Newsgroups: sci.med
Subject: Keeping Vitamins Legal 2/3
Date: Thu, 13 Aug 1992 07:24:00 -0500

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
said.

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
said.

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

Newsgroups: sci.med