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FDA Consumer Magazine

VOL. 31 NO. 2
MARCH 1997
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Features

Big Steps Forward for Amputees
Bioengineers using new materials and high technology are forging
artificial limbs that are more and more lifelike--in appearance and
function. Many amputees are now able to put aside their wheelchairs for
an active lifestyle.

Fighting Phobias, the Things That Go Bump in the Mind
Panic arising from an intense fear of everyday objects, events or
feelings may seem irrational, but for the 18 percent of the U.S adult
population who suffer from phobias, the feeling is very real. One or
more of several anti-anxiety medicines approved by FDA can help.

Fruits and Vegetables: Eating Your Way to 5 A Day
First your mother told you to eat your fruits and vegetables; then the
government chimed in with its 5-servings-a-day campaign. But you're
still not following the advice? Here's some help to make eating right a
little easier and, in the process, lower your risk of heart disease and
cancer.

Inside FDA: Barring People from the Drug Industry
Since a 1992 law empowered FDA to ban drug company employees found
guilty of wrongdoing from working in their chosen field for the rest of
their lives, 38 people have been permanently "debarred." Here's how, and
why, this process works to protect the public.

New Attitudes Towards Menopause
Menopause is becoming a popular conversation piece. And for a major
reason: By the end of this century, as the "baby boomers" reach their
50s, more women than ever will be experiencing menopause. Estrogen
replacement therapy can help alleviate their symptoms, such as hot
flashes, and also protect their bones. But it does carry some risks.

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Departments

Updates

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


Notebook

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


Investigators' Reports

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


Summaries of Court Actions

Cases involving seizure, criminal and injunction proceedings.


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Big Steps Forward for Amputees

by Robert A. Hamilton

David S. Barr of Bodfish, Calif., took an 80,000-mile motorcycle trip
that spanned North and South America, Europe, Asia, and Africa.

"Only 70 people have ever done anything like it before," Barr said.
"There've been more people in outer space than have made this trip."

What makes it more extraordinary is that Barr, 41, is a double amputee.
Fighting in Angola in 1981, he lost one leg above the knee and the other
below the knee. But that hasn't kept him from riding a two-wheel 1972
Harley Davidson and writing a book about his around-the-world motorcycle
trip.

And that is not all. Barr is one of only a handful of double-amputee
parachutists who jump with special prosthetics. And he walks 3 or 4
miles a day and mows his own grass.

Advances in prosthetics, and the example set by amputees such as Barr,
have shown more and more people that an amputation does not always mean
confinement to a wheelchair. At private companies and key centers such
as Northwestern University in Chicago and the University of Utah at Salt
Lake City, research that sounds like something out of "The Six Million
Dollar Man" could give amputees even more control over artificial limbs.

Physical therapist Marie A. Schroeder, chief of the Food and Drug
Administration's restorative devices branch, explains that FDA regulates
prostheses, but manufacturers do not have to undergo a full review for
each new device. Instead, they must register the products and keep a
record of any complaints.

"But if there's a significant change in the technology, we could get
involved," Schroeder said.

For instance, she said, her branch has seen some interest in implantable
electrodes for stimulating muscles in spinal cord injury cases. Such
devices would require review by FDA.

Some innovators are also exploring ways to use computers to design and
manufacture custom prostheses, to attach muscles directly to a
prosthesis, to develop powered fingers with microelectronics, and even
to use brain waves to power prostheses.

For thousands of years, inventors have tried to replicate what nature
cannot replace. Prostheses have been used since at least 300 B.C., when
crude devices consisting of metal plates hammered over a wooden core,
were attached to an amputated limb.

Advances in the science of prosthetics burgeon during and immediately
after wars, when large numbers of people need to be fitted with
artificial limbs. The technology of modern prosthetics has changed
little since shortly after World War II.

"There's a real need for revolution in design," said Giovani M. Ortega,
research and development project manager at Sabolich Prosthetics &
Research in Oklahoma City, Okla., a division of NovaCare. "The systems
that we have, have been around for a long time, and at best there have
been only improvements. As far along as we've come, we're still far
behind many other industries in terms of implementing new technologies."

Estimates of the amputee population in the United States vary widely,
from fewer than 400,000 to more than 1 million. About 9 out of 10
amputations involve the leg, from the foot to above the knee.

Three-quarters of all amputations are the result of disease, often
cancer or peripheral vascular disease. The latter is a narrowing of the
arteries in the extremities that is often associated with diabetes. Most
other amputations are the result of workplace or automobile accidents.
And a small fraction, perhaps 3 percent, are due to birth defects that
constrict bone growth.

Preventing Amputation

Because so many amputations result from disease, considerable attention
has been paid to prevention. For example, the American Diabetes
Association recommends people stop smoking, which can speed the progress
of peripheral vascular disease. Patients with diabetes should monitor
their blood glucose levels carefully, eat a healthy, balanced diet, see
their doctors regularly, control their weight, and check their feet each
day for small cuts or blisters.

Electric blankets and heating pads carry warning labels that say people
with diabetes should not use them without talking to their doctors
first. This is because people with diabetes may lose sensation in their
limbs. Patients can be seriously burned by an electric blanket or
heating pad because they cannot feel how hot it really is.

Patients are also advised to develop an exercise plan after consulting
with their doctors. Regular exercise maintains strength, flexibility,
and blood flow to damaged areas and can help control pain. However, it's
important not to stress the legs, feet or joints. Some good exercises
are bicycling or easy rowing on a rowing machine. Swimming and aqua
aerobics are also good choices.

"We know of many things that can help people avoid amputation, but
unfortunately, it's no fun to do daily foot care or wear only proper
fitting, well-designed shoes," said Jennifer Mayfield, M.D., chairwoman
of the association's Foot Care Council. "Everybody keeps waiting for a
magic bullet, and that would be nice, but it's not coming anytime soon."

Richard J. Gusberg, M.D., chief of vascular surgery at Yale University,
said one of the first signs of peripheral occlusive disease is
claudication, an aching, tired feeling in the leg muscles when they are
exercised.

"The vast majority of people with claudication remain stable, or nearly
stable, for an indefinite period of time," Gusberg said. In most cases
the progress of the disease can be slowed if people control the risk
factors, which includes reducing blood pressure, controlling their
diabetes through diet or insulin, and reducing cholesterol levels.
Regular exercise has also proven effective because it can strengthen
circulation, he said.

The drug Trental (pentoxifylline) is approved by FDA for people with
peripheral artery disease. Its use can decrease the thickness and
stickiness of blood, and can reduce the deformities of red blood cells,
so the blood can get through the narrowed arteries, but it is not
effective in all patients, Gusberg said. The use of other drugs in
treating occlusive disease has largely been abandoned, he said.

If the disease progresses, the patient might develop gangrene, or ulcers
in the leg, as blood flow is reduced.

"When people get to that stage, most of them need to be evaluated for a
bypass operation," Gusberg said. Replacing the arteries in the lower leg
is effective for five years or more in 70 to 80 percent of cases.

Sensory Loss

Another danger with diabetes is a deadening of the nerves in the
extremities. John F. Glass, a biologist with FDA's pacing and
neurological devices branch, said there are now a variety of devices
that measure sensory loss in the affected limbs. In a patient with
diabetes, loss of sensation because of nerve damage signals a need for
diligence. Even minor injuries, undetected because the feeling is gone
and thus left untreated, can become infected easily and lead to
gangrene.

"If you're aware of sensory loss, you want to keep a close watch on it,"
Glass said. "There's a range of measurement devices, from those that
detect general loss of sensation, to those that assess the specific
degree of sensory loss, or that can quantify sensitivity to pressure or
temperature."

Many of the devices are easy-to-use mechanical implements with no
significant health risk to patients. One of the simplest is a hand-held
device that looks like an old typewriter eraser with thin wires attached
to it. The wires are placed on the toes or fingertips to see if there is
tactile sensitivity.

Such simple devices are typically not reviewed by FDA before they are
made available to the public. They are intended for use by the patient
for monitoring only, not self-diagnosis.

"Loss of sensation in an extremity could indicate a lot of other
conditions or disorders, so we would encourage the patient to see a
physician immediately for a complete physical examination," Glass said.

Unavoidable Limb Loss

Precautions such as Glass advocates can often delay the progression of
the disease. Sometimes, though, the loss of a limb is unavoidable. In
those cases, physical therapy starts a day or two after surgery. Since
more than 9 out of 10 amputations involve one or both legs, physical
therapy usually involves the use of parallel bars, and later a walker or
crutches. Part of the training involves how to fall and get up safely.

There are other adjustments as well. Barr said the loss of both legs,
and covering the stumps with plastic, means his body has become much
less effective at cooling itself, so he has to be on the lookout for
hyperthermia. And he learned other tricks to cope, as well.

"I'm constantly on the move, never standing still, always readjusting my
balance even when I'm staying in one place, because I don't want one
particular area on the stump to get sore," Barr said.

Until recently, patients were not fitted with an artificial limb for
four to eight weeks after surgery, but new techniques allow the use of a
protective foam over a sterile bandage, and the prosthesis can be fit as
soon as the day following surgery.

New Prosthetic Materials

For centuries, wood and leather were the only materials for prostheses,
but today's physical therapist has a much wider range available,
including advanced plastics and carbon fiber, which are much stronger
and lighter and more durable.

"The industry is really moving towards composite materials, because
they're lighter in weight, easier to work with, and more durable," said
Douglas McCormack, vice president of the Amputee Coalition of America.

Silicone-based compounds used to make prosthetic arms, for instance,
give the appearance of real skin, unlike the rigid plastic or metal
limbs of years ago, and they are more comfortable for the person wearing
them. Women can get prosthetic feet with life-like toes for when they
wear sandals; men can get legs with the appearance of hair.

But even materials that work out in one application might not work in
another.

"We tested a silicone foot at one point. On a machine it was subjected
to 300 pounds of stress for a million cycles, and it didn't have any
problems. But an amputee broke it within a few minutes. It really
surprised us. Torque and other stresses can fatigue the material
quickly," said Sabolich's Ortega. "You'd be amazed at the toll that a
human body puts on even the strongest material."

New computer programs better determine where and what the forces are.
But it's not just a question of choosing a material that will withstand
those forces.

"With some of the new materials being developed, we could make a foot to
take any of the pressures that the human body will give it," Ortega
said. "The problem is it might not have any springiness. You give up
flexibility for strength. You have to balance all the considerations in
a prosthetic."

Prostheses are typically sold as components, so that someone who has an
above-the-knee amputation would be able to choose leg, knee and foot
units, often from different manufacturers, depending on their individual
needs.

Most of the units are adjustable. Shock absorbers in knees, for
instance, can be made more flexible as a person gains controls over the
artificial leg. Ankles can be adjusted to the weight and activity level
of the patient.

Arm amputees today can choose between prostheses that are powered by a
harness and cable attached to the residual limb, or externally powered
devices. Powered arms can be controlled by switches mounted inside or
outside the socket, that the patient can activate by flexing certain
muscle groups.

Energy Requirements

Some prosthetics research is aimed at providing active devices, which do
part of the work of the amputated limb, as opposed to passive devices
that are controlled by the residual limb. An amputee with prostheses
expends two to three times more energy than a nondisabled person to
perform even the simplest activities, such as walking across a room or
climbing stairs.

"A semi-active system, in which the limb itself performs part of the
function, could reduce that energy requirement significantly," said
Sabolich's Ortega. "And there would also be a psychological benefit,
because the prosthesis would no longer be just a dead limb, but
something that is helping."

Ortega said one area Sabolich is researching would provide sensory
feedback from the prosthesis to the remaining limb. For instance, in an
artificial leg, pressure sensors in the foot would send a mild
electrical signal to the thigh muscles when there is pressure on the
back, front or sides of the foot.

That kind of feedback would be similar to what they would get with the
pressure of the ground against a natural foot, which would make their
adjustment to the prostheses go more quickly, Ortega said.

Ortega said prosthetic designs are limited only by how large a power
pack the amputee can carry.

"The crucial issue when it comes to trying to introduce any new
prosthesis is the energy requirements," said Ortega. "Our muscles are so
efficient, in terms of the power that they produce versus the fuel that
they use, that we have a difficult time matching it."

Scientists are also working to build a better socket--the part of the
prosthesis that attaches to the residual limb.

Dudley S. Childress, Ph.D., of Northwestern University's Rehabilitation
Engineering Program, is working on applying the industrial practice
known as rapid prototyping to socket production.

Sockets are now produced largely by hand. A cast is made of the residual
limb, and plaster is poured into the cast to make a positive mold. The
mold is then used to create a plastic or laminated polyester socket that
fits over the residual limb.

Childress employs a computer-aided design program to measure the
residual limb and design a socket. Then, using a modified "plastic
deposition technology" called squirt shaping, a computer lays down small
amounts of polypropylene to produce the desired shape, to very tight
tolerances. In industry, the technology is used to quickly produce
prototypes of everything from car parts to military weapons, to test
them before starting mass production.

