"The attack has begun! What started as investigative interest
into the safety of ephedra after widespread negative publicity has mushroomed
into an all-out attack on all supplements, including prohormones."
This startling warning comes from the website "bodybuilding.com"
sponsored by the United Supplement Freedom Association. The "attackers"
in question are primarily two U.S. Senators: Dick Durbin (D-IL) and
George Voinovich (R-OH).
At issue is the Dietary Supplement Health and Education Act (DSHEA)
of 1994. It requires the Food and Drug Administration (FDA) to prove
that a dietary supplement is harmful. Manufacturers do not have to show
that their products are safe, nor do they have to report adverse reactions
in persons taking them, as is required of the producers of pharmaceuticals.
Like many other Americans, however, Senators Durbin and Voinovich discovered
to their dismay that the FDA has largely failed to enforce this weak
law. When the FDA admitted that regulations will be issued "as
soon as possible," the two senators were aghast. "Consumers
are endangered by the FDA's inability to act on particular supplements,"
explained Durbin. "It's unacceptable that it takes 10 years to
get something done," charged Voinovich.
Given the FDA's failure to protect consumers from the damages they incur
from ineffective and dangerous supplements and from outright frauds,
Senator Durbin introduced the Dietary Supplements Safety Act (S. 722)
on March 26, 2003. It mandates pre-market approval for supplements carrying
stimulants, as well as the categorization of products promoting muscle
growth as anabolic steroids rather than supplements. The manufacturers,
packers, and distributors will also be required to report to the FDA
any information they get about adverse medical reactions in supplement
consumers.
The reaction to Senator Durbin's badly needed initiative ranges from
the hysterical to the critical. "Senator Durbin, Please Don't Touch
Our Supplements," pleaded a writer in Conscious Choice, a magazine
purporting to "help readers live healthier lives." She asks
Congress "to restrain the FDA's historical abuse of discretionary
authority over supplements... When you figure that prescription drugs
kill more than 100,000 people every year, this is exactly the reason
why we're using dietary supplements in the first place."
Yet, shortly before Mr. Durbin introduced S. 722, the American Herbal
Products Association asked the FDA to make adverse events reporting
mandatory. The Council for Responsible Nutrition, however, did not endorse
the proposed bill. Instead, it has been trying to convince Senators
Durbin and Voinovich that dietary supplements are not drugs but food,
and should therefore not be regulated like pharmaceuticals. The Council
refuses to concede that there is an essential difference between, for
example, a slice of bread and 250 milligrams of Echinacea.
Increasingly, consumers have become suspicious of the supplement hucksters,
not only of the exaggerated claims they often make for the medical benefits
of particular products, but also of the veracity of their labeling.
Fore that reason, Healthgate Data Corporation of Burlington, MA, now
offers subscribers the results of tests showing if a supplement contains
all ingredients in the quantities indicated on the label.
Senator Durbin frequently cites the case of the fat-burning and energy-boosting
supplement ephedra that caused 117 deaths and more than 17,000 health-related
problems. Before it was outlawed, it was "sold over the counter
at grocery stores, drugstores, gas stations, and fitness clubs, and
on TV under brand names like Metabolife 356, Stacker 2 and NaturalTrim.
The industry estimated that over 3 billion servings of ephedra were
sold in 1999."
A survey commissioned by the National Institute of Health's National
Center for Complementary and Alternative Medicine (reported by the Chicago
Tribune) found that 1 in 5 Americans use "natural" products,
such as herbs and enzymes, with Echinacea taken by 40 percent, ginseng
by 24 percent, and ginkgo biloba by 21 percent.
Consumers expect government to insure the safety of the products of
the pharmaceutical industry and the honesty of its advertising. Why
should the same requirements not be legislated for the $18 billion a
year supplement industry?
Americans pay enough federal tax to expect the FDA to protect the consumers
of dietary supplements as effectively as the consumers of pharmaceutical
products.