresh
off the farm." They should be bred and raised in a biomedical animal
facility under strict conditions.

Battling Rejection 

The other formidable obstacle to xenotransplants is that posed by the
human body's own immune system. Even before a person is born, his or her
immune system learns to detect and resist foreign substances in the body
called antigens. These could be from anything that's not supposed to be
there: viruses, bacteria, bacterial toxins, any animal organs, or even
artificial parts.

Antigens trigger the body's white blood cells, called lymphocytes, to
produce antibodies. Different lymphocytes recognize and produce
antibodies against particular antigens. B cell lymphocytes produce
antibodies in the blood that remove antigens by causing them to clump or
by making them more susceptible to other immune cells. T cell
lymphocytes activate other cells that cause direct destruction of
antigens or assist the B cells.

Transplant physicians try to suppress the immune system with powerful
drugs. While these drugs are often successful, they leave the patient
vulnerable to many infections. FDA-approved immunosuppressive drugs
include Sandimmune (cyclosporine), Imuran (azathioprine), Atgam
(lymphocyte immune globulin), Prograf (tarolimus), and Orthoclone
(muromonab-CD3). New drugs are also being researched, including some
"designer" immune suppressants. These drugs may enable doctors to
suppress the immune system from rejecting a particular organ, but leave
the rest of the body's immune system intact.

Drugs designed to help transplant patients may end up also aiding those
who are stricken with diseases such as arthritis, multiple sclerosis and
diabetes, because these involve problems with the human immune system.
For example, Imuran is approved to treat severe rheumatoid arthritis,
and Prograf has already shown some promise to MS patients. A large study
is under way to determine if it is effective. 

Genetic engineering is the next step in battling organ rejection.
Researchers have begun experimenting with ways to insert human genes
into animal organs, so that the organs will produce proteins the body
will recognize as "human." FDA is active in basic research that may lead
to better gene therapies and ways of manipulating animal organs.

For example, Judy Kassis, Ph.D., an FDA biochemist, has been studying a
fruit fly gene that is important to the insects' early development.
Using some DNA and a harmless virus, she has developed a way to insert
this gene precisely into its natural position on the fly's chromosomes.
Carolyn Wilson, Ph.D., an FDA virologist, has been researching pig
viruses and whether they could infect humans in a transplant setting.

FDA scientists are also studying ways that individual genes "turn on" as
they develop, how viruses activate each other, and how viruses can be
used safely to deliver genes for new therapies.

"Gene therapy is really in its infancy," says Kassis. "That's the thing
about basic research--you can't really predict how useful this will be
in the future. Hopefully, it will have direct relevance someday."

Gene therapies and their role in xenotransplantations are still in the
early stages of development. For now, it's only in science fiction that
doctors can order a custom-designed pig liver from the hospital
pharmacy. Whether or not that ever becomes reality, FDA's goal in
regulating xenotransplant experiments is to make sure these procedures
are openly discussed, that data is carefully collected, that patients
give their fully informed consent, and that safety precautions are taken
with every effort.

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


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Transplant Organs: Too Little, Too Late

For patients with severe kidney failure, liver disease, heart defects,
and other diseases, an organ transplant is often their only hope for
survival. Surgeons have made great strides in transplant techniques, yet
many patients never get the benefit of them. There are simply not enough
organs to go around.

Human organs must be taken quickly from healthy people who have died
through trauma such as car and motorcycle wrecks. The potential donor
pool is small, and only about 20 percent of the families of trauma
victims consent to have their loved ones become donors. Stricter seat
belt and helmet laws have reduced motor vehicle deaths and the numbers
of potential donors.

Even with increased public awareness of the need for organ donors,
transplant surgeons predict the shortage will only get worse.

As of January, there were 44,000 Americans waiting for organ
transplants, yet only 18,270 transplants were performed last year,
according to the United Network for Organ Sharing, the organization that
oversees organ donations. More than 28,000 people die of liver failure
each year, yet only about 3,800 donors are available. Thousands of
people die every year waiting for other organs. Many more never make the
organ recipient list because they are too ill to receive one.

Organ donation is free to the donor. After organs are removed, the body
is suitable for viewing and burial. Becoming a donor is simple--there
are organ donor cards on the back of driver's licenses in many states.
Even if you sign a card, make sure your family knows you want to be an
organ donor. Hospital staffs always ask permission before arranging for
donations.

--R.D.W. 

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

Infant Formula:
Second Best but Good Enough

by Isadora B. Stehlin 

A century ago, babies who couldn't be breast-fed usually didn't survive.
Today, although breast-feeding is still the best nourishment for
infants, infant formula is a close enough second that babies not only
survive but thrive.

Commercially prepared formulas are regulated by the Food and Drug
Administration.

The safety of commercially prepared formula is also ensured by the
agency's nutrient requirements (see "Nutrient Requirements") and by
strict quality control procedures that require manufacturers to analyze
each batch of formula for required nutrients, to test samples for
stability during the shelf life of the product, to code containers to
identify the batch, and to make all records available to FDA
investigators.

The composition of infant formula is similar to breast milk, but it
isn't a perfect match, because the exact chemical makeup of breast milk
is still unknown.

Human milk is very complex, and scientists are still trying to unravel
and understand what makes it such a good source of nutrition for rapidly
growing and developing infants. However, John C. Wallingford, Ph.D., an
infant nutrition specialist with FDA's Center for Food Safety and
Applied Nutrition, notes that "infant formula is increasingly close to
breast milk."

More than half the calories in breast milk come from fat, and the same
is true for today's infant formulas. This may be alarming to many
American adults watching their intake of fat and cholesterol, especially
when sources of saturated fats, such as coconut oil, are used in
formulas. (In adults, high intakes of saturated fats tend to increase
blood cholesterol levels more than other fats or oils.) But the low-fat
diet recommended for adults doesn't apply to infants.

"Infants have a very high energy requirement, and they have a restricted
volume of food that they can digest," says Wallingford. "The only way to
get the energy density of a food up is to have a high amount of fat."

While greater knowledge about human milk has helped scientists improve
infant formula, it has become "increasingly apparent that infant formula
can never duplicate human milk," write John D. Benson, Ph.D, and Mark L.
Masor, Ph.D., in the March 1994 issue of Endocrine Regulations. "Human
milk contains living cells, hormones, active enzymes, immunoglobulins
and compounds with unique structures that cannot be replicated in infant
formula."

Benson and Masor, both of whom are pediatric nutrition researchers at
infant formula manufacturer Abbott Laboratories, believe creating
formula that duplicates human milk is impossible. "A better goal is to
match the performance of the breastfed infant," they write. Performance
is measured by the infant's growth, absorption of nutrients,
gastrointestinal tolerance, and reactions in blood.

Wallingford agrees, explaining that while FDA's regulations on what goes
into infant formula are to ensure there are enough nutrients, "that's
just a starting point. What's really important is how infants thrive."

Cow's Milk or Soy? 

Normal, full-term infants should get a conventional cow's-milk-based
formula, says John N. Udall Jr., M.D., chief of nutrition and
gastroenterology at Children's Hospital of New Orleans. However, adverse
reactions to the protein in cow's milk formula or symptoms of lactose
intolerance (lactose is the carbohydrate in cow's milk) may require
switching to another type of formula, he says.

Symptoms that may indicate an adverse reaction to cow's milk protein
include vomiting, diarrhea, abdominal pain, and rash. With lactose
intolerance, the most common symptoms are excessive gas, abdominal
distension and pain, and diarrhea. Since some of the symptoms overlap, a
stool test may be necessary to determine the culprit. Usually, lactose
intolerance will produce acidic stools that contain glucose. If the
protein is the problem, stools will be nonacidic and have flecks of
blood.

The main alternative to cow's milk formula is soy formula. About 20
percent of the formula sold in the United States is soy. "Lactose
intolerance is probably the biggest reason to switch to soy formula,"
says William J. Klish, M.D., chairman of the American Academy of
Pediatrics Committee on Nutrition. 

The carbohydrates in most soy formulas are sucrose and corn syrup, which
are easily digested and absorbed by infants. However, soy is not as good
a protein source as cow's milk. Also, babies don't absorb some minerals,
such as calcium, as efficiently from soy formulas. Therefore, according
to the American Academy of Pediatrics, "Healthy full-term infants should
be given soy formula only when medically necessary."

For a child who can't tolerate cow's milk protein, Klish recommends the
use of hydrolyzed-protein formula. Although hydrolyzed-protein formulas
are made from cow's milk, the protein has been broken up into its
component parts. Essentially, it's been predigested, which decreases the
likelihood of an allergic reaction. 

Iron 

The infant formulas currently available in the United States are either
"iron-fortified"--with approximately 12 milligrams of iron per liter--or
"low iron"--with approximately 2 milligrams of iron per liter.

"There should not be a low-iron formula on the market for the average
child because a low-iron formula is a nutritionally deficient formula,"
says Klish. "It doesn't provide enough iron to maintain proper blood
cell counts or proper hemoglobin." (Hemoglobin is a blood protein that
carries oxygen from the lungs to the tissues, and carbon dioxide from
the tissues to the lungs.)

In addition, studies have shown that school children who had good iron
status as infants because they were fed iron-fortified formula performed
better on standardized developmental tests than children with poor iron
status. However, Wallingford says that "FDA has permitted marketing of
low-iron formulas because some pediatricians prefer to use them, with
the caveat that the physician would be monitoring iron status and
prescribing iron supplements when appropriate."

Why is there low-iron formula on the market? "In the past there have
been a lot of symptoms that have been attributed to iron, including
abdominal discomfort, constipation, diarrhea, colic, and irritability,"
says Klish. "Also there was some concern about too much iron interfering
with the immune system. All of those concerns and questions have been
laid to rest with appropriate studies."

Another reason for originally producing low-iron formulas was that human
milk contains low amounts of iron--less than a milligram per liter.
However, it is now understood that an infant absorbs virtually 100
percent of the iron from human milk, but considerably less from infant
formula.

Researchers continue to try to determine the best amount of iron for
infant formula. While low-iron formulas don't supply enough iron, the
best amount of iron for formulas has not been established. "We did not
have much data at the time the regulations were written for different
intake levels of iron," says Wallingford. He explains that the current
amounts give good developmental results, "but, based on European
experience, half [of the high level] is probably good enough to do the
same thing." Currently, the Federation of American Societies for
Experimental Biology is evaluating what the best levels may be and will
make recommendations to FDA on what levels of iron to require in
formulas. The study is also reviewing the level of all other nutrients
in infant formula, as well as the need for nutrients not currently
included.

Cooking Lessons 

Both milk and soy formulas are available in powder, liquid concentrate,
or ready-to-feed forms. The choice should depend on whatever the parents
find convenient and can afford.

