New York Times, August 9, 1992, Front Page

        F.D.A. Steps Up Effort to Control Vitamin Claims

                        by Lena Williams

In Texas, state health inspectors raided health food stores
across the state in May and, as startled customers and bystanders
watched in amazement, removed hundreds of products, including
vitamin C, aloe vera products and herbal teas.

In Kent, Wash., armed agents of the United States Food and Drug
Administration burst into the Tahoma Clinic, where practitioners
of alternative medicine used injections of vitamins, minerals and
amino acids to treat a variety of ailments.

That raid on May 6, captured on videotape by a patient and later
broadcast on television news programs, shows F.D.A. agents,
dressed in bullet-proof vests, bursting into the clinic and
commanding clinic employees to freeze. The agency said the clinic
was raided because it made illegal drugs, including "vitamin-
mineral concoctions," that were being injected into patients.

                    Aiming at Unproven Claims

No charges have been filed in either incident, but officials at
the F.D.A. say the raids are part of the agency's increased
efforts to stop manufacturers of nutritional supplements from
making unproven claims for their products, to bar their use by
doctors unless first it is approved by the agency, and to halt
their sale as medicines.

The F.D.A. says its actions are grounded in hard science and law.
But across the country the agency's tactics have caused anger,
frustration and in some areas organized consumer rebellion.  The
interest groups fighting the F.D.A. represent the makers of
health foods and vitamins and the practitioners of so-called
alternative medicine -- some doctors as well as herbalists and

This Saturday, some of these alternative-medicine advocates will
be joined by a group of Hollywood celebrities at a news
conference in Beverly Hills to urge the public to "start
screaming at Congress and the White House not to let the F.D.A.
take our vitamins away," said Sissy Spacek, the actress.  She and
many other celebrities say they use vitamins, herbs and other
homeopathic remedies at work and at home.

The agency's actions come amid the growing phenomenon of megadose
vitamin therapy, popular among New Agers, health faddists, the
back-to-nature movement and self-styled nutritionists.  The
therapies are partly based on intriguing but unproven theories
that call for taking huge doses of vitamins, minerals and herbal
medicines to enhance health or to treat chronic ailments like

The newly aggressive policy by the F.D.A. has brought into the
legal arena the simmering battle between mainstream medical
science, which is cautious or dismissive about many of the
unconventional medical treatments. like vitamin therapy and
acupuncture, and the alternative health movement, which argues
that these treatments can be effective, whether or not they are
backed by science.

                Are Regulations An Overreaction?

The F.D.A. says it is acting under authority of the Nutrition
Labeling and Education Act, signed into law by President Bush in
1991, to provide reliable nutritional information for consumers.
But others argue that the agency is jumping the gun, enforcing
the law before the regulations are ready, and that it is
overreacting to issues consumers could sort out for themselves.
The F.D.A. proposal cannot be made final until Nov. 8, the
deadline for public comment and agency review.

Last year, the F.D.A. proposed regulations for the labeling law
that would classify vitamins and minerals as drugs if dosages
exceeded the daily recommended allowances; restrict or prevent
the sale of most medicinal herbs like camomile; prevent
unsubstantiated health claims for most dietary supplements, and
lower the recommended vitamin-intake levels for various age

"Once we set those levels, it is my belief that anything above
those levels would be considered unapproved food additives, and
it couldn't be made," said Gary Dykstra, the agency's Deputy
Commissioner for Regulatory Affairs.  "You couldn't get it by
prescription or otherwise; you'd just have to take more pills."

Under the proposal, food labels could not carry health claims
about the relationship between the food and specific disease or
health conditions, except in the cases of calcium and
osteoporosis, sodium hypertension, fat and cardiovascular
disease, and fat and cancer.  For 90 years, until 1987, a food
product with such a claim in its label was treated as a drug and
considered misbranded unless the claim was backed by an approved
drug application.  The F.D.A. under President Ronald Reagan,
prodded by arguments that food packages were a good way to
disseminate information about nutrition, began to allow such

The F.D.A., under the proposal, would have the authority to
recall or embargo products and impose fines of up to $250,000 on
individuals and $1 million on companies for each violation.

Under the proposed recommended intake levels -- which replace the
daily recommended allowances -- vitamin C could not be sold over
the counter at dosages greater than 60 milligrams, nor could the
label say "prevents the common cold."

                    38 Deaths Are a Catalyst

Officials at the F.D.A. say the regulations are needed to protect
the public against manufacturers who promote the supposed healing
powers of supplements and make phony health claims.  Some
officials say the crackdown is a direct response to the hundreds
of cases of a blood disorder and 38 deaths recently linked to a
tainted shipment of the amino acid L-tryptophan, which was widely
used as a stress reducer and to treat insomnia.

"That got us very concerned and the wheels turning," Mr. Dykstra

Overdoses of some vitamins, like A and D can be toxic, and in
1991 the deaths of 16 children under 6 years old were attributed
to accidental poisoning from iron supplements.

The F.D.A. denies that it is overstepping its legislative
authority, which requires it to insure that drugs and devices are
safe and effective for their intended uses and that all labeling
and packaging is truthful, informative and not deceptive.

"No one is proposing to take vitamins off the shelves, so no one
can buy them," said Dr. Sid Wolfe, director of Public Citizens'
Health Research Group, a health-care research and advocacy group
based in Washington that has worked closely with the F.D.A. on
its labeling proposals.  "But you shouldn't be able to make
claims that some thing works, without scientific evidence.  Right
now, we don't know what the final proposals will say because
there is a huge amount of pressure from the food industry, and
the White House and the Office of Management and Budget are
trying to weaken the proposals."