"Essentially, every socket is a prototype, and there are potentially
some significant advantages to applying these techniques to prosthesis
manufacture," Childress said. "We can make a socket in about 50 minutes,
which isn't bad, but as people continue to work with the technology, it
may be possible to get that down even faster."

The process would also allow manufacturers to make sockets out of
different types of material than have been used in the past, or alter
the thickness or characteristics of the material very quickly.

Another innovation being explored at Northwestern is powered prosthetic
fingers. That might be difficult if you were going to match real
fingers, he acknowledged, but most of the time that's unnecessary.
Picking up a spoon and holding a book don't require much power, just
control. Small motor technology and power storage capability have both
improved vastly in recent years.

"If you want to do something like squeeze orange juice, you need force,"
Childress said. "But even for people without a prosthesis, that's
tiresome, so we have all kinds of devices to do those jobs for us. So
the intent of the powered fingers would be to provide prehensile
[wrap-around] force."

Childress said his laboratory is also looking at devices that would
improve the "feel" of prostheses over current devices. It would be
comparable, he said, to the way power steering reduces the muscle power
needed to steer a car, but you can still "feel" the road through the
wheel.

Cables in artificial fingers and hands would connect to the muscles of
the forearm, either through holes in the muscle that are surgically
lined with skin, or tendons could be taken outside the residual limb and
covered with skin. Either option would give the muscle the sense of how
hard it is working and how fast it is moving.

Mundane, but Important, Needs

Joan E. Edelstein, Ph.D., director of Columbia University's physical
therapy program, stresses the need for prosthetics research to focus not
just on high-technology improvements, but to the more mundane but
critical things such as fit, to make them as comfortable as possible,
particularly among the elderly, whose needs may not be fully considered.

"Most patients are older people who have lost a limb because of
diabetes, and the assumption is that they're going to be relatively
undemanding of their prosthesis," Edelstein said.

Better prostheses for the elderly might prevent skin breakdown and
infections, yet hardly any research dollars are being spent in that
area, she said, explaining that, "It's not as glamorous as developing
better prostheses for sport, or for children, and they are very
difficult problems to overcome."

Research often proceeds along several courses at once, she noted, and
you can never know which might yield the next major breakthrough.

Robert A. Hamilton is a writer in Franklin, Conn.

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Fighting Phobias,
The Things That Go Bump in the Mind

by Lynne L. Hall

From 50 yards away, you see the animal approaching. Silently it watches
you as it slinks ever so much closer with each padded step. Stay calm,
you tell yourself. There's nothing to fear.

But suddenly, panic seizes you in a death grip, squeezing the breath out
of you and turning your knees to Jell-O. Your heart starts slam-dancing
inside your chest, your mouth turns to cotton, and your palms are so
sweaty you'd swear they'd sprung a leak. You'd escape this terrifying
confrontation, if only you could make your legs work!

Just what is this wild and dangerous animal making you hyperventilate
and turning your legs to rubber? A man-eating tiger, hungry for a meal?
A lioness bent on protecting her cubs? Guess again. That's Tabby, your
neighbor's ordinary house cat, sauntering your way. Ridiculous, right?
How can anyone experience so much fear at the sight of such an innocuous
animal? If you're one of the thousands who suffer from galeophobia--the
fear of cats--or any one of hundreds of other phobias, sheer panic at
the appearance of everyday objects, situations or feelings is a regular
occurrence.

Irrational Fears

A phobia is an intense, unrealistic fear of an object, an event, or a
feeling. An estimated 18 percent of the U.S. adult population suffers
from some kind of phobia, and a person can develop a phobia of
anything--elevators, clocks, mushrooms, closed spaces, open spaces.
Exposure to these trigger the rapid breathing, pounding heartbeat, and
sweaty palms of panic.

There are three defined types of phobias:


 * specific or simple phobias--fear of an object or situation, such as
   spiders, heights or flying

 * social phobias--fear of embarrassment or humiliation in social
   settings

 * agoraphobia--fear of being away from a safe place.

No one knows for sure how phobias develop. Often, there is no
explanation for the fear. In many cases, though, a person can readily
identify an event or trauma--such as being chased by a dog--that
triggered the phobia. What puzzles experts is why some people who
experience such an event develop a phobia and others do not. Many
psychologists believe the cause lies in a combination of genetic
predisposition mixed with environmental and social causes.

Phobic disorders are classified as part of the group of anxiety
disorders, which includes panic disorder, post-traumatic stress
disorder, and obsessive-compulsive disorder. Several drugs regulated by
the Food and Drug Administration are now being used to treat phobias and
other anxiety disorders.

Dogs, Snakes, Dentists . . .

A person can develop a specific phobia of anything, but in most cases
the phobia is shared by many and has a name. Animal phobias--cynophobia
(dogs), equinophobia (horses), zoophobia (all animals)--are common. So
are arachnophobia (spiders) and ophidiophobia (snakes). And, of course,
there's the fear of flying (pterygophobia), heights (acrophobia), and
confined spaces (claustrophobia).

"One of the most common phobias is the fear of dentists
[odontiatophobia]," says Sheryl Jackson, Ph.D., a clinical psychologist
and associate professor at the University of Alabama at Birmingham.
"People who suffer with this phobia will literally let their teeth rot
out because they are afraid to go to a dentist."

Jackson says that most specific phobias do not cause a serious
disruption in a person's life, and, consequently, sufferers do not seek
professional help. Instead, they find ways to avoid whatever it is that
triggers their panic, or they simply endure the distress felt when they
encounter it. Some may also consult their physicians, requesting
medication to help them through a situation, such as an unavoidable
plane trip for someone who is phobic about flying.

Drugs prescribed for these short-term situations include benzodiazepine
anti-anxiety agents. These medications include two approved for treating
anxiety disorders: Xanax (alprazolam) and Valium (diazepam). Beta
blockers such as Inderal (propranolol) and Tenormin (atenolol), approved
for controlling high blood pressure and some heart problems, have been
acknowledged, partly on the basis of controlled trials, to be helpful in
certain situations in which anxiety interferes with performance, such as
public speaking.

Some phobias cause significant problems that require long-term
professional help. "People usually seek treatment when their phobia
interferes in their lives--the person who turns down promotions because
he knows public speaking will be required, someone who must travel
frequently but who is afraid of flying, or a woman who wants to have
children but who has a fear of pain or blood. These are the people who
seek long-term treatment," says Jackson.

While anti-anxiety medication sometimes may be used initially,
systematic desensitization may also be an effective initial approach.
Jackson explains that this nondrug treatment works on the theory that
the more a person is exposed to the object of his phobia, the less fear
that object generates.

First, the patient and therapist establish a hierarchy of feared
situations, from the least to the most feared. For someone who fears
elevators, for example, stepping onto the elevator causes a certain
level of anxiety; going up one flight causes another level of anxiety.
With each additional flight the anxiety increases until it becomes
intolerable.

Therapy begins with the patient and therapist practicing the least
fearful event, riding out the anxiety until the physiological symptoms
subside. This step is repeated until the anxiety level is acceptable.
Then the person progresses to the next step in the hierarchy. Each
successive step is repeated until the physical reactions and anxious
mood decrease to the point where the person can step onto an elevator
and ride to the top floor without panicking.

Everyone's Looking at Me!

Social phobia is a complex disorder, characterized by the fear of being
criticized or humiliated in social situations. There are two types of
social phobias: circumscribed, which relates to a specific situation
such as "stage fright," and generalized social phobia, which involves
fear of a variety of social situations.

People suffering from social phobia fear the scrutiny of others. They
tend to be highly sensitive to criticism, and often interpret the
actions of others in social gatherings as an attempt to humiliate them.
They are afraid to enter into conversations for fear of saying something
foolish, and may agonize for hours or days later over things they did
say.

"I always believed that everybody else knew the secret to enjoying
themselves in social situations, that I was the only one who was so
afraid," says Lorraine from Birmingham, Ala., who asked that her last
name not be used. "For a long time, I avoided as many situations as
possible, even talking on the telephone. After a while, the loneliness
and boredom would overwhelm me, and I would try again. I wanted to have
fun, but I never really enjoyed myself because of the anxiety I felt. I
always believed that others were looking at me and judging me."

Many people with social phobia are so sensitive to the scrutiny of
others that they avoid eating or drinking in public, using public
restrooms, or signing a check in the presence of another. Social phobia
may often be associated with depression or alcohol abuse.

Neurotransmitter-receptor abnormalities in the brain are suspected to
play a part in the development of social phobias. Neurotransmitters are
substances such as norepinephrine, dopamine and serotonin that are
released in the brain. The substance then either excites or inhibits a
target cell. Disorders in the physiology of these neurotransmitters are
thought to be the cause of a variety of psychiatric illnesses.

Negative social experiences, such as being rejected by peers or
suffering some type of embarrassment in public, and poor social skills
also seem to be factors, and social phobia may be related to low
self-esteem, lack of assertiveness, and feelings of inferiority.

Treatment can include cognitive-behavior therapy and medications, though
no drug is approved specifically for social phobia. In addition to the
anti-anxiety drugs and beta-blockers, medications may include the
monoamine oxidase (MAO) inhibitor antidepressants Nardil (phenelzine)
and Parnate (tranylcypromine), and serotonin specific reuptake
inhibitors (SSRIs) such as Prozac (fluoxetine), Paxil (paroxetine),
Zoloft (sertraline), and Luvox (fluvoxamine). Of the latter four drugs,
Prozac, Zoloft and Paxil are approved for depression; Prozac, Paxil,
Luvox, and Zoloft are approved for obsessive-compulsive disorder; and
Paxil is approved for panic disorder.

Chris Sletten, Ph.D., a clinical psychologist and behavioral medicine
specialist at the Mayo Clinic, says the use of SSRIs with behavior
therapy is becoming more popular in the treatment of social phobia.
Because there are fewer side effects associated with these drugs and a
very low addiction potential, practitioners are more comfortable
prescribing them. Plus, the antidepressant action of these drugs is
helpful in treating patients who suffer from depression in addition to
social phobia, he says.

"My therapist prescribed Prozac, and it has been an absolute godsend for
me," Lorraine says. "After only a couple of months taking it, those
voices in my head, the ones that always assured me that everyone was
judging me--and finding me lacking--just seemed to shut up. I didn't
feel high or drugged in any way. I felt like I always thought a "normal"
person would feel. It's not a complete cure, of course. I still feel
anxiety in social situations. But I don't avoid them as much. In fact, I
actually pick up the phone now and ask friends to dinner, and I can
relax enough to have fun. It's a whole new life for me."

The Wide Open Spaces

Agoraphobia comes from Greek, meaning literally "fear of the
marketplace," but it usually is defined as a fear of open spaces.
Sletten says it stems more from the fear of being someplace where you
will not be able to escape. It is closely identified with panic
disorder, and in many cases, agoraphobia is directly related to the fear
of experiencing a panic attack in public.

A person with panic disorder suffers sudden bouts of panic for no
apparent reason. These attacks can occur anywhere at any time. One
minute everything is fine, the next the person is engulfed by a feeling
of terror. The heart races, breathing comes in gasps, and the entire
body trembles. The attack may last only minutes, but its memory is
etched indelibly in the brain, and the anticipation of another causes
almost as much terror as the attack itself.

People who suffer agoraphobia avoid places and situations where they
feel escape would be difficult in case an attack occurs. This could be
anywhere--the grocery store, a shopping mall, the office. As the fear of
an attack increases, the agoraphobic's world narrows to only a few
places where he or she feels safe. In the most severe cases, this is
limited to the home.

Agoraphobia is the most disabling of all the phobias, and treatment is
difficult because there are so many associated fears--the fear of
crowds, of elevators, of traffic. As with social phobias, treatment
involves behavioral therapy combined with anti-anxiety or antidepressant
medications, or both. Paxil has received FDA approval for use in
treating panic disorders with or without agoraphobia, and at press time,
Zoloft was being considered for this additional use.

"The most important thing for people with phobias to remember," says
Sletten, "is that phobic disorders do respond well to treatment. It's
not something they have to continue to suffer with."

Lynne L. Hall is a writer in Birmingham, Ala.


