
FDA Consumer magazine

VOL. 31 NO. 3 APRIL 1997


Features

   Hair Replacement: What Works, What Doesn't
   If you want to cover up a balding head, there are three ways to do
   it. Each has advantages and disadvantages.

   When Heartbeats Go Haywire: New Treatments Can Save Lives
   Ventricular arrhythmias, or irregular heartbeats, can range from harmless
   palpitations to deadly fibrillation, which can kill within minutes.
   But new drugs and devices show promise in curbing this common condition.

   A Time to Heal: Chronotherapy Tunes In to Body's Rhythms
   Successful treatment of diseases may depend on the time of day or
   month that a medicine is taken or surgery performed. Asthma and
   arthritis pain are among conditions now being treated by the clock or
   calendar.

   Protecting Against Unintended Pregnancy: A Guide to Contraceptive Choices
   The latest on contraception includes a new type of condom for people
   allergic to latex, a progestin implant that remains in place for only
   three years, and a revised assessment of spermicides and their
   ability to protect against sexually transmitted diseases, including
   AIDS.

   Inside FDA: Center for Food Safety and Applied Nutrition
   Twenty cents of every consumer dollar Americans spend goes to food and
   cosmetics, two types of products regulated by the Center for Food
   Safety and Applied Nutrition. Center issues likely to affect
   consumers in the near future are food safety, food additives, and
   foods derived from genetic engineering.

   Letter to FDA Consumer Readers: Starting this month, FDA Consumer
   will be published every other month.

Departments

  Updates

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

  Consumer Forum

    Letters to the editor.

  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.


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

Hair Replacement:
What Works, What Doesn't

by Larry Hanover 

When the advertising slogan "Be Like Mike" caught America's fancy, it
wasn't because every man decided to go for the Michael Jordan look by
reaching for a razor and shaving his head.

Sure, men like Jordan, Charles Barkley, and "Star Trek's" Patrick
Stewart are part of a small minority who are proud of their baldness.
But combating and covering up hair loss hasn't turned into an estimated
$1 billion-a-year industry because Americans like the idea of hair
collecting in the shower drain.

"It probably represents aging," says Ken Washenik, M.D., director of
dermatopharmacology at New York University Medical Center. "I think our
concept of a bald person is of an older person. I think anything that
reminds us in the mirror every day of the inevitability of aging is less
than optimal."

When you talk about restoring hair, you're essentially looking at three
different approaches. The first is to medicate, using a 2 percent
solution of minoxidil found in Rogaine (and other brands since Pharmacia
& Upjohn's patent expired in February 1996). Minoxidil is the only drug
approved by the Food and Drug Administration for regrowing hair.

That doesn't mean minoxidil is by any means the panacea that men have
been searching for since at least 1150 B.C., when Egyptians covered
their baldness with a mixture of fats from ibex (a mountain goat), lion,
crocodile, serpent, goose, and hippopotamus.

Surgical procedures, including hair transplantation and scalp reduction,
are another modern-day approach. And, finally, there's the solution that
Julius Caesar, according to legend, used in ancient days--cover it up.
The most powerful man in the Roman Empire is said to have turned to the
ceremonial wreath of laurel leaves to hide his ever-emerging scalp. The
modern alternative is the hairpiece.

Uncovering Baldness 

When discussing baldness, which affects an estimated 40 million men and
20 million women in the United States, the topic is generally about a
hereditary condition called androgenetic alopecia. Ninety-five percent
of hair loss is of this variety.

Male-pattern baldness refers to the upward retreat of the hairline from
the forehead, as well as an expanding area of fallout from the crown of
the head. In the end, all that might be left is a horseshoe-shaped
fringe around the sides and back of the head. Female-pattern baldness,
which recently has received more attention since Pharmacia& Upjohn began
packaging and marketing Rogaine separately for women, refers to a
diffuse pattern of hair loss throughout the scalp.

Research continues in search of ways to treat androgenetic alopecia and
allow hair to sprout in barren scalps. But, at this time, all you can
do, if you're a man, is to look at your father's head and your mother's
father's head to see how they fared, because chances are you'll wind up
with a similar fate. In addition, female-pattern baldness can be passed
down from mother to daughter.

"I think it's just the luck of the draw what your genetics are," says
Allan Kayne, M.D., a dermatologist and assistant clinical professor of
medicine at the University of Washington Medical Center in Seattle.

In male- and female-pattern baldness, the culprit is something called
dihydrotestosterone, or DHT, which is derived from androgen, a male
hormone. Circulating through the bloodstream, androgen is converted to
DHT by the enzyme 5-alpha reductase. Those with greater enzyme activity
have more DHT binding to hair-follicle receptors. If flooded by DHT, the
follicles sprout thinner and thinner hairs until nothing regrows, and
the follicles eventually wither away.

Minoxidil 

Currently, if you want to regrow hair, topical minoxidil is the only
approved way to go. As Washenik explains, no one is quite certain how
minoxidil, an oral medication originally approved to treat high blood
pressure, works to grow hair.

To be effective, minoxidil must be used twice a day. It works better on
those who are younger and whose hair loss is recent, according to
clinical studies by Pharmacia& Upjohn.

Those studies show that 26 percent of men between 18 and 49 reported
moderate to dense hair regrowth after four months of Rogaine treatment.
An additional 33 percent had minimal hair regrowth. Almost 20 percent of
women between 18 and 45 had moderate regrowth, while an additional 40
percent showed minimal regrowth.

A company spokesman said the research accounted for the fully pigmented
hair fibers normally seen on the scalp and not vellus hair, which is
more like peach fuzz. Many doctors, however, say the number of their
patients who have as much success is much lower, and some find that only
vellus hair appears.

"I have not been that impressed that it helps regrow hair," Kayne says.
"I think that occurs in a very small minority."

One plus that Denise Cook, M.D., medical officer in FDA's division of
dermatologic and dental drug products, points out is that patients
report a decrease in shedding due to minoxidil use, though whether that
perception is the result of fewer hairs being lost or more hairs being
produced is unknown. Normally, you should lose only about 100 hairs a
day.

One possible side effect of minoxidil is an itchy scalp. Another
drawback is that it must be used for life or any regrown hair will fall
out. Also, only those people losing hair on the crown, not in front, are
candidates for regrowth.

Researchers are optimistic that more products to boost hair regrowth
will be coming down the pike. For example, Proscar (finasteride), now
used to treat enlarged prostate glands, has anti-androgen properties
that may make it marketable as a hair-loss prescription, Washenik says.
Theoretically, he says, if a drug can be targeted to halt the conversion
of testosterone to DHT in the scalp region only, it could stop hair from
falling out. He foresees combinations of medications as the wave of the
future.

Surgery 

Twenty years ago, many people felt they risked looking like a Cabbage
Patch doll if they chose surgery to eliminate baldness. Now, says Carlos
Puig, D.O., director of Puig Medical Group, which is headquartered in
Houston, better surgical techniques--used by increasingly skilled
surgeons--are getting more eye-pleasing results.

"When I started in 1973 ... it was like the Stone Age," the cosmetic
surgeon says, referring to the equipment and techniques in use. Now, he
says, surgeons have learned to create a much more natural-looking hair
line, using scalpels to cut either small slits or holes in the scalp to
receive transplanted hair.

While there are numerous types of surgery, they can be sifted into two
main categories: transplantation and scalp reduction.

Transplantation involves moving hair from densely covered sites on the
sides or back of the head to bald areas of the scalp.

The key to success, explains Anthony Santangelo, president of the
American Hair Loss Council, is to have good sites on the sides or back
of the head from which to move hairs. Otherwise, patients can't expect
ample coverage. Because their hair loss is diffuse, women generally lack
good donor sites, making transplantation impractical for them.

The biggest improvement in transplants is with "micro" or "mini" grafts.
"You're looking at one to two hairs shot into the head with a needle,"
Santangelo says. "It achieves a very, very fine, natural-looking hair
line. The significant difference there is you need a lot of hair to do
that."

Surgeons also use larger round plugs of seven to 10 hairs. Line grafts,
the shifting of strips of nine to 12 hairs, are common, too.

One thing to keep in mind is that prosthetic hair fibers for
transplantation are banned by FDA. Implanting them, according to Stephen
Rhodes, acting chief of FDA's plastic and reconstructive surgery devices
branch, caused a high incidence of adverse reactions, including
infection.

If male-pattern baldness has left you with too much balding area to
cover, you may benefit from scalp reduction: the surgical removal of
large sections of a bald scalp. Extenders and expanders, elastic devices
placed under the skin to stretch the hair-bearing scalp regions on the
side of the head, have been used as a complement to reduction surgery.

Another surgical method is the flap technique, which rotates
hair-bearing scalp areas from the sides or moves those areas from the
back forward. The flap technique has the highest complication rate,
though, Puig says. Bleeding, scarring and infection can occur from
surgery. But advances, such as knowing what size flap to use and how to
enhance blood supply to the region, have cut down on the visibility of
scars.

Hairpieces 

Finally, if you prefer to dodge the pain, time and cost of surgery,
there's always the old, reliable hairpiece.

Obviously, all toupees and wigs are not created equal. Just as the
transplant is only as good as the surgeon, the hairpiece is only as good
as the person creating it and the materials used.

There are a variety of ways of affixing the hairpiece, which consists of
human or synthetic hair implanted one hair at a time into a nylon
netting. No method is permanent.

The hair weave involves sewing a wig into existing hair.

Also there are more traditional methods: You can use bonding (a type of
glue), metal clips, or simple tape to attach the hairpiece to the scalp.
Unlike the weaves, these give you the option to take the hairpiece on or
off with ease. Many companies advertise "hair systems" or "hair clubs,"
which, according to Santangelo, offer check-ups to clean, color and
tighten the hairpiece.

Lark Lambert, consumer complaint coordinator for FDA's Office of
Cosmetics and Colors, notes that in addition to maintaining the
cleanliness of hairpieces and wigs, it is important not to neglect the
scalp under the wig. Keeping it clean and healthy avoids skin irritation
and disease, he says. Also, as a precautionary safety measure,
first-time users of hairpiece adhesives and solvents should test a patch
of skin for 48 hours to determine possible skin sensitization to these
products.

Health-Related Hair Loss 

While hair loss is more harmful to the psyche than anything else, some
of the causes of baldness may represent serious health problems. That's
why it's important to talk about hair loss with a physician.

One problem, says FDA's Cook, could be a condition called alopecia
areata. It's an autoimmune disease of unknown cause in which
inflammatory cells attack the bulbs of the follicles under the scalp,
leaving hairless patches. In more serious cases, hair may fall out from
the entire head--eyebrows and beard included--and the entire body. Many
times, though, the hair returns spontaneously.

Childbirth, severe malnutrition, chemotherapy, thyroid problems, and a
form of lupus can also cause hair loss.

Something as simple as pigtails or cornrows, if worn too long, can cause
hair loss, too, because of the stress they cause to the hair shaft.

The medical opinion concerning the role of emotional stress in balding
is mixed. If stress does play a role, however, it's only at times of
extreme emotional trauma, according to Kayne at the University of
Washington Medical Center.

Mythical Treatments

The mythology of hair loss is a book unto itself. Wearing hats won't
cause it, doctors say. Nor will standing on your head to increase blood
flow cure it. Massaging your scalp and brushing your hair won't save
you. Toweling off your head lightly rather than vigorously will only
postpone the inevitable for a few days.

Perhaps the biggest myth is that cleaning your scalp of sebum (the
semifluid secretion of glands attached to the follicle) will unclog
those follicles and allow hair to grow. Surgeons will tell you that when
they're performing transplants, there's no trapped hair to be found.

In 1989, FDA banned all nonprescription hair creams, lotions, or other
external products claiming to grow hair or prevent baldness. And it has
taken action against companies that continue to sell such products. In
1996, the agency sent a warning letter to Daniel Rogers Laboratories
Inc., of Paramus, N.J., the manufacturer of "Natural Hairs," for
claiming its product could promote hair growth and prevent hair loss.
Two years earlier, after an FDA investigation, a U.S. district court
judge enjoined the market ing of "Solution 109 Herbal Shampoo" because
of claims that the product warded off hair loss.

Advertisements for "hair farming" products and others that hint they can
regrow hair are still plentiful. But if you're desperate, keep one thing
in mind:

"There will be never be a secret [ingredient] that works for hair loss,"
NYU's Washenik says. And, if they were to find it, he says: "It will be
on the cover of the New York Times. It will be on the nightly news. ...
When this happens, it's going to be wildness. You're not going to need
an expert to tell you the name of the drug."

Larry Hanover is a writer in Mount Laurel, N.J. 


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


The Thick and Thin of Hair Cosmetics

While Rogaine and other minoxidil-based products are giving consumers
hopes of regrowing hair, another part of the hair-care industry has been
jumping into the fray.

Drugstore chains, beauty shops, and salons are offering a number of
products claiming to make hair appear thicker or fuller. While they
won't solve baldness, such products can help women in particular by
giving the appearance of more hair--if, and only if, the products are
used regularly.

"The reality is," says Anthony Santangelo, president of the American
Hair Loss Council, "[the products] just build hair for the day."

A quick walk down the store aisle shows a multitude of shampoos,
conditioners, gels, mousses, and volumizers competing for your dollars.
Many labeling claims target people with thinning hair, while others hint
they can regrow hair, creating controversy about whether such a claim
constitutes going too far. Any product claiming to regrow hair would
have to file a new drug application. The Food and Drug Administration
has approved only one product, the drug minoxidil, for regrowing hair.

"It's marketing; it's puffery," Santangelo says. "They'll take it as
close as they possibly can without crossing the line, and they'll run
with it."

Many of these products seem to thicken hair by coating it with chemicals
called polymers. Hair has a negative charge, and the polymers' positive
charge causes the polymers to adhere to the hair shaft, says Charles
Fox, a Fair Lawn, N.J., consultant to the cosmetics industry. That
results in better hair manageability and shine, he says. The hair also
retains moisture, causing the shaft to swell and its diameter to expand
slightly.

Also, says Stanley Milstein, Ph.D., special assistant to the director of
FDA's Office of Cosmetics and Colors, some products coat the hair with
various oils, waxes and silicone, claiming to restore moisture balance
as they thicken hair.

Clarence Robbins, vice president of advanced technology for
Colgate-Palmolive Co. and author of Chemical and Physical Behavior of
Human Hair, says that if the products work, it's because they keep hair
shafts from sliding past each other (think of the fly-away hair you get
after blow-drying on a winter day.) In that way, hair volume appears
greater.

If you're one to use bleach (peroxide) occasionally, he says, the bleach
can achieve that sliding effect. Perms also make your hair wavier and
fuller looking.

Many promoters of these products say their pro-vitamin B5 (panthenol)
formulas can lead to fuller hair. Experts say don't bet on it, and
according to the agency, the claim has never been proved.

By the way, there are products that simply color your scalp to create
the appearance of hair. "But get any closer than 20 feet from an
individual, they're gonna see your head's been spray-painted or covered
with powder," Santangelo says.

--L.H. 

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

When Heartbeats Go Haywire:
New Treatments Can Save Lives

by Margie Patlak 

Two-time Olympic gold-medalist skater Sergei Grinkov shocked the world
in fall 1995, when he collapsed on the ice rink and died hours later at
the young age of 28. A blood clot that blocked blood flow to his heart
triggered it to quiver instead of beat. Medical technicians were unable
to restore a normal heart rhythm, and by the time he reached a hospital,
Grinkov's heart had stopped beating altogether.

Grinkov suffered what is known as ventricular fibrillation. This
inefficient and deadly quivering of the heart is one of several types of
irregular heartbeats, or arrhythmias, that afflict the lower chambers,
called the ventricles, of the heart. Not all arrhythmias are
ventricular; some, for example, arise from the upper chambers of the
heart.

Ventricular arrhythmias often occur in people with various forms of
heart disease and, according to the American Heart Association, cause
most cases of sudden cardiac death. But new drugs and devices show
promise in curbing the number of deaths from this condition. These new
treatments, approved by the Food and Drug Administration, include a
longer-acting form of an antiarrhythmia drug, a wide availability of
portable and implantable electrical devices that can spark a return to
normal heart rhythm, and tec hniques for destroying heart tissue that
triggers ventricular arrhythmias.

Heart of the Matter 

[Omitted: illustration showing the chambers of the human heart]

Not much bigger than a fist, the human heart beats 100,000 times each
day, sending about 2,000 gallons of blood coursing through vessels,
which, laid end-to-end, would be long enough to circle the earth more
than twice.

To carry out the vital task of pumping blood, the electrical timing of
millions of heart cells must be exquisitely coordinated. Their timing
sparks the heart to pump in a rhythmic, efficient fashion. When that
coordination is disrupted, life-threatening ventricular arrhythmias
result.

Each heartbeat normally starts in the upper right chamber of the heart,
or right atrium. Here, a specialized bunch of cells called the sinus
node, or pacemaker, sends an electrical signal. The signal spreads
throughout the right and left atria and then travels along specific
pathways to the lower chambers or ventricles. As the signal travels, the
heart muscle contracts. First the atria (the upper right and left
chambers) contract, pumping blood into the ventricles. A fraction of a
second later, the ventricles contract in a squeezing motion, sending
blood throughout the body. Each contraction is a heartbeat.

Ventricular arrhythmias occur when a group of heart cells in the
ventricles triggers contractions out of sync with the normal rhythm
established by the sinus node. A number of factors can prompt a
ventricular arrhythmia, including stress, exercise, caffeine, tobacco,
alcohol, amphetamines, tricyclic antidepressant drugs, and cough and
cold medicines containing pseudoephedrine, as well as several drugs
(such as diuretics and digitalis) used to treat various heart
conditions.

Many types of heart disease also are associated with ventricular
arrhythmias. Atherosclerosis, the buildup of plaque on artery walls, can
reduce blood flow to heart tissue. That, in turn, can impede the
transmission of electrical signals governing heart contractions. This
can prompt groups of ventricle cells to generate their own "back-up"
rhythm. In the extreme case of a heart attack, blood flow to specific
parts of the heart muscle is completely blocked, and that heart tissue
dies. If the affected area includes cells in the electrical pathways of
the heart, arrhythmias ensue.

People with enlarged hearts or faulty heart valves also are prone to
experiencing ventricular arrhythmias. Ventricular arrhythmias also
commonly occur after heart attacks, heart infections, or heart surgery,
or when the body is under severe physical stress from, for example, lack
of oxygen, very low blood pressure, or major blood loss. They also are
triggered by heart failure, surgery, and other conditions that cause
abnormal blood and tissue concentrations of potassium, magnesium,
sodium, or calcium. These minerals play key roles in triggering and
conducting electrical impulses in the heart.

Harmless or Deadly Beats 

Ventricular arrhythmias can be either deadly or innocuous, depending on
their type and persistence and whether the person's heart function is
already compromised. The most common type of ventricular arrhythmia in
both healthy and diseased individuals is the ventricular premature beat.
The incidence of this condition increases with age.

A premature beat occurs when there is an extra contraction of the
ventricles midway between two normal contractions or shortly after a
normal contraction. In the latter case, they can delay the next
heartbeat prompted by the natural pacemaker.

Ventricular premature beats often do not prompt symptoms, but they may
be perceived as skipped beats or fluttering or thumping in the chest
known as heart palpitations, and they may cause dizziness or weakness.
Probably everyone develops ventricular premature beats at one time or
another, according to the American Heart Association. This type of
arrhythmia is commonly encountered in cardiac monitoring, even in
healthy individuals.

Ventricular premature beats are not by themselves harmful, but they can
be a precursor to two more serious types of ventricular arrhythmias:
ventricular tachycardia and ventricular fibrillation.

Ventricular tachycardia is rapid heartbeat that arises from the lower
chambers of the heart and is usually much faster than the normal heart
rate of 60 to 100 times per minute. Ventricular tachycardia is
considered "nonsustained" if it lasts only seconds or "sustained" if it
lasts for more than 30 seconds. Like ventricular premature beats,
ventricular tachycardias commonly occur in healthy people, particularly
those who are frightened or excited.

Ventricular tachycardias prevent ventricles from properly filling with
blood. This reduces pumping efficiency, which can be made worse if there
are underlying heart muscle abnormalities.

Nonsustained ventricular tachycardias may cause no noticeable symptoms,
or they may be felt as palpitations. When sustained, however,
tachycardias often cause palpitations, as well as weakness, dizziness,
chest pain, and breathing difficulties. Particularly rapid or
long-lasting ventricular tachycardias or sustained tachycardias in
people whose heart function is already compromised by disease can cause
loss of consciousness or lead to fatal cardiac arrest.

A ventricular tachycardia can degenerate into ventricular fibrillation,
which is an extremely rapid, chaotic rhythm that starts in the
ventricles and causes the heart to quiver. Such quivering prevents the
heart from pumping blood to the rest of the body. The onset of a
ventricular fibrillation is dramatic: People suddenly lose consciousness
and collapse in a shock-like state. Their pulse, heartbeat and blood
pressure cannot be detected, and death occurs in minutes without
effective treatment. A common cause of ventricular fibrillation is a
heart attack.

Emergency Care 

Patients with ventricular fibrillation must be treated immediately with
one or more electric shocks to the heart, which are transmitted
externally with defibrillator paddles placed on the chest. Severe
ventricular tachycardias also must often be treated with defibrillators.

Defibrillators tend to synchronize the heart's electrical system. "By
giving a shock you start things from scratch again and organize a
disorganized rhythm," said Andrew Epstein, M.D., of the University of
Alabama at Birmingham.

Defibrillators may become more readily available as a result of FDA's
approval in September 1996 of a smaller portable version that may be
particularly beneficial to police officers, firefighters, flight
attendants, and others who may be the first to respond to cardiac
emergencies and can now equip their vehicles with the compact units.

Once the heartbeat has been restored, patients usually are given
lidocaine hydrochloride (Xylocaine) or bretylium tosylate (Bretylol)
intravenously to stabilize their heart rhythm.

The Telltale Heart 

The safety and effectiveness of long-term arrhythmia treatment depend on
accurate diagnosis. Sometimes ventricular arrhythmias can be detected by
listening to the heart with a stethoscope. The diagnostic tool of
choice, though, is the electrocardiogram (ECG or EKG), which shows the
relative timing of atrial and ventricular electrical events. ECG's
generate telltale spikes, whose characteristic rhythm and shape identify
the specific type of arrhythmia.

To make an ECG, a technician attaches several electrodes to the chest
and sometimes the limbs. The electrodes detect electrical activity that
is recorded on a moving strip of paper or projected on a computer-like
screen. The procedure is harmless and painless.

Because of the fleeting nature of many arrhythmias, they may not occur
while the ECG is running, and so they may go undetected on the ECG. In
these cases, doctors may ask patients to wear a small portable ECG
recorder, called a Holter monitor, for 24 hours. This device, about the
size of a tape recorder, records continuous electrocardiographic signals
or selectively records arrhythmias causing symptoms. Holter monitoring
requires patients to wear electrodes continuously on their chests during
the 24 hours.

ECG's of arrhythmias with symptoms that occur less frequently than daily
can be transmitted via the telephone to a doctor's office or a hospital
with a hand-held device called an event monitor. This monitor converts
ECG signals into tones that travel over a telephone line and are then
converted to paper tracings. If a telephone is not available at the time
the arrhythmia occurs, the ECG signals can be recorded and stored in the
device's memory for transmission later. For such transtelephonic
monitoring, patients place electrodes on their chests only when they are
experiencing symptoms.

Another diagnostic option for infrequent arrhythmias is to provoke them
purposely through exercise or with electrical devices. For example, a
patient whose arrhythmias are thought to be prompted by exercise may
undergo a treadmill workout while his or her heart activity is being
monitored by an ECG device.

An arrhythmia also may be induced with electrophysiologic testing. In
this procedure, electrodes are attached to small tubes known as
electrode catheters, which are threaded through arm or leg veins until
they reach the heart. There, they are placed at strategic positions in
the ventricles, atria or both.

These electrodes record electrical signals and allow doctors to "map"
the spread of electrical impulses during each heartbeat. The electrodes
also can electrically stimulate the heart at programmed rates to trigger
latent ventricular tachycardias. These arrhythmias are then stopped by
electrical stimuli transmitted via the electrode catheters. An
externally applied shock may be required if the patient loses
consciousness during the tachycardia.

Being able to "turn on" tachycardias during electrophysiologic testing
allows doctors to test antiarrhythmic drugs quickly for effectiveness.
It also can indicate the electrically blocked areas of the heart
responsible for triggering a patient's arrhythmia. If these areas are
limited in size and number, destruction of them is a treatment option.

Cardiologists usually reserve electrophysiologic testing for patients
whose arrhythmias do not occur during ECG monitoring or are not
controlled by their current medication. Electrophysiologic testing is
considered safe, although rare complications, such as bleeding,
infection, perforation of the heart, and fatal arrhythmias, can occur.

Preventive Treatment 

Before starting any preventive drug treatment regimen, doctors first try
to rule out reversible causes of ventricular arrhythmias: for example,
caffeine, alcohol and tobacco consumption, and certain over-the-counter
and prescribed medicines.

Also, because treatments pose substantial risks relative to the risk of
the arrhythmias themselves, doctors tend not to treat ventricular
arrhythmias unless they are tied to significant symptoms or are
life-threatening. For this reason, FDA has not approved any treatments
for premature ventricular beats.

However, there are several drugs approved for preventing ventricular
tachycardia. The main types are beta blockers and sodium or potassium
channel blockers. Most drugs to prevent ventricular tachycardias are
taken orally up to four times daily and often must be taken for life.

Beta blockers, such as propranolol hydrochloride (Inderal and others),
stem the automatic stimulation of heart contractions by the nervous
system. Sodium and potassium channel blockers hamper transmission of
electrical impulses in heart cells. Some sodium channel blockers are
quinidine (Quinidex Extentabs, Quinaglute and others) and procainamide
hydrochloride (Procan, Pronestyl and others). FDA approved in February
1996 a long-acting form of procainamide, Procanbid, which is taken only
twice a day, compared with other procainamides, which must be taken four
times daily.

Potassium channel blockers, such as amiodarone hydrochloride (Cordarone)
and sotalol (Betapace), also are used to prevent ventricular
tachycardias.

Doctors monitor the effectiveness of antiarrhythmia drug therapy with an
ECG, or with electrophysiologic testing. Monitoring is essential not
only to ensure effectiveness but safety, as well, because many of these
drugs can make arrhythmias worse. Other side effects of antiarrhythmia
drugs that can limit their use are low blood pressure, lung damage,
nausea, and dizziness.

According to Wilber Aronow, M.D., a cardiologist with Mount Sinai School
of Medicine in New York City, studies show that people treated with
certain beta blockers following a heart attack have a significantly
reduced risk of sudden cardiac death. But many large-scale studies of
several different types of sodium channel blockers, as well as studies
of certain potassium channel blockers, have shown that treatment with
these drugs following heart attacks does not improve survival odds, or
reduce them.

Ventricular arrhythmias are common within a month of a heart attack and
are associated with an increased risk of sudden cardiac death.

An Internal Jolt 

Another treatment option for people at risk for life-threatening
arrhythmias is an implanted cardioverter defibrillator. FDA approved the
first implantable defibrillators more than 10 years ago.

Today's device typically consists of a generator slightly smaller than
the size of a wallet attached to electrode catheters. The generator is
surgically placed under or over chest or abdominal muscles. The
catheters are threaded through veins to their permanent positions in the
heart. Complications of implanting defibrillators are rare but serious
and include bleeding, infections, and perforation of the heart.

Implanted defibrillators monitor the heart rhythm and automatically
treat, with electrical stimuli or shocks, rhythms recognized as
abnormal. Newer devices also can record and store data of the electrical
activity of the heart that doctors can later download and evaluate for
arrhythmias. The data also can be used to perform electrophysiologic
testing.

Implanted defibrillators can often stem ventricular arrhythmias with
low-energy shocks. Sometimes, however, high-energy shocks are needed.
These shocks, though short-lasting, can be painful--somewhat akin to a
kick in the chest.

The generators in implanted defibrillators usually last three to five
years and can be replaced with a surgical procedure that usually
requires only local anesthesia. The electrode leads tend to last longer,
although they can develop cracks or component failures that require
their replacement.

A recent study of heart attack survivors by Arthur Moss and colleagues
from the University of Rochester (N.Y.) Medical Center found implantable
defibrillators cut survivors' risk of death in half.

A National Heart, Lung, and Blood Institute study under way is assessing
whether implanted defibrillators or drug therapy is more effective in
extending the lives of patients with ventricular arrhythmias.

Opening the Chest 

Open-heart surgery to remove heart tissue causing or contributing to
arrhythmias may be warranted for patients whose ventricular arrhythmias
cannot be controlled by drugs. But, this is feasible only for patients
whose arrhythmias can be attributed to heart sites that are limited in
size and number. Most patients who undergo this procedure survive.

To avoid the risks and painful recovery of this procedure, a number of
clinical investigators have used radiofrequency energy, delivered via
catheters threaded through veins to the heart, to destroy heart tissue
at the root of ventricular arrhythmias. FDA has not yet fully evaluated
the safety and effectiveness of this experimental procedure.

But the availability of other treatment options means that many patients
with ventricular arrhythmias can be treated effectively.

That wasn't true a decade ago, cardiologist Epstein points out. "We're a
lot further along."

Margie Patlak is writer in Elkins Park, Pa. 

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

A Time to Heal:
Chronotherapy Tunes In to Body's Rhythms

by Isadora Stehlin 

How our bodies marshal defenses against disease depends on many factors,
such as age, gender and genetics. Recently, the role of our bodies'
biological rhythms in fighting disease has come under study by some in
the medical community.

Our bodies' rhythms, also known as our biological clocks, take their cue
from the environment and the rhythms of the solar system that change
night to day and lead one season into another. Our internal clocks are
also dictated by our genetic makeup. These clocks influence how our
bodies change throughout the day, affecting blood pressure, blood
coagulation, blood flow, and other functions.

Some of the rhythms that affect our bodies include:

 * ultradian, which are cycles shorter than a day (for example, the
   milliseconds it takes for a neuron to fire, or a 90-minute sleep cycle)

 * circadian, which last about 24 hours (such as sleeping and waking
   patterns)

 * infradian, referring to cycles longer than 24 hours (for example
   monthly menstruation)

 * seasonal, such as seasonal affective disorder (SAD), which causes
   depression in susceptible people during the short days of winter.

"The biology of human beings is not constant throughout the day, the
menstrual cycle, and the year," says Michael Smolensky, Ph.D., director
of the Chronobiology Center at the University of Texas. "Instead, it
varies predictably in time."

Coordinating biological rhythms (chronobiology) with medical treatment
is called chronotherapy. It considers a person's biological rhythms in
determining the timing--and sometimes the amount--of medication to
optimize a drug's desired effects and minimize the undesired ones.

According to Smolensky, patients are more likely to follow schedules for
taking their medications when those medications are formulated as
chronotherapies because of better medical results and fewer adverse side
effects. "With better compliance, the disease can be better contained,
which means fewer doctor visits and potential trips to the hospital
because of acute flare-ups," he says.

The area in which chronotherapy is most advanced--drug
chronotherapy--for the most part does not involve new medicines but
using old ones differently. Revising the dosing schedule, reformulating
a drug so its release into the bloodstream is delayed, or using
programmable pumps that deliver medicine at precise intervals are some
of the simple changes that may reap enormous benefits. Drugs that are
reformulated as chronotherapeutics are regulated by the Food and Drug
Administration.

Here's a look at how chronotherapy is being used or studied for various
diseases.

Asthma 

Normal lung function undergoes circadian changes and reaches a low point
in the early morning hours. This dip is particularly pronounced in
people with asthma.

Chronotherapy for asthma is aimed at getting maximal effect from
bronchodilator medications during the early morning hours. One example
is the bronchodilator Uniphyl, a long-acting theophylline preparation
manufactured by Purdue Frederick Co. of Norwalk, Conn., and approved by
FDA in 1989. Taken once a day in the evening, Uniphyl causes
theophylline blood levels to reach their peak and improve lung function
during the difficult early morning hours. There are other
bronchodilators that act similarly to address the early morning dip in
lung function, but the manufacturers have not sought or received FDA
approval for chronotherapeutic labeling.

Writing in the April 15, 1996, issue of Hospital Practice, Richard
Martin, M.D., who directs the division of pulmonary medicine at the
National Jewish Center for Immunology and Respiratory Medicine in
Denver, stated his belief that "the key to managing [asthma] cases is
chronotherapy. I have found that unless treatment improves nighttime
asthma, it is hard to improve its daytime manifestations." For people
with severe asthma who wake up several times a night gasping for breath,
a good night's sleep can be a dream come true.

Arthritis 

Chronobiological patterns have been observed with arthritis pain. People
with osteoarthritis, the most common form of the disease, tend to have
less pain in the morning and more at night. But for people with
rheumatoid arthritis, the pain usually peaks in the morning and
decreases as the day wears on. Recent animal studies showing that joint
inflammation in rats fluctuates over a 24-hour period support these
observations by both patients and physicians.

Chronotherapy for all forms of arthritis uses standard treatment,
nonsteroidal anti-inflammatory drugs and corticosteroids; however, the
dosages are timed to ensure that the highest blood levels of the drug
coincide with peak pain.

For osteoarthritis sufferers, the optimal time for a nonsteroidal
anti-inflammatory drug such as ibuprofen would be around noon or
mid-afternoon. The same drug would be more effective for people with
rheumatoid arthritis when taken after the evening meal. The exact dose
would depend on the severity of the patient's pain and his or her
individual physiology.


Cancer 

Animal studies suggest that chemotherapy may be more effective and less
toxic if cancer drugs are administered at carefully selected times.

"The data in animals are very compelling," says Gerald Sokol, M.D., an
oncologist with the division of oncology in FDA's Center for Drug
Evaluation and Research. However, he says, additional studies in humans
are needed.

"There really aren't any controlled trials demonstrating that
chronotherapy for cancer is important," says Robert Justice, M.D.,
deputy director of the division. "I'm not saying it can't be. I just
don't think it's been demonstrated."

The studies so far suggest that there may be different chronobiological
cycles for normal cells and tumor cells. If this is true, the goal would
be to time the administration of cancer drugs to the chronobiological
cycles of tumor cells, making them more effective against the cancer and
less toxic to normal tissues, Sokol explains.

Before chronotherapy could become part of standard cancer treatment,
Sokol adds, it would have to be determined whether there is an optimal
time to give a drug.

Also to be determined would be how to handle the logistics of giving
drugs at scattered times throughout the day and night. "Chronotherapy
means we can't bring in all our cancer patients in the morning to
receive their drug therapies," says Sokol, who also has a hospital
practice in Tampa, Fla. "Some patients may be better served by getting
their drugs late in the afternoon or even at night."

Portable infusion pumps may hold the answer. "The patient can be sent
home with an implantable pump that will automatically distribute the
drug at the appropriate time," he explains.


Cancer Surgery 

[Omitted: chart showing hormonal changes of the menstrual cycle]

The optimal timing of cancer surgery, particularly breast cancer, has
also come under study. Some researchers believe that in premenopausal
women, surgical cure of breast cancer is more likely if surgery is
performed in the middle of a woman's menstrual cycle in the week or so
following ovulation.

At the May 1996 International Conference on Breast Diseases in Houston,
Umberto Veronesi, M.D., of the European Institute of Oncology in Milan,
Italy, presented 20 years of follow-up data on nearly 1,200
premenopausal women who underwent surgery for breast cancer. Of patients
who had surgery in the week following ovulation, 76 percent were
tumor-free after five years, compared with 63 percent in patients who
had surgery earlier in their menstrual cycle.

Many experts believe that any improved outcome is hormone-related. In
the first half of the menstrual cycle, estrogen levels are high, and
progesterone is not produced. In the second half, progesterone rises and
estrogen falls. It is believed that progesterone may inhibit the
production of some enzymes that help cancer spread.

However, some experts dispute the need to time breast cancer surgery
according to the menstrual cycle. G.M. Clark, M.D., of the University of
Texas Health Science Center at San Antonio, reported at the conference
that retrospective analyses from at least 23 studies involving more than
6,000 patients failed to find any significant impact of the menstrual
cycle division on breast cancer prognosis.


Regulatory Implications 

Chronotherapeutics present new challenges to regulators and scientists
alike. For example, according to FDA's Sokol, chronotherapeutic clinical
studies need to consider additional parameters not usually required of
other clinical trials. Among additional factors that must be considered,
he says, are:


 * time of day a drug is administered

 * time-related biological factors, such as seasonal disorders (for
   example, seasonal affective disorder)

 * patients' normal routines (for example, eating times and sleep
   patterns).

Making chronotherapy the focus of more clinical trials would be welcome
news to many in the medical community, according to a 1996 American
Medical Association survey. The study found that about 75 percent of the
doctors surveyed said they would like more treatment options to match a
patient's circadian, or daily, rhythms.

But chronotherapy has a way to go, considering that only 5 percent of
the doctors surveyed said they were "very familiar" with the subject.

"Chronotherapy is not well recognized in the medical community," Sokol
says, "but awareness is increasing. The implications are broad in every
area of medicine."

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

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

Protecting Against Unintended Pregnancy:
A Guide to Contraceptive Choices

by Tamar Nordenberg 

 I am 20 and have never gone to see a doctor about birth control. My
 boyfriend and I have been going together for a couple of years and have
 been using condoms. So far, everything is fine. Are condoms alone safe
 enough, or is something else safe besides the Pill? I do not want to go
 on the Pill.

   --Letter to the Kinsey Institute for Research in Sex, Gender, and
     Reproduction

This young woman is not alone in her uncertainty about contraceptive
options. A 1995 report by the National Academy of Sciences' Institute of
Medicine, The Best Intentions: Unintended Pregnancy and the Well-being
of Children and Families, attributed the high rate of unintended
pregnancies in the United States, in part, to Americans' lack of
knowledge about contraception. About 6 of every 10 pregnancies in the
United States are unplanned, according to the report.

Being informed about the pros and cons of various contraceptives is
important not only for preventing unintended pregnancies but also for
reducing the risk of illness or death from sexually transmitted diseases
(STDs), including AIDS. (See "Preventing HIV and Other STDs.")

[Omitted: illustration of Norplant insertion, insertion of female
condom, and IUD in position]

The Food and Drug Administration has approved a number of birth control
methods, ranging from over-the-counter male and female condoms and
vaginal spermicides to doctor-prescribed birth control pills,
diaphragms, intrauterine devices (IUDs), injected hormones, and hormonal
implants. Other contraceptive options include fertility awareness and
voluntary surgical sterilization.

"On the whole, the contraceptive choices that Americans have are very
safe and effective," says Dennis Barbour, president of the Association
of Reproductive Health Professionals, "but a method that is very good
for one woman may be lousy for another."

The choice of birth control depends on factors such as a person's
health, frequency of sexual activity, number of partners, and desire to
have children in the future. Effectiveness rates, based on statistical
estimates, are another key consideration. (See the Birth Control Guide,
available both in table format and as a 109K PDF file.) FDA is
developing a more consumer-friendly table to be added to the labeling of
all contraceptive drugs and devices.

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

Barrier Methods


Male Condom.

The male condom is a sheath placed over the erect penis before
penetration, preventing pregnancy by blocking the passage of sperm.

A condom can be used only once. Some have spermicide added, usually
nonoxynol-9 in the United States, to kill sperm. Spermicide has not been
scientifically shown to provide additional contraceptive protection over
the condom alone. Because they act as a mechanical barrier, condoms
prevent direct vaginal contact with semen, infectious genital
secretions, and genital lesions and discharges.

Most condoms are made from latex rubber, while a small percentage are
made from lamb intestines (sometimes called "lambskin" condoms). Condoms
made from polyurethane have been marketed in the United States since
1994.

Except for abstinence, latex condoms are the most effective method for
reducing the risk of infection from the viruses that cause AIDS, other
HIV-related illnesses, and other STDs.

Some condoms are prelubricated. These lubricants don't provide more
birth control or STD protection. Non-oil-based lubricants, such as water
or K-Y jelly, can be used with latex or lambskin condoms, but oil-based
lubricants, such as petroleum jelly (Vaseline), lotions, or massage or
baby oil, should not be used because they can weaken the material.


Female condom.

The Reality Female Condom, approved by FDA in April 1993, consists of a
lubricated polyurethane sheath shaped similarly to the male condom. The
closed end, which has a flexible ring, is inserted into the vagina,
while the open end remains outside, partially covering the labia.

The female condom, like the male condom, is available without a
prescription and is intended for one-time use. It should not be used
together with a male condom because they may not both stay in place.


Diaphragm.

Available by prescription only and sized by a health professional to
achieve a proper fit, the diaphragm has a dual mechanism to prevent
pregnancy. A dome-shaped rubber disk with a flexible rim covers the
cervix so sperm can't reach the uterus, while a spermicide applied to
the diaphragm before insertion kills sperm.

The diaphragm protects for six hours. For intercourse after the six-hour
period, or for repeated intercourse within this period, fresh spermicide
should be placed in the vagina with the diaphragm still in place. The
diaphragm should be left in place for at least six hours after the last
intercourse but not for longer than a total of 24 hours because of the
risk of toxic shock syndrome (TSS), a rare but potentially fatal
infection. Symptoms of TSS include sudden fever, stomach upset,
sunburn-like rash, and drop in blood pressure.


Cervical cap.

The cap is a soft rubber cup with a round rim, sized by a health
professional to fit snugly around the cervix. It is available by
prescription only and, like the diaphragm, is used with spermicide.

It protects for 48 hours and for multiple acts of intercourse within
this time. Wearing it for more than 48 hours is not recommended because
of the risk, though low, of TSS. Also, with prolonged use of two or more
days, the cap may cause an unpleasant vaginal odor or discharge in some
women.


Sponge.

The vaginal contraceptive sponge has not been available since the sole
manufacturer, Whitehall Laboratories of Madison, N.J., voluntarily
stopped selling it in 1995. It remains an approved product and could be
marketed again.

The sponge, a donut-shaped polyurethane device containing the spermicide
nonoxynol-9, is inserted into the vagina to cover the cervix. A woven
polyester loop is designed to ease removal.

The sponge protects for up to 24 hours and for multiple acts of
intercourse within this time. It should be left in place for at least
six hours after intercourse but should be removed no more than 30 hours
after insertion because of the risk, though low, of TSS.

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

Vaginal Spermicides Alone

Vaginal spermicides are available in foam, cream, jelly, film,
suppository, or tablet forms. All types contain a sperm-killing
chemical.

Studies have not produced definitive data on the efficacy of spermicides
alone, but according to the authors of Contraceptive Technology, a
leading resource for contraceptive information, the failure rate for
typical users may be 21 percent per year.

Package instructions must be carefully followed because some spermicide
products require the couple to wait 10 minutes or more after inserting
the spermicide before having sex. One dose of spermicide is usually
effective for one hour. For repeated intercourse, additional spermicide
must be applied. And after intercourse, the spermicide has to remain in
place for at least six to eight hours to ensure that all sperm are
killed. The woman should not douche or rinse the vagina during this
time.

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

Hormonal Methods

Combined oral contraceptives.

Typically called "the pill," combined oral contraceptives have been on
the market for more than 35 years and are the most popular form of
reversible birth control in the United States. This form of birth
control suppresses ovulation (the monthly release of an egg from the
ovaries) by the combined actions of the hormones estrogen and progestin.

If a woman remembers to take the pill every day as directed, she has an
extremely low chance of becoming pregnant in a year. But the pill's
effectiveness may be reduced if the woman is taking some medications,
such as certain antibiotics.

Besides preventing pregnancy, the pill offers additional benefits. As
stated in the labeling, the pill can make periods more regular. It also
has a protective effect against pelvic inflammatory disease, an
infection of the fallopian tubes or uterus that is a major cause of
infertility in women, and against ovarian and endometrial cancers.

The decision whether to take the pill should be made in consultation
with a health professional. Birth control pills are safe for most
women--safer even than delivering a baby--but they carry some risks.

Current low-dose pills have fewer risks associated with them than
earlier versions. But women who smoke--especially those over 35--and
women with certain medical conditions, such as a history of blood clots
or breast or endometrial cancer, may be advised against taking the pill.
The pill may contribute to cardiovascular disease, including high blood
pressure, blood clots, and blockage of the arteries.

One of the biggest questions has been whether the pill increases the
risk of breast cancer in past and current pill users. An international
study published in the September 1996 journal Contraception concluded
that women's risk of breast cancer 10 years after going off birth
control pills was no higher than that of women who had never used the
pill. During pill use and for the first 10 years after stopping the
pill, women's risk of breast cancer was only slightly higher in pill
users than non-pill users.

Side effects of the pill, which often subside after a few months' use,
include nausea, headache, breast tenderness, weight gain, irregular
bleeding, and depression.

Doctors sometimes prescribe higher doses of combined oral contraceptives
for use as "morning after" pills to be taken within 72 hours of
unprotected intercourse to prevent the possibly fertilized egg from
reaching the uterus. On June 28, 1996, FDA's Advisory Committee for
Reproductive Health Drugs concluded that certain oral contraceptives are
safe and effective for this use. At press time in January, no drug firm
had submitted an application to FDA to label its pills for this use, and
the agency had not yet acted on the committee's recommendation.

Minipills.

Although taken daily like combined oral contraceptives, minipills
contain only the hormone progestin and no estrogen. They work by
reducing and thickening cervical mucus to prevent sperm from reaching
the egg. They also keep the uterine lining from thickening, which
prevents a fertilized egg from implanting in the uterus. These pills are
generally less effective than combined oral contraceptives.

Minipills can decrease menstrual bleeding and cramps, as well as the
risk of endometrial and ovarian cancer and pelvic inflammatory disease.
Because they contain no estrogen, minipills don't present the risk of
blood clots associated with estrogen in combined pills. They are a good
option for women who can't take estrogen because they are breast-feeding
or because estrogen-containing products cause them to have severe
headaches or high blood pressure.

Side effects of minipills include menstrual cycle changes, weight gain,
and breast tenderness.


Injectable progestins.

Depo-Provera, approved by FDA in 1992, is injected by a health
professional into the buttocks or arm muscle every three months.
Depo-Provera prevents pregnancy in three ways: It inhibits ovulation,
changes the cervical mucus to help prevent sperm from reaching the egg,
and changes the uterine lining to prevent the fertilized egg from
implanting in the uterus. The progestin injection is extremely effective
in preventing pregnancy, in large part because it requires little effort
for the woman to comply: She simply has to get an injection by a doctor
once every three months.

The benefits are similar to those of the minipill and another
progestin-only contraceptive, Norplant. Side effects are also similar
and can include irregular or missed periods, weight gain, and breast
tenderness.

(See "Depo-Provera: The Quarterly Contraceptive" in the March 1993 FDA
Consumer.)


Implantable progestins.

Norplant, approved by FDA in 1990, and the newer Norplant 2, approved in
1996, are the third type of progestin-only contraceptive. Made up of
matchstick-sized rubber rods, this contraceptive is surgically implanted
under the skin of the upper arm, where it steadily releases the
contraceptive steroid levonorgestrel.

The six-rod Norplant provides protection for up to five years (or until
it is removed), while the two-rod Norplant 2 protects for up to three
years. Norplant failures are rare, but are higher with increased body
weight.

Some women may experience inflammation or infection at the site of the
implant. Other side effects include menstrual cycle changes, weight
gain, and breast tenderness.


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


Intrauterine Devices

An IUD is a T-shaped device inserted into the uterus by a health-care
professional. Two types of IUDs are available in the United States: the
Paragard CopperT 380A and the Progestasert Progesterone T. The Paragard
IUD can remain in place for 10 years, while the Progestasert IUD must be
replaced every year.

It's not entirely clear how IUDs prevent pregnancy. They seem to prevent
sperm and eggs from meeting by either immobilizing the sperm on their
way to the fallopian tubes or changing the uterine lining so the
fertilized egg cannot implant in it.

IUDs have one of the lowest failure rates of any contraceptive method.
"In the population for which the IUD is appropriate--for those in a
mutually monogamous, stable relationship who aren't at a high risk of
infection--the IUD is a very safe and very effective method of
contraception," says Lisa Rarick, M.D., director of FDA's division of
reproductive and urologic drug products.

The IUD's image suffered when the Dalkon Shield IUD was taken off the
market in 1975. This IUD was associated with a high incidence of pelvic
infections and infertility, and some deaths. Today, serious
complications from IUDs are rare, although IUD users may be at increased
risk of developing pelvic inflammatory disease. Other side effects can
include perforation of the uterus, abnormal bleeding, and cramps.
Complications occur most often during and immediately after insertion.

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


Traditional Methods

Fertility awareness.

Also known as natural family planning or periodic abstinence, fertility
awareness entails not having sexual intercourse on the days of a woman's
menstrual cycle when she could become pregnant or using a barrier method
of birth control on those days.

Because a sperm may live in the female's reproductive tract for up to
seven days and the egg remains fertile for about 24 hours, a woman can
get pregnant within a substantial window of time--from seven days before
ovulation to three days after. Methods to approximate when a woman is
fertile are usually based on the menstrual cycle, changes in cervical
mucus, or changes in body temperature.

"Natural family planning can work," Rarick says, "but it takes an
extremely motivated couple to use the method effectively."


Withdrawal.

In this method, also called coitus interruptus, the man withdraws his
penis from the vagina before ejaculation. Fertilization is prevented
because the sperm don't enter the vagina.

Effectiveness depends on the male's ability to withdraw before
ejaculation. Also, withdrawal doesn't provide protection from STDs,
including HIV. Infectious diseases can be transmitted by direct contact
with surface lesions and by pre-ejaculatory fluid.


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


Surgical Sterilization

Surgical sterilization is a contraceptive option intended for people who
don't want children in the future. It is considered permanent because
reversal requires major surgery that is often unsuccessful.


Female sterilization.

Female sterilization blocks the fallopian tubes so the egg can't travel
to the uterus. Sterilization is done by various surgical techniques
performed under general anesthesia.

Complications from these operations are rare and can include infection,
hemorrhage, and problems related to the use of general anesthesia.


Male sterilization.

This procedure, called a vasectomy, involves sealing, tying or cutting a
man's vas deferens, which otherwise would carry the sperm from the
testicle to the penis.

Vasectomy involves a quick operation, usually under 30 minutes, with
possible minor postsurgical complications, such as bleeding or
infection.

Research continues on effective contraceptives that minimize side
effects. One important research focus, according to FDA's Rarick, is the
development of birth control methods that are both spermicidal and
microbicidal to prevent not only pregnancy but also transmission of HIV
and other STDs.

Tamar Nordenberg is a staff writer for FDA Consumer. 

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


Preventing HIV and Other STDs

[Omitted: photo of condom]

Some people mistakenly believe that by protecting themselves against
pregnancy, they are automatically protecting themselves from HIV, the
virus that causes AIDS, and other sexually transmitted diseases (STDs).
But the male latex condom is the only contraceptive method considered
highly effective in reducing the risk of STDs.

Unlike latex condoms, lambskin condoms are not recommended for STD
prevention because they are porous and may permit passage of viruses
like HIV, hepatitis B and herpes. Polyurethane condoms are an
alternative method of STD protection for those who are latex-sensitive.

Because it is a barrier method that works in much the same way as the
male condom, the female condom may provide some protection against STDs.
Both condoms should not be used together, however, because they may not
both stay in place.

According to an FDA advisory committee panel that met Nov. 22, 1996,
over-the-counter spermicides, such as nonoxynol-9, can help reduce the
risk of chlamydia and gonorrhea transmission. The panel had concerns,
however, about the possibility that tissue irritation from spermicides
may increase susceptibility to HIV and other STDs.

As stated in their labeling, birth control pills, Norplant,
Depo-Provera, IUDs, and lambskin condoms do not protect against STD
infection. For STD protection, a male latex condom can be used in
combination with any of these methods. The relationship of the vaginal
barrier methods--the diaphragm, cap and sponge--to STD prevention is not
yet clear.


--T.N. 


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


Inside FDA:
Center for Food Safety and Applied Nutrition

by Paula Kurtzweil 

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

Olestra garnered headline news when the Food and Drug Administration
approved it in 1996, but the agency component that approved the fat
substitute may not be well known to many consumers.

This agency component, the Center for Food Safety and Applied Nutrition
(CFSAN), regulates $240 billion worth of domestic food, $15 billion
worth of imported foods, and $15 billion worth of cosmetics sold across
state lines. This regulation takes place from the products' point of
U.S. entry or processing to their point of sale.

CFSAN is one of six centers within FDA. With a work force of about 800,
the center promotes and protects the public health and economic interest
by ensuring that:

 * Food is safe, nutritious and wholesome, and cosmetics are safe.

 * Food and cosmetics are honestly, accurately and informatively labeled.

To achieve these goals, the center strives to be a leader in food
safety, protect consumers from economic fraud, promote sound nutrition,
and encourage innovation.

Recent center activities demonstrate the center's commitment. For
example, in approving olestra as the first synthetic fat-based fat
substitute, the center's scientific staff evaluated more than 150
studies on olestra's safety. Concerned about olestra's potential ability
to reduce nutrient absorption in the body, the center approved olestra
on the conditions that vitamins A, D, E, and K be added to
olestra-containing foods and that a statement appear on such foods to
inform consumers of possible nutrient losses and thus the reason for the
addition of the fat-soluble vitamins. The center also requires the
statement to warn consumers about the possible side effects of abdominal
cramping and loose stools.

A Sampling of Highlights 

Examples of other more recent center actions include:

 * revamping food labels to make it easier for consumers to get
   nutrition information about the foods they eat

 * approving certain health claims supported by scientific evidence
   showing a link between a food or nutrient and a disease or health
   condition. These health claims can be used in food labeling.

 * requiring warning labels on iron-containing drugs and dietary
   supplements and individual-dose packaging for products with 30
   milligrams or more of iron per unit to protect children from
   accidental iron pois ng, a leading cause of death in children under 6

 * establishing new regulations based on modern food safety techniques
   to improve seafood safety

 * issuing regulations calling for folic acid fortification of enriched
   grain products by 1998 to reduce the chances of certain birth defects
   in infants

 * signing an agreement with the University of Maryland to form the
   Joint Institute for Food Safety and Applied Nutrition, paving the way
   for both organizations to pool specialized knowledge, equipment and
   facilities.

Behind the Scenes 

Employees ranging from secretaries and other support staff to highly
specialized professionals--such as chemists, microbiologists,
toxicologists, food technologists, pathologists, pharmacologists,
nutritionists, epidemiologists, mathematicians, and sanitarians--carry
out the center's mission.

The center is divided into seven offices dealing with:

 * cosmetics and colors
 * food labeling
 * plant and dairy foods and beverages
 * premarket approval
 * special nutritionals, such as dietary supplements and infant formula
 * special research skills and support.

Other center offices deal with consumers, industry and other outside
groups; field programs; agency administrative tasks; scientific analysis
and support; and policy, planning and handling of critical foods'
issues.

Most center staff members work out of the center's headquarters in
Washington, D.C. The center also operates research facilities in Laurel,
Md., and a fisheries research center in Dauphin Island, Ala., and helps
staff the National Center for Food Safety and Technology in the Chicago
area. Next summer, according to Arnold Borsetti, Ph.D., director of the
center's executive operations staff, the center plans to move its
molecular biology and seafood safety research laboratories from
Davisville, R.I., to Baltimore, Md., where it will share space with the
Maryland Center for Marine Biotechnology.

In Touch with Others 

Much of the information evaluated by center personnel is gathered by FDA
employees across the country. For example, FDA field investigators
inspect food and cosmetic companies, examine food shipments from abroad,
and collect samples. Laboratory scientists and technicians analyze
samples. Compliance officers recommend legal action and follow through
on enforcement issues.

Center personnel also work with other government agencies, such as the
Centers for Disease Control and Prevention and state health departments,
to resolve food safety concerns and economic fraud cases, for example.

Borsetti said the center is increasingly being called on to work with
international organizations, such as the Codex Alimentarius
Commission--an international food standard-setting organization of the
Food and Agriculture Organization and World Health Organization--and
foreign governments, to help establish internationally recognized safety
standards, rules and regulations for imported foods.

"In the past, most of the center's efforts dealt with U.S. products," he
said. "But that's changing as a result of recent international treaties.
Now, more and more food is traveling in international circles."

That trend will likely continue, he said, consuming much of the center's
future focus.

Future Considerations 

Other areas that will increasingly draw the center's attention are:

 * Foods derived from genetic engineering. The first of these on the
   market, the Flavr Savr tomato, can be shipped vine-ripened, thus
   improving texture and flavor. Future possibilities include
   insect-resistant apples, long-lasting raspberries, and potatoes that
   absorb less fat.

 * New packaging materials. These include recycled products and those
   that prolong shelf life.

 * The hazard analysis critical control point (HACCP) food safety
   system. HACCP is considered more effective than the current system
   because focuses on preventing problems rather than reacting to them
   after they've occurred. FDA is considering whether to make HACCP
   mandatory for all of the food industry it regulates.

 * Food adulteration for economic gain. Citing technology as the reason,
   Michael McLaughlin, Ph.D., project manager for food carbohydrates and
   economic adulteration in the Center for Food Safety and Applied
   Nutrition, said: "People are coming up with new adulterants
   constantly. We have to remain vigilant in order to stop these
   violations."

 * Reconsidering the review process for new food additives. Borsetti
   said the center is eyeing several proposals to see how to increase
   the pace of its review of new food additives without jeopardizing
   public safety.

Considering that almost 20 cents of every consumer dollar Americans
spend goes to food and cosmetics, these and other concerns for the
Center for Food Safety and Applied Nutrition eventually come to rest
with American consumers. Center dealings that make news one day, such as
the approval of olestra, usually make it to the marketplace another.

Computer users can keep up-to-date on CFSAN activities on the World Wide
Web at http://vm.cfsan.fda.gov/list.html.

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

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

Center Director

The Center for Food Safety and Applied Nutrition is headed by Fred
Shank, Ph.D., a nutritionist with a broad interest in food processing,
quality and safety; human nutrition; and consumer food practices.

A Ph.D. graduate of the University of Maryland, he joined the center in
1978, after spending seven years as a nutritionist with the U.S.
Department of Agriculture. He has held several positions in the center,
including deputy director of the division of nutrition and director of
the Office of Physical Sciences. He was named center director in 1989.

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


April 1997

Dear FDA Consumer Readers:

For many years, FDA Consumer has been published every month, except for
combined issues for July-August and January-February. Budget
constraints, however, prevent us from maintaining this publication
frequency. So, starting next month, FDA Consumer will be published every
other month.

The change to bimonthly publication will actually have some benefits.
First, the cost of a yearly subscription will drop from $15 to $10 (from
$18.75 to $12.50 for subscribers in foreign countries). And second, each
bimonthly issue will be bigger than before with more of the kinds of
information you've come to expect from FDA Consumer. We will continue to
focus on topics related to FDA-regulated products, including food
safety, nutrition, prescription and over-the-counter medicines, medical
technology, cosmetics, and all the other products and services that fall
under FDA's jurisdiction and come into your life every day. And, we will
continue to give you a behind-the-scenes look at how FDA uncovers
fraudulent and illegal activities through our popular "Investigators'
Reports" section.

We are confident that FDA Consumer will retain--if not improve on--the
high quality and esteem it has held for many years.

Despite the change, current subscribers will still receive their
full-year's subscription.

We welcome your comments. Please write to: FDA Consumer Editor, Food and
Drug Administration (HFI-40), 5600 Fishers Lane, Rockville, MD 20857.

Sincerely yours,

Paula Kurtzweil
Acting Editor, FDA Consumer

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


Updates

Plan Will Give Consumers Better Prescription Drug Info

A new public-private plan for giving patients useful, easy-to-read
information about their prescription drugs aims to help consumers better
understand their medicines and reduce the medicine misuses that yearly
lead to thousands of hospitalizations.

The voluntary plan calls for the information to reach 75 percent of
patients by the year 2000 and virtually all patients (95 percent) by
2006.

It parallels requirements of a 1995 FDA proposal for medication guides
that would be easily understood, non-promotional in tone and content,
and scientifically accurate. (See "FDA's Rx for Better Medication
Information" in the November 1995 FDA Consumer.) Following publication
of the proposal, Congress directed HHS Secretary Donna E. Shalala to
convene a committee of diverse interest groups to develop a long-range,
voluntary plan to improve oral and written communication to patients
about their prescription medicines.

The plan fulfills the congressional mandate by:

 * encouraging health-care professionals to communicate better with
   patients about prescription medicines

 * ensuring that voluntary efforts meet the distribution targets for the
   years 2000 and 2006

 * establishing criteria for developing useful written drug information
   for patients

 * encouraging activities to increase patients' understanding of the
   benefits of the information

 * providing periodic evaluation of the voluntary program

 * promoting consistency with relevant state board regulations.

A 34-member steering committee developed the Action Plan for the
Provision of Useful Prescription Medicine Information with assistance
from The Keystone Center, a nationally recognized, nonprofit
organization for mediating public policy. The steering committee
represents the pharmaceutical industry, pharmacists, doctors, consumer
and patient advocacy groups, patient drug information database
companies, and other interested groups.

In accepting the plan in a Jan. 13 letter to Keystone, Secretary Shalala
said the information provided to patients will cover all uses that FDA
has approved for a medicine. In addition, she said, doctors and
pharmacists may provide any further needed information about "off-label"
use, provided they customize the information for each patient.
Information can therefore be made available about uses that generally
lack the strong scientific base required for FDA approval but are deemed
appropriate by the prescriber or dispenser. She said she would continue
to evaluate progress by the private sector in meeting the plan's goals
and welcomed similar monitoring by industry and consumer groups.

Drug, Biologic Approvals Up, Review Times Down

A record-setting 139 drugs and biological products were approved by FDA
in 1996--an increase of 63 percent over the number approved in 1995.

FDA attributed the increase to the Prescription Drug User Fee Act
five-year program, in which the agency uses fees paid by manufacturers
to shorten drug review and approval times. Median approval times in 1996
were 15.4 months for drugs and 14.9 months for biologics, down from 16.5
months and 17.6 months, respectively, in 1995.

Fifty-three of the drugs approved were new molecular entities. They
included three drugs for HIV (the virus that causes AIDS), two for
cancer, and one each for asthma, Alzheimer's disease, and multiple
sclerosis.

Eight of the licensed biological products were first-time entities.
Major biological products licensed in 1996 included Respigam, the first
medication to protect infants against serious respiratory syncytial
virus disease; Avonex, the second interferon product for multiple
sclerosis; and Verluma, a diagnostic imaging agent for determining at
one time the extent of small cell lung cancer in different parts of the
body. Also of note were five new HIV test kits.

New Health Claims Approved for Whole-Oat Products

The claims that foods with soluble fiber from whole oats may reduce
heart disease risk when eaten as part of a diet low in saturated fat and
cholesterol is now allowed under an FDA final rule. Foods covered by the
action include rolled oats, oat bran, and whole-oat flour.

FDA concluded that the beta-glucan soluble fiber of whole oats is the
primary component responsible for lowering total and LDL (low-density
lipoprotein), or "bad," blood cholesterol in diets including these foods
at appropriate levels. This conclusion is based on a scientific review
showing a link between the soluble fiber in whole-oat foods and a
reduction in coronary heart disease risk.

To qualify for the claim, whole-oat foods must provide at least 0.75
grams of soluble fiber per serving. About 3 grams of soluble fiber is
needed daily for an effect on cholesterol levels.

The whole-oat claims must include the words "diets low in saturated fat
and cholesterol" because consumers might otherwise think that eating a
diet high in oats is all that is needed to reduce heart disease risk.

FDA acknowledges that other sources of beta-glucan soluble fiber and
other types of soluble fiber may have similar effects on cholesterol
levels. But the agency is awaiting evidence before judging these
effects. 

FDA regulates health claims on food labels to ensure that claims are
accurate and don't mislead consumers. The agency requires a "significant
scientific agreement" on claims before allowing them. (See "Look for
'Legit' Health Claims on Foods" in the FDA Consumer special report Focus
on Food Labeling.)

More details on the final rule are in the Jan. 23, 1997, Federal
Register.

Test for Home Use Detects Drugs of Abuse

A home test system for drugs of abuse--such as marijuana, heroin and
cocaine--will be available in drugstores, pharmacies, and other places
selling over-the-counter medical products.

Earlier this year, FDA cleared Dr. Brown's Home Drug Testing System, the
first nonprescription test system for detecting marijuana, PCP,
amphetamines, cocaine, heroin, codeine, and morphine in urine. Results
are available anonymously by identification number.

"The approval of this test gives parents another option to consider to
help ensure that their children remain drug-free," said Health and Human
Services Secretary Donna E. Shalala.

The system includes a kit to collect and mail a urine sample. Directions
for use and for obtaining and interpreting results are also provided.
The user labels the urine sample with an identification number provided
in the kit and sends it to a specified government-certified laboratory
for analysis. The laboratory evaluates the sample for possible
tampering, tests it for drugs of abuse, does a confirmation test to
minimize false positive readings, and then forwards the results by
computer to the manufacturer's results center.

To obtain the results, which are available one to three days after the
lab receives the urine sample, the user calls a toll-free phone number
and provides the sample identification number. In addition to learning
whether the test showed the presence of drugs, the user receives
information explaining the results and the potential for erroneous
results. If needed or requested, referrals are offered for drug abuse
counseling and medical assistance.

A positive result indicates the presence of one or more of the drugs in
amounts sufficient for detection. Some medicines and, rarely, certain
foods can cause a false positive reading. A negative result indicates
the absence of drugs, or an insufficient quantity to be detected. A
result may be falsely negative if too much time has elapsed between
exposure to the substance and urine collection. In rare cases, it is
also possible that technical or procedural errors in the lab could
interfere with test results. Therefore, both FDA and the test
manufacturer recommend that test users who receive a positive result, as
well as others who have questions about their results, consult a
physician for follow-up evaluation.

Dr. Brown's Home Drug Testing System is manufactured by Personal Health
and Hygiene Inc., Silver Spring, Md. FDA cleared the test system Jan.
21, and the company expected to start marketing it in March.


Rule to Protect Children From Iron Poisoning

Efforts to protect children from accidental iron poisoning are getting a
boost from a new FDA rule.

Beginning July 15, when the rule will take effect, labels on all drugs
and dietary supplements that contain iron or iron salts will have to
display prominently and conspicuously this boxed warning:

"WARNING: Accidental overdose of iron-containing products is a leading
cause of fatal poisoning in children under six. Keep this product out of
reach of children. In case of accidental overdose, call a doctor or
poison control center immediately."

In addition, products containing 30 milligrams (mg) or more of iron per
dosage unit, such as most iron pills for pregnant women, will have to be
packaged as individual doses--for example, in blister packages. This is
to limit the number of pills or capsules a small child could
accidentally consume once the package is opened.

FDA published the final rule in the Jan. 15, 1997, Federal Register.

Accidental overdose of iron pills is a leading cause of poisoning deaths
among young children. Since 1986, more than 110,000 incidents of iron
ingestion by children have been reported, and 35 children have died.

Under U.S. Consumer Product Safety Commission regulations, most drugs
and food supplements with more than 250 mg of iron per container must
have child-resistant packaging. However, in some poisoning cases, young
children had been left unattended in the presence of uncapped
containers. FDA and a consensus of public health officials and industry
groups hope that the additional safeguards, together with greater public
awareness of the problem, will reduce the incidence and severity of iron
poisonings in children.

New Type II Diabetes Drug May Reduce Insulin Needs

The first in a new class of drugs to treat the most common form of
diabetes could reduce or eliminate the need for insulin in as many as 1
million patients.

Rezulin (troglitazone) reduces the body's resistance to insulin, an
important underlying cause of adult-onset diabetes. In two clinical
studies of more than 500 patients, the drug significantly improved the
body's ability to use insulin in managing diabetes.

FDA approved Rezulin only for patients already taking insulin shots for
adult-onset diabetes, also called Type II diabetes or
non-insulin-dependent diabetes mellitus. The drug should be prescribed
with caution in patients with advanced heart failure or liver disease.
And, as with other drugs for diabetes, patients should maintain an
appropriate weight and follow a careful diet.

FDA's Jan. 29 approval of Rezulin followed a unanimous recommendation by
FDA's Endocrinologic and Metabolic Drugs Advisory Committee and came
within six months of submission of the new drug application.

Parke-Davis, a division of Warner Lambert, Morris Plains, N.J., will
market Rezulin. Under a business agreement between Warner-Lambert and
Sankyo USA, New York City, the drug may also be marketed under the trade
name Prelay.

(See also "Probing the Pancreas" in the October 1996 FDA Consumer, "The
New Food Label: Coping with Diabetes" in the November 1994 issue, and
"Improving Blood Glucose Monitoring for Diabetes" in the May 1990
issue.)

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

Consumer Forum

Health Fraud Leader Speaks Out on Homeopathy

Isadora Stehlin's article on homeopathy ["Homeopathy: Real Medicine or
Empty Promises?" December 1996] was useful in that it reveals that there
is no level playing field for those who market medicines. Homeopathy is
a fraud perpetrated on the public with the government's blessing, thanks
to the abuse of political power of Sen. Royal Copeland [chief sponsor of
the 1938 Food, Drug, and Cosmetic Act].

There are at least six reasons why users may say homeopathic remedies
work:

1.The placebo effect. This was inadequately dealt with by Stehlin and
obviously misunderstood by Jennifer Jacobs, M.D. [a family physician
with a license to practice homeopathy]. Placebo responses are due to
more than just pep talks. Belief in a substance is only one mechanism of
placebo action. Suggestibility and conditioning are among some others.
Animals are subject to both. Recall Pavlov's classical experiments.
Animals also respond well to attention by humans. Further, whether the
animal is better or not is determined by humans observing the creature,
not objective reporting by the animals.

2.Natural ups and downs of symptoms or natural remission. The person (or
animal) would have gotten better anyhow through natural healing
processes. Such responses can be long term and are unpredictable.

3.The remedy contains an effective dose of real medicine. There is no
way of interpreting the labels of homeopathic products because active
ingredients are not quantified. There have been reports of toxicity from
homeopathic products. Most products are not 24X dilutions.

4.Adulteration. Remedies may be spiked with real medicines or stimulants
not named on their labels. These may work effectively or produce a "Dr.
Feelgood" response.

5.Denial of discomfort. For true believers, homeopathy is a religion.
Homeopathic vitalism validates the existence of soul for many. Such
believers are delusional and see only what they want to see.

6.Liars, with a financial interest in selling the products or with a
self-interest in selling a good story.

The National Council Against Health Fraud believes that all medicines
should comply with standards American consumers have a right to expect:

1.interpretable labels

2.premarketing proof of safety

3.premarketing proof of efficacy

4.good manufacturing standards that guarantee product quality

5.effective tracking to uncover unanticipated adverse effects

6.truthful advertising.

Let's have a level playing field.

William Jarvis, Ph.D.
President, National Council Against Health Fraud Inc.
Professor of Public Health and Preventive Medicine
Loma Linda University Schools of Public Health and Medicine


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

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.

Women with bladder control problems should know that these disorders are
treatable, says a new campaign from the National Institutes of Health.
The campaign emphasizes that many women may not be aware that treatments
ranging from pelvic floor exercises to surgery can improve the
condition.

About 11 million of the 13 million Americans with urinary incontinence
are women. The condition can have a major effect on the social and
economic well-being of people trying to cope without treatment. Some
elderly people become reclusive or are institutionalized unnecessarily
because of incontinence.

The "Let's Talk About Bladder Control for Women" campaign offers
consumer kits designed to encourage communication between women and
their health-care providers. The materials are available free by calling
(1-800) 891-5388. They are also available at http://www.niddk.nih.gov/
on the World Wide Web.

------------------------------------------------------------------------
Survival rates for organ transplant recipients are increasing. But the
number of people waiting for a transplant--a record 50,000--is triple
that of just seven years ago, according to the United Network for Organ
Sharing (UNOS).

In its annual report, UNOS states that survival rates for some types of
transplants are rising dramatically. For example, the one-year survival
rate for a lung transplant patient in 1994 was 76 percent, up from 47
percent in 1988. Five-year survival rates ranged from 81 percent for
kidney recipients to 41 percent for heart-and-lung recipients.

The bad news is that the number of patients waiting for organs is rising
much faster than organs can be made available. As a result, transplant
candidates now wait longer. Some die while waiting, which underscores
the need for more donors, says the report.

A free booklet summarizing transplant trends and statistics is available
by calling (804) 327-1432. The UNOS annual report is on the World Wide
Web at http://www.ew3.att.net/unos/.

------------------------------------------------------------------------
Preventing out-of-wedlock teen pregnancies and encouraging adolescents
to remain abstinent are new goals of the Health and Human Services
Department's teen pregnancy prevention programs. 

These programs already reach at least 30 percent of U.S. communities.
HHS now aims to ensure that all communities work to prevent
out-of-wedlock pregnancies. The new goals emphasize parental and adult
involvement and personal responsibility. They place special emphasis on
encouraging abstinence, especially among 9- to 14-year-old girls,
through a campaign called "Girl Power!" Information about the campaign
can be found at http://www.health.org/gpower/index.htm on the World Wide
Web.

------------------------------------------------------------------------
Endodontic dry heat sterilizers for sanitizing dental instruments may no
longer be marketed unless the manufacturer or importer files with FDA a
premarket approval application or notice of product development protocol
completion, according to an FDA final rule. An FDA advisory panel had
earlier recommended that FDA take this action after it concluded that
the devices fail to sterilize instruments adequately. The devices
present "an unreasonable risk of illness or injury," the panel warned.
(FR Jan. 21)

------------------------------------------------------------------------
Cobalt-60 radiation to control Salmonella bacteria in poultry feed"is
safe" in specified doses, says FDA, reiterating an earlier ruling. In a
final rule, the agency denied four requests for a hearing on objections
to FDA's original approval of the cobalt treatment in 1992. The agency
said the objections "do not raise issues of material fact ... ." (FR
Jan. 6)
------------------------------------------------------------------------


Investigators' Reports

Sticking Public with Impure Products
Puts Syrup Makers in Prison

by Paula Kurtzweil 

Federal and state regulators hope that prison sentences stemming from an
FDA criminal investigation have finally put a plug in a lucrative but
fraudulent decades-old Mississippi honey- and syrup-making business.

The prison sentences--as much as two and a half years for one man--are
the stiffest ever imposed on a company or individual for violations
based solely on the Federal Food, Drug, and Cosmetic Act.

For almost a quarter of a century, the family-run business in rural
DeKalb, Miss., touted its products as the real thing and sold them in
old-fashioned copper-colored tins at farmers' markets and produce stands
around the country. The marketing technique may have charmed consumers
with its homeyness, but, as regulators repeatedly found, these products
were nothing more than a homespun hoax.

Labeled as pure honey and pure maple, cane and sorghum syrups, the
products were in fact made with low-cost sweeteners--mainly corn syrups.

Despite countless federal and state warnings, injunctions, embargoes,
and other attempts to stop the illegal practice, it continued. But the
most recent court action--prison sentences and a lifetime ban on syrup
and honey making for two of the most flagrant violators--may finally
help convince the family to reform their business practices.

Serving time--19 months and 30 months respectively--are brothers J.H.
Pilgrim, 52, who did business under his own name, and Paul Pilgrim, 64,
proprietor of Paul Pilgrim Syrup Co. They were sentenced in October
after pleading guilty to selling adulterated honey and syrup. In
addition to prison and the manufacturing ban, Chief Judge William
Barbour of the U.S. District Court for the Southern District of
Mississippi fined the men $20,000 each and sentenced them to one-year
supervised probation.

"For 20-plus years, this family has arrogantly ignored the agency's
authority and adamantly refused to comply with the law of the land,"
said James Blakely, an investigator with FDA's Jackson (Miss.) resident
post who has been involved with investigations of the Pilgrim family
since 1978. "They would just snub their noses at the government."

"We had to make an example of these guys," he said, referring to J.H.
and Paul Pilgrim.

Although made under crude conditions--in plywood buildings, where boat
paddles were used for stirring and tube socks for straining--the
products never posed a significant health hazard. "This was an economic
problem," Blakely said. 

The outcome of the first prosecution of a Pilgrim family member,
initiated by FDA in the late 1980s, had little effect on the rest of the
family's business activities. In that case, family patriarch Nathan H.
Pilgrim pleaded guilty in April 1990 to four felony counts of
misbranding honey and syrup. He was fined $130,000 and served three
years' probation. To the best of FDA's knowledge, he no longer is in the
honey and syrup business.

Following the sentencing, however, FDA continued to receive complaints
from industry and consumers about Pilgrim products. Industry complained
that the products were priced so low that legitimate companies could not
compete, and some were forced out of business. FDA estimated that the
Pilgrims' illegal activities enabled them to undercut costs of
legitimate honey and syrup makers by as much as 85 percent.

Consumers complained about the products' taste. Blakely recalled one
call he received from a consumer who made and sold maple cookies. She
used a Pilgrim "pure" maple syrup in a batch of cookies, but the final
product didn't taste anything like her usual cookies. "She like had a
duck," Blakely said. "She was extremely upset that her recipe and
possibly her reputation were being compromised by this substituted
product."


Regulatory actions continued. For example:


 * The state of North Carolina, in cooperation with FDA, embargoed in
   1993 two lots of honey and one lot of molasses made by H.W. Pilgrim,
   another family member. The products contained corn syrup, a sugar not
   found in pure honey or molasses. As allowed under North Carolina law,
   Pilgrim reclaimed his embargoed products and said he would bring them
   into compliance by relabeling them.

 * The state of Florida notified family members in 1994 that their
   products were illegal, and any further attempt to sell, distr te and
   make adulterated food in Florida would result in a fine of up to
   $3,000. Laboratory analyses indicated that Pilgrim products sold in
   state did not contain pure substances as indicated on the label.

 * At the request of FDA's Seattle district office, U.S. marshals seized
   $15,000 worth of Pilgrim syrup targeted for export to Austria. The
   Austrian government had rejected the shipment because laboratory
   analysis of samples indicated the entire load was adulterated and
   misbranded with corn syrup. Exporter F rank Schenk von Stauffenburg
   of Trans World Trade in Bothell, Wash., complained to FDA.

That same month, FDA's Office of Criminal Investigations and New Orleans
district office began a criminal investigation of J.H. and Paul Pilgrim
because previously gathered evidence indicated their businesses were the
family's most active.

Early in October, FDA learned from the credit manager of Cargill Corn
Milling in Memphis, Tenn., that within the two previous days, the
company had delivered 21.6 metric tons (48,000 pounds) of corn syrup to
J.H. Pilgrim and 18 metric tons (40,000 pounds) to Paul Pilgrim.

In October, FDA executed a search warrant of the premises of both
brothers' businesses, seizing business records, labels, flavorings, and
$5,000 worth of syrups and honey. In addition, FDA investigators around
the country collected samples of Pilgrim products in their areas for
laboratory analyses. Investigators also took testimony from experts in
the syrup industry and scores of state officials.

Laboratory analyses, testimony, and business records indicated the
brothers substituted primarily corn syrup for pure ingredients and
distributed the bogus products coast to coast. "They seemed to be
everywhere," said FDA Special Agent David Bodge, who participated in the
investigation. "They had a long list of customers."

Business records indicated that between 1993 and 1995, J.H. Pilgrim sold
about $750,000 worth of adulterated and misbranded syrup and honey,
making a net profit of about $300,000. During that same period, Paul
Pilgrim sold about $440,000 worth of illegal products, earning about
$204,000.

The two men were charged in 10-count indictments in February 1996. At
their arraignment on March 5, FDA's Blakely recalled that U.S.
Magistrate Judge Alfred Nichols told the brothers that as of that date,
they were not to sell any more illegal syrup products and that if any of
their illegal products were found on the market, he would revoke their
bond. He also told them that it was his opinion that FDA intended to put
the brothers out of business and that as far as he was concerned, they
were out of business as of that date.

However, in a conversation with a confidential informant on March 8,
FDA's Blakely learned that Paul Pilgrim was manufacturing syrup labeled
as pure sorghum. The informant pointed out to Blakely that Pilgrim was
making sorghum syrup at a time of year when sorghum is in very short
supply. The plant is harvested in the United States in October, and
Blakely recalled learning earlier in the investigation that small
producers usually use up their sorghum supply quickly. Also, the Sorghum
Producers Association had told him that its members will not sell
sorghum to Paul Pilgrim.

The informant also told Blakely that Paul Pilgrim's son, Douglas
Pilgrim, 40, planned to deliver a truckload of sorghum syrup to Alabama,
Texas or New Mexico, within the next few days.

Blakely, Special Agent Bodge, and Mississippi state investigators
executed a search warrant of Paul Pilgrim's residence on March 12. In
the back of a truck parked on the premises, they found 150 cases of
product labeled "Country Made" pure sorghum and pure cane syrups. The
labels on the cases were the same as those previously used by Paul
Pilgrim with one exception: The manufacturer was now listed as Douglas
Pilgrim instead of "Paul's Sorghum House" and "Paul Pilgrim & Son." The
investigators collected samples for laboratory analyses.

Within a few days, the investigators contacted Millhouse Printing of
Decatur, Miss., the company that had printed the labels. FDA learned
that both Paul and Douglas Pilgrim had ordered new labels on or about
March 8. The printer told the investigators that Paul Pilgrim had asked
for a label imprinted with "Douglas Pilgrim" so that it could be laid
over the existing manufacturer's name. Douglas Pilgrim picked up the new
labels on March 11.

Laboratory analyses of the samples of sorghum and cane syrups again
showed the products were adulterated and misbranded.

When presented with this information in April 1996, Judge Nichols
immediately revoked Paul Pilgrim's bond and ordered him jailed until
sentencing. According to Blakely, the bond revocation followed by
immediate jailing is the first of its kind in FDA food case history.

J.H. and Paul Pilgrim pleaded guilty to four and three counts
respectively of their 10-count indictments. J.H. Pilgrim was sentenced
Oct. 3 nd Paul Pilgrim Oct. 22.

They are banned from participating in honey and syrup
manufacturing--either directly or indirectly through family members--for
the rest of their lives. Meanwhile, they remain incarcerated in federal
prison.

"We got the impression early in the investigation that they thought FDA
was never going to get them," FDA's Bodge said. "I think they were
surprised at FDA's involvement. Jail was the furthest thought from their
minds."

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

   ___________________________________

  IMPORTER, EXECUTIVES CONVICTED
  OF SELLING SUBSTANDARD SHRIMP

     A St. Petersburg, Fla., corporation and three of its executives were
convicted of felonies and misdemeanors related to selling about $4.5 million
worth of decomposed shrimp. Much of the tainted seafood ended up in
supermarkets and restaurant chains, but it was not possible to determine if
consumers got sick from eating the shrimp.

     A federal jury in the U.S. District Court for the Middle District of
Florida returned guilty verdicts Oct. 18 against Sigma International Inc.;
its vice president, William Andrew Walton, 47; plant manager Charles
Sternisha, 64; and head salesman, international division, Robert Fields, 34;
on a variety of federal crimes involving FDA and U.S. Customs fraud. They
were found guilty of conspiring to import shrimp from India using false entry
documents and false labeling to avoid compulsory product testing, of
obstructing justice, and of adulterating and selling tainted shrimp.

     Two other indicted defendants, Yaw Bin "Tony" Huang, owner of Sigma, and
Geogy Kannikal, Sigma's purchase agent in India, remain fugitives in India
and east Asia. A sixth defendant, Jagadeesh Reddy, was acquitted of charges
against him.

     During a 10-week trial, the government proved that Sigma had chemically
treated the decomposed Chinese shrimp with a solution of chlorine and copper
sulfate and then, with some success, passed it off to customers as "fresh
frozen." It also showed that the firm imported frozen shrimp from unapproved
packers in India. FDA places shipments from unapproved manufacturers on
automatic detention, prohibiting the shipments' entry into the country until
the shipper or importer proves the product meets FDA standards. Sigma used
false invoices with the names of approved packers to avoid detention.

     For three years, FDA's Office of Criminal Investigations (OCI) and the
U.S. Customs Service collected evidence to bring the defendants to trial.
"Chemists and experts in the shrimp business were flown in from India and
England to testify for the government," said OCI agent Rande Matteson. He
noted that Sigma spent more than $1 million for its defense.

     The investigation was prompted by a routine FDA inspection of imported
shrimp in Tampa, Fla., in October 1991. Norman Harvey, an investigator with
FDA's Tampa resident post, noticed that the labels on cartons of shrimp
imported from India identifying the packer had been altered or removed. Other
cartons from the same shipment had labels from unapproved packers. Further
checking revealed that the invoice submitted for the shipment listed the name
of an approved packer. Examination of other entry documents showed
discrepancies indicating that the invoice and India's Certificate of Health
had been altered.

     Harvey then notified the Customs Service about the problem and told
inspectors that another shipment was scheduled to arrive in November. Harvey
and a Customs Service inspector examined cartons from the November shipment
and found the same kinds of discrepancies.

     "Shrimp can be purchased from unapproved packers at rock-bottom prices
and sold as legitimate product for handsome profits," Matteson explained.
FDA's review of documents later showed that Sigma had imported more than 50
shipments of shrimp with false labels over a two- to three-year period.

     The U.S. Customs Service initiated a criminal investigation, and customs
agent Robert Siberski called Matteson to enlist OCI's collaboration. In
December 1992, FDA and the Customs Service executed a search warrant of
Sigma's business premises and subpoenaed letters of credit from the Los
Angeles branch of a Taiwanese bank Sigma used to purchase its shrimp from
India. The search turned up evidence that included correspondence in which
Sigma's vice president, Walton, instructed Kannikal, the firm's purchasing
agent in India, to falsify invoices and other documents to avoid automatic
detention of the shipment. Copies of invoices in the bank's letter of credit
files showed the shrimp was processed and packed by an unapproved packer,
while the invoices Sigma submitted to FDA and the Customs Service showed the
name of an approved packer.

     In addition, Matteson said, "We found many handwritten notes by Walton
instructing Kannikal to get doctored paperwork to present to the Customs
Service and FDA showing that the shrimp came from an approved packer." At one
point, Walton sent a message to Huang, Sigma's owner, apparently warning him
that a U.S. firm in the New York-New Jersey area had been charged with
importing shrimp from unapproved packers. That message, Matteson said,
established that they both knew and were concerned that the Customs Service
and FDA scrutinized shrimp from unapproved packers.

     A review of additional records corroborated other evidence that Sigma
engaged in a dual invoicing scheme, using false invoices to fraudulently
bring the shrimp from India into the United States.

     In December 1994, Jean Peoples, a consumer safety inspector in FDA's
Tampa resident post, told Matteson that during a routine inspection of a cold
storage facility, she walked by a pallet of frozen shrimp imported by Sigma
from China and could smell it was rotten.

     "She recalled that she and investigator Harvey told Sigma officials that
they wanted to sample shrimp from those pallets," Matteson said, "and Sigma's
traffic manager became very upset." FDA collected and sampled the shrimp,
nevertheless, and laboratory results indicated the shrimp contained levels of
class 2 and 3 decomposition. "That means it's not fit for human consumption,"
Matteson said.

     The next month, a storage facility employee told Peoples that one of
Sigma's buyers had rejected shrimp Sigma imported from China because it was
rotten. Huang, Walton and Sternisha, Sigma's plant manager, decided to bring
the rejected lots stored in all of their cold storage facilities to their
plant at St. Petersburg and see if any of the shrimp could be salvaged.

     "They had so much returned shrimp that the freezers were busting at the
seams," Matteson said. "Then they hatched the idea to dump the bad shrimp
into vats containing a mix of chlorine, lemon juice, trisodium phosphate,
water, and a product containing copper sulfate." Sigma concocted this
chemical treatment to get rid of the odor and reduce the amount of indoles
(chemicals released by decomposition), he said.

     Investigators later learned that Sigma had aluminum freezer trays
custom-built so that the refrozen shrimp would fit the original cartons from
China. But they found that the frozen blocks of shrimp stuck to the aluminum,
so Huang arranged for plastic trays to be sent by air from China. They then
refroze the shrimp and repacked them in the original cartons.

     To keep its inventory straight, investigators later learned, Sigma
stamped a 7000 or 8000 series on the boxes. The 7000 series indicated
products that had been rejected by the buyer, then washed by Sigma and OK'd
for its standards. Sigma would then send the shrimp back to the same buyers
that had rejected it, as well as to others.

     "But one of the buyers had ink-stamped numbers on its boxes before it
returned them to Sigma, and the company noticed the same ink stamps on the
boxes of shrimp they got back from Sigma," Matteson said. "Company officials
questioned Sigma about the stamps and were told that only good product
salvaged from the lots was returned to them." The company accepted Sigma's
explanation and kept the shrimp.

     The 8000 series was rejected shrimp that had been treated and deemed
unacceptable by Sigma's standards. Sigma sold this product to a Virginia
Beach processor, which in turn sold it to the public.

     On Feb. 23, 1995, after obtaining a second search warrant, Matteson,
along with a team of OCI, Customs Service, and State of Florida Department of
Agriculture Food Safety agents, went to Sigma and found employees washing the
shrimp in the chemical mix. The agents also found chemicals and more than
100,000 documents indicating that Sigma had imported frozen shrimp from
unapproved packers in India, refunded money to distributors for bad shrimp,
and treated shrimp with chemicals. With additional search warrants, the
government also obtained and examined documents indicating that Sigma had
taken measures to influence witnesses in India and to create additional false
documents in an effort to obstruct the government's investigation.

     They also found computerized inventory records with notations such as
"rejected by" and the name of the company following. Matteson interviewed
officials from these companies, and when told that the shrimp they received
had been treated with chemicals or previously rejected, the officials said
that had they known, they would not have bought it.

     FDA laboratory analyses of sampled shrimp again showed high levels of
indole. At FDA's request, the State of Florida put a stop-sale notice on all
of Sigma's products.

     FDA and the Customs Service presented the evidence to a grand jury,
which indicted the corporation and the six executives in September 1995.

     In February 1996, agents Matteson and Siberski and Assistant U.S.
Attorney Michael Rubenstein went to India to interview Kannikal. However, an
injunction had been filed in India prohibiting the U.S. government from
taking depositions from Kannikal or other witnesses.

     After hiring attorneys to challenge the injunction, they finally were
able to depose one witness, P.P. Makkar. Makkar, an approved packer whose
company's name Sigma had used, attested that he had not packed the shipments
in question.

     In July, defense attorneys claimed they had a witness in India who they
wanted to depose. So, Siberski and assistant U.S. Attorney Dennis Moore
returned to India to take the deposition from the defense witness, who was a
competitor of Makkar.

     The witness attested that his company had processed and packed the
shrimp in question but that a supervisor from Makkar's company had been
present during the processing and packing, and therefore Makkar's company
name could legally be represented as the packer and processor. Indian
officials called as witnesses for the prosecution, however, dispelled the
contention that this was legal practice in their country.

     Another deception revealed at the trial related to the 8000 series of
shrimp that Sigma had rejected under its own standards, yet sold to a
processor in Virginia Beach, Va. In his opening statement for the defense,
Sigma's attorney said it was a mistake that the 8000 product got out but that
the firm got all of it back from the processor. The defense presented credit
invoices and returned checks attesting to this, and Sigma's head salesman,
Robert Fields, testified that it was all true and accurate.

     However, FDA's Matteson knew this was not true, and at his
recommendation, the prosecution arranged for the vice president of the
Virginia Beach firm to testify at the trial. He told the court that in April
1995--several months after FDA and the Customs Service had searched Sigma's
warehouse--Fields called, asking the vice president to return the product but
didn't tell him why. When the vice president told Fields he had already sold
the shrimp, Fields said to send something that looked like the original
product, and so the vice president sold back other shrimp to Sigma.

     At press time, the firm and the three executives were expected to be
sentenced in March 1997. Sigma is still in business but prohibited from
selling shrimp.

--Marian Segal


___________________________________

YM OWNER JAILED FOR GHB SALES

An Alabama man received a 2 1/2-year prison term and $2,000 fine after
pleading guilty to eight felony counts of illegally manufacturing and selling
the drug gamma hydroxy butyrate (GHB).

David "Doc" Speer, 64, is a medical doctor whose physician's license was
revoked in 1990 by the state of Alabama for abuse of prescription-writing
privileges. Evidence collected by FDA showed that Speer made GHB at his home
and sold it at Doc's Gym, a health club he owned in Hartselle, Ala.

GHB is a "synthetic steroid" that has become popular with bodybuilders
for its alleged uses in "bulking up" and building strength. It also is
prevalent at nightclubs, where it is used for its alleged hallucinogenic
qualities. At one time, health food stores and pharmacies sold GHB over
the counter as a dietary supplement. But in 1990, because GHB was found
to have serious side effects, such as nausea, uncontrolled shaking,
coma, and even death, FDA warned all distributors to take the drug off
the market or face legal action. The drug is not approved for any use.

The Speer case began in 1992, when FDA's Montgomery (Ala.) resident post
received a report from the Alabama state forensic laboratory that a
Hartselle teenager had passed out at a baseball game. The teenager's
reaction was attributed to GHB bought from Speer.

Several times between August and December 1992, FDA investigators posing
as customers bought GHB from Speer. In December 1992, under warrant,
they searched Speer's business, home, and a storage site, seizing large
quantities of GHB and the chemicals needed to make the drug, along with
business records and computer files. The evidence showed that Speer was
manufacturing GHB in his home.

A grand jury for the U.S. District Court of the Northern District of
Alabama indicted Speer in March 1996 on:

   six counts of selling GHB without adequate directions or warnings and with
   intent to defraud and mislead buyers of the drug

   one count of manufacturing a drug in an unlicensed facility

   one count of misrepresenting information on a Drug Enforcement Agency
   application for prescribing controlled substances. He claimed he was a
   licensed physician, when, in fact, his license had been revoked.

In July, Speer signed a plea agreement admitting guilt to all eight
felony counts. Before sentencing, Speer's attorney asked the court to
grant "downward departure" from sentencing guidelines because Speer
suffers from a heart condition and depression. But the Bureau of Prisons
assured the court that the federal prison system is equipped to manage
Speer's medical condition and that his ill health is no reason for him
to avoid imprisonment.

On Aug. 30, the court sentenced Speer, who began serving the prison term
right away.

--John Henkel


___________________________________

CONTAMINATION LEADS TO CONSENT DECREE

A Pennsylvania manufacturer of a biological product linked to reports of
life-threatening blood infections has agreed to stop distributing most
of its products until it can meet FDA's manufacturing standards.

     Centeon L.L.C., King of Prussia, Pa., signed a consent decree of
permanent injunction in January agreeing to stop nearly all distribution at
its Bradley, Ill., facilities until it takes corrective actions, including
hiring an outside consultant. Bradley is Centeon's only U.S. manufacturing
plant.

     FDA allowed the company to produce and distribute two products
considered essential for the public health--H.P. Acthar Gel treatment for
infant seizures and MVI-12 injectable multivitamin.

     The consent decree followed a 10-week FDA inspection in which serious
violations of federal safety and quality standards were found.

     FDA began its investigation Sept. 27, 1996, four days after Centeon
recalled one lot--about 17,000 vials--of Albuminar brand human albumin
product because it was contaminated with bacteria and linked to reports of
septicemia, a life-threatening systemic blood infection.

     On Oct. 3, FDA announced that the recall was expanded to include nine
additional lots of Albuminar and on Oct. 4 that it also included one lot of
Monoclate-P, an antihemophilic factor (Factor VIII) used to treat hemophilia
A. Vials in these lots may have been damaged during manufacture and, as a
result, could have become contaminated, the agency said. On Oct. 9, as a
further precaution, Centeon recalled all its Albuminar human albumin and
Plasma Plex plasma protein products.

FDA decided an injunction was necessary to protect the public health,
and negotiations between the agency and Centeon began in mid-December.

Under the consent decree, Centeon has agreed to stop distribution
(except for the two products) until it:

   hires an outside expert consultant to inspect the facilities, identify
   Centeon's status of compliance with federal rules, and report this to FDA

   has enough trained staff to ensure product safety
   establishes and implements a comprehensive quality control program

   develops and implements standard procedures to ensure prompt, adequate
   investigation of adverse reactions and, when necessary, prompt recall of
   products

   establishes laboratory controls to ensure that product components,
   including product containers and closures, conform to appropriate
   standards

   establishes valid testing plans

   properly cleans, maintains and operates the building and equipment,
   including having proper water, air and cleaning systems, to ensure
   products are free of microbiological contamination

   establishes and maintains records and reports to document all stages of
   production and all steps taken to correct and prevent problems.

The consent decree requires follow-up inspections by an outside expert
consultant at least once a year for four years after the first report,
required next October.

FDA will inspect Centeon to determine whether it is complying before
allowing the company to release products.

--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: Dog food, at Chicago, Ill. (N.D. Ill.); Civil Action No.
94C-1658.

CHARGED 3-17-94: While held for sale after shipment in interstate
commerce at Freight-A-Ranger, Inc., in Chicago, Ill., the article was
adulterated in that it consisted of rodent hairs, rodent excreta
pellets, and rodent-gnawed paper--402(a)(3). The article was also
adulterated in that it was held under insanitary conditions whereby it
might have become contaminated with filth--402(a)(4).

DISPOSITION: A consent decree of condemnation and destruction ordered
the article destroyed. However, the claimant turned the article into a
component of animal feed and sold it. The claimant was ordered to pay
for damages. (F.D.C. No. 66945; S. No. 94-740-806; S.J. No. 1)


PRODUCT: Olive oil, at Miami, Fla. (S.D. Fla.); Civil Action No. 96-1834
CIV-Davis.

CHARGED 7-3-96: While held for sale after shipment in interstate
commerce at Greco-Roman, Inc., in Delray Beach, Fla., the article was
adulterated in that canola oil was substituted for olive oil--402(b)(2).
The article was misbranded in that the name on its labeling was false
and misleading--403(a)(1).

DISPOSITION: A consent decree of condemnation and destruction ordered
the article destroyed. (F.D.C. No. 67144; S. No. 96-683-103; S.J. No. 2)



PRODUCT: Rice, enriched, at Beltsville, Md. (D. Md.); Civil Action No.
WMN-95-4022.

CHARGED 12-29-95: While held for sale after shipment in interstate
commerce at Chung Wah Noodle Company in Beltsville, Md., the articles
were adulterated in that they were held under insanitary conditions
whereby they might have become contaminated with filth--402(a)(4).

DISPOSITION: A consent decree of condemnation and destruction ordered
the articles destroyed. (F.D.C. No. 67121; S. No. 96-656-364; S.J. No.
3)



Drugs/Human Use

PRODUCT: Guarana, capsules, at Albany, Ga. (M.D. Ga.); Civil Action No.
93-56-ALB-AMER.

CHARGED 5-13-93: While held for sale after shipment in interstate
commerce at Bill's Wholesale Warehouse, Inc., in Albany, Ga., the
articles were adulterated in that they were new drugs without an
approved application--505(a). The articles were misbranded in that their
labeling failed to bear adequate directions for use--502(f)(1).

DISPOSITION: The articles were destroyed. (F.D.C. No. 66699; S. No.
93-700-038; S.J. No. 4)


PRODUCT: Oxygen, at Monroe, La. (W.D. La.); Civil Action No. CV95-1349.

CHARGED 7-28-95: While held for sale after shipment in interstate
commerce at Greene Welding Supply, Inc., in Monroe, La., 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). The articles were misbranded in that their
labeling failed to bear a warning statement--503(b)(4).

DISPOSITION: The articles were reconditioned. (F.D.C. No. 67139; S. No.
96-763-219; S.J. No. 5)



Medical Devices

PRODUCT: Intraocular lenses, at Largo, Fla. (M.D. Fla.); Civil Action
No. 93-2009-Civ-T-24A.

CHARGED 12-17-93: While held for sale after shipment in interstate
commerce at IOL International, Inc., in Largo, Fla., the articles were
adulterated in that they were classified as 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). The
articles were misbranded in that the labeling falsely represented they
were investigational devices--502(a).

DISPOSITION: The articles were destroyed. (F.D.C. No. 66768; S. No.
93-682-750; S.J. No. 6)


PRODUCT: Source plasma, at Abbott Park, Ill. (N.D. Ill.); Civil Action
No. 94C 1219.

CHARGED 2-28-94: While held for sale after shipment in interstate
commerce at Abbott Laboratories Diagnostic Division in Abbott Park,
Ill., the articles were 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). The articles were misbranded in that the labeling
falsely implied that the products were licensed and suitable for use in
manufacturing when, in fact, they were not licensed or suitable for
manufacturing--502(a). The articles were also misbranded in that their
labeling failed to bear the name and location of the manufacturer and
the proper article name and other required information--502(c).

DISPOSITION: The articles were destroyed. (F.D.C. No. 66925; S. No.
94-661-765; S.J. No. 7)



PRODUCT: Sterilizing solution, at Jonesborough, Tenn. (E.D. Tenn.);
Civil Action No. CIV 2-91-416.

CHARGED 12-13-91: While held for sale after shipment in interstate
commerce at Chem-Mix, Inc., in Jonesborough, Tenn., the articles were
adulterated in that their quality differed from that which they
represented to possess--501(c). The articles were misbranded in that
they presented a danger to health when used in the dosage, manner,
frequency, or duration prescribed in their labeling--502(j). The
articles were also misbranded in that their labeling was false and
premarket notifications were not provided as required--502(a) and
502(o).

DISPOSITION: A consent decree ordered the articles destroyed. (F.D.C.
Nos. 66265 and 66263; S. No. 91-585-880; S.J. No. 8)

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


FDA Consumer magazine (April 1997)

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.

Electronic copies of FDA Consumer are available on the FDA WWW Server
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ASCII. Beginning with the July-August 1995 issue, HTML text of the
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