Whatever form is chosen, proper preparation and refrigeration are
essential. Opened cans of ready-to-feed and liquid concentrate must be
refrigerated and used within the time specified on the can. Once the
powder is mixed with water, it should also be refrigerated if it is not
used right away. The exact amounts of water recommended on the label
must be used. Under-diluted formula can cause problems for the infant's
organs and digestive system. Over-diluted formula will not provide
adequate nutrition, and th e baby may fail to thrive and grow.

Until recently, the American Academy of Pediatrics felt that municipal
water supplies were safe enough without boiling the water before mixing
with the formula. But because of the contamination of Milwaukee's water
with the parasite Cryptosporidium in 1993, "the whole business of
boiling water has come up again," says Klish. "The academy is now again
recommending boiling water for infant formulas."

Klish advises heating the water until it reaches a rolling boil,
continue to boil for one to two minutes, and then let it cool. "That
should take care of all the bacteria and parasites that might be in the
water," he explains.

The American Academy of Pediatrics does not have any recommendations
about bottled water. Klish says bottled water is fine, but it still
needs to be boiled. "There's no reason to think that bottled water is
any safer than city water," he says. 

Bottled water must meet specific FDA quality standards for contaminants.
These are set in response to requirements that the Environmental
Protection Agency has established for tap water.

A new regulation published in the Nov. 13, 1995, Federal Register sets
standard definitions for different types of bottled waters, helping
resolve possible confusion about what different terms mean. 

The regulation also requires accurate labeling of bottled waters
marketed for infants. If a product is labeled "sterile," it must be
processed to meet FDA's requirements for commercial sterility.
Otherwise, the labeling must indicate that it is not sterile and should
be used as directed by a physician or according to infant formula
preparation instructions.

What about sterilizing the bottles and nipples? "Dishwashers tend to
sterilize bottles and nipples fairly well," says Klish. They can also be
sterilized by placing in a pan of boiling water for five minutes.

Warming the formula before feeding isn't necessary for proper nutrition,
but most infants prefer the formula at least at room temperature. The
best way to warm a bottle of formula is by placing the bottle in a pot
of water and heating the pot on the stove.

Don't Try This at Home

Homemade formulas should not be used, says Nick Duy, a consumer safety
officer in FDA's Office of Special Nutritionals. Homemade formulas based
on cows' milk don't meet all of an infant's nutritional needs, and cow's
milk protein that has not been cooked or processed is difficult for an
infant to digest. In addition, the high protein and electrolyte (salt)
content of cow's milk may put a strain on an infant's immature kidneys.
Substituting evaporated milk for whole milk may make the homemade
formula easier to digest because of the effect of processing on the
protein, but the formula is still nutritionally inadequate and still may
stress the kidneys.

Today's infant formula is a very controlled, high-tech product that
can't be duplicated at home, says Udall.

Isadora B. Stehlin is a member of FDA's public affairs staff. 


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


Nutrient Requirements

FDA regulations specify minimum and, in some cases, maximum nutrient
level requirements for infant formulas, based on recommendations by the
American Academy of Pediatrics Committee on Nutrition. The following
must be included in all formulas:

 * protein
 * fat
 * linoleic acid
 * vitamin A
 * vitamin D
 * vitamin E
 * vitamin K
 * thiamin (vitamin B1)
 * riboflavin (vitamin B2)
 * vitamin B6
 * vitamin B12
 * niacin
 * folic acid
 * pantothenic acid
 * vitamin C
 * calcium
 * phosphorus
 * magnesium
 * iron
 * zinc
 * manganese
 * copper
 * iodine
 * sodium
 * potassium
 * chloride

In addition, formulas not made with cow's milk must include biotin,
choline and inositol.


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


Whole Milk for First Birthday

There's nothing like a cold glass of milk with a slice of birthday cake.
That works out great for babies because, in general, parents should stop
the formula and introduce milk around the time of a baby's first
birthday. 

The milk, however, should be whole milk. Low-fat and skim milk do not
have enough fat and calories to supply the nutritional needs of a
1-year-old, explains John Udall, chief of nutrition and gastroenterology
at Children's Hospital of New Orleans. At that age, "the child is
growing so quickly, and the fat is so important for brain and central
nervous system development," he says. "The recommendation that our daily
intake of fat should compose less than 30 percent of our caloric intake
does not apply to children under 2 years of age."

New on the market are special toddler formulas that claim to be better
than milk. The formulas are good nutritionally, says Udall, but they're
not necessary. "A well-balanced diet with milk and juices would be just
as good in a healthy, normally active, normally growing child," says
Udall.

William Klish, chairman of the American Academy of Pediatrics Committee
on Nutrition, says that if a child needs to take a vitamin supplement,
the toddler formula, fortified with a full range of vitamins and
minerals, including iron, can serve that purpose. In addition, the
toddler formulas don't need refrigeration, making them a convenient
choice for snacks away from home.

--I.B.S. 


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


Counterfeit Formulas

In February 1995, FDA special agents arrested a suspect in Southern
California in a scheme to distribute infant formula in counterfeit
packaging. The agency also seized 17,236 kilograms (38,000 pounds) of
powdered formula at the suspect's counterfeit manufacturing operations
in Southern California and 6,366 0.45-kilogram (1-pound) cans from
retail and wholesale outlets.

The scheme involved the purchase of bulk infant formula labeled "for
export only" from a legitimate manufacturer. The bulk formula was then
packaged in the 1-pound cans that looked like Similac, an authentic
formula made by Ross Products Division of Abbott Laboratories, Columbus,
Ohio. 

The agency did not receive any reports of illness attributable to the
counterfeit formula.

The California counterfeit scheme has been completely suppressed, but it
is just part of a diversion market in numerous products. One of FDA's
concerns is the conditions the formula is subjected to during the
illegal manufacturing operations.

Production records like those normally kept by legitimate manufacturers
don't exist, explains Jim Dahl, assistant director of FDA's Office of
Criminal Investigations. "How it was transported, what temperature
conditions, what sanitary conditions, how cans were treated, how long
they were held in those conditions, all of that is unknown," he says.

To protect their babies, parents need to be on the lookout for any
changes in formula color, smell or taste, Dahl says. He also advises
parents and retailers to:

 * make sure lot numbers and expiration dates on both the can and the
   cardboard case are the same

 * check containers for damage

 * call the manufacturer's toll-free number with any concerns or
   questions.

--I.B.S. 

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

Health Information On-Line

by Marilynn Larkin 

Consumers are using the Internet to get information about health. How
reliable is this information? That's not an easy question to answer.

It's no secret that the Internet--especially its graphics portion, the
World Wide Web--is enjoying unprecedented popularity in business and
professional communities, and in homes across America. A recent survey
by the Times Mirror Center for the People & the Press revealed that the
number of Americans subscribing to on-line services jumped from 5
million at the end of 1994 to nearly 12 million in mid-1995, while an
additional 2 million people have direct connections to the Internet.

Among people with home offices, approximately one-third have access to
the Internet, and, of these, about 10 percent have a home page on the
Web, according to a survey conducted by the Gallup Organization and
reported in the Dec. 19, 1995, issue of PC Magazine.

Another survey, by CDB Research & Consulting, indicates that consumers
are showing a growing interest in obtaining information about health and
beauty aids on-line as a means of supplementing traditional medical
counsel. The company speculates that the discretion and convenience of
the on-line environment may hold special appeal to people with
disabilities and chronic illnesses.

However, easy access to virtually limitless health and medical
information has pitfalls, experts caution. "My advice to consumers about
information on the Internet is the same as it is for other media: You
can't believe everything you see, whether it's in a newspaper, on TV, or
on a computer screen," says Bill Rados, director of FDA's Communications
Staff. Since anyone--reputable scientist or quack--who has a computer, a
modem (the device that permits a computer to dial and connect to the
Internet or an on-line service), and the necessary software can publish
a Web page, post information to a newsgroup, or proffer advice in an
on-line chat room, "you must protect yourself by carefully checking out
the source of any information you obtain."

World Wide Web 

By far, the most consumer-friendly part of the Internet is the World
Wide Web. It is also the newest part of the Internet, having become
accessible only in the past couple of years, with the wider availability
of browsers such as Mosaic and Netscape Navigator. While the rest of the
Internet displays text only, the Web, as it has come to be called, has
the ability to display colorful graphics and multimedia (sounds, video,
virtual reality) to complement text-based information. For example,
sites that offer m edical information on neurological diseases, such as
stroke, may also contain images of the brain showing which areas are
affected by disease or may have downloadable (files that can be copied
from one computer to another) "movies" of actual magnetic resonance
imaging (MRI) exams pinpointing blockages in blood vessels.

Many legitimate providers of reliable health and medical information,
including FDA and other government agencies, are taking advantage of the
Web's popularity by offering brochures and in-depth information on
specific topics at their Web sites. Material may be geared to consumers
as well as industry and medical professionals (see "Sources of Internet
Health Information").

But con artists have also infiltrated the Web. "A physician was browsing
the Web when he came across a site that contained a fraudulent drug
offering. He called us to report it," says Roma Jeanne Egli, a
compliance officer in FDA's division of drug marketing. "The person who
maintains the site claimed he had a cure for a very serious disease, and
advised those with the disease to stop taking their prescription
medication. Instead, they were told to buy the product he was selling,
at a cost of several hundre d dollars."

More details can't be released because FDA has a case pending against
the Web site owner who, according to Egli, has a history of marketing
bogus cures. She advises consumers to be skeptical when someone
advocates a purported "cure" to be purchased and taken in lieu of
prescribed medicine.

If you come across a suspected fraudulent offering on the Internet,
alert FDA by E-mail: otcfraud@cder.fda.gov. 

If con artists and scientists have equal publishing rights on the
Internet, what's to keep a health-conscious consumer from getting
sidetracked by an official-looking page offering unsound advice?

"This is a real concern," says Valencia Camp, of FDA's Office of
Information Resources Management. "Although the Internet can be a
reliable source of information, it is important to be aware that what is
found there is only as good as the quality and integrity of the original
information. What you find cannot be taken as gospel. It should be
checked out and supported by other sources." (See "Is This Site
Reliable?")

FDA On-Line 

The FDA home page provides an excellent jumping off point for those who
want to learn more about the agency and the drugs, food supplements, and
medical devices it regulates. "Twenty-five cents of every dollar spent
by consumers goes for something that FDA regulates," Rados notes. These
products "could be used more safely and more effectively if people know
more about them." Because it is expensive to print and mail materials,
FDA offers many of its publications on the Internet, including the text
of this m agazine.

FDA material can be downloaded to a home or office computer and then
printed out. Those who don't have a personal computer can try accessing
the Internet from their local library or from a community organization.
If you have a computer but do not have Internet access, you can receive
text from FDA's site (no graphics) by dialing by modem the agency's
bulletin board service (BBS): (1-800) 222-0185; type "bbs" and select
the information you want from the menu.

"Our goal is to have virtually all consumer education material available
on the Internet," says Rados. "Every new piece we publish is immediately
placed on our Web site. We now have more than a hundred different
publications to choose from." FDA also has a "comments" button on many
of its Web pages so that visitors can offer suggestions and feedback.
However, questions about specific drugs, devices, or food supplements
should be addressed to the agency in writing at "FDA" (HFE-88),
Rockville, MD 20857, or b y calling your local public affairs specialist
listed under FDA in your local phonebook, Rados adds. Before beginning
any particular therapy, however, consult with your doctor or pharmacist.

In addition to providing consumer education materials, the FDA site also
offers technical information to help industry professionals file
regulatory materials.

Exchanging Information 

In Internet "newsgroups," such as Usenet groups, people post questions
and read messages much as they would on regular bulletin boards. Through
"mailing lists," messages are exchanged by E-mail, and all messages are
sent to all group subscribers. In "chat" areas on some services and on
the Internet's IRC (Internet Relay Chat) users can communicate with each
other live. 

Assessing the value and validity of health and medical information in
news and chat groups demands at least the same--and maybe
more--discrimination as for Web sites, because the information is more
ephemeral and you often can't identify the source. Although these groups
can provide reliable information about specific diseases and disorders,
they can also perpetuate misinformation.

"Around Christmas time last year, I saw a whole bunch of messages
implying that mistletoe has anti-cancer properties," recalls Serena
Stockwell, editor of the medical trade publication Oncology Times and
longtime user of various cancer-related forums and resources on one of
the commercial on-line services. "I wondered where this was coming from,
since it seemed a little odd."

Stockwell did some digging and discovered that in an announcement of a
new drug to treat lung cancer, "one of the researchers had a slip of the
tongue and said the drug was derived from mistletoe instead of
periwinkle. As a result, the word soon spread to the newsgroups, where
people inadvertently perpetuated the mistake."

In another instance, Stockwell saw that the herbal tea Essiac was being
touted in a newsgroup as a cancer remedy. "Doctors were being questioned
about it, so I assigned a reporter to cover the story," she says. As it
turned out, there is no evidence to support this claim.

As with all health and medical information in cyberspace, advice in
newsgroups "should not be taken by itself," Stockwell says. "As a writer
and editor, I find newsgroups useful for keeping in touch with topics of
conversation among patients, doctors and researchers. But to determine
whether the information is trustworthy, I'd want to document it in the
usual ways."

Other information services are commercial on-line services, fee-charging
companies that provide vast amounts of proprietary information. They
often include health and medical databases, electronic versions of
popular newspapers and magazines, and their own chats and newsgroups, as
well as Internet access.

The fact that information may be screened by a commercial service does
not necessarily make it more reliable than other sources. And most
services do not verify what is posted in their newsgroups, nor control
what is "said" in chat rooms. Health and medical material obtained
through services also should be corroborated by your physician or other
medical sources.

Regulatory Concerns 

The fact that it is easy to publish health and medical information and
reach vast audiences without having the information verified by other
sources presents potential issues for FDA and other government agencies,
according to Melissa Moncavage, a public health advisor in FDA's
division of drug marketing, advertising, and communications. FDA has
created a working group from each of its divisions to address the issues
that fall within the agency's purview.

"We are working together to determine the scope and type of product
information that is going directly to consumers. Product information on
the Internet is unlike traditional forms of advertising and labeling.
Current regulations on prescription drug advertising differ between
print and broadcast media. The Internet presents additional challenges,"
Moncavage says.

While regulatory agencies try to devise ways of ensuring that accurate
and well-balanced health and medical information is presented on the
Internet, consumers "will have to use a lot more discretion in
evaluating what they see," Moncavage says. "A Web page can be changed
very quickly. It is easy to put up, and easy to take down. There is no
guarantee that what you see one day will be there the next." So on the
Internet, as elsewhere, "caveat emptor"--let the buyer beware--are
watchwords for the foreseeable future.

Marilynn Larkin is a medical writer whose Web site links to the Web
sources of health information listed in this article:
http://members.gnn.com/mlco 


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


Is This Site Reliable?

FDA staff and others familiar with Internet medical offerings suggest
asking the following questions to help determine the reliability of a
Web site:

Who maintains the site? Government or university-run sites are among the
best sources for scientifically sound health and medical information.
Private practitioners or lay organizations may have marketing, social or
political agendas that can influence the type of material they offer
on-site and which sites they link to.

Is there an editorial board or another listing of the names and
credentials of those responsible for preparing and reviewing the site's
contents?

Can these people be contacted by phone or through E-mail if visitors to
the site have questions or want additional information?

Does the site link to other sources of medical information? No reputable
organization will position itself as the sole source of information on a
particular health topic. On the other hand, links alone are not a
guarantee of reliability, notes Lorrie Harrison of FDA's Center for
Biologics Evaluation and Research. Since anyone with a Web page can
create links to any other site on the Internet--and the owner of the
site that is "linked to" has no say over who links to it--then a person
offering suspect medical advice could conceivably try to make his or her
advice appear legitimate by, say, creating a link to FDA's Web site.
What's more, health information produced by FDA or other government
agencies is not copyrighted; therefore, someone can quote FDA
information at a site and be perfectly within his or her rights. By
citing a source such as FDA, experienced marketers using careful wording
can make it appear as though FDA endorses their products, Harrison
explains.

When was the site last updated? Generally, the more current the site,
the more likely it is to provide timely material. Ideally, health and
medical sites should be updated weekly or monthly.

Are informative graphics and multimedia files such as video or audio
clips available? Such features can assist in clarifying medical
conditions and procedures. For example, the University of Pennsylvania's
cancer information site, called OncoLink, contains graphics of what a
woman can expect during a pelvic exam. Bear in mind, however, that
multimedia should be used to help explain medical information, not
substitute for it. Some sites provide dazzling "bells and whistles" but
little scientifically sound information.

Does the site charge an access fee? Many reputable sites with health and
medical information, including FDA and other government sites, offer
access and materials for free. If a site does charge a fee, be sure that
it offers value for the money. Use a searcher (see "Sources of Internet
Health Information") to see whether you can get the same information
without paying additional fees.

If you find something of interest at a site--say, a new drug touted to
relieve disease symptoms with fewer side effects--write down the name
and address of the site, print out the information, and bring it to your
doctor, advises Valencia Camp of FDA's Office of Information Resources
Mangement. Your doctor can help determine whether the information is
supported by legitimate research sources, such as journal articles or
proceedings from a scientific meeting.

In addition, your doctor can determine if the drug is appropriate for
your situation. Even if the information comes from a source that is
reputed to be reliable, you should check with your doctor to make sure
that it is wise for you to begin a certain treatment. Specific
situations (such as taking other drugs) may make the therapy an
inadvisable choice. Your doctor can decide whether the drug is suitable
for you and may be able to offer more appropriate alternatives.

--M.L. 


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


Sources of Internet Health Information

There are literally thousands of health-related Internet resources
maintained by government agencies, universities, and nonprofit and
commercial organizations. Following are the addresses of Usenet groups
(newsgroups), mailing lists, and reputable sites that link to other
sites with medical information. This list is by no means complete; it is
offered as a jumping-off point.

Usenet Groups

(Access is through the Internet provider)

bionet.immunology (immunology research and practice)

bionet.aging (issues related to aging theory and research)

misc.health.diabetes (discussion of diabetes management in daily life)

sci.med.diseases.cancer (cancer treatment and research)

sci.med.vision (treatments for vision problems)



Mailing Lists

(to subscribe, send an E-mail message to the address given; in the
message area type "subscribe," followed by the name of the list and then
your name)

Alzheimer's Disease
List name: ALZHEIMER
Subscribe: listserv@wubois.wustl.edu 

Breast Cancer
List name: BREAST-CANCER
Subscribe: listserv@MORGAN.UCS.MUN.CA 

Stroke
List name: STROKE-L
Subscribe: listserv@UKCC.UKY.EDU 

Geriatrics
List name: GERINET
Subscribe: listserv@UBVM.CC.BUFFALO.EDU 

(Source: A Guide To Healthcare and Medical Resources on the Internet by
Michael S. Brown)


World Wide Web Sites

American Cancer Society: http://charlotte.npixi.net/acs/facts.html 

American Heart Association: http://www.amhrt.org/ahawho.htm 

American Medical Association: http://www.ama-assn.org/ 

Centers For Disease Control and Prevention: http://www.cdc.gov/ 

Department of Health and Human Services: http://www.os.dhhs.gov/ 

Food and Drug Administration: http://www.fda.gov/ 

National Cancer Institute: http://www.nci.nih.gov/ 

National Institutes of Health: http://www.nih.gov/ 

National Institute for Allergies and Infectious Diseases:
http://www.niaid.nih.gov/ 

National Library of Medicine: http://www.nlm.nih.gov/ 

Oncology Data Base/University of Pennsylvania (ONCOLINK):

http://cancer.med.upenn.edu/about_oncolink.html 



Search Programs

Because the Internet contains no central indexing system, getting the
information you want quickly can be a major challenge. That's where
search engines come in. These powerful tools can help narrow the field
if you have a specific topic to pursue, or the name of a specific
organization but no address for its site. Input a few words that
describe what you're looking for, and the searcher returns a list of
sites related to your query.

Be aware, however, that although a searcher can point the way, it does
not evaluate the information it points to. For example, a search on the
words "breast cancer" is just as likely to point to a page advertising a
reconstructive surgeon or a health food store's article on the purported
benefits of phytochemicals as it is to the National Cancer Institute.
The reason? Scott Stephenson, production engineer and spokesman for
Webcrawler, one of the popular searchers, explains. "Webcrawler scans
documents and counts the number of times a particular word or expression
searched for appears on a Web page. That alone determines whether the
page is listed in our results, and where it appears on the list." This
means that by mentioning, say, breast cancer many times in the Web page
copy, a savvy marketer of bogus medicinals could draw a lot of people to
his or her site. It is up to the visitor to evaluate the information the
site contains. Here are a few of the many search engines:

Alta Vista: http://www.altavista.digital.com/ 

Excite: http://www.excite.com/ 

Lycos: http://www.lycos.com/ 

Webcrawler: http://www.webcrawler.com/ 

Yahoo: http://www.yahoo.com/Health/Medicine/ 

--M.L.

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

Evening Out the Ups and Downs
Of Manic-Depressive Illness

by Ricki Lewis, Ph.D. 

