initial sponsors of the Dietary Supplement Health and
Education Act of 1994 were Senator Orrin Hatch (R-UT)
and Congressman Bill Richardson (D-NM). At the time
of final passage, the legislation had been cosponsored
by 65 Senators and 261 members of the House of Representatives
-- almost two-thirds of the Senate and more than half
of the House.
Clinton's statement regarding signing of the DSHEA:
"After several years of intense efforts, manufacturers,
experts in nutrition, