'LEGALIZE IT!'

(FDA Blocks Herbal Medicine)

Garlic reduces cholesterol. Ginger prevents motion sickness. Goldenseal
is an antibiotic. Why do FDA regulations prohibit labels from saying so?

If I were in the business of selling garlic, the following sentence
could land me in a heap of trouble: "Garlic reduces cholesterol."

The statement is true. But no one who sells garlic is allowed to tout
its health benefits.

Welcome to the Alice-in-Wonderland world of the Food and Drug
Administration, a topsy-turvy realm where the agency responsible for
protecting the nation's health winds up threatening it. "The FDA knows
little, if anything, about medicinal herbs," explains Varro Tyler,
Ph.D., the Lilly Distinguished Professor of Pharmacognosy (natural
product pharmacy) at Purdue University. "As far as the public health is
concerned, FDA regulations governing medicinal herbs do more harm than
good."

The above claim is no lie: Garlic does reduce cholesterol. Earlier this
year, the Journal of the Royal College of Physicians of London, a
prestigious medical journal, analyzed 16 studies to conclude that,
compared with people who took placebos, garlic users showed an average
cholesterol reduction of 12 percent. A similar review of other studies
last year in the Annals of Internal Medicine showed that eating just
one clove of garlic a day reduced cholesterol levels an average of 9
percent.

Few Americans understand garlic's value, but they should. A high
cholesterol level is a significant risk factor for heart attack, the
nation's leading killer. Heart attacks now hit 1.5 million Americans a
year. Studies suggest that garlic might help prevent up to 360,000 of
them - or 30,000 a month - an astonishing benefit for any therapy.

Garlic costs only pennies per clove. It requires no prescription, adds
zing to low-fat diets, and causes no side effects (unless you're
offended by garlic breath, in which case, another medicinal herb,
parsley, can minimize it).

Doctors increasingly recommend a low-fat diet for cholesterol control.
But instead of garlic, physicians promote prescription drugs like
cholestyramine (Questran). Cholestyramine is effective, but it costs $1
to $2 a day, requires regular professional monitoring that adds to its
cost, and may cause side effects, notably constipation, vomiting, loss
of appetite, bleeding, and vitamin deficiencies. In addition, animal
research hints that cholestyramine might accelerate tumor growth.

What we have here is a public-health no-brainer. Some people with
superelevated cholesterol levels might still need cholestyramine, but
everyone with high cholesterol should be encouraged to eat at least one
clove of garlic a day.

Unfortunately, if growers or marketers attached this information to
bags of the aromatic bulbs, the FDA could confiscate their garlic.
Ditto if they reprinted it in a pamphlet and mailed it to consumers or
supermarket produce buyers.

Why? Because under FDA regulations, using garlic to reduce cholesterol
makes the culinary herb a "drug." To the FDA, the assertion that
"garlic reduces cholesterol" constitutes a "new drug claim." The FDA
has never approved this claim, and it is a violation of FDA regulations
to make unapproved claims on drug labels or promotional materials.

U.S. drug regulations made their first modern appearance in 1906, when
"The Jungle," Upton Sinclair's indictment of the meat-packing industry,
convinced a grossed-out Congress to pass the Food and Drug Act. The law
created what is now the FDA, but it gave the agency no enforcement
authority. The Food, Drug, and Cosmetic Act of 1938 rectified that,
giving the FDA the authority to set - and enforce - drug safety
standards.

The FDA remained pretty laid-back until 1961, when about 8,000 babies
worldwide were born with flippers instead of arms and legs.
Investigators quickly found the causeathalidomide, an over-the-counter
sedative sold in several European countries. The thalidomide scandal
spurred the U.S. Congress in 1962 to direct the FDA to require safety
and effectiveness testing for new drugs.

Those standards were so rigid that they threatened not only herbs, but
also hundreds of over-the-counter (OTC) pharmaceuticals. To address
this issue, the FDA appointed panels of physicians, pharmacists, and
pharmacologists to write monographs determining if drugs already on
shelves were safe and effective. The OTC Review Panels mainly examined
data submitted by manufacturers and other concerned citizens. The OTC
monographs, which are being finalized now, incorporated hundreds of
drugs and some medicinal herbs, including the active ingredients in
many OTC laxatives (senna, psyllium seed, and cascara sagrada) and a
few decongestants (peppermint oil and eucalyptus oil). But the approved
herbs represented only a tiny fraction of the hundreds of botanical
medicines with extensive historical and clinical evidence of safety and
efficacy.

Despite America's long history of using herbs, herbalism had almost
died between the 1930s and the 1960s, the victim of antibiotics'
miraculous effectiveness. Only since the mid-1970s have Americans
become skeptical enough of high-tech pharmacology to fuel today's
modest Herbal Renaissance.

At the time of the OTC review, however, the resurrection of herbal
medicine had barely begun. The herb companies that did exist in the
1970s and early 1980s, when the review panels did most of their work,
were run by mom-and-pop herbalists who sold medicinal teas at local
health food stores. While these people knew the review was taking
place, for the most part they lacked either the money or the political
will to participate.

When they did organize, it was already too late. "We would have tried
to submit data to several OTC Review Panels," says Lynda Sadler,
president of Traditional Medicinals, an herb company in Sebastopol,
Calif. "But the public comment period was already over, and that was
that."

Having missed the review process, herbal missionaries now have to file
a new drug application (NDA). Drug companies claim the process costs
$230 million per drug approval.