German composer Robert Schumann led a life of extreme ups and downs. In
1833, at the age of 23, he attempted suicide; in 1840, he experienced a
period of inexplicable, great elation. Then in 1844 he fell into another
deep depression, with another "up," or "manic," period five years later.
In 1853, his mental illness forced him to resign as musical director of
the Dusseldorf Symphony Orchestra, and a year later, he tried to kill
himself by jumping into the Rhine River. He was rescued and placed in an
asylum, where he died two years later of self-imposed starvation.

Some of Schumann's musical compositions noticeably reflect his dramatic
mood swings. One account of the composition "Carnaval" describes the
part called Florestan as the product of an "emotional, impulsive, stormy
extrovert," yet attributes another portion, called Eusebius, to a "quiet
introspective dreamer."

Robert Schumann suffered from manic-depressive illness, also known as
bipolar disorder. This condition affects 1 percent of the U.S.
population at some time in their lives. Periods of expansive,
hyperactive thinking and behavior with elevated mood occur in sharp
contrast to periods of extreme despair and sadness. Either phase can
greatly disrupt a person's life.

Other gifted artists, writers, poets, and composers who suffered from
manic-depressive illness include Walt Whitman, Cole Porter, Tennessee
Williams, Mark Twain, Edgar Allen Poe, Sylvia Plath, and Vincent van
Gogh. The incidence among creative people is 10 to 20 times greater than
that of the general population, according to Kay Redfield Jamison,
professor of psychiatry at Johns Hopkins University School of Medicine,
who has studied manic-depressive illness and its effects on the creative
community.

But bipolar disorder also makes plenty of regular folk miserable. Two
million people in the United States have the condition, and researchers
estimate that a third of them receive no treatment. Untreated, the
suicide rate is 15 percent.

Treatment Options 

For many years, the standard treatment for manic-depressive illness has
been lithium, a pure chemical sold under many brand names, including
Carbolith, Duralith, Lithobid, Lithizine, Eskalith, and Lithane. It is
the best-studied drug to treat manic-depressive illness, and is
effective not only in the acute treatment of mania, but also in
long-term prevention of relapses. 

While effective in many people, lithium also brings significant side
effects to some. In May 1995, FDA approved the anti-seizure drug
Depakote (divalproex sodium) for a new use: short-term treatment of
manic depressive illness. It is not yet known whether the drug is
effective in preventing relapses over the long term.

"This is a different bullet in the armamentarium against this illness.
It has been widely used to treat mania for years. What's new is clinical
trial evidence showing that it's efficacious," says Steven Hardeman,
consumer safety officer at FDA's division of neuropharmacological drugs.

Depakote has been approved in the United States to treat seizures since
1983. The formulation has since been altered slightly to minimize
gastrointestinal side effects. The drug may be helpful for some of the
30 to 40 percent of people with manic-depressive illness who do not
respond to lithium.

Eighteen-year-old Melissa Kluth, who lives in upstate New York, has been
taking Depakote to treat manic-depression for a few months. While her
experience may not run true for all persons who try Depakote, Kluth, who
never took lithium, says she feels like a new person. "When I'm off the
medication, if you say anything to me, I get angry. I scream and yell
and kick and throw chairs. When I'm on the medication, I'm fine; nothing
bothers me," she says.

Diagnosing Mania 

Depakote and lithium treat the mania portion of bipolar illness. Jack
Gorman, M.D., deputy director of the New York State Psychiatric
Institute, describes mania's distinctive symptoms: "The patient becomes
very hyperactive. He or she doesn't sleep, and doesn't need to sleep.
Thoughts race, and they talk very, very fast. They may be hypersexual
and spend huge amounts of money. They get in all kinds of trouble,
fights, even car accidents. Most people are diagnosed in their early 20s
after having a few depressive episodes, and then a manic one."

To diagnose manic-depressive illness, a psychiatrist compares a
patient's symptoms with the diagnostic criteria for the disorder in the
fourth (1994) edition of the Diagnostic and Statistical Manual of the
American Psychiatric Association. DSM-IV distinguishes two variants.
Bipolar I consists of major depression and mania. Bipolar II includes
major depression and a milder form of mania called hypomania. The manual
classifies manic-depressive illness as a "mood disorder," a designation
that also includes altered mood due to a medical condition or taking a
mood-altering substance.

In diagnosing manic-depressive illness, sometimes psychiatrists also
consult scales and behavioral assessment tests that are more commonly
used in clinical studies. These tools help assess signs such as elevated
mood, diminished need for sleep, excess energy and activity, grandiosity
(feeling that one can do anything), racing thoughts, poor judgment,
irritability, and fast speech.

As is the case for many mental illnesses, the causes of manic-depression
aren't at all clear, although there are inherited components. Yale
University professor of psychiatry Joel Gelernter, M.D., describes the
causes of manic-depressive illness as "utterly unknown" in an editorial
in the May 1995 issue of the American Journal of Human Genetics. But in
some cases, the condition, or susceptibility to it, appears to be
inherited. A flurry of research reports in 1987, 1994, and 1996 trace
the illness to specific chromosomes in a few very large families, but
different studies point to different chromosomes. This indicates that
there may be several ways to inherit the condition.

Twin studies--another way of looking for genetic clues--also suggest an
inherited tendency to manic-depressive behavior. Several studies show
that if one identical twin has the illness, chances are from 70 to 100
percent that the other twin does, too. Among identical twins reared
apart, the probability of both suffering from manic-depressive illness
is two-thirds, suggesting an inherited predisposition that persists even
when identical twins are raised in very different environments. Among
fraternal twins, who, unlike identical twins, are no more closely
related genetically than are any two siblings, the chance that the
second twin is affected is only 20 percent.

A Tale of Two Drugs 

Drug treatment for manic-depressive illness has a long and fascinating
history. Lithium's effects on manic-depressive illness were discovered
by chance in 1949 by an Australian physician named John Cade. He used
lithium to treat gout in hamsters, and they calmed down. "They would sit
and be quiet instead of running around their cages," says Paul Keck,
M.D., associate professor of psychiatry and pharmacology at the
University of Cincinnati College of Medicine.

Tests on humans in Australia in the 1960s showed that lithium alleviated
symptoms of mania. After additional clinical tests focusing on safety
aspects, including, according to Keck, its toxicity when used as a salt
substitute, FDA approved lithium in 1971 for treating manic episodes of
manic-depressive illness.

Meanwhile, researchers were noticing that brain activity is similar in
seizure disorders and in mania, giving rise to the idea that seizure
medications might also relieve symptoms of mania.

"Valproic acid was discovered in the 1960s by a French psychiatrist to
benefit people with manic-depressive illness, but for reasons that are
not understood, that research was not followed up. Then, in the
mid-1980s in the United States, people got re-interested in it for
treating bipolar disorder," says Keck.

Adds Gorman, "Robert Post [M.D.], at the National Institute of Mental
Health used the seizure medication Tegretol (carbamazepine) to treat
lithium-refractive patients. He combined lithium and Tegretol, and the
response was excellent. So the work was extended to other
anti-convulsants, and people decided to test valproic acid."

These observations led to two studies. One, published in the January
1991 issue of the Archives of General Psychiatry, compared valproic acid
to a placebo. Another, published in the January 1992 issue of the
American Journal of Psychiatry, compared valproic acid to lithium. Both
found valproic acid to be promising. Then the Journal of the American
Medical Association published a study in the March 23/30, 1994, issue,
comparing all three regimens--valproic acid, lithium, and placebo.

The Depakote Mania Study Group, led by Charles L. Bowden, M.D., of the
department of psychiatry at the University of Texas Health Science
Center in San Antonio, carried out the study. They randomly assigned 179
patients at nine participating university hospitals to one of the three
treatments. Neither the patients nor the physicians knew which patients
were receiving lithium, Depakote or placebo. This approach, called a
double-blind study, lessens the likelihood of either a patient or a
physician expecting a certain response and thus obscuring the
investigation's results or conclusions.

The study continued for only 21 days for two reasons. First, previous
work had shown that 21 days is sufficient for symptom relief. Second,
the researchers did not want to subject patients receiving placebo to
their symptoms longer than was necessary to see results. Several
participants in each group dropped out because either the treatment's
side effects or the illness' symptoms were intolerable.

The researchers concluded that both drugs were similarly effective in
lessening manic symptoms and both were markedly superior to placebo. The
percentage of patients experiencing a greater than 50 percent
improvement, as judged by rating scales, was 49 percent for lithium, 48
percent for Depakote, and 25 percent for placebo.

The researchers said they also found that:

 * fewer people dropped out who were receiving Depakote than the other
 two options

 * Depakote worked in several patients on whom lithium had previously
 shown no effect

 * Depakote relieved symptoms in the most severe type of
 manic-depression, called the rapid-cycling form because mood swings
 occur more frequently.

Depakote and lithium have different side effect profiles, which a
physician considers in prescribing one or the other for a particular
patient. Side effects indicating too high a dose of lithium include
trembling hands, nausea, weight gain, and frequent urination.

Depakote's side effects include nausea, vomiting, sleepiness, and
dizziness. The physician labeling of Depakote carries a boxed warning
about potentially fatal liver problems with the drug. Using either
lithium or Depakote requires periodic blood monitoring to ensure that
the dosage is therapeutic, but not toxic.

Pregnancy Precautions 

Valproic acid is known to cause birth defects in offspring of women who
take the drug while pregnant. Specific birth defects linked to Depakote
include poor growth, small head, developmental delay, and several
distinctive facial characteristics, such as a short and broad nose,
small teeth, flattened midface area, and a thin upper and thick lower
lip. A more serious effect is increased risk of spina bifida, a birth
defect in which the spinal column does not close completely, leading to
a lesion on the newborn's back and loss of feeling from the point of the
lesion down.

In the general population, spina bifida occurs in fewer than 1 in 1,000
births. Among women exposed to Depakote, it occurs in 1 to 2 in 100. The
defect occurs during the fourth week of gestation--often before a woman
realizes that she is pregnant.

It is unclear whether lithium can cause birth defects. In studies
conducted in the early 1970s, lithium was found to be associated with
birth defects, specifically a rare heart defect called Ebstein's
anomaly. However, Lee Cohen, M.D., a psychiatrist at Massachusetts
General Hospital, and co-workers from other institutions reported in the
Jan. 12, 1994, issue of the Journal of the American Medical Association,
that these studies were not well-controlled. These researchers concluded
that the risk was far less than had been thought.

They reevaluated four more recent studies, involving a total of 207
children with Ebstein's anomaly. None of the mothers had taken lithium.
Based on these results, Cohen's team suggests that some pregnant women
with severe manic-depressive illness might be able to continue lithium
treatment without great risk to the fetus. The researchers suggest that
obstetricians take these revised risks into account when determining
whether a specific woman should continue using lithium during pregnancy.