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Getting Help

For more information on these disorders and their treatment call:

American Psychological Association
(202) 336-5500
750 First St., N.E.
Washington, DC 20002
http://www.apa.org/

American Psychiatric Association
(202) 682-6000
1400 K St., N.W.
Washington, DC 20005
http://www.psych.org/

Freedom From Fear, Inc.
(718) 351-1717
308 Seaview Ave.
Staten Island, NY 10305

National Mental Health Association
(1-800) 969-6642
1021 Prince St.
Alexandria, VA 22314-2971
http://www.nmha.org/

Phobics Anonymous
(619) 322-2673
P.O. Box 1180
Palm Springs, CA 92263

National Alliance for the Mentally Ill
(1-800) 950-6264
200 Glebe Road
Suite 1015
Arlington, VA 22203-3754

Anxiety Disorders Association of America
(301) 231-9350
6000 Executive Boulevard
Suite 513
Rockville, MD 20852

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Fruits and Vegetables: Eating Your Way to 5 A Day

by Paula Kurtzweil

Are you taking the 5 A Day challenge? You may be if you find yourself:


 * snacking on raw vegetables instead of potato chips
 * adding fruit to your cereal at breakfast
 * using the salad bar when you go out for lunch or to the grocery store
 * loading up on juice instead of a usual coffee, tea or soda.

The challenge, offered by the National Cancer Institute--a branch of the
National Institutes of Health--is to eat at least five servings of
fruits and vegetables a day, and these are some ways consumers are
rising to the occasion.

They're taking advantage of the healthful benefits of fruits and
vegetables. Studies by the U.S. Department of Health and Human Services,
U.S. Department of Agriculture, and the National Academy of Sciences
suggest that the nutritional goodness of fruits and vegetables, with a
diet that is low in fat, saturated fat and cholesterol and that contains
plenty of whole-grain breads and cereals, may decrease the risk of heart
disease and cancer.

Fruits' and vegetables' potential to help improve the health of
Americans led NCI to begin a multi-year public education campaign in
1992. Its goal is to increase consumers' awareness of the importance of
fruits and vegetables and to give consumers ideas on how they can
increase their intake. With its partner, the Produce for Better Health
(PBH) Foundation--a nonprofit consumer education foundation funded by
the produce industry--NCI has taken the "5 A Day for Better Health"
message to grocery stores, classrooms, television, work sites, churches,
and elsewhere.

Food labeling of fresh, frozen and canned fruits and vegetables may
carry the message, too. And if you need more specific nutrition
information about a particular item, you can find it in the labeling of
most products, as well. The Food and Drug Administration regulates this
information, which corresponds to NCI's Five A Day guidance and the
government's Dietary Guidelines for Americans.



Emphasis on More

A 1991 NCI and PBH survey, which has the best available, most up-to-date
information on consumers' consumption of fruits and vegetables, found
that the average American consumer eats only about three servings of
fruits and vegetables a day. Forty-two percent eat less than two
servings a day. Compare those figures with the five to nine servings a
day recommended by the Dietary Guidelines for Americans and you can see
that many of us have a way to go.

A major reason to eat more fruits and vegetables is their
nutritiousness. Unless baked in a pie or dripping in butter, most are
low in fat and calories--except avocados, coconut and olives, all of
which contain fat naturally. Many are excellent sources of the important
vitamins A and C and provide ample fiber.

In addition, many fruits and vegetables, particularly dried beans and
peas, are significant sources of folate, a B vitamin that can help
reduce the risk of certain serious and common birth defects. (See "How
Folate Can Help Prevent Birth Defects" in the September 1996 FDA
Consumer.)

Produce has other positive qualities. Many items, such as raisins,
grapes, cherry tomatoes, and bananas, can be eaten on the spot, with
minimal preparation. (Fresh produce in which the peel will be eaten
should be rinsed with water beforehand to remove any surface dirt and
bacteria.) NCI campaign literature refers to fruits and vegetables as
the "original fast food."

"They're easy to pick up and eat," said Daria Chapelsky, state
coordinator for NCI's 5 A Day Program. "Just as easy as picking up fast
food."

And, unlike other types of foods (such as those high in fat that many of
us eat too much of), plain fruits and vegetables are items we don't need
to restrict. Genda Potter, a registered dietitian for cardiac patients
at Memorial Medical Center in Springfield, Ill., said that factor was a
major reason she began a regular 5 A Day class for outpatients.

"I wanted to emphasize something positive," she said. "People often look
on dietitians as people 'out-to-ruin-my-enjoyment-of-food.' But fruits
and vegetables are foods they can add to their diet rather than
something they're going to be told to take away."



No Excuses

Still, for any number of reasons, consumers often find it difficult to
eat more fruits and vegetables. They may avoid them because they believe
they are too expensive or take too long to prepare. These and other
perceived problems became evident to NCI in 1991, when it asked members
of small group studies to come up with reasons people may not want to or
might be unable to eat at least five servings of fruits and vegetables a
day.

Their responses led NCI to develop ideas to help consumers overcome
reported difficulties in meeting the 5 A Day goal. Some of those ideas
follow, along with other information from nutritionists and food safety
experts to help consumers overcome any reluctance they may have to
eating fruits and vegetables.

Perceived Problem: Fruits and vegetables cost too much.
Possible Solutions:

[illustrations of banana, apple, cookies, and potato chips
showing relative costs per serving omitted] It may help to realize,
according to dietitians, that fruits and vegetables are actually good
buys, if you consider that they are nutrient-dense, containing many of
the vitamins and minerals we need more of--for example, vitamins A and
C. But the foods we often buy in place of them--cookies and chips, for
example--usually offer more of the nutrients--fat and sodium, for
example--that most of us should eat less of. And the cookies and chips
aren't cheap. For example, based on prices at a Rockville, Md., grocery
store, a serving of potato chips costs about 25 cents and a serving of
packaged chocolate chip cookies about 24 cents. A banana, on the other
hand, sold for 17 cents, and the price of an apple ran as low as 13
cents.

"Compared to packaged foods, fruits and vegetables are not expensive,"
says Diane Quagliani, a registered dietitian and spokeswoman for the
American Dietetic Association.

And there are ways to reduce the costs of fruits and vegetables even
further:


 * Buy fresh fruits and vegetables in season. Not only will they be
   cheaper but they also will be at their flavor and nutritional peaks,
   Quagliani says.

 * Clip coupons for money off on your favorite canned and frozen fruits
   and vegetables and juices.

 * Watch local grocery advertisements for reduced prices on your
   favorite fruits and vegetables.

 * If you're not partial to a particular brand, compare prices of
   different brands of canned and frozen fruits and vegetables and
   juices and buy the cheapest.

Perceived Problem: Fruits and vegetables take too long to prepare.
Possible Solutions:


  * Take advantage of grocery store salad bars, which offer ready-to-eat
    raw vegetables and fruits and prepared salads made with fruits and
    vegetables.

 * Shop for precut and cleaned fruits and vegetables. Many grocery
   stores now carry packaged precut fruits, such as melons and
   pineapple; cleaned and cut-up salad greens and stir-fry vegetables;
   and cleaned, peeled baby carrots.

 * Keep on hand canned and frozen fruit,
   canned and bottled juices, and dried fruits. Just open and use.

 * Stock up on frozen vegetables for easy cooking in the microwave oven.

 * Prepare fruits and vegetables ahead of time; for example, wash and,
   if feasible, cut up fresh produce and store it in the refrigerator
   for handy, immediate use.

Perceived Problem: Fresh fruits and vegetables spoil too quickly.
Possible Solutions:


  * If you shop once a week or less often, buy both fresh and
    processed--that is, canned or frozen--fruits and vegetables, and
    juices. Use the fresh first; save the processed items for use later.

 * Buy both ripe and not-so-ripe fresh fruits and vegetables--for
   example, yellow and green bananas--so that the not-so-ripe items will
   last a few days longer and be ready for eating after you've finished
   the ripe ones.

  * Keep fruits and vegetables where you can see them often--on the top
    shelf of the refrigerator, or, for fruits that don't need
    refrigeration (such as bananas and apples), on the table or counter
    or another easy-to-spot-place. The more often you see the fruits and
    vegetables, the more likely you may be to eat them.

Perceived Problem: Fruits and vegetables contain harmful pesticides.
Possible Solutions:

It is a fact that pesticides are used in the production of most fruits
and vegetables sold in this country. They help protect crops from
insects, diseases, weeds, and mold, thus helping to increase crop yield.
"They allow for production of a plentiful and affordable food supply,"
said John Jones, Ph.D., pesticides and chemical contaminants strategic
manager in FDA's Center for Food Safety and Applied Nutrition.

"They are not contaminants. They are substances applied intentionally
for a specific purpose and therefore are subject to very rigorous
regulatory control," he said. "A new pesticide law enacted in 1996 puts
even tighter controls on the use of pesticides."

Several federal agencies share responsibility for pesticide oversight.
The Environmental Protection Agency registers pesticides for food use
and sets tolerance levels--the upper permitted limit for pesticide
residues in individual foods. FDA enforces these limits for all foods
except meat and poultry, which fall under USDA's jurisdiction.

FDA collects and analyzes almost 10,000 samples of fruits and vegetables
yearly for pesticide residues. Since 1987, when the agency began
reporting the results of its monitoring program annually, more than 99
percent of domestic fruit and vegetable samples and more than 95 percent
of imported samples have been found free of illegal pesticide residues
or had low-level residues that fell within established tolerances.
Violations mainly occurred because low-level pesticide residues not
approved for a particular product were identified in that food. However,
most of the pesticides causing these violations were approved for use on
many other foods, Jones said.

"Most violations are not due to the presence of banned pesticides, such
as DDT, chlordane and heptachlor, or to very high levels of residues,"
he said. "Most are due to very low-level residues on the wrong
commodity."

So, FDA's position is that the U.S. fruit and vegetable supply does not
contain excessive pesticide residues and that the benefits of eating
fresh produce far exceeds any risk from residues, Jones said.

However, if you're still concerned, here are some steps you can take to
reduce your risk further:


  * Wash fruits and vegetables with water and scrub with a dish brush
    when appropriate: for example, before eating apples, cucumbers,
    potatoes, or other produce in which the outer skin or peeling is
    consumed.

 * Throw away the outer leaves of leafy vegetables, such as lettuce and
   cabbage.

  * Peel and cook when appropriate, although some nutrients and fiber
    may be lost when produce is peeled.


What to Eat

For the most part, any fruit or vegetable will do in helping consumers
reach their 5 A Day goal. But certain types of fruits and vegetables
should be selected regularly because of their nutritional value. These
include those that are good sources of vitamins A and C and fiber.

Variety also is important because fruits and vegetables provide other
nutrients, such as folate, potassium, calcium, and iron. Varying choices
increases the likelihood of getting all the nutritional advantages of
fruits and vegetables.

Also, nutrition experts advise against replacing all fruits and
vegetables in the diet with dietary supplements because supplements
often do not contain all the known--and perhaps unknown--nutritional
benefits of fruits and vegetables.

Preparation presents another nutritional concern. Since a reduced-fat,
reduced-saturated-fat intake is important to a healthful diet, it's
important not to overindulge in fruits and vegetables prepared with
high-fat ingredients. Some dishes to look out for include fried
vegetables, such as french fries; cooked vegetables in cheese or cream
sauces or with added bacon or butter; fruit pies or fruit served with
whipped cream; and dips for raw vegetables. Some of these high-fat foods
now have reduced-fat versions, such as low-fat dips and whipped
toppings.



A Label with a Lot

You can determine the nutritional value of fruits and vegetables by
looking at the Nutrition Facts panel on the side or back of labels of
frozen and canned items. Nutrition information also is available for
many fresh items, under FDA's voluntary point-of-purchase nutrition
information program for raw foods. This information may appear on the
labels of packaged fresh fruits and vegetables or on posters or
brochures at or near the point of purchase.

The nutrition information lists the kinds and amounts of important
nutrients in a serving of the fruit or vegetable and gives the Percent
Daily Value, which shows how much those amounts contribute to the daily
diet.

Some information is required: for example, the amount of fat, fiber,
vitamins A and C, and iron and calcium, even if there is none. Some
labels will carry additional information, such as the amount of folic
acid and iron, depending on the types of label claims made.

You can quickly find fruits and vegetables that provide the nutrients
you're looking for--for example, vitamin A or C or both--by looking for
short descriptive terms on the front, side or back of the food label.
For example, an orange juice label may say "provides 100 percent of the
Daily Value for vitamin C." A package of frozen broccoli may state "good
source of fiber." These claims refer to the contents of one serving of
the item.

Less frequently, you may see longer claims describing the relationship
between the labeled food or one or more nutrients in the food to a
certain disease or medical condition. Only claims approved by FDA can be
used in food labeling. Three approved health claims pertain to fruits
and vegetables. These claims can describe how:


  * fruits and vegetables may help lower the risk of some cancers

  * fruits, vegetables and grain products that contain fiber,
    particularly soluble fiber, may help reduce the risk of coronary
    heart disease

  * fiber-containing grain products, fruits and vegetables may help reduce
    the risk of some cancers.

In addition, in spring 1996, FDA approved a claim stating that a diet
with adequate folic acid may reduce the risk of certain birth defects.
This claim might appear, for example, on labels of dried beans, brussels
sprouts, asparagus, tomato juice, and orange juice--foods that are
excellent or good sources of folate.



A Campaign Continues

Are consumers paying attention to all this information?

In a way, yes, according to a 1996 NCI/PBH survey. That survey found
that the percentage of consumers who were aware of the need to eat at
least five servings of fruits and vegetables a day rose from 8 percent
in 1991 to 35 percent in September 1996.

But whether the information has helped increase Americans' consumption
of fruits and vegetables remains to be seen. Late last year, NCI planned
to analyze national food consumption data--the most recent of which was
collected in 1994--to determine whether fruit and vegetable intake had
increased since the 1991 survey. According to Gloria Stables, a
registered dietitian and NCI's 5 A Day Program director, NCI plans to
release the results this year.

Meanwhile, NCI, the produce industry, state health departments, and
other groups will continue the 5 A Day campaign through at least the
year 2000. Said Stables, "This is the largest national public-private
nutrition education program ever launched."

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


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


What's a Serving Size?

Here's what the National Cancer Institute recommends as a serving of
fruit and vegetables:


  * 1 medium fruit or 1/2 cup of small or cut-up fruit

  * 3/4 cup (180 milliliters) of 100 percent juice

  * 1/4 cup dried fruit

  * 1/2 cup raw non-leafy or cooked vegetables

  * 1 cup raw leafy vegetables (such as lettuce)

  * 1/2 cup cooked beans or peas (such as lentils, pinto beans, and
    kidney beans)


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




Tips for Safe Handling of Fruits and Vegetables

E. coli in fresh apple cider.

Salmonella in melons.

Shigella in tossed salad.

These aren't dishes you'd want to order from a menu. They're
descriptions of several causes of food-borne illness reported in recent
years. The bacteria Escherichia coli O157:H7, Salmonella and Shigella in
these fruits and vegetables were the culprits.

Although not commonly associated with food poisoning, fruits and
vegetables can harbor disease-causing bacteria. Their growth
environment, such as soil, is a rich source of microbes. Poor
agricultural practices--such as irrigation with unsanitary water--also
may introduce bacteria. Poor storage and transportation practices can
result in contamination, too, as can poor food handling by grocers,
restaurants and consumers in the home.

FDA regulates certain production practices aimed at reducing bacterial
contamination. For example, FDA bars the use of animal fertilizers and
allows only potable water for irrigation. These regulations apply to
foreign producers that sell fruit and vegetables in this country and to
domestic producers that market their products across state lines.

Industry practices, such as rinsing fresh fruits and vegetables with
chlorinated water and transporting them in refrigerated cars, help
reduce the risk further. Restaurants and grocers also have certain
standards to follow, based on their local food safety laws. These laws
are often based on FDA's model food code for food establishments.

But, just as with other foods, safe handling of fruits and vegetables
doesn't end there. Consumers have a responsibility, too. Here are some
pointers to keep in mind when handling fruits and vegetables, and other
foods, as well:


 * Wash hands with warm water and soap for at least 20 seconds before
   and after handling food, especially fresh whole fruits and
   vegetables and raw meat, poultry and fish.

 * Rinse raw produce in warm water. Don't use soap or other detergents.
   If necessary--and appropriate--use a small scrub brush to remove
   surface dirt.

 * Use plastic, rather than wooden, cutting boards. Bacteria can hide in
   the grooves of wooden ones.

 * Wash cutting boards with a solution of 1 teaspoon (5 milliliters) of
   chlorine bleach in 1 quart (about 1 liter) of hot water. Always wash
   boards after cutting raw meat, poultry or seafood and before cutting
   another food to prevent cross-contamination.

 * Store cut, peeled and broken-apart fruits and vegetables (such as
   melon balls) at or below 41 degrees Fahrenheit (5 degrees
   Celsius)--that is, in the refrigerator.

 * Stick with pasteurized juices and cider. If you do buy unpasteurized
   cider, boil it for 5 minutes before drinking. This will kill
   bacteria.

 * When buying from a salad bar, avoid fruits and vegetables that look
   brownish, slimy or dried out. These are signs that the product has
   been held at an improper temperature.

--P.K.

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


More Information

5 A Day Program
National Cancer Institute
EPN 232
6130 Executive Blvd., MSC 7330
Bethesda, MD 20892-7330
Telephone: (1-800) 4-CANCER
World Wide Web: http://www.dcpc.nci.nih.gov/5aday/

Produce for Better Health Foundation
1500 Casho Mill Road
Newark, DE 19174-6035
Telephone: (302) 738-7100

FDA
Office of Consumer Affairs (HFE-88)
Rockville, MD 20857
Telephone: (1-800) 532-4440
(10 a.m. to 4 p.m. Eastern time, Monday through Friday)

Also check with:

  * grocery stores

  * state health departments. Ask for the 5 A Day coordinator.


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


What About Waxes?

A thin wax-like coating is often applied to some fruits and vegetables
after harvesting. This is mainly to keep the produce fresh longer by
sealing in moisture.

"Contrary to belief, it is not applied just to make fruits and
vegetables look pretty," a United Fresh Fruit and Vegetable Association
brochure says.

Some fruits and vegetables typically--but not always--coated with wax
are apples, melons, grapefruit, peaches, oranges, rutabagas, cucumbers,
squash, and tomatoes, according to the association.

FDA regulates these waxes, or coatings, as food additives approved or
"generally recognized as safe" for human consumption. However, some
consumers have concerns about their use. Vegetarians and others who
avoid animal products may worry that fruits and vegetables contain
animal-based waxes, such as oleic acid. Some people fear that the wax
traps pesticides, making the fruit or vegetable unsafe to eat--even
though FDA's pesticide monitoring program indicates that pesticide
residues on fruits and vegetables are consistently within acceptable
safe limits.

If consumers want to avoid waxed fruits and vegetables, FDA regulations
that took effect in 1994 may help them identify the appropriate products
for them. These regulations require produce packers or grocers to
provide point-of-sale information about the presence of waxes on fresh
fruits and vegetables. This information can appear on labels of
individual products, packing cartons (if they are used at the point of
sale), or on counter cards or signs. The information will say that the
product is:


  * Coated with food-grade animal-based wax to maintain freshness, or

  * Coated with food-grade vegetable-, petroleum-, beeswax-, and/or
    shellac-based wax or resin to maintain freshness. If only one of
    these types of waxes is applied, the label can simply identify the
    type, such as "vegetable-based."

FDA also will allow the statement "No wax or resin coating" on fresh
fruits and vegetables that do not contain wax.

Besides reading labeling information, consumers can reduce their
concerns about waxes by rinsing fruits and vegetables with warm water
and, when appropriate, scrubbing with a brush. This will eliminate much
of the wax.

--P.K.

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


Inside FDA: Barring People from the Drug Industry

by Tamar Nordenberg

This is one in a series of articles on FDA activities and concerns.

"Some may object that the bill is unduly harsh, but let us not forget,
this bill is only aimed at those who have engaged in criminal
misconduct, those who put corporate profits ahead of public safety."
--Generic drug company representative Kip Schwartz, testifying before
Congress about debarment.


For putting unlawful profit ahead of consumer safety, 38 drug industry
employees are facing a lifetime bar on practicing their livelihood. They
were convicted, under the Federal Food, Drug, and Cosmetic Act, of
felonies that included submitting false data to the Food and Drug
Administration, lying to FDA investigators, paying or accepting bribes,
and selling prescription drug samples. As a result, the 38 were
"debarred" by FDA from working for a drug company.

Most worked for generic drug firms (firms that make drugs that are
equivalent to the first, brand-name versions) in positions like "vice
president for quality control" or "director for research and
development."

The word "debar" means to shut out or exclude. FDA's authority to debar
people from the drug industry comes from the Generic Drug Enforcement
Act of 1992, often called the "debarment act" because it authorizes, and
sometimes even requires, FDA to forbid people (or firms) convicted of
certain crimes--basically, crimes related to FDA's regulation of
drugs--from participating in the drug industry.

Other parts of this act give the agency additional authorities.

When a person is debarred, FDA notifies the public by publishing a
notice in the Federal Register. Also, FDA keeps an up-to-date debarment
list. A copy of the list can be obtained by contacting FDA's Office of
Enforcement (HFC-230), 12720 Twinbrook Parkway, Rockville, MD 20852;
phone: (301) 827-0410; fax: (301) 827-0482; E-mail:
tchin@fdaem.ssw.dhhs.gov.

Each time a company--any drug company, not just a generic drug
maker--applies for approval of a drug, it must submit to FDA a signed
statement that no debarred people worked on the application. If a drug
firm employs a debarred person, even as a consultant or contractor, it
can be fined up to $1 million. The person illegally working in the
industry can be fined up to $250,000.

Cleaning Up Generics

The law is broader than its title implies, affecting in large part
brand-name as well as generic drug companies. It is called the "Generic
Drug Enforcement Act" because Congress passed the public protection
measure in response to the confidence-shaking discovery in 1989 of
widespread corruption in the generic drug industry.

That year, FDA learned that some generic drug companies had committed
illegal acts--things like falsifying data on drug formulations and
illegally giving money to FDA chemists reviewing their drug
applications--to gain preferential treatment.

"The data falsifications weren't just honest mistakes by generic
companies," says David Read, chair of FDA's Debarment Task Force, which
meets as necessary to make debarment policy decisions. "They were
calculated attempts to circumvent FDA's regulations. They constituted
serious violations of the public trust."

To restore confidence in generic drugs, FDA fired agency employees who
had taken bribes and reinspected drug manufacturing facilities. FDA also
tightened its regulatory processes, for better verification of data used
to support approval decisions.

Protection, Not Punishment

Even with improved procedures, FDA lacks the resources to audit every
piece of data in every drug application. "The drug approval process is
based on a system of trust," Read says. "The agency receives hundreds of
drug applications a year, each consisting of many volumes. When Congress
created the new drug approval process, it was relying on drug companies
and the agency to be fundamentally honest in their dealings with each
other."

Debarment supplements FDA's existing compliance
instruments--injunctions, seizures, recalls, civil penalties, and
criminal sanctions. By rooting out dishonest people, the debarment act
bolstered FDA's efforts to clean up the generic industry.

Under the law, a debarred person can't work for a drug firm "in any
capacity." According to the U.S. Court of Appeals for the District of
Columbia, even a job as a cook in a drug firm's cafeteria would be
forbidden because of the opportunity for close contact between the
debarred person and the drug firm's management. "All direct employment
by a drug company, whether in the board room or the cafeteria or
somewhere in between" is forbidden, the court said.

Besides direct employment, some jobs for a contractor that provides
services to a drug firm are also off-limits.

"Debarment is a serious measure, but it's not intended as punishment,"
says Read. "It protects the public by ensuring that people with a
history of dishonest conduct in the drug approval process will no longer
be participants in that process."

Some debarees have claimed that the law is unconstitutional--that it is
an ex post facto law--because it applies to crimes committed before the
Generic Drug Enforcement Act was even passed in 1992. Because the law is
a public protection measure and not punishment, courts have found that
it is not illegal to debar people for conduct occurring before the law
existed.

For the same reason, the act doesn't violate the constitution's double
jeopardy clause because it doesn't punish someone twice for the same
offense.

Termination

Even the permanence of so-called "mandatory debarment" doesn't make
debarment punishment. All debarments except one so far have been
mandatory debarments, meaning that the types of convictions--federal
felony convictions relating to the development, approval or regulation
of a drug product--compelled FDA to exclude the people from the
industry.

Unlike "permissive debarment," which lasts up to five years, mandatory
debarments of individuals are considered permanent. Although the
mandatory debarments are imposed for a lifetime, the label of permanent
may be misleading because the law provides a way for debarees to apply
for "termination" of the debarment. They may be allowed to return to the
drug industry if they substantially assist in the investigations or
prosecutions of others in drug-related cases and submit persuasive
evidence that they are rehabilitated and are no longer a threat to the
drug approval process.

So far, no debarments have been terminated. But, Read says, "A small
number of the people debarred so far may be eligible to have their
debarments terminated."

Tamar Nordenberg is a staff writer for FDA Consumer.


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


Act's Other Authorities

Mandatory debarment isn't the only authority given to FDA by the Generic
Drug Enforcement Act. Other authorities include:

Civil Penalties: Besides fines for violating a debarment, fines of up to
$1 million may also be imposed on a company for bribery, false
statements, or other wrongful conduct involving a generic drug
application.

Permissive Debarment of Individuals: FDA has the option to debar, for up
to five years, individuals convicted of certain crimes, described in the
act, that are related to the regulation of drugs but do not require
mandatory debarment. In January 1997, FDA used this authority for the
first time, debarring the head of a blood plasma facility convicted of
falsifying blood records.

Debarment of Firms: Firms are also subject to mandatory or permissive
debarment. They can be prohibited from submitting applications for
generic drug approval (in this case, the law lives up to its name and
only applies to generics) for certain crimes relating to the development
or approval of generic drug applications. They can be debarred for up to
10 years, depending on the seriousness of the crime and other factors,
and they can be debarred permanently if they are convicted a second time
while debarred.

Suspension of Distribution: FDA can suspend marketing of some or all of
a company's drug products if the company is under investigation for
certain conduct that may influence the safety or effectiveness of a
drug.

Temporary Denial of Approval: FDA can withhold approvals of generic drug
applications if the firm is under active criminal investigation for
dishonest conduct involving its drug applications (for example, bribery
or material misrepresentations).

Withdrawal of Approval: For a generic drug that's already been approved,
FDA may withdraw that approval if the company used bribery or fraud to
get approval or if the company can't produce the drug properly.

--T.N.

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

New Attitudes Towards Menopause

by Sheryl Weinstein

Imagine a cocktail party conversation in 1966 turning to menopause. It
would have been as unlikely as a female high school student yearning to
be a soccer star.

But times have changed. Just as participating in sports has now become
significant to many young women so has being open and even activist
about menopause become equally important to their mothers.

The first women of the post-World War II generation known as baby
boomers are reaching the age of 50, one year away from the average age
of menopause among U.S. women. By the end of this century, more women
than ever before will be experiencing the sometimes uncomfortable
symptoms that accompany the end of menstruation and natural childbearing
capacity.

For many years, U.S. doctors knew little about and paid little attention
to menopause. "About 20 years ago, medical attitudes started changing,"
says Isaac Schiff, M.D., chief of obstetrics and gynecology,
Massachusetts General Hospital. "We Ob-Gyns used to think that when
women reached age 50, they weren't interested in sex anymore. But
studies in retirement communities showed otherwise. We also began to see
an increase in the female life expectancy. When a woman reaches age 50,
she typically has another 30 years to live. As physicians, we became
interested not only in the quantity of her life, but the quality of it."

The pace of medical inquiry has accelerated over the last five years, as
the first of the baby boomers turned 45 and started experiencing
menopausal symptoms. "It's not uncommon to hear it discussed at cocktail
parties," says Schiff. "This is a radical turn-around from the way the
mothers of these women treated it. Speak to a 50-year-old woman and
she'll say, my mother never discussed it with me."

With such thinking, a new attitude toward treatment and research has
emerged, says Schiff. Until recently, there were few studies on
menopause. One of the largest and potentially most fruitful is the
Women's Health Initiative, sponsored by the National Institutes of
Health, which will study 164,500 women of various racial and ethnic
backgrounds across the United States. The scientific investigation,
which will not be completed until 2005, is expected to find out whether
a low-fat diet, hormone replacement therapy, calcium, and vitamin D
might prevent heart disease, breast and colorectal cancers, bone
fractures, and memory loss.

Hormone Replacement Therapy

As many as 15 to 25 percent of postmenopausal American women take
hormone replacement therapy, according to an article in the January 1995
issue of the Journal of Obstetrics and Gynecology by Diane Wysowski,
Ph.D., of the Food and Drug Administration, and colleagues. Women take
estrogen to alleviate menopausal symptoms, especially hot flashes
(sometimes called by doctors "hot flushes"), and also to protect bones.

Since the 1940s, FDA has approved many estrogen drugs to reduce
menopausal symptoms. In the 1980s, FDA also began approving specific
estrogen drugs to prevent osteoporosis (literally "porous bones," a
condition in which bones break easily). The agency has approved four
estrogen drugs--Premarin, Estraderm, Estrace, and Ogen--for long-term
use to prevent osteoporosis. Other approved uses for estrogen drugs
include the treatment of symptoms of vaginal atrophy, which may include
itching, burning or dryness around the vagina, certain abnormal uterine
bleeding conditions due to hormonal imbalance, and the comfort-promoting
treatment of certain advanced cancers.

Many scientists believe that estrogen may fight heart disease by
lowering harmful cholesterol (LDL), raising beneficial cholesterol
(HDL), and strengthening the lining of the blood vessels, but this has
not been clearly proven. Some research also suggests that estrogen may
help prevent memory loss and Alzheimer's disease, but the scientific
evidence remains speculative.

Nearly all the studies on heart disease and cognitive function have been
retrospective or "look back" studies. The Women's Health Initiative
Study will be prospective, that is, future-oriented, says Deborah Smith,
M.D., a medical adviser in FDA's Office of Women's Health. Researchers
will select a group of generally healthy women to treat and observe for
a number of years to see if, and at what rate, they develop symptoms.
Elements of the study will be scientifically controlled and data freshly
recorded. Most important, treated and untreated women will be equally
healthy at the start of the study. Retrospective studies depend on
information sometimes clouded by time and memory loss, and women
selected by their doctors for hormone replacement have usually been
healthier than the women not so prescribed.

"The other important difference about the Women's Health Initiative is
that it includes a clinical trial of estrogen," says Jacques Rossouw,
the lead project officer for the study. "Participants will have an equal
chance of being on either estrogen or a placebo, and any differences in
their health at the study's end can be ascribed to the estrogen."

Risks of Estrogen Therapy

Estrogen is most commonly prescribed in pill form. It is also available
in transdermal patches, which allow the drug to be slowly absorbed into
the bloodstream, in vaginal creams, which treat localized discomforts.

Estrogen replacement therapy is not risk-free. "There's been much
experimental evidence and patient experience showing estrogen given
alone can lead to endometrial cancer," says FDA's Smith. For that
reason, a woman who still has a uterus is usually prescribed progestin
in addition to estrogen. This significantly reduces the risk of abnormal
changes in the uterine lining.

Endometrial cancer is not the only risk from estrogen use. Gallbladder
disease is another. Women who use estrogens after menopause are more
likely to develop gallbladder disease needing surgery than women who
don't use estrogens.

The drug's labeling also includes warning about abnormal blood clotting.
Clots can cause a stroke, heart attack, or pulmonary embolus, any of
which can be fatal.

Estrogen can produce uncomfortable side effects such as nausea and
vomiting. It can enlarge breasts and make them tender. Women who use it
can also retain excess fluid, which can aggravate conditions like
asthma, epilepsy, migraines, and heart and kidney disease. A spotty
darkening of the skin, particularly on the face, can occur.

For women who take progestin along with estrogen, menstrual-like
bleeding and premenstrual symptoms often occur. Also under study is
whether adding progestin counters the potential heart-protective effects
of estrogen.

It is not known whether estrogen use increases the risk of breast
cancer, or what effect adding progestin would have on this risk. In
recent years, many studies on breast cancer and estrogen use have been
conducted, with conflicting results, says Smith. Last year, following
the publication in June 1995 of opposing views in two of the nation's
most prestigious medical journals, the New England Journal of Medicine
and the Journal of the American Medical Association, NIH scientists
advised women to consult their "medical caregiver for advice that is
based on the individual's own personal health profile." Physicians urge
women who receive estrogen therapy to have regular breast examinations
by a health professional, perform monthly self-exams, and have yearly
mammograms starting at age 50.

Before Menopause

The medical term for the usually gradual period of change leading into
natural menopause is "perimenopause." The two to three years following
the last period are called the "climacteric." According to the American
College of Obstetricians and Gynecologists, the average age of menopause
in the United States is around age 51. But some women go through natural
menopause as early as age 35, while others don't experience it until
their late 50s. Menopause occurs at any age with surgical removal of the
ovaries.

During perimenopause, estrogen production is low and the ovaries stop
producing eggs. As estrogen levels decline, certain signs may appear.
The most common sign, the one that doctors sometimes call the "hallmark"
of menopause, is the hot flash. A hot flash is a sudden rush of heat to
the neck, face, and possibly other parts of the body that may last from
30 seconds to five minutes. Some women go from feeling hot to feeling
cold. The hot flash may begin with a sudden tingling in the fingers,
toes, cheeks, or ears.

Some people used to think the hot flash didn't exist, that it was "all
in a woman's head," says Smith.

Ironically, it is in a woman's head--but it has a very real physical
cause. The hot flash is an alteration in thermal stability, which is
maintained by the hypothalamus, a brain region located above the
pituitary gland on the brain's floor. The hypothalamus operates the
body's temperature regulation system. Estrogen levels manipulate some
functions of the hypothalamus. During menopause, as the ovaries produce
less estrogen, the hypothalamus senses and responds to the lower
estrogen levels by rapidly changing body temperature. The result may be
a hot flash.

Perspiration, sometimes extreme sweating, can accompany hot flashes.
Many of them typically occur in the middle of the night, which causes
some women to have trouble falling back to sleep. How many women are
affected by hot flashes has not been clearly determined, and the
reported numbers depend in part on whether healthy populations or women
in medical settings are surveyed. Some scientists say as few as 30
percent of women are afflicted by them; others believe the figure is
much higher.

According to Morris Notelovitz, M.D., Ph.D., and colleagues in the text
Menopause in Midlife Health, 85 percent of perimenopausal women
experience hot flashes. Fifty-four percent of the women experience them
in their climacteric years; 25 percent of these women experience hot
flashes up to 10 years after the climacteric. About 10 percent of the
women who continue to have hot flashes still have them for 10 years
after the climacteric, according to Notelovitz.

Obese women are less likely to have hot flashes because they have more
estrogen, which is converted from adrenal hormones by stored fat. Many
women cope with hot flashes by trying to relax until the discomfort
passes and by lowering the room temperature, dressing in light layers of
clothing, avoiding spicy food, and cutting back on caffeine and alcohol.

Vaginal dryness is another symptom of estrogen decrease and may lead to
painful intercourse, vaginal infections, and urinary problems.
Over-the-counter vaginal lubricants (Replens and others) may help.
Prescription estrogen replacement creams are approved by FDA to relieve
these symptoms.

Other symptoms attributed to menopause include difficulty concentrating,
depression, headache, memory loss, a feeling of insects crawling across
the skin, and lower backaches, which may be related to osteoporosis.

Barbara Sherwin, Ph.D., at the University of Toronto, and colleagues
have been researching an association between menopause and memory loss,
even Alzheimer's disease, and whether estrogen can halt these problems.
Sally Shumaker, Ph.D., of the Bowman-Gray School of Medicine, North
Carolina, is leading a $16 million study, the Women's Health Initiative
Memory Study, to determine whether estrogen treatment affects a woman's
risk of developing dementia after age 65. Wyeth-Ayerst Laboratories is
funding the study.

Probably the disease with the strongest link to menopause is
osteoporosis. Scientists believe women can help control bone loss with
weight-bearing exercises, including walking, running or weightlifting. A
low-fat diet, rich in calcium and vitamin D, is also believed to be
important, as are cutting back on alcohol and stopping smoking. FDA has
approved a nonhormonal drug to treat osteoporosis. (See "Boning Up on
Osteoporosis" in the September 1996 FDA Consumer.)

Despite its sometimes annoying, peripheral problems, more than ever
before menopause is now seen as a natural process, not a disease.
"There's nothing embarrassing about it," says Schiff. "It's healthy.
It's physiologic."

It is such new thinking that best explains why at cocktail parties and
other places baby boomers congregate that menopause is a hot
conversation topic.

Sheryl Weinstein is a writer in Livingston, N.J.


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


More Resources

American College of Obstetricians and Gynecologists (ACOG)
409 12th St., S.W.
Washington, DC 20024-2188
Telephone: (202) 484-3321
Send a self-addressed stamped envelope for three pamphlets about
estrogen, osteoporosis and menopause.

North American Menopause Society (NAMS)
P.O. Box 94527
Cleveland, OH 44101
Telephone: (216) 844-8748
World Wide Web: http://www.menopause.org/
Answers written requests for information about menopause, and publishes
a medical journal.

American Association of Retired Persons (AARP) Women's Initiative
601 East St., N.W.
Washington, DC 20049
Telephone: (1-800) 424-3410
Has a free fact sheet about hormone replacement therapy.

National Institute on Aging Information Center
P.O. Box 8057
Gaithersburg, MD 20898-8057
Telephone: (1-800) 222-2225
Has free information on menopause, exercise and nutrition.

Planned Parenthood Federation of America, Inc.
810 Seventh Ave.
New York, NY 10019
Has a booklet, "Menopause--Another Change in Life," available from the
above address for $3. It can also be downloaded free through the World
Wide Web at http://www.ppfa.org/ppfa/menopub.html.

The Power Surge Reading Room
An on-line menopause discussion area with an electronic newsletter. It
can be accessed in its entirety through America Online with the keyword
"Women," followed by the "well-being" icon, and in part through the
World Wide Web at http://members.aol.com/dearest/news.htm.

Women's Health Initiative
Federal Building, Room 6A09
7550 Wisconsin Ave.
Bethesda, MD 20892-9112
Telephone: (1-800) 54-WOMEN
Women interested in participating in the Women's Health Initiative can
also find information on the World Wide Web at
http://www.nih.gov/od/odp/whi/.

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

Updates

Second Alzheimer's Drug OK'd

The second drug for treating mild-to-moderate symptoms of Alzheimer's
disease has received FDA approval.

