Newsgroups: sci.med
Subject: Keeping Vitamins Legal 1/3
Date: Thu, 13 Aug 1992 07:23:00 -0500

The following is reprinted without permission and has not yet
been 100% proofread.


           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
acupuncturists.

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
allergies.

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
groups.

"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
claims.

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

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