Treatment can radically improve the life of a person suffering from
manic-depressive illness. One of the most frustrating aspects of this
disorder, patients say, is the delay until they are diagnosed. Sometimes
young people endure years of punishment for bad behavior, followed by
misdiagnoses, before discovering that their mood swings are part of a
chronic but on-again off-again illness. Finding an effective treatment
is an enormous relief, to them and their families.

This is what happened for Melissa Kluth, who says, "I'm 18, and I think
I've had manic-depression all my life. When I was younger, an allergist
said it was attention deficit disorder, so I was put on Ritalin to treat
that. But when I became a teenager, in the eighth grade, I became
suicidal. This past February, I just couldn't deal with it. I just
wasn't myself." Since her psychiatrist put her on Depakote, Kluth says,
she feels more like a "normal" person on the brink of adulthood--and
looks forward to a much brighter future.

Ricki Lewis is a writer in Scotia, New York. 


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


Updates


First Blood Test for Breast Cancer

The first blood test to help determine whether a woman's breast cancer
has recurred was recently approved by FDA.

The Truquant BR Radioimmunoassay (RIA) test kit measures CA 27.29, an
antigen found in the blood of patients with breast and certain other
types of cancer. As breast cancer progresses, the blood level of CA
27.29 rises. Test results can be analyzed in a few hours at a hospital
laboratory.

In clinical studies of 166 women who had previously had breast cancer,
the test found the cancer antigen in 15 out of the 26 women who had
recurrence. It also indicated cancer in 8 of 140 patients who did not
have recurrence.

Because the immunoassay did not detect the cancer antigen in all cases
and detected it falsely in some, the new test is not intended as the
sole basis for the detection of cancer recurrence, which can only be
made after the test results are verified by other procedures, such as
mammography, magnetic resonance imaging, and x-rays.

The test kit is manufactured by Biomira Diagnostics, Inc., of Rexdale,
Ontario.


Public Can Comment on Mammography Regs

The public has until July 2, 1996, to comment on FDA's recently proposed
regulations to enhance current requirements for high-quality
mammography. 

The agency published proposed new rules on April 3, 1996, to expand and
strengthen interim regulations effective since late 1993. The rules
support FDA's implementation of the 1992 Mammography Quality Standards
Act, which requires that mammography facilities meet quality standards,
be accredited by an FDA-approved accreditation body and certified by
FDA, and be inspected annually.

The proposed regulations would:

 * strengthen interim requirements for the qualifications and training
   of personnel performing mammography and interpreting mammograms

 * require that mammography equipment meets specified design and
   performance criteria

 * expand mammography reporting requirements so that doctors and
   patients receive results quickly

 * add a consumer complaint requirement to ensure that consumer
   complaints are followed up adequately

 * add requirements for special methods of examining women with breast
   implants and for training p onnel to do the exams properly.

FDA is also asking for comments on alternative approaches to ensuring
quality mammography that would keep the facilities' administrative
requirements to a minimum. 

To comment on the proposed rules, write to: FDA Dockets Management
Branch, HFA-305, Docket No. 95N-0192, Rockville, MD 20857. 

For names and locations of FDA-certified mammography facilities, call
the Cancer Information Service toll-free at (1-800) 4-CANCER, or (1-800)
422-6237.



AIDS Drug Approved in 42 Days

The third in a new class of drugs for treating HIV infection was granted
accelerated approval in record time--42 days after FDA received the
drug's application for marketing.

FDA granted early approval to indinavir (Crixivan), a protease
inhibitor, last March 13 for use alone or in combination with nucleoside
analog drugs, such as AZT (zidovudine, marketed as Retrovir), in people
with HIV or AIDS.

The agency's accelerated approval process allows early marketing
approval for a product based on laboratory markers, but the sponsor must
continue with studies to show the product provides true clinical
benefit, such as extending life or slowing disease progression.

Studies reviewed by FDA indicated that indinavir alone or in combination
with the nucleoside analogues AZT or 3TC (lamivudine, marketed as
Epivir) can improve such laboratory markers as CD4 cell counts, an
indicator of immune system strength, and viral load, a measure of the
amount of virus that can be detected in the blood. Patients receiving
indinavir alone or indinavir with AZT or 3TC had a marked increase in
their CD4 levels and a marked decrease in their viral load.

Major side effects included, infrequently, kidney stones and,
frequently, increases in bile production.

The drug is manufactured by Merck & Co. Inc.



First Screen Approved for HIV Antigens

FDA recommends that all registered blood and plasma establishments this
month start using the first blood test approved to screen blood donors
for antigens of HIV-1, the virus responsible for most AIDS cases in the
United States.

The agency approved the new test, the Coulter HIV-1 p24 Antigen Assay,
on March 14 and also allows it for diagnosing HIV-1 infection and
monitoring progress of the disease.

The test should not replace currently used HIV antibody tests for
routine patient testing and counseling in a medical setting, according
to the Centers for Disease Control and Prevention. Antibody testing is
still the most efficient way to diagnose HIV routinely in individual
patients.

Current donor screening detects HIV antibodies, which typically appear
within three months of infection. The new test detects antigens, which
are proteins of the virus. Antigens can be detected about one week
earlier than antibodies.

According to medical literature estimates, HIV-1 antigen screening could
prevent five to 10 cases a year of AIDS transmitted by blood
transfusion. It reduces the "window" period, when donors may be
HIV-infected but still have negative antibody tests.

In clinical studies, the test detected HIV-1 antigens before antibodies
were detected in 80.6 percent of cases. The test also correctly
identified HIV-1 negative specimens 99.95 percent of the time, based on
analyses of more than 300,000 normal blood donations.

The Coulter test will be marketed to blood establishments by Ortho
Diagnostic Systems Inc., a subsidiary of the Johnson and Johnson
Company, Raritan, N.J.



Nicotine Nasal Spray to Help Smokers Stop

The first prescription nicotine nasal spray to help adults who are
trying to quit smoking has been approved by FDA. The product is not
recommended for use in children.

The agency based its approval, last March 25, on results of studies with
730 patients given various doses of the nasal spray or placebo. All
patients received other supportive therapy for quitting, such as
counseling. Nearly 54 percent of patients given the drug stopped smoking
for six weeks, as opposed to 27 percent of the patients given placebo.
About 25 percent of patients receiving the drug stopped smoking for at
least one year, while only 13 percent in the placebo group reached this
goal. The effective

ness of the nasal spray is comparable to other stop-smoking aids such as
nicotine gum or patches.

It is recommended that patients use nicotine nasal spray for three
months. Because nicotine is addictive, it is possible to become
dependent on the nasal spray. Patients' chances of becoming dependent on
the nasal spray increase if they use it longer than six months.
Therefore, this product should be used no longer than six months.

Common side effects of the spray are nasal or sinus irritation. Although
most people can tolerate these effects, the spray is not recommended for
people with nasal or sinus conditions, allergies, or asthma.

The spray will be sold under the name Nicotrol NS by McNeil Consumer
Products Co. of Fort Washington, Pa., under license from Pharmacia of
Sweden.



Cancer Initiatives to Expand Access to Therapies

Four initiatives to improve patient access to promising new cancer
therapies are under way at FDA. FDA is:

 * shortening approval times for cancer treatments by recognizing that
   tumor shrinkage is often an early indicator of a treatment's
   effectiveness

 * working with pharmaceutical companies to make promising cancer
   therapies approved by foreign countries available to cancer patients
   before the product is approved here

 * improving the therapy review process

 * making it easier for investigators to test new uses for cancer
   therapies already on the market.

FDA announced the initiatives last March. For a backgrounder providing
more information, write to FDA, HFI-40, Rockville, MD 20857. The
backgrounder is available on FDA's World Wide Web site at
http://www.fda.gov/opacom/backgrounders/cancerbg.html. Additional
information on the initiatives can be found at
http://www.fda.gov/opacom/7reinvnt.html. 


Acupuncture Needles No Longer Investigational

The needles used for acupuncture no longer need "investigational use"
labeling. FDA recently reclassified them for "general acupuncture use"
by qualified practitioners.

Acupuncture needles, which are used as part of a centuries-old Chinese
healing technique, are medical devices under FDA regulations. Last
March, the agency reclassified the needles from class III, a category
that requires clinical studies, to class II, which means they can be
used by licensed, registered or certified acupuncture practitioners. As
with other class II devices, the needles are required to have proper
labeling, and good manufacturing practices must be followed.

The agency's decision to reclassify acupuncture needles was based on a
review of available data on acupuncture and the needles used for this
purpose.

Before a firm can market acupuncture needles in the United States, it
must obtain clearance from FDA through the premarket notification (510k)
process.

Manufacturers must include on the label the statement "for single use
only" and provide information about device material sterility and
compatibility with the body. The needles must also bear a prescription
label restricting use to qualified practitioners as determined by
individual states.

Foreign manufacturers must meet the same premarket clearance and
manufacturing quality requirements as U.S. manufacturers.



Street Drug Alternatives with Ephedrine

Consumers should not buy or consume ephedrine-containing dietary
supplements whose labels portray them as apparent alternatives to
illegal street drugs because these products pose significant health
risks--possibly even death.

These products contain botanical, or so-called "natural," sources of
ephedrine. Ephedrine is an amphetamine-like stimulant that can
dangerously affect the nervous system and heart. Any of the following
ingredients listed on a label indicates ephedrine: ma huang, Chinese
ephedra, ma huang extract, ephedra, Ephedra sinica, ephedra extract,
ephedra herb powder, epitonin, or ephedrine.

Consumers who have an injury or adverse effect after taking a supplement
or any product containing ephedrine should call (1-800) FDA-4010. Health
professionals who have treated patients suffering from an adverse event
should report it to FDA's medWatch hot line: (1-800) FDA-1088.

Possible adverse effects of ephedrine range from heart attack, stroke,
seizures, psychosis, and death to less significant problems such as
dizziness, headache, gastrointestinal distress, irregular heartbeat, and
heart palpitations. The clinically less significant problems may
indicate the potential for more serious effects.

Labels on many ephedrine-containing dietary supplements appear to be
directed to adolescents and young adults, implying the products can
produce a "high." FDA considers that such promotion and claims violate
the Federal Food, Drug, and Cosmetic Act, even as amended by the Dietary
Supplement Health and Education Act of 1994, which governs U.S.
marketing of supplements.

The agency is investigating the production and marketing of
ephedrine-containing products marketed as alternatives to illegal street
drugs, such as "ecstacy."



Labeling Change for Lindane Lice Treatments

Revised labeling now required by FDA for lice and scabies treatments
containing the insecticide lindane (gamma benzene hexachloride)
encourages using the prescription products only if other approved
therapies without lindane have not worked.

The labeling also advises health-care providers and parents not to
confuse prolonged itching with a reinfestation of these parasitic
infections. Even after successful treatment, itching can continue, due
to residual inflammation in the skin.