Aricept (donepezil) is a "cholinesterase inhibitor" that increases
levels of a neurotransmitter important to memory, judgment, ability to
reason, and other cognitive functions. The drug was approved last Nov.
25. Tacrine (cognex) was approved in 1993 to treat the disease.

Alzheimer's disease affects an estimated 4 million Americans.

In a 30-week trial of 473 patients, those treated with Aricept improved
on two assessment scales compared with those on a placebo. A second
15-week study confirmed these results. One scale gauged memory,
attention, language, and reasoning. The other was a physician's
interview-based evaluation to confirm treatment benefit.

In the trials, most patients tolerated typical side effects of diarrhea
and nausea. Other possible side effects include a slowed heartbeat and
fainting spells.

Eisai America Inc., Teaneck, N.J., and Pfizer, New York City, market
Aricept.

(For more on the disease, see "Despite New Clues, Alzheimer's Mystery
Remains Unsolved" in the March 1992 FDA Consumer.)



FDA Proposal Aims to Protect
Animals, Humans from Diseases

To help protect animals from transmissible, fatal degenerative nerve
diseases and to minimize the risk of the diseases being transmitted to
humans, FDA has proposed banning tissue from cows, sheep, goats, and
other ruminant animals in ruminant feeds. Mink tissue would also be
prohibited in such feeds.

These animal diseases are known as transmissible spongiform
encephalopathies (TSEs), which are characterized by a long incubation
period and a relatively short clinical course of neurological signs,
leading to death. A major concern is that one type of animal TSE, bovine
spongiform encephalopathy (BSE), could in the future be identified as
the cause of a new TSE in humans.

In March 1996, the British government announced a possible link between
BSE and 10 cases of a variant form of Creutzfeldt-Jakob disease, a
degenerative nerve disorder in humans. That same month, U.S. national
livestock organizations and professional health groups announced a
voluntary moratorium on the use of ruminant protein in ruminant feed.

Although there has never been a reported case of BSE in the United
States, FDA proposed the new rule as a precautionary measure. "It will
add another level of safeguards to protect the U.S. against the
potential risk from these diseases," said Donna E. Shalala, Secretary of
Health and Human Services.

FDA's proposal would ban nearly all potential sources of ruminant and
mink protein in feed for ruminants. Bovine blood and ruminant-derived
milk and gelatin would be excepted, however, as FDA has no information
suggesting these proteins are potential carriers of TSEs.

FDA published the proposal in the Jan. 3, 1997, Federal Register. The
agency also published the fact sheet "Bovine Spongiform Encephalopathy
and Creutzfeldt-Jakob Disease, Public Health Service Actions to Ensure
Against Health Risks" Single copies can be ordered by writing to FDA,
HFE-88, Rockville, MD 20857.



Leukemia Drug Approved for Prostate Cancer

A drug already approved by FDA for leukemia has been given another
approval: initial chemotherapy for pain related to prostate cancer that
has progressed despite standard hormone treatment.

Studies showed that Novantrone (mitoxantrone), in combination with
steroids, can reduce the intense pain that occurs as cancer cells
multiply and spread to the bone. The drug combination also was shown to
stabilize or reduce reliance on analgesic pain relievers.

FDA's Nov. 13 approval of Novantrone's new use came less than six months
after the manufacturer applied for the new use. The application was one
of the first following FDA's announcement of a new plan to speed cancer
drug approvals.

Prostate cancer is the second leading cause of cancer deaths in the
United States. Of the 310,000 new cases that were expected to be
diagnosed last year, more than 40,000 of them will likely become
resistant to hormone therapy.

In clinical trials, the Novantrone-steroids combination significantly
reduced pain in 38 percent of patients, compared with 21 percent of
those treated with steroids alone. Patients responding to Novantrone had
an average eight months of pain relief, compared with two months for
those given steroids alone. However, survival rates for both groups were
the same.

Immunex Corp., Seattle, markets Novantrone.

(For more on prostate cancer, see "Prostate Cancer: New Tests Create
Treatment Dilemmas" in the December 1994 FDA Consumer.)



Toll-Free Number Gives
Cosmetics, Colors Information

A toll-free automated FDA information line is in place with taped
messages about dozens of topics concerning cosmetics and color
additives.

The line gives information on cosmetics- and colors-related recalls and
other current public health issues. It also provides general information
on such topics as cosmetic labeling and ingredients, hair dyes,
aromatherapy, and sun care, and tells how to report adverse reactions.
For additional information, callers can request that related documents
be faxed or mailed to them.

The telephone number is (1-800) 270-8869. Callers must use a touch-tone
telephone to access the information line, which can be reached 24 hours
a day.



Ivermectin Approved
For Two Parasitic Diseases

The antiparasitic animal drug ivermectin was approved by FDA to treat
two human parasitic diseases, strongyloidiasis and onchocerciasis.

Strongyloidiasis is common in many tropical countries and is
occasionally acquired in some areas of the United States. Infection is
usually confined to the small intestine. It can persist for many years,
causing abdominal pain, diarrhea, and elevated levels of white blood
cells. In people with weakened immune systems, the infection can spread
through the body and be fatal.

Onchocerciasis, commonly known as river blindness, is most often found
in Africa and South and Central America. The parasite is transmitted by
the bite of a black fly, which deposits immature forms of the parasite
under the skin. There, the worms mature and the adult females produce
more larvae. The immature worms migrate under the skin, causing intense
itching. They can also migrate to the eyes, causing inflammation and
blindness.

Ivermectin is better tolerated than other drugs approved to treat these
conditions, and it is more effective than the previously approved
treatment for onchocerciasis. In clinical studies, a single dose of
ivermectin cured between 64 and 100 percent of patients with
strongyloidiasis who had normal immune systems. In studies of
onchocerciasis, a single dose of the drug reduced the number of larvae
under the skin an average of 83 percent at three days and 99.5 percent
at three months. Adverse reactions to the drug differ depending on which
disease is being treated but can include skin rashes, itching,
dizziness, diarrhea, and nausea.

Merck & Co. Inc., of West Point, Pa., sells ivermectin in the United
States under the trade name Stromectol. (Elsewhere it is marketed as
Mectizan.) Before its approval on Nov. 25, 1996, ivermectin had been
available here for limited human use as an investigational drug.

Ivermectin has been used worldwide since 1987 to treat river blindness.
More than 5.2 million people have received the drug through the World
Health Organization's Onchocerciasis Control Program and Merck's
Mectizan Donation Program.

(See also "Treating Tropical Diseases" in the January-February 1997 FDA
Consumer.)



First Rx Drug for Severe Mouth Sores

The first prescription treatment for painful, severe canker sores in the
mouth in people with normal immunity has been approved by FDA. The
medical name for these sores is aphthous ulcers.

The agency approved the drug, Aphthasol (amlexanox oral paste, 5
percent), Dec. 17. In clinical studies, Aphthasol reduced ulcer healing
time by a day to a day and a half, compared with a placebo or no
treatment. Pain was relieved as the ulcers healed. Some participants
reported stinging or burning where the medicine was applied, and, less
frequently, nausea and diarrhea.

While people with AIDS acquire especially virulent aphthous ulcers, the
new drug's safety and effectiveness in individuals with weakened
immunity has not been assessed at this time.

Users should apply Aphthasol paste directly to their ulcers four times a
day, following oral hygiene after meals and before bedtime. If the
ulcers have not healed in 10 days, patients should visit their dentists
or health-care providers.

Aphthasol is manufactured by Block Drug Co. Inc., Jersey City, N.J.



FDA Offers Quick Info
On Blood Product Recalls

Health providers and consumers can get immediate information about blood
product and plasma recalls from two new FDA communication systems.

The agency's Center for Biologics Evaluation and Research has
established a 24-hour toll-free number--(1-888) CBER-BPI--and an
automated electronic mailing list. Both provide current information on
recalls and market withdrawals of therapeutic products derived from
blood, such as immune globulins and clotting factors to treat
hemophilia. In a recall, a product is taken off the market because it
violates a federal law. In a market withdrawal, a product is removed
from the market by the manufacturer for some other reason.

These new systems augment CBER's existing methods of notification, which
include the FAX Information System (1-888-CBER-FAX), a consumer
information line (1-800-835-4709), and a link from FDA's home page on
the World Wide Web.



Public Can Comment
On Device Proposal

The public has until March 19 to comment on an FDA proposal to make it
easier for desperately ill patients to be treated as soon as possible
with promising but unapproved medical devices undergoing research.
Current rules allow use on a crisis basis only.

Written comments on the proposal, published in the Dec. 19, 1996,
Federal Register, may be sent to the FDA Dockets Management Branch,
HFA-305, 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857. The
Federal Register document is available at some libraries and on FDA's
World Wide Web site at http://www.fda.gov/cdrh/fr1219af.html.

Under the proposal, experimental devices could be granted "treatment
use" status, meaning they could be used to treat or diagnose only
patients whose illness poses a significant threat of death within months
or premature death if the course of disease is not altered quickly. The
proposal would ensure that data gathered from the treatment could be
used to evaluate product safety and effectiveness. It also would ensure
integrity of the clinical studies and prevent commercialization of the
device during this phase.

Normally, a sponsor must obtain an Investigational Device Exemption, or
IDE, from FDA to use an experimental device on human patients. Only
patients enrolled in the studies can be treated with the device. Then,
in the marketing application, the sponsor uses the study data to show
product safety and effectiveness.

Under FDA's proposal, patients would not have to be enrolled in a study.
But a sponsor desiring "treatment use" for an experimental device would
have to submit a Treatment Use IDE application to FDA, showing that:

  * The device is intended to treat or diagnose a serious or immediately
    life-threatening disease or condition.

  * No comparable or satisfactory alternative device or other therapy is
    commercially available.

  * The device is under investigation in an approved IDE or that such
    studies have been completed.

  * The manufacturer is pursuing marketing approval.

FDA would have 30 days to consider the application, the same as for
standard IDE applications.


Brochures Available

Safe weight loss and poison prevention are the subjects of two brochures
for people with low reading skills, now available from FDA. Their titles
and publication numbers are:

  * Losing Weight Safely (FDA) 96-1247
  * Protect Your Child from Poisons in Your Home (FDA) 96-1262

To order single copies, write to FDA, HFE-88, Rockville, MD 20857. To
order 2 to 100 copies, write to FDA, HFI-40, at the same address, or fax
your order to (301) 443-9057. Include the publication number.

Correction

"Three Free Reprints" in the December 1996 FDA Consumer Updates section
listed an FDA Consumer reprint that is not available at this time. The
reprint "Adults Need Tetanus Shots, Too" was a limited printing only.
The article originally published in the July-August 1996 FDA Consumer.

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

Notebook

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

Some dairy products that contain more than 1 percent fat, such as "2%"
milk, may no longer use the term "lowfat" on the label, according to an
FDA final rule. Instead, these products must be labeled "reduced fat."
Products with 1 percent or less fat may continue to be labeled "lowfat."
"Skim" will mean the same as "nonfat."

Effective January 1998, the rule holds dairy products to the same
standards as low-fat claims for other foods, under the Nutrition
Labeling and Education Act of 1990. (FR Nov. 20)

------------------------------------------------------------------------
Chlamydia, a sexually transmitted disease, can spread as easily from
women to men as from men to women, according to the National Institutes
of Health. Over a four-year period, NIH researchers tested 494 couples
involved in heterosexual partnerships. The study was the first to use
both the traditional cell culture test and the newer polymerase chain
reaction (PCR) test for chlamydial genital infections.

Cell culture testing showed chlamydia in 8.5 percent of male
participants and 12.9 percent of females. But PCR testing found the
disease in 14.2 percent of males and 15.8 percent of females.

An estimated 50 million cases of chlamydia occur each year. The
infections are associated with such diseases as pelvic inflammatory
disease, which can lead to infertility and ectopic pregnancy. (Journal
of the American Medical Association, Dec. 3)


------------------------------------------------------------------------
"Extralabel" uses of certain approved animal and human drugs may be
prescribed for animals, according to an FDA final rule. The rule is
intended to give veterinarians greater flexibility in prescribing drugs.

There are restrictions, though. For example, an extralabel use may not
be prescribed for food animals if this would result in residues that
could be a public risk. Also prohibited from extralabel use are nine
drugs, including clenbuterol, diethylstilbestrol (DES), and
ipronidazole.

The rule went into effect Dec. 9. (FR Nov. 7)


------------------------------------------------------------------------
A food's fat content listed on its label could be based on the reduced
availability of fat to the body from a fat substitute in the food,
according to an FDA proposed rule. The proposal stems from a petition
filed by Nabisco Group. This proposal takes into account that some fat
substitutes can limit the amount of fat and fatty acids the body absorbs
from foods.

Written comments on the proposal must be submitted by April 21, 1997, to
the FDA Dockets Management Branch, HFA-305, 12420 Parklawn Drive, Room
1-23, Rockville, MD 20857. (FR Dec. 20)


------------------------------------------------------------------------
Selenium supplements may help protect against cancers of the lung,
colon, rectum, and prostate, according to a University of Arizona study
of 1,312 patients.