In a statement read at an F.D.A. hearing, the American Medical
Association said that it supported certain aspects of the F.D.A's
proposals, like one that would disallow health claims for
nutrients that must be taken in amounts "not ordinarily
consumable," but that it opposed the replacement of recommended
daily allowances for vitamins and minerals.

                        A Change of Heart

On June 11, Senator Orrin G. Hatch, Republican of Utah,
introduced the Health Freedom Act of 1992, which would protect
dietary supplements from being classified as drugs "solely
because the labeling or advertising for the supplement provides
information about the potency of a substance in the supplement."

The Senator, who had long been an influential supporter of the
F.D.A., said he entered the controversy after hearing from
constituents in his home state, including both consumers and
makers of dietary supplements.  "Unfortunately, some people in
the Government, including some people at the F.D.A., appear to
have unfairly treated dietary supplements and have tried to
establish unreasonable regulatory burdens on some products," he

F.D.A. officials say the Hatch bill would take away some of the
agency's enforcement powers.  "It may not prove to be the level
of safety that we believe consumers are looking for for these
products," Mr. Dykstra said.

But another bill in Congress, sponsored by Representative Henry
A. Waxman, Democrat of California, would grant to the agency what
some consumer advocates say are sweeping new powers, including
warrantless searches and electronic surveillance if there is
reason to believe that a food drug, device or cosmetic is in
violation of the regulations of the nutrition labeling act.

Combined with the F.D.A. proposals, the Waxman bill "will be an
erosion of provisions established under the 1976 Proxmire
Amendment, which specifies that the F.D.A. may not classify a
food substance as a drug solely because it exceeds the level of
potency that the F>D.A. believes is nutritionally rational or
useful," said Mike Evers, legislative co-ordinator for the
Nutritional Health Alliance, a new organization representing
25,000 vitamin makers and natural-food stores.

Mr. Dykstra described as "an over-statement" assertions that the
agency was attacking the vitamin and supplement industry.  "We
have no intention of putting the health-food industry out of
business," he said.

In letters to his colleagues, Mr. Waxman denied that his bill --
H.R. 3642 -- is "in any way specifically addressed to vitamins."
The Congressman, who is chairman of the House Subcommittee on
Health and Environment, said the legislation was intended to give
the F.D.A. the enforcement tools it needed to prevent, in the
words of a committee report, "adulterated food, substandard
medical devices and prescription drugs of dubious effectiveness
from reaching consumers."

                    Protesting F.D.A. Tactics

The F.D.A. has not prosecuted or imposed criminal penalties in
any of its raids, but that has done little to assuage the health-
store owners or Dr. Jonathan V. Wright, the founder of the Tahoma
Clinic, and his patients, who organized a protest outside the
Federal building in Seattle in June demanding that the F.D.A.
return more than $100,000 in medicines, office supplies and
equipment confiscated in the raid.

More than a dozen new groups, including the Nutritional Health
Alliance, have undertaken a protest campaign aimed at the Whit
House and Congress.  Within 24 hours, some 2,000 letters were
faxed to President Bush from consumers -- some from as far away
as London and Brazil.  Hundreds of letters have also poured into
the F.D.A.'s offices.

The Seattle Post-Intelligencer declared in a May 11 editorial,
"if there is any plausible excuse for the Gestapo-like tactics
used in a raid on a Kent alternative medicine clinic, it had
better be forthcoming and fast."

Organizers have gone door-to-door in many communities, met with
members of Congress and held demonstration.  The regulations have
also been strongly criticized by trade groups representing makers
of and dietary supplements and grocery and health-food stores.
"For God's sake, we're talking about vitamin C, B12 injections
and Sleepytime tea," said Alex Schauss, executive director of the
newly formed Citizens for Health, a consumer advocacy group based
in Tacoma, Wash.

Two months ago, rallies in Los Angeles, Washington and New York,
sponsored by People for Reason in Science and Medicine, a
California-based group involved in door-to-door canvassing on
alternative health  and environmental issues, drew thousands who
marched to protest the F.D.A. proposals, some carrying signs
warning, "Act now or kiss your vitamins goodbye!"

                       Of Rights and Costs

Many advocates are afraid that the general public is not fully
aware of the repercussions the agency's actions could have, not
only on consumer's rights to chose alternative forms of
medicines, but also on their pocket-books.  Health experts have
also noted that many parents are afraid to give children huge
numbers of pills.  "It's easy to say, 'Just take more pills' if
you want higher doses or potency," said the actress Mariel
Hemingway, who has been vocal in her opposition to the proposals.
"But that means you'll go through a bottle of vitamins every

Dr. Vaughn Harada, a California dentist who uses electro-
acupuncture to treat patients and is president of the Association
of Health Practitioners, a trade association of doctors,
dentists, acupuncturists and naturopaths, said a growing number
of its members use nutritional supplements, homeopathic remedies
and medications in their practices.  "Now they're afraid they may
be targeted by the F.D.A. like Dr. Wright was," Dr. Harada said.

Deborah Widel, one of the co-founders of People for Reason in
Science and Medicine and a patient of Dr. Harada, said she feared
such scenes would become more commonplace.  "We're not trying to
put the F.D.A. out of business," she said.  "It's an agency that
has served a useful and necessary purpose.  But we don't need Big
Brother, either."

"Basically, we as consumers want a freedom of choice.  What the
F.D.A. proposes is a direct violation of our constitutional right
to life, liberty and the pursuit of happiness."