FDA required the revisions because of concerns that some parents may be
unintentionally medicating beyond the recommended procedure when
children continue to scratch. In other cases, parents may overuse the
products in their zeal to treat children as quickly as possible. This
increased exposure raises the likelihood of adverse reactions.

The drug's label already warns parents that neurotoxicity (damage to
nerves or nerve tissue) is possible, especially among infants. 

FDA investigated claims that lindane causes neurological damage in
children. After reviewing available data, agency scientists concluded
that lindane is generally safe and effective if used according to its
approved directions, but that overuse can be harmful. Previously, an FDA
advisory committee made the same determination.


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


Consumer Forum



Bacteria and Tea

As usual, I look forward to the arrival of the FDA Consumer. It is one
of the very few magazines I read cover to cover!

In the March 1995 issue, you present "Tea--A Story of Serendipity." It
has much useful information but in one area, it may be misleading.

The article says that a study of Cincinnati restaurants found "high
levels of coliform bacteria (from fecal matter) ..."

Just because the bacteria might appear to be from fecal matter does not
necessarily mean it is so.

Dr. Joseph M. Madden of the Dept. of Health and Human Services on
December 20, 1995, reported that the bacterial genera Klebsiella and
Enterobacter, which can be naturally found in tea leaves, are included
in the routine test procedures for fecal coliform bacteria. That is,
these two bacteria produce acid and gas from fermentation of lactose and
grow at 44.5 degrees Celsius--often considered the "proof" of fecal
coliform.

Thus, only if the specific test for E-coli is made, can it be properly
concluded that there is fecal contamination with a particular brewed ice
tea sample.

Marvin E. Winston
Food Scientist
Winston Laboratories, Inc.
Ridgefield Park, N.J.

Marvin E. Winston is correct. Joseph Madden, Ph.D., a microbiologist in
FDA's Center for Food Safety and Applied Nutrition, reiterates Winston's
point that Klebsiella and Enterobacter can be normal inhabitants of
plant material and do not necessarily result from contamination with
fecal material. In the case of brewed teas, these microbes could have
been introduced by the tea leaves and allowed to reproduce to high
numbers due to non-refrigeration of the brewed tea or inadequate
cleaning or sanitization of the storage vessel on a routine basis.


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


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.

Two proposed food labeling rules about nutrient content claims have had
comment periods extended to July 18. In "Food Labeling: Nutrient Content
Claims, General Principles; Health Claims, General Requirements and
Other Special Requirements for Individual Health Claims," FDA proposes
to provide flexibility for certain claims. In "Food Labeling: Nutrient
Content Claims, Definition of the Term: Healthy," FDA proposes to allow
certain processed fruits, vegetables, and enriched cereal-grain products
to be labeled as "healthy." Comments may be sent to the Dockets
Management Branch, FDA, Room 1-23, 12420 Parklawn Drive, Rockville, MD
20857. (FR March 22)

On food labels, the term "extra" may now be substituted for "added,"
says FDA in a final rule. The agency granted use of the term in response
to a citizen petition. (FR March 22)

Lead-based paint in homes built before 1978 must now be disclosed to
prospective buyers or renters, according to an EPA-HUD final rule
effective last March 6. Sellers and people offering homes for rent must
provide a federally approved lead hazard information pamphlet. Also,
sellers must give buyers 10 days to inspect the property for lead-based
paint before being obligated by a purchase contract. (FR March 6)

Increased immune response to TB proteins occurred in mice given a
genetically engineered version of tuberculosis (TB) vaccine known as
bacillus Calmette-Guerin (BCG) vaccine. In its standard form, BCG is the
only TB vaccine currently available. A study sponsored by the National
Institute of Allergy and Infectious Diseases used genetic engineering
methods to insert genes for five immune-stimulating compounds into the
BCG organism. (Proceedings of the National Academy of Sciences, 1996)

If livestock are implanted with identifying electronic devices, the
devices should be placed in an inedible portion of the animal unless a
human food additive regulation for implantation in an edible area has
been published, FDA warns. Noncompliance would render food adulterated
and subject to regulatory action. The devices are valuable because they
allow FDA to trace a slaughtered animal to its source when drug residues
or contaminants are found in edible tissue. (FDA Veterinarian,
March/April 1996) 

Understanding the brain is the subject of a new volume of research
papers available for nonspecialists. Containing information about the
brain's role in learning, memory and language, the volume includes
selections from the proceedings of symposia sponsored by the National
Institute of Mental Health and the Library of Congress. "Neuroscience,
Memory, and Language" is available for $26 from the Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify stock
number SIN 030-001-00149-1. 

For more information, phone (202) 512-1800.

Black tea, fruits, and other foods containing compounds known as
flavanoids may protect against stroke if consumed on a regular,
long-term basis. In a study of 552 men, aged 50 to 69, those who drank
more than 4.7 cups of tea per day had a 69 percent reduced risk of
stroke, compared with those who drank less than 2.6 cups per day. (AMA
Archives of Internal Medicine, March 25) 

Calcium supplementation can reduce high blood pressure during pregnancy,
according to a recent study in which researchers at McMaster University
in Hamilton, Ontario, Canada, analyzed 14 studies from 1966 to 1994.
(Journal of the American Medical Association, April 9)

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


Investigators' Reports


Generic Drug Manufacturer Convicted

A Gurnee, Ill., generic drug company with a long history of drug
violations was recently convicted of eight felony counts, including
conspiracy to defraud FDA.

In addition, Baldev Raj Bhutani, president of the company, ALRA
Laboratories, Inc., was convicted of seven felony counts, including
conspiracy, drug adulteration, failure to comply with good manufacturing
practices (GMPs), and interstate shipment of adulterated products. His
wife, Neelam Bhutani, the company's quality assurance director, was
convicted of four counts, including conspiracy, drug adulteration, and
interstate shipment of adulterated products.

The convictions were handed down Feb. 12 by a jury in the U.S. District
Court for the Northern District of Illinois, Eastern Division. At press
time in March, sentencing had been set for June 27.

ALRA manufactures several generic drugs, including: lactulose syrup for
treating liver problems; Eryzole (erythromycin ethylsuccinate), an
antibiotic; K+10 (potassium chloride) extended-release tablets, for
potassium depletion; and Gelpirin, buffered analgesic tablets.

FDA is not aware of any illnesses or deaths caused by the company's
products.

From the initial inspection on July 23, 1982, FDA's Chicago district
office found that ALRA regularly failed to comply with the agency's GMP
requirements. Over the next seven years, FDA continued to follow the
company, conducting nine inspections. Deficiencies noted during these
inspections led FDA to issue several warning and regulatory letters to
the company.

On Aug. 27, 1989, ALRA's former chief engineer contacted FDA
investigator Joseph Stojak and told him that the firm was "out of
control and disregarding FDA regulations."

The comments were verified during an inspection 10 days later, from
Sept. 6 to Oct. 13, 1989. FDA investigators identified serious problems
in many of the firm's major operations, including record-keeping,
production, process control, packaging, labeling, laboratory controls,
written procedures, and training.

The investigators found, among other things:

 * falsified batch records showing that certain operations reported as
   being done were not actually done

 * batch records not completed concurrently with drug manufacture

 * products being made against established procedures

 * invalid manufacturing processes, such as equipment adjustments by
   trial and error

 * failure to note deviations from established procedures

 * written procedures inaccessible to workers

 * lack of written procedures for cleaning and operating certain
   equipment, such as the lactulose filling mace

 * inadequate employee training for the jobs being performed

 * incomplete laboratory testing of finished products

 * lack of employee knowledge of basic GMPs.

In addition, during the month-long inspection, Bhutani did not allow
investigators to observe and talk to employees at work. On several
occasions, he ordered employees to leave work areas during production so
that investigators could not observe work in progress, and he refused to
make copies of required documents investigators requested.

Investigators also found production records for one lot of lactulose
syrup manufactured on Aug. 30 that showed the firm used thirteen
55-gallon (209-liter) drums of lactulose syrup concentrate when master
records called for only 10 drums. FDA's Stojak was suspicious because,
he said, "Had they used the 13 drums like they said, the syrup would
have overflowed the mixing tank."

Stojak also found that the firm had received a shipment earlier that
month of sixty 55-gallon drums of lactulose syrup concentrate from
Japan. The former engineer had reported that although many of the drums
were damaged and possibly contaminated, they were used in production of
the firm's product.

During a subsequent grand jury investigation, FDA learned that 36 of the
60 drums received in that shipment had been damaged and possibly
contaminated in transport and were leaking lactulose syrup. Bhutani told
his employees to stop the leaks by filling the holes using a hot glue
gun and then placing duct tape over the holes. The damaged drums of
syrup concentrate were then used in the production of the firm's
lactulose syrup product, and the finished product was sold to consumers.

On April 30, 1990, FDA issued a warning letter to ALRA, notifying the
firm of its need to come into compliance with GMPs.

Another FDA inspection, conducted Jan. 22 to March 5, 1991, found many
of the same deficiencies.

On March 19, 1991, U.S. marshals, at FDA's request, seized all of ALRA's
finished and in-process prescription drugs at the Gurnee facility.
Products stored at ALRA's distributors were placed on "hold"--they could
not be sold. The total value of the products was about $5 million.

Bhutani signed a consent agreement on July 9, 1991, allowing the firm to
try to recondition the seized products. The same day, he signed a
voluntary agreement stating that his firm would refrain from violating
GMPs.

Following a March 1991 meeting to determine what action FDA should take
against the firm, the agency turned the case over to the Department of
Justice's Office of Consumer Litigation. The Justice Department, working
with Chicago's U.S. Attorney's Office, initiated a grand jury
investigation of suspected criminal activities by the firm.

During the next two years, Justice Department attorneys and FDA
investigators Stojak and Gretchen Hartlage collected evidence and
information from subpoenaed documents and interviews with current and
former ALRA employees.

On Aug. 12, 1993, a federal grand jury returned an initial five-count
indictment, charging the company and its owners with misbranding and
adulteration of prescription drug products.

Additional FDA and Justice Department investigations of the firm's
activities resulted in a 15-count superseding indictment issued Jan. 27,
1994. The grand jury charged ALRA and the Bhutanis with criminal
conspiracy; violations of the federal Food, Drug, and Cosmetic Act; mail
fraud; wire fraud; and making false statements to FDA.

The case went to trial on Dec. 7, 1995, and the firm was found guilty on
Feb. 12, 1996. During the trial, evidence showed that the defendants:

 * knowingly and willingly conspired to defraud and mislead FDA

 * adulterated lactulose syrup by adding sodium hydroxide to mask the
   fact that the drug had passed its expiration date and then shipped
   the finished product

 * adulterated lactulose syrup by using lactulose raw material that had
   been stored in punctured, leaking drums plugged with hot glue and
   duct tape and then shipped the finished product

 * adulterated potassium chloride tablets by directing employees to make
   tablets out of raw materials that coined metal fragments from a
   stainless steel pipe

 * committed mail fraud by using the U.S. Postal Service to obtain money
   from the state of Illinois to train new employees under a grant
   program without ever hiring or training any new employees.