The FDA contests that figure, saying that drug companies add in the
cost of testing drugs that fail the approval process. So let's assume
that the approval process costs less than half of what the drug
companies claim, say only $100 million. And let's pick garlic to push,
since persuasive studies already exist showing that garlic reduces
cholesterol; we'll assume that an herb marketer wouldn't have to
finance much, if any, new research. So the NDA process for garlic could
conceivably cost as little as 1 percent of the $100 million figure, or
$1 million, an amount a large herb company or garlic grower might be
able to afford.

Here's the catch: When a drug company wins approval for a new drug, it
also gets a patent with exclusive rights to market the drug. "But who
in their right mind would spend $1 million on a new drug application
for garlic?" asks James Duke, Ph.D., a senior botanist at the U.S.
Department of Agriculture. "They could never recoup the investment,
because they could never hold exclusive rights to an herb anyone can
grow and use themselves."

In 1990, Congress passed the Nutritional Labeling and Education Act,
allowing foods, including vitamins and herbs, to carry approved health
claims. So far, the FDA has allowed claims that fiber helps prevent
certain cancers, that calcium prevents osteoporosis, and that folic
acid helps prevent spinal birth defects.

The FDA claims to be "very open" to NLEA petitions for medicinal herbs.
But Loren Israelsen, a Utah attorney specializing in natural-product
regulation, says that the NLEA regulations make it "difficult, if not
impossible, for herbal products to win approval."

And, unfortunately, an NLEA petition poses the same sticking point as
an NDA: No herb company will pay for the approval when it can't win the
exclusive marketing rights that will allow it to recoup its investment.

Germany has a different drug-approval process, one that's considerably
more open to herbal medicines. Like the FDA, Germany requires
preapproval testing for all new synthetic pharmaceuticals. But it does
not hold herbs to so high a standard.

In 1978, the former West Germany's FDA-equivalent agency began to study
the enormous scientific literature on medicinal herbs. Over the last 15
years, the agency has published 285 monographs that Tyler calls
"probably the best information available today on [herbs]." Today, an
estimated 70 percent of German physicians routinely prescribe herbal
medicines, with their cost generally covered by German government
health insurance. At a German pharmacy, right next to brands like
Sominex and Nytol, you find OTC herbal sedatives containing valerian.

Canada has a similar process. In Canada, medicinal herbs fall under the
regulatory authority of the Health Protection Branch. In 1986,
recognizing the increasing popularity of herbal medicines, the HPB
created a new drug category, now officially termed "Traditional Herbal
Medicines." They have yet to approve many herbal claims. "But at
least," says Mark Blumenthal, executive director of the American
Botanical Council, a nonprofit that sponsors herb research, "Canada is
moving in the direction of allowing herbal medical claims."

Herbalists wish the United States would adopt a similar system. But
mention Germany, and FDA officials cringe: "Most of the thalidomide
babies were born in Germany," says FDA Public Affairs Specialist Janet
McDonald. "The Germans let drugs on the market with much less
preapproval testing than we insist on. When problems develop, as they
often do, they withdraw them."

German drug-approval standards may not be as strict as ours, but the
results have been quite similar. In fact, from 1976 through 1985, more
than half of the new prescription drugs approved by the FDA (102 of
198) were later found to cause unanticipated reactions serious enough
to warrant relabeling or withdrawal.

The current state of medicinal herb regulations leaves most U.S.
consumers confused about how herbs might help - or harm - them. In an
effort to get information, some consumers turn to medicinal herb guides
("herbals"), but many contain inaccuracies, and few mention possible
side effects or discourage use by pregnant women (see sidebar:
"Potentially Hazardous Herbs").

Others turn to health food store personnel, who may not know much - at
least according to the FDA. Last year, the agency asked staffs at 129
health food stores to recommend natural therapies for a variety of
ailments. Employees at 120 of the stores made recommendations the FDA
considered improper. But health food store personnel are not
responsible for safeguarding the public health; the FDA is. And the
main reason that health food store personnel don't know as much as they
should is that the FDA prohibits informative labeling of medicinal
herbs.

The World Health Organization estimates 80 percent of the world's
population currently use herbal medicines. More than one-third of
Americans now use non-mainstream approaches to meet at least some of
their medical needs, and the number is growing. American health care
costs have soared, and the Clinton administration has identified drug
industry profits as a significant part of the problem. Today seems like
a perfect time for the FDA to move forward into our medical past.

It's time to rethink the regulation of herbal medicines as Germany has
done and as Canada is doing. The FDA should create a "traditional
herbal medicines" category and appoint experts to draft monographs on
the effectiveness, safety, cautions, and labeling of herbs. Just as
they are free to take vitamins, Americans should be able to choose what
they take for such conditions as motion sickness, indigestion, anxiety,
insomnia, immune deficiency, and urinary tract infection.

P.S. If you have elevated cholesterol, consult a physician and reduce
the fat in your diet. In addition, eat more garlic. I have no financial
interest in any garlic product, so I can urge people to use this herb.
FDA officials may call me irresponsible in a future Letter to the
Editor, but research clearly shows that a clove of garlic a day might
help you live long enough to see this country adopt a more enlightened
policy toward traditional herbal medicines.

San Francisco-based health writer Michael Castleman is the author of
"The Healing Herbs" (Rodale, 1991), a best-selling scientific
investigation of 100 plants used in traditional herbal medicine.
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