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Are Supplements Drugs?
Last March, Senator Richard Durbin (D-Ill.) introduced a bill, S. 722, titled the Dietary
Supplement Safety Act of 2003, that would expand the FDA's power to remove nutritional
supplements from the market. It would not only require manufacturers to report adverse events
or reactions to the federal government, but also ask for premarket approval for dietary
supplements containing stimulants. As written, the bill would also categorize products
promoting muscle growth as anabolic steroids rather than as dietary supplements, thus requiring
expensive testing protocols before they can be sold.
In short the bill would apply to nutritional supplements standards similar to those applied
to drugs in cases where adverse effects are reported. New pharmaceutical products incur
millions of dollars of costs for proof of safety and efficacy, which makes sense - most drugs
contain synthetic substances never before encountered by human physiology. But applying those
same standards to nutritional supplements, as S. 722 proposes, would generate costs entirely
inappropriate for substances that are, for the most part, more food-like than drug-like.
What was Durbin thinking?
He was thinking about ephedra. It's true that ephedra appears to have been over-marketed
and abused. And there appears to be justification for regulating it. It has resulted in
several adverse reactions, including heart attacks, strokes, and at least two deaths. But
it is quite a stretch to equate the isolated instances of ephedra's side effects with those
of all nutritional supplements. And it would be a shame if a few products that are arguably
risky take down most of our freedoms to use the supplements of our choice.
Why didn't the FDA simply pull ephedra from the market if the safety of this substance was
in doubt? It could have been done under existing laws.
According to a 2002 report by the Washington, D.C.-based Council for Responsible Nutrition
(CRN), the use of multi-vitamins, antioxidants, folic acid, calcium, and other nutritional
supplements could reduce the incidence of neural tube birth defects by 50 percent, osteoporosis
- caused hip fractures by at least 20 percent, and sick days due to infectious diseases in the
elderly by 50 percent. The CRN reports that nutritional therapies could delay the onset of
cardiovascular disease, stroke, and osteoporosis by five years, potentially saving $89 billion
a year in health care costs.
A part of that $89 billion now being spent goes straight into the pockets of the pharmaceutical
industry. So it's no surprise that a powerful lobby is making the case for this bill, which
would restrict our access to some of our best, most cost-effective health care tools.
Fortunately, the pharmaceutical companies don't always get what they want.
Please do what you can to derail Durbin's bill. With conventional prescription medicine
pricing itself out of the market, there is no question as to who would hold the upper hand
in the long run. If S. 722 passes, it will be an unpopular disaster, and most Americans will
realize that quickly enough. Let's make sure it never happens.
S. 722 must be stopped. Write or fax your senator today, using the following letter, or your
own version.
The Honorable (your senator's name here), __________________________
(today's date),__________________2004
United States Senate
Washington, D.C. 20510
Dear Senator (your senator's name here), ___________________________
Please kill S. 722, introduced March 26, 2003, by Sen. Richard Durbin (D-Ill.), cosponsored
by Sens. Charles Schumer (D-N.Y.), Hillary Clinton (D-N.Y.), and Dianne Feinstein (D-Calif.).
S. 722 will amend the U.S. Food and Drug Act to unfairly shift the burden of proof of the
safety of herbal and dietary supplements from the FDA to the millions of distributors of
these supplements.
In 1994 Congress unanimously voted to properly place the burden of proof on the FDA when
it enacted the Dietary Supplement Health and Education Act (DSHEA). The law now clearly states
that "in any proceeding [before the FDA can declare an herb or a dietary supplement an imminent
hazard to public health] the United States (FDA) shall bear the burden of proof..."
The FDA now has, and should have, broad authority to seize and remove dangerous herbs and
dietary supplements from the marketplace if they are an imminent hazard. If the seizure is
contested, the burden of proof should be on the FDA to prove its case.
Name (print): _______________________________________________________
Signature: _________________________________________________________
Address: __________________________________________________________
__________________________________________________________________
City ______________________________________________________________
State ________________________________________ Zip __________________
Letter Prepared by:
Clinton Ray Miller
Health Freedom Legislative Advocate
704.924.8615
704.924.8616 (Fax)
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The information in this document is intended to educate. Do not substitute it for the advice of a
qualified health care professional. Viewer discretion is advised.
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