--Kevin L. Ropp 


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


FDA Detains Uncertified Clams

When FDA import inspectors examined a shipment of Canadian clams in New
York, they found a truckload of trouble: no refrigeration, mislabeled
cartons, unlabeled inner packets, and no certification of seafood safety
from the Canadian shipper.

FDA's discovery of the illegal clams led to state charges against J & K
Seafood Inc., a New York City distributor, and, in May 1995, to
destruction of the shipment, valued at $1,000.

To avoid criminal charges for refusing to pay a $2,000 fine, J & K
pleaded guilty out of court last Dec. 5 to a civil stipulation. The firm
paid $500 for not having an import permit and $500 for importing
uncertified clams. The state suspended the remaining $1,000 fine imposed
for importing untagged clams and will drop it June 5 as long as J & K
doesn't break the law again.

The case began May 11, 1995, while Janet Feeley and Lawrence Patrick,
inspectors with FDA's Buffalo, N.Y., district import operations branch,
were working in the agency's office at Peace Bridge, the port of entry
in Buffalo. At 3:15 p.m., two men approached Feeley with entry papers
for 100 cases of clams from Lobster Island Seafood Co., Toronto,
destined for J & K.

"I asked if they owned the truck and clams," Feeley says. "They said
yes, and also said they owned the Canadian firm."

Feeley checked to see if the Canadian firm was in FDA's current
Interstate Certified Shellfish Shippers List. Updated monthly, the list
names shippers who take their clams and other shellfish from approved
waters.

Mark Prusak, a compliance officer with FDA's Buffalo district office,
explains its importance: "If shellfish are harvested from polluted
waters, toxins can accumulate in the edible meat and present a health
hazard to the consumer. Public health officials worldwide test shellfish
and the waters where they live to ensure high quality. When proper
standards are met, shellfish are tagged to indicate they came from
unpolluted waters."

One Toronto shipper was on the list. But it wasn't Lobster Island
Seafood.

Feeley and Patrick promptly inspected the load.

They saw the truck was unrefrigerated. And while the import papers
listed the product as clams, various cartons were labeled as "Live
Dungeness Crab," "Live Lobster," and other seafood.

"When we opened the cartons," Feeley says, "lo and behold, we saw what
looked to be shucked clams, frozen in bulk in plastic bags." But the
bags did not have the tags that FDA requires, she says.

Also, she says, the bags contained water, and the cardboard cases were
damp. Unrefrigerated, the product was thawing, indicating it was not
maintaining a proper temperature to prevent bacterial contamination.

Feeley collected samples from five cartons. The notice of sampling she
issued to the drivers stated that the shipment had to be held intact
locally, pending further written notice from FDA. The drivers were
allowed to go on to J & K, with the product to be held intact there.

The next day, after reviewing Feeley's inspection report, Prusak
notified the Department of Environmental Conservation, the state agency
having jurisdiction over the case.

On May 16, FDA detained the shipment at J & K. Since the clams were
already considered illegal because they were uncertified, the agency
decided not to analyze the samples.

On May 18, Francisco Lopez, a police officer with the New York
Department's law enforcement division, visited J & K, obtaining copies
of the invoice and other information. Later he paid a surprise visit, he
says, "to make sure they still had the clams and that this was a
one-chance event, that they weren't getting additional clams."

On May 22, the state served J & K's manager civil summonses for
uncertified and untagged clams, ordering the firm to pay fines at a
meeting on June 13.

On May 31, New York police officer Karen Staniewski watched as the state
destroyed the clams by burying them in a landfill.

June 13 came and went. J & K's president didn't show up at the meeting
to pay the fine, so the state issued the company a criminal summons.

Serving the summons, however, proved difficult. For five months, Lopez
visited J & K repeatedly to try to do so.

"Every time I went back," he says, "the manager wasn't there. Then on
Nov. 21, I went back in plain clothes. I served the summons before he
could go anywhere."

On Dec. 3, Lopez got a call from a J & K representative. The firm
decided to plead guilty and settle out of court.

--Dixie Farley 


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


Appellate Court Backs FDA
In Contested Seizure

A federal appeals court in Louisiana reversed a 1994 district court
ruling, paving the way for FDA to oversee destruction of 216,000 cans of
adulterated and misbranded mushrooms detained in New Orleans since 1992.

Last September, the Court of Appeals for the Fifth Circuit overturned a
decision by the U.S. District Court for the Eastern District of
Louisiana that barred FDA from destroying the mushrooms, which were
processed in China.

At issue had been whether FDA had the authority to seize and dispose of
the products, or whether the importer could "reexport" them to another
country.

The appeals decision established that goods intended for sale are in
"interstate commerce" when they are first offered for entry into the
United States, affirming FDA authority to seize and destroy any food
products intended for import that violate federal statutes.

U.S. marshals disposed of the mushrooms in the New Orleans city landfill
last Feb. 8.

FDA detained the mushrooms, worth $67,800, when First Phoenix Group
Limited Inc., of Springfield, N.J., attempted to import the goods in
July and December 1992.

Three years earlier, FDA had issued an "import alert" warning agency
field offices that canned mushrooms processed in China could contain
staphylococcal enterotoxin, a bacterial byproduct that can cause
vomiting and diarrhea. FDA had found the toxin in mushroom products from
nine Chinese factories.

Though First Phoenix's mushrooms were labeled as being packaged at
Taiwan-based Hwa Chen Industrial Corp., a second FDA import alert in
July 1992 advised FDA field offices to detain canned mushrooms from Hwa
Chen and other Taiwanese manufacturers. These products, FDA said, were
being processed and packaged in a Chinese factory and were labeled with
Hwa Chen's can codes to dodge the import alert.

Initially, FDA informed First Phoenix that the mushrooms could not be
admitted to the United States and that the company could reexport them
only under strict conditions. But after laboratory analysis identified
staphylococcal enterotoxin in a portion of First Phoenix's mushrooms in
late 1992, the agency decided to seize and destroy the product.

First Phoenix contested this action, saying that provisions in the
Federal Food, Drug, and Cosmetic Act entitled the company to reexport
the mushrooms because the products hadn't yet entered "interstate
commerce" when detained.

On Nov. 3, 1993, FDA filed a complaint in the U.S. District Court for
the Eastern District of Louisiana seeking condemnation of the mushrooms
as adulterated and misbranded. U.S. marshals seized the goods--which had
entered the United States in Savannah, Ga., and Long Beach, Calif.--and
stored them in a New Orleans warehouse.

The district court, however, dismissed FDA's case on April 19, 1994, and
ruled that First Phoenix can reexport the mushrooms. But the court also
granted a stay of the judgment, which allowed FDA to continue detaining
the mushrooms while appealing the case.

On Sept. 26, 1995, the Court of Appeals for the Fifth Circuit in
Louisiana ruled that Congress, in passing the Food, Drug, and Cosmetic
Act, intended for FDA to have "the broadest possible authority over
imported contaminated goods" and that the agency was within its bounds
to seek seizure and disposal of the mushrooms. The court also explained
that if "goods are destined for sale in a state other than the place
from which they are shipped, then goods are in 'interstate commerce'
without the necessity of ph

ysically crossing a state boundary." Thus, the mushrooms "undoubtedly
constituted an interstate shipment from the moment they left Taiwan,"
the court ruled.

First Phoenix argued that the mushrooms hadn't yet been placed in
"interstate commerce" because "sale of these goods in the United States
was prohibited by the FDA." But the court called this claim "impossibly
narrow" and said the "goods had been shipped to the United States for
the express purpose of sale. ..."

On Jan. 22, 1996, First Phoenix signed a consent decree that released
the mushrooms into FDA's custody.

--John Henkel 


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


Two Men Sentenced
For Assaulting Inspector

In the first conviction for assaulting an FDA employee under a new
federal criminal misdemeanor law, two officials of a New York food
warehouse were fined and sentenced to probation. The officials had
pleaded guilty to assaulting an FDA investigator during an inspection.

The investigator said the officials shoved, hit, and further threatened
him.

"It was a completely unprovoked assault," says E. Pitt Smith, director
of FDA's Buffalo, N.Y., district office. "Fortunately, the investigator
was not seriously harmed."

In the U.S. District Court, Northern District of New York, Magistrate
Judge David Hurd last Jan. 29 sentenced two brothers, Roger and Anthony
Ferris, each to a $1,500 fine, a $25 special assessment, 100 hours of
community service, and one year of probation, during which they are to
undergo drug testing, as routinely ordered by this district court.

On Aug. 16, 1995, investigator David McNew, with FDA's Syracuse resident
post, conducted a routine sanitary inspection of R. Ferris & Sons Inc.,
a distributor at the Regional Market wholesale produce center, in Utica.

According to McNew, he was accompanied during most of the inspection by
Roger Ferris, partner and vice president of the firm.

At one point, McNew found rotten potatoes dumped below the dock at the
back of the building and two pallets of bags of rotten potatoes being
stored near the dock. When asked about the potatoes, Ferris said people
dumped their garbage there at night. McNew told Ferris it was his
responsibility to store food under sanitary conditions. Ferris replied
it was not his responsibility because the state owned the building.

McNew repeated to Ferris that it was his responsibility to store the
food under conditions in which it would not be contaminated. Ferris
walked away and entered a walk-in cooler.

About a minute later, he came out of the cooler and went to the office
of Anthony Ferris, the firm's president. McNew followed him into the
office and said that after Anthony Ferris had finished a phone call, he
wanted to talk with them.

When the call was completed, the brothers yelled obscenities. Roger
Ferris grabbed the investigator's arm with both hands, yelled, "You
finished your inspection," and shoved him to the door, McNew said.

Continuing to shout obscenities, the brothers followed McNew into the
warehouse, where he went to get his briefcase. Anthony Ferris repeatedly
yelled, "Come on," posturing as if to fight, McNew said. Ferris clenched
his fist toward McNew's face, approaching quickly, but was restrained by
his brother.

Then, with his hand open, Roger Ferris struck McNew on the side of the
head, knocking off his glasses. McNew caught his glasses and put them
back on. Ferris immediately struck the side of his head again.

About 6 meters (20 feet) away, Anthony Ferris, holding an object about 1
meter (3 feet) long that McNew said looked like a broom handle or pipe,
threatened him, saying, "I'll hurt you so bad."

McNew put his notebook and flashlight in his briefcase, left the
building, and walked across the parking lot to his car. Both brothers
continued to yell obscenities.

McNew reported the incident to the agency, which immediately notified
the FBI and the U.S. Attorney's Office in Syracuse.

FBI agents arrested the brothers the next day. Arraigned on Aug. 18,
they pleaded "not guilty." They were released on $10,000 bond but
ordered to stay away from McNew.

Over the next few months, the U.S. Attorney's Office began negotiating a
plea agreement under the new misdemeanor provision of the law. The
brothers signed the agreement Oct. 17.

Enacted in September 1994, the new law amends an existing statute that
makes it a crime to assault federal officials. This statute used to have
only felony capability, which may have discouraged some prosecutors from
charging a felony for a simple assault.

The amendment adds a misdemeanor charge capability, so that simple
assaults can now be federally prosecuted. A criminal may be jailed for
up to a year and fined as much as $100,000 under the law, if convicted
of a simple assault.

--Dixie Farley 


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


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: Cumin seeds, at Jamaica, N.Y. (E.D.N.Y.); Civil No. CV-95-4855.

CHARGED 11-27-95: While held for sale after shipment in interstate
commerce at William E. Martin & Sons Company, Inc., in Jamaica, N.Y.,
the articles were adulterated in that they consisted of a filthy
substance, rodent urine--402(a)(3).

DISPOSITION: A decree of condemnation ordered the articles destroyed.
(F.D.C. No. 67113; S. No. 95-782-274; S.J. No. 1)


PRODUCT: Mushrooms, at Bayonne, N.J. (D.N.J.); Civil No. 95-2793 (JWB).

CHARGED 6-14-95: While held for sale after shipment in interstate
commerce at Railhead Warehouse in Bayonne, N.J., the articles were
adulterated in that they contained a poisonous and deleterious substance
which might have rendered them injurious to health--402(a)(1). The
articles were unfit for food in that they were contained in swollen and
leaking cans, and they were prepared and packed under conditions whereby
they might have been rendered injurious to health--402(a)(3) and (a)(4).

DISPOSITION: A default judgment and final order of forfeiture ordered
the articles destroyed. (F.D.C. No. 67089; S. No. 1985607; S.J. No. 2)


PRODUCT: Peppers, dried, at Chicago, Ill. (N.D. Ill.); Civil No.
94-C-00900.

CHARGED: 2-11-94: While held for sale after shipment in interstate
commerce at La Hacienda Brands, Inc., in Chicago, Ill., the articles
were adulterated in that they were held under insanitary conditions
whereby they might have been contaminated with filth--402(a)(4).

DISPOSITION: A consent decree of condemnation ordered the articles
destroyed. (F.D.C. No. 66929; S. No. 94-710-098/9; S.J. No. 3)


PRODUCT: Porcelain food service articles, at San Francisco, Calif. (N.D.
Calif.); Civil No. C-93-0439 (JPV).

CHARGED 2-5-93: While held for sale after shipment in interstate
commerce at Wing Sing Chong Company, Inc., in San Francisco, Calif., the
articles were adulterated in that they contained lead, an unsafe food
additive--402(a)(2)(C).

DISPOSITION: A default decree of condemnation and destruction ordered
the articles destroyed. (F.D.C. No. 66651; S. No. 92-706-261; S.J. No.
4)


PRODUCT: Scallops, at Hanover, Pa. (M.D. Pa.); Civil No. 1:CV-95-0232.

CHARGED 2-15-95: While held for sale after shipment in interstate
commerce at Hanover Cold Storage, Inc., in Hanover, Pa., the articles
were adulterated in that they consisted of decomposed
scallops--402(a)(3).

DISPOSITION: A default decree of condemnation and destruction ordered
the articles destroyed. (F.D.C. No. 67063; S. No. 95-693-660; S.J. No.
5)


PRODUCT: Shrimp, frozen, at Brownsville, Texas (S.D. Texas); Civil No.
H-95-3399.

CHARGED 6-26-95: While held for sale after shipment in interstate
commerce at Gulf Cold Storage, in Brownsville, Texas, the articles were
adulterated in that they consisted of decomposed shrimp--402(a)(3).

DISPOSITION: A default decree of forfeiture ordered the articles
destroyed. (F.D.C. No. 67090; S. No. 95-666-542; S.J. No. 6)


PRODUCT: Various articles of food, at San Francisco, Calif. (N.D. Calif.); Civil No. C-93-3245 (SBA).

CHARGED 9-2-93: While held for sale after shipment in interstate
commerce at Lop Sing Trading Company, in San Francisco, Calif., the
articles were adulterated in that they contained unsafe food
additives--402(a)(2)(C). The articles were also adulterated in that they
contained filth, and they were held under insanitary conditions whereby
they might have been contaminated with filth--402(a)(3) and 403(a)(4).
The articles were misbranded in that their labeling was false and failed
to reveal that the articles contained an ingredient that might have
been hazardous--403(a)(1). The articles were also misbranded in that
they failed to bear labeling stating the place of business of the
manufacturer, packer or distributor, and they failed to bear labeling
with an accurate statement of the quantity of contents in terms of
weight, measure, or numerical count--403(e)(1) and 403(e)(2). The
articles also failed to bear labeling containing the common or usual
name of the food, and of two or more ingredients from which the articles
were fabricated--403(i)(1) and 403(i)(2). The articles labeling failed
to state that they contained a chemical preservative, and their labeling
failed to bear a warning label regarding saccharin contained in the
articles--403(k) and 403(o)(1).

DISPOSITION: A default decree of condemnation and destruction ordered
the articles destroyed. (F.D.C. No. 66759; S. No. 93-449-929; S.J. No.
7)


PRODUCT: Wahoo fish fillets, frozen, at Charlotte, N.C. (W.D.N.C.);
Civil No. 3:95CV-307-H.

CHARGED 7-26-95: While held for sale after shipment in interstate
commerce at United Refrigerated Services in Charlotte, N.C., the
articles were adulterated in that they consisted of decomposed
fish--402(a)(3).

DISPOSITION: The articles were destroyed by the potential claimant.
(F.D.C. No. 67091; S. No. 95-617-827; S.J. No. 8)



CRIMINAL ACTIONS

DEFENDANTS: Robert Cetrone, Gerald Seymour, Timothy Hyzy, Vicky Finney,
Maria Paradise, Michelle Tynes Rauscher, Robert Thomson Jr., Luisito
Sison, Jan Stankowicz, and Michael Walton, at South Bend, Ind. (N.D.
Ind.); Criminal No. SCR 92-19.

CHARGED 6-11-92: Count 1: The defendants willfully conspired to tamper
with implantable pacemaker pulse generators and cardiovascular permanent
pacemaker electrodes by relabeling the devices with false make, model,
serial numbers, and dates, selling expired devices for implanting, and
implanting used devices--18 U.S.C. section 1365(a).

Count 2: Defendant Michael Walton tampered with devices by changing the
validated date to a false use-before date--18 U.S.C sections 2 and
1365(a).

Count 3: Defendant Michael Walton tampered with the make, model, and
serial number of a device that was implanted into a patient--18 U.S.C.
section 1365(a).

Count 4: Defendant Michael Walton tampered with the use-before date on a
device that was implanted into a patient--18 U.S.C. sections 2 and
1365(a).

Count 5: Defendant Michael Walton tampered with the labeling of a used
device that was resterilized and implanted into a patient--18 U.S.C.
sections 2 and 1365(a).

Count 6: Defendant Michael Walton sold a used pacemaker for implantation
into a patient that was labeled "not for human implant" by the
resterilization company--18 U.S.C. sections 2 and 1365(a).

Count 7: The defendants knowingly conspired to (a) obstruct FDA's
regulatory authority, (b) pay unlawful gratuities to physicians
regarding the sale of medical devices for which payment may be made
under medicare, and (c) use the U.S. mails in a scheme to defraud--18
U.S.C. section 1341 and 42 U.S.C. section 1395y(h).

Count 8: Defendant Michael Walton devised a scheme to defraud various
hospitals of money and property by knowingly making false and fraudulent
representations regarding medical devices--18 U.S.C. sections 2 and
1341.

Count 9: Defendants Luisito Sison and Michael Walton, with the intent to
defraud, knowingly caused an invoice for an accessory kit to be sent by
U.S. mail to a hospital in Indiana--18 U.S.C. 1341.

Count 10: Defendant Michael Walton, with the intend to defraud,
knowingly caused an invoice for a device to be sent by U.S. mail to a
hospital in Indiana--18 U.S.C. section 1341.

Count 11: Defendant Michael Walton knowingly offered to pay for an
all-expense-paid trip for a physician in order to induce him to
purchase, order, and arrange for and recommend the purchase and order of
pacemakers under the medicare program--42 U.S.C. section 1320a-7b(b)(2).

Count 12: Defendant Michael Walton possessed an embossing tool designed
to make an impression of the seal of the State of Illinois with the
intent of producing a false identification document--18 U.S.C. section
1028(a)(5).

Count 13: Defendant Michael Walton possessed an embossing tool designed
to make an impression of the seal of the State of Indiana Board of
Health with the intent of producing a false identification document--18
U.S.C. section 1028(a)(5).


DISPOSITION: Defendants Maria Paradise, Michelle Tynes Rauscher, Jan
Stankowicz, Robert Cetrone, Timothy Hyzy, and Vicky Finney pleaded
guilty to count 1. They were sentenced to one year of probation and were
ordered to pay a $50 special assessment. Defendant Gerald Seymour
pleaded guilty to counts 1 and 2. He was sentenced to one year of
probation, and ordered to pay a $100 special assessment. Defendant
Robert Thomson Jr. pleaded guilty to count 1 and was sentenced to one
year of probation, and ordered to pay a $5,000 fine. Defendant Luisito
Sison pleaded guilty to count 9. He was sentenced to two years of
probation, and ordered to pay a $50 special assessment. Defendant
Michael Walton pleaded guilty to all counts. He was sentenced to six
years of prison and two years of probation. He appealed his conviction,
but the appellate court affirmed. (F.D.C. No. 66137; S.J. No. 9)



INJUNCTION ACTIONS

DEFENDANTS: Kasz Enterprises, Inc., and James Kaszyk, at Warwick, R.I.
(D.R.I.); Civil No. 93-0455P.

CHARGED 8-23-93: While held for sale at Kasz Enterprises in Warwick,
R.I., the defendants introduced into interstate commerce unapproved new
drugs--331(d). The articles were misbranded in that their labeling
failed to bear adequate directions for use--352(f)(1). The defendants
introduced into interstate commerce misbranded drugs--331(a).

DISPOSITION: The court issued an injunction restricting the defendants
from introducing the articles into interstate commerce. (Inj No. 1318;
S. No. 92-658-944/945; S.J. No. 10) 


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

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FDA Consumer is published monthly, except for combined issues for
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