The study initially examined whether selenium could prevent two types of
skin cancer, but found no reduction in incidence. However, midway
through the study, researchers decided to evaluate selenium's value in
preventing other types of cancers and in reducing cancer deaths.

When cancer cases were studied over an average 4.5 years in groups given
either daily 200-microgram supplements of selenium or a placebo, the
selenium group had 37 percent fewer cancers and a 50 percent reduction
in cancer deaths. Selenium users had 63 percent fewer prostate cancers,
58 percent fewer colorectal cancers, and 46 percent fewer lung cancers.
(Journal of the American Medical Association, Dec. 25)


------------------------------------------------------------------------
Recurring vaginal infections may be helped by a daily diet of 5 ounces
(141.75 grams) of yogurt containing the live bacteria Lactobacillus
acidophilus, according to an Israeli study. Researchers gave 23 patients
yogurt containing the live bacteria. Another 23 patients ate yogurt that
had been pasteurized, which kills the bacteria. The group eating the
live bacteria yogurt had significantly fewer cases of vaginal infections
than the pasteurized group. For example, cases of bacterial vaginosis in
the live cultures group dropped from 60 percent in the first month to 20
to 28 percent in the second month. (Archives of Family Medicine, Nov-Dec
1996)

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

Investigators' Reports

Message Sent Loud and Clear to Hearing Aid Marketer

by Tamar Nordenberg

The distributor of an under-$30 hearing aid is paying $515,000 to settle
consumer fraud suits for falsely advertising its hearing aids and
selling them without the required FDA approval. Under a 1996 court
settlement, the distributor, Telebrands Corp. of Roanoke, Va., also was
forced to recall the hearing aids, refund the purchase price to
consumers, and stop selling or advertising the products without FDA
clearance.

Seventeen states, supported by an affidavit from FDA, took Telebrands to
court over the company's unproven marketing claims for its Whisper XL
hearing aids. Newspaper ads and television commercials, some of them
featuring entertainer Steve Allen, indicated the device was a bona fide
hearing aid by telling consumers, "Take it to the movies, theater or
lecture hall and you'll never miss a word" and saying, "Now you can
enjoy the crisp clear sound of a TV or radio playing at low levels,
without annoying everyone else in the room."

FDA started investigating Telebrands based on some 1994 advertisements
in Parade magazine and various newspapers. The agency sent a warning
letter to Telebrands in July 1994, stating that the Whisper XL was an
adulterated product being illegally marketed without FDA clearance.

The agency classified the Whisper XL as a medical device because it fit
the legal definition of a hearing aid: "a wearable sound-amplifying
device that is intended to compensate for impaired hearing."

Telebrands protested FDA's classification in several letters and a
citizen petition it submitted to FDA in 1994. The company argued that
the Whisper XL was not a hearing aid because it wasn't intended for
people with hearing loss but rather for people with normal hearing to
achieve "super hearing."

FDA responded by reiterating its position that the Whisper XL was a
medical device--a hearing aid--that required FDA clearance for
marketing. FDA said it based its decision in part on claims made in
promotional labeling and advertising, including ads depicting older
people using the product while doing normal daily activities, such as
riding in a taxi, boarding an airplane, and watching television. This
implied the product was intended to compensate for hearing impairment,
the agency told the company, because people with normal hearing don't
need sound amplification for these kinds of daily activities.

While never admitting the Whisper XL was a medical device, Telebrands
offered to change its ads "to further expressly emphasize that the
Whisper XL is intended to enhance normal hearing." The agency responded,
in letters to Telebrands and in a September 1994 meeting with the
company president and his attorney, that a market had already been
established for the product and that relabeling the Whisper XL would not
overcome the impression that the product could compensate for hearing
loss.

While FDA collected evidence to support an intended seizure of the
hearing aids, a number of state attorneys general were looking at
Telebrands' marketing practices. In September 1995, 17 states, led by
the Minnesota Attorney General Hubert H. Humphrey III, sued the company
for falsely advertising the Whisper XL and selling it without FDA
clearance.

FDA decided to support the states' efforts rather than pursue seizure.
"It was more efficient for FDA to support the individual actions brought
by the states," says Eric Latish, chief of FDA's dental, ear, nose and
throat, and ophthalmic devices branch.

FDA gave the states a sworn statement explaining its classification of
the Whisper XL as an unapproved medical device, not just a sound
amplification device for people with normal hearing. Such devices for
people with normal hearing might not require FDA clearance.

"The agency wasn't making a judgment about whether the product did or
didn't work," says Byron Tart, director of FDA's devices promotion and
advertising policy staff. "Our issue was that the device was a hearing
aid, and a medical device without clearance to be marketed."

Minnesota and the 16 other states--Arizona, California, Connecticut,
Florida, Illinois, Massachusetts, Missouri, Maryland, New Jersey, New
Mexico, North Carolina, New York, Pennsylvania, Texas, Vermont, and
Wisconsin--reached settlements with Telebrands on July 30, 1996.
Telebrands, which had sold about $12 million worth of the Whisper XL
hearing aids, agreed to the terms without any admission of wrongdoing.

The Federal Trade Commission reached a separate agreement with
Telebrands for violations of that agency's advertising and mail-order
rules.

In a press release filed by Minnesota's Humphrey the day the settlement
was reached, the attorney general called the Whisper XL a "cheap,
poorly-performing device." Continuous use of the Whisper XL could cause
hearing damage, the release said.

FDA never received any complaints of injuries from the product.

Telebrands apparently has stopped marketing the Whisper XL, according to
FDA's Latish. Since the July settlement, agency officials have not seen
any ads for the hearing aid and have not received any complaints.

Between August 1994 and August 1996, FDA sent warning letters to more
than 10 other companies that made unsupported claims for their hearing
aids. Some companies have already notified FDA that they will correct
the violations by revising the claims or ceasing marketing of the
products.

Do these kinds of false claims mean consumers should ignore all
promotional claims they see and read about hearing aids? Not
necessarily. One clue to look for is a product's price, says Minnesota
Assistant Attorney General David Woodward. "People should be skeptical
of claims like those made for the Whisper XL hearing device--that
they'll hear a pin drop from 50 feet away or that they'll hear a deer
coming before it hears them--especially for a [hearing aid] being sold
for $29."

Hearing aids typically cost between $300 and $3,000, according to the
International Hearing Society. Says FDA's Tart: "Advertising is biased
and intended to sell the product. Most consumers wouldn't know if a
product had received clearance from FDA. But a hearing aid for $29? That
sounds too good to be true, and it was."

Tamar Nordenberg is a staff writer for FDA Consumer.


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Device Maker Sentenced
For Violating Injunctions

When two injunctions didn't stop a Salt Lake City man from selling and
promoting his unapproved medical devices, one of which he promoted as a
cure for AIDS, the federal government went back to court.

As a result, in June 1996, Tim Themy-Kotronakis was convicted in the
U.S. District Court for the District of Utah of criminal contempt for
violating a 1989 and a 1994 injunction against his selling and promoting
unapproved medical devices and a drug solution. Judge J. Thomas Greene
sentenced Themy-Kotronakis Oct. 25 to six months' probation and 50 hours
of community service.

Themy-Kotronakis originally manufactured the Ster-O-Lizer, a device he
said could sterilize surgical instruments. He began making this device
in 1984. In 1993, he began a large-scale promotion of the AIDS Treating
Machine. The only difference between the two devices is shape. The
Ster-O-Lizer is completely rectangular, while the AIDS Treating Machine
has a cylinder on top of a rectangular base.

The AIDS Treating Machine supposedly turns salt water, or "Solution A,"
into a treatment to "de-activate" pathogens and viruses. According to
the instructions, Solution A becomes a potent drug after exposure to the
electric currents inside the cylinder. The drug can then be administered
intravenously, intramuscularly, orally, rectally, or in any combination
of these methods.

Themy-Kotronakis operated under several business names, most recently as
Brinecell Inc. and T & T Medical Products.

After receiving complaints from health professionals about the "AIDS
Treating Machine," James Moore, an investigator with FDA's Salt Lake
City resident post, inspected Brinecell in August 1993. During the
inspection, Moore asked Themy-Kotronakis several times if he was
manufacturing, marketing, promoting, or selling any medical devices.
Each time, Themy-Kotronakis said no. He also denied operating under any
other business name besides Brinecell. However, as the inspection
continued, Moore noticed an envelope with the return address T & T
Medical Products and the same street address as Brinecell. Also printed
on the envelope was the statement "Ask about our AIDS Treating Machine."
At that point, Themy-Kotronakis admitted he was promoting the machine
for AIDS treatment. He added, however, that he was not going to sell any
machines until he had FDA approval.

When Moore returned the next day to continue the inspection,
Themy-Kotronakis would not allow him to enter the firm.

On Sept. 8, Moore, FDA investigator Frederic French, who was with the
agency's Salt Lake City office at that time, and two U.S. marshals
returned to Brinecell with an inspection warrant. This time,
Themy-Kotronakis allowed them to enter.

During this inspection, Moore and French learned that Themy-Kotronakis
had manufactured at least one AIDS Treating Machine and sent promotional
letters all over the world. These measures indicated he intended to
manufacture and sell the devices and Solution A. Their inspection found
that the device had not been evaluated for safety and effectiveness by
FDA and that the devices and Solution A were manufactured in complete
absence of current good manufacturing practice requirements.

Themy-Kotronakis told the investigators he didn't realize he had to
follow FDA laws and regulations. He said this even though the agency had
cited him for violations seven times since September 1983, and seized
his devices for violations in 1986 and 1987. Also, the agency had
enjoined him in 1989 based on these violations.

On March 21, 1994, at FDA's request, the Department of Justice filed in
the U.S. District Court for the District of Utah a request to
permanently enjoin Themy-Kotronakis from selling and promoting his AIDS
Treating Machine, Solution A, and any other medical devices and drugs
until he obtains FDA approval.

Themy-Kotronakis signed a consent decree of permanent injunction July 7,
1994. But within days he was violating the injunction by running
help-wanted ads for a national sales manager to promote the
Ster-O-Lizer, says Shelly Maifarth, a compliance officer with FDA's
Denver district office. Although the July 7 decree specifically
prohibited selling and promoting the AIDS Treating Machine, it applied
also to all unapproved medical devices, including the Ster-O-Lizer,
explains Maifarth. In addition, the 1989 injunction prohibiting
Themy-Kotronakis from manufacturing and shipping unapproved devices was
still in effect.

On Aug. 2, Themy-Kotronakis held a press conference at the Hilton Hotel
Conference Center in Salt Lake City to promote his AIDS Treating Machine
and complain about the consent decree. During the next few months, he
continued to promote both the AIDS Treating Machine and the Ster-O-Lizer
in letters to individuals, firms and governments around the world. FDA
investigators found these letters during an inspection Oct. 13 through
24.

Then, in May 1995, a Salt Lake City export broker told FDA that
Themy-Kotronakis was trying to ship the Ster-O-Lizer to Spain. On June
2, U.S. marshals seized the device.

These violations prompted the Department of Justice, at FDA's request,
to file a petition on June 12 with the U.S. District Court for the
District of Utah requesting that Themy-Kotronakis be tried for criminal
contempt of the two injunctions.

The court agreed, and a trial was held Jan. 29 and 30, 1996. On June 26,
U.S. District Judge Greene found Themy-Kotronakis guilty of criminal
contempt of both injunctions.

At press time, Themy-Kotronakis was appealing his conviction.

--Isadora Stehlin


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N.Y. Blood Center Agrees
To Correct Deficiencies

After FDA found continuing breaches of blood safety laws and regulations
at the New York Blood Center, the facility and three of its officers
agreed in a consent decree with FDA and the Department of Justice to a
series of measures designed to ensure the integrity of its operations
and thereby the safety of the blood it provides.

The government filed the decree last Dec. 16 simultaneously with a civil
complaint in the U.S. District Court for the Southern District of New
York.

This consent decree is the latest in a series of actions by FDA to
ensure the continued safety of the U.S. blood supply. FDA entered into
similar agreements with Blood Systems Inc./United Blood Systems in 1996,
and with the American Red Cross in 1993.

The New York Blood Center collects blood at both fixed and mobile
donation sites in New York City and Melville, N.Y., and in New Jersey.
It also performs blood donor testing for facilities in New Jersey,
Pennsylvania and Tennessee and imports and exports blood products to and
from Europe.

In late 1994, FDA investigators inspected the center's New York City
facility on Amsterdam Avenue and found that the center was:

 * engaging in allegedly improper testing practices

 * not maintaining complete and adequate standard operating procedures

 * not following the company's existing standard operating procedures

 * not following the manufacturer's testing instructions

 * keeping incomplete, inaccurate records

 * not adequately training employees

 * maintaining inadequate security controls of computerized operations
   to ensure data integrity.

These findings led FDA to issue the blood center a warning letter in
March 1995. A month later, the director of FDA's New York district
office met with blood center senior officials, who then agreed to remedy
deficiencies in their operations.

In late 1995, FDA investigators inspected the center's East 67th Street
location, in New York City, examining a number of operations, including
the center's interpretation of Western Blot testing. This test is done
on blood from donors whose screening tests showed them to be reactive
for infection with HIV, the AIDS virus. It helps distinguish true
positive screening test results from false positive results.

Also that winter, FDA reinspected the Amsterdam Avenue location.

In those and follow-up inspections, FDA investigators found efforts for
improving operations to be inadequate. The civil complaint followed.

Under the decree, approved by the court Dec. 17, 1996, the center agreed
to:

 * strengthen its quality assurance and quality control program

 * assess its management controls and organizational structure to ensure
   they meet FDA rules

 * improve its system for testing donated blood for infectious agents

 * improve its management and supervision of technicians who perform the
   blood screening tests

 * improve its formal training program for employees, including
   establishing ethics training

 * improve its computer systems and record keeping

 * improve its system for investigating suspected transfusion-linked
   infections and other problems

  * improve its tracking and notification procedures concerning blood
    from donors who subsequently test positive for HIV

  * improve its internal audit procedures

  * put the improvements in place according to specific timetables.

FDA protects the U.S. blood supply with overlapping safeguards designed
to prevent release of unsuitable products. Failure of an individual
safeguard does not automatically translate into the release of unsafe
products, but it may increase the potential risk.

For planned medical procedures, FDA generally advises patients that it
is prudent to set aside their own blood, in advance, in case a blood
transfusion is needed. The agency emphasizes that the risk of not having
a medically necessary transfusion far outweighs the risk of receiving
blood.

--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: Cocktail shrimp, at Port Newark, N.J. (D. N.J.); Civil Action
No. 91-3990.
CHARGED 9-13-91: While held for sale after shipment in interstate
commerce at Port Newark Refrigerated Warehouse, in Port Newark, N.J.,
the articles were misbranded in that the package failed to bear a label
containing an accurate statement of the net quantity of
contents--403(e)(2).
DISPOSITION: A consent decree of condemnation ordered the articles
destroyed. (F.D.C. No. 66254; S.J. No. 91-643-384; S.J. No. 1)

PRODUCT: Infant formula, at Orlando, Fla. (M.D. Fla.); Civil Action No.
96-182-CIV-ORL-19.
CHARGED 2-20-96: While held for sale after shipment in interstate
commerce at 4C Transportation Warehouse, in Orlando, Fla., the articles
were adulterated in that they were not processed in compliance with
current good manufacturing practice requirements because the containers
failed to bear lot codes--412(a)(3). The articles were misbranded in
that the labels failed to bear a declaration of the nutrients in the
order given and the unit specified and a statement of the number of
fluid ounces supplying 100 kilocalories. The labels also failed to bear
a statement of the amount of each nutrient supplied by 100 kilocalories
and directions for use that contain the weight and volume of powdered
formula to be reconstituted--403(j).
DISPOSITION: A default decree of condemnation and destruction ordered
the articles destroyed. (F.D.C. No. 67128; S. No. 96-712-384; S.J. No.
2)

PRODUCT: Milk, evaporated, at Angola, La. (M.D. La.); Civil Action No.
96-3331-B-2.
CHARGED 8-1-96: While held for sale at Louisiana State Penitentiary, in
Angola, La., after shipment in interstate commerce, the articles were
adulterated in that they were unfit for food because the cans of milk
were heavily rusted and dented, and they were held under insanitary
conditions whereby they might have become contaminated with
filth--402(a)(3) and 402(a)(4).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67145; S. No.
96-690-738; S.J. No. 3)



Drugs/Human Use

PRODUCT: Oxygen, at Mesa and Phoenix, Ariz. (D. Ariz.); Civil Action No.
Civ-90-0805 PHX PGR.
CHARGED 5-29-90: While held for sale after shipment in interstate
commerce at Apollo Medical, Inc., in Mesa and Phoenix, Ariz., the
articles were adulterated in that the methods used in and the facilities
and controls used for their manufacture, processing, packaging, and
holding were not in conformity with current good manufacturing practice
requirements--501(a)(2)(B).
DISPOSITION: A consent decree of condemnation was filed. Subsequently,
the company declared bankruptcy and went out of business. The articles
were seized and sold at auction. (F.D.C. No. 65858; S. No. 90-567-953;
S.J. No. 4)

PRODUCT: Oxygen, at Pocatello, Idaho (D. Idaho); Civil Action No. CIV
94-0340-E-HLR.
CHARGED 8-3-94: While held for sale after shipment in interstate
commerce at Maag Prescription & Medical Supply, Inc., in Pocatello,
Idaho, the articles were adulterated in that the methods used in, and
the facilities and controls used for, their manufacture, processing,
packing, and holding were not in conformity with current good
manufacturing practice requirements--501(a)(2)(B).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 66933; S. No.
94-628-683; S.J. No. 5)



Medical Devices

PRODUCT: In vitro diagnostic products, at Loganville, Ga. (M.D. Ga.);
Civil Action No. 3:95-CV-27-DF.
CHARGED 3-7-95: While held for sale after shipment in interstate
commerce at Roach Laboratories, Inc., in Loganville, Ga., the articles
were adulterated in that they were class III devices without an
application for premarket approval--501(f)(1)(B). The articles were also
adulterated in that the methods used in, and the facilities and controls
used for, their manufacture, packing and storage were not in conformity
with current good manufacturing practice requirements--501(h).
DISPOSITION: The articles were donated to the Centers for Disease
Control and Prevention. Subsequently, the firm ceased doing business,
and the claimant filed a voluntary dismissal. (F.D.C. No. 66912; S. No.
93-654-171; S.J. No. 6)



CRIMINAL ACTIONS

DEFENDANT: New England Shrimp Company and G. Robert Randazzo, at Ayer,
Mass. (D. Mass.); Criminal No. 94-10039-RWZ.
CHARGED 10-28-94: Count 1: The defendants knowingly conspired to conceal
that shrimp supplied by the New England Shrimp Company (NESC) contained
tripolyphosphates (STPs), which were prohibited by contracts with
several federal government agencies--18 U.S.C. section 1001. The
defendants also knowingly conspired to make fraudulent claims for
payment against several federal government agencies by submitting
invoices where the shrimp failed to meet contract requirements--18
U.S.C. section 287. The defendants, with the intent to defraud,
conspired to obstruct a federal auditor from performing quality
assurance inspections of shrimp relating to contracts under which NESC
received in excess of &100,000 in a one-year period--18 U.S.C. section
1516.
Counts 2 to 51: The defendants knowingly made fraudulent claims for
payment against the United States by submitting invoices for shrimp that
did not meet the contract requirements--18 U.S.C. sections 287 and 2.
Count 52: The defendants, with the intent to defraud, conspired to
introduce into interstate commerce shrimp adulterated with saccharin, an
unsafe food additive--301(a) and 303(a)(2). The defendants, with the
intent to defraud, also conspired to add saccharin to shrimp while the
shrimp was held for sale after shipment in interstate commerce--301(k)
and 303(a)(2).
Counts 53 to 64: The defendants, with the intent to defraud, knowingly
introduced into interstate commerce adulterated shrimp--301(a) and
303(a)(2), 18 U.S.C. section 2.
Count 65: The defendants, with the intent to defraud, conspired to
introduce into interstate commerce misbranded shrimp. The shrimp was
misbranded in that its labeling failed to disclose that the shrimp had
been colored with sodium hydroxide, and it failed to list the common or
usual name for one of the ingredients from which the shrimp had been
fabricated. The labeling also falsely represented that the shrimp was
from the United States when, in fact, it was from China--301(a) and
303(a)(2). The defendants, with the intent to defraud, conspired to
misbrand shrimp while it was held for sale after shipment in interstate
commerce--301(k) and 303(a)(2). The defendants also conspired to falsely
state that the shrimp was from the United States when, in fact, it was
from China--18 U.S.C. section 1001.
Counts 66 to 78: The defendants, with the intent to defraud, introduced
into interstate commerce shrimp that was misbranded in that its labeling
failed to disclose that the shrimp was colored with sodium hydroxide.
The labeling also failed to list the common or usual name for one of the
ingredients from which the shrimp food was fabricated, namely sodium
hydroxide, or designate such an ingredient as coloring. The shrimp was
also misbranded in that its labeling falsely represented that the shrimp
was from the United States when, in fact, it was from China--301(a) and
303(a)(2), 18 U.S.C. section 2.
Count 79: The defendants, with the intent to defraud, conspired to
introduce into interstate commerce frozen raw breaded shrimp that was
misbranded in that the shrimp represented a food for which a standard of
identity was prescribed by regulation, but it did not conform to such
standard of identity because it contained STPs, which were not permitted
by the standard--301(a) and (k) and 303(a)(2), 18 U.S.C. section 371.
Counts 80 to 97: The defendants, with the intent to defraud, introduced
into interstate commerce frozen raw breaded shrimp that was misbranded
in that it was represented to be a food for which a standard of identity
was prescribed by regulation, but did not conform to such standard
because it contained STPs, which were not permitted by
regulation--301(a) and 303(a)(2), 18 U.S.C. section 2.
Counts 98 to 101: Defendant Robert Randazzo willfully filed a Corporate
Income Tax Return Form for NESC in which he overstated the cost of
purchases made by the company when he knew that the amount filed was not
the true cost of purchases. Randazzo also overstated the amount paid to
employees for work performed by including an amount he knew was not
truly the salary of an employee--18 U.S.C. section 2, 26 U.S.C. section
7206(1).
DISPOSITION: The New England Shrimp Company was sentenced to pay a
nominal fine after the court determined that it no longer had
substantial assets. Defendant Robert Randazzo, who was found guilty on
all counts, was sentenced to three years of imprisonment and two years
of supervised release, and was ordered to pay a $5,050 assessment.
Randazzo appealed his conviction, but the Court of Appeals upheld the
district court's ruling. (F.D.C. No. 66479; S.J. No. 7)

DEFENDANT: Ortho Pharmaceutical Corp., at Raritan, N.J. (D. N.J.);
Criminal No. 95-12 (WGB).
CHARGED 1-11-95: Count 1: The defendant knowingly conspired to impede a
federal grand jury investigation--18 U.S.C. section 371.
Count 2: The defendant knowingly obstructed a federal grand jury
investigation in that employees under the direction of high-ranking
representatives shredded documents and other records responsive to the
grand jury subpoena--18 U.S.C. sections 1503 and 2.
Counts 3 to 10: The defendant corruptly persuaded individuals to destroy
documents and other objects for use in an official investigation
conducted by federal agencies--18 U.S.C. sections 1512(b)(2)(B) and 2.
DISPOSITION: The defendant pleaded guilty to all counts and was ordered
to pay a $5 million fine and $2.5 million in restitution. (F.D.C. No.
65986; S.J. No. 8)



INJUNCTION ACTIONS

DEFENDANT: Enzymatic Therapy, Inc., Terence Lemerond, and Bradley
Lemerond, at Green Bay, Wis. (E.D. Wis.); Civil Action No. 91-C-1174.
CHARGED 11-5-91: The defendants introduced into interstate commerce
misbranded and unapproved new drugs--301(a) and 301(d). The articles
were misbranded in that their labeling failed to bear adequate
directions for their intended use--502(f)(1).
DISPOSITION: The articles were reconditioned. (Inj. No. 1232; S. No.
89-528-927; S.J. No. 9)



MISCELLANEOUS ACTIONS

ACTION: Barnes et al. v. Shalala, at Verona, Wis. (W.D. Wis.); Civil
Action No. 94C-0090C.
CHARGED 2-3-94: The plaintiffs alleged that the defendant violated the
Federal Food, Drug, and Cosmetic Act, the National Environmental Policy
Act, and the Administrative Procedure Act in approving the use of the
synthetic bovine growth hormone (rBGH)--also referred to as bovine
somatotropin (bST)--to increase milk production in cows.
DISPOSITION: The defendant filed a motion to dismiss, and several
plaintiffs were dismissed for lack of standing. The case was resolved in
the agency's favor on summary judgment. An appeal was not filed. (Misc.
No. 1012; S.J. No. 10)

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FDA Consumer is the official magazine of the U.S. Food and Drug
Administration. Each issue contains in-depth feature articles written
for the general public on FDA-related health issues. The magazine also
includes reports from FDA's own investigators that go behind the scenes
to show how the agency protects the public from unsafe or worthless
products.

FDA Consumer is published monthly, except for combined issues for
July-August and January-February. Subscriptions are available for $15
per year by writing:

Superintendent of Documents
Government Printing Office
Washington, DC 20402-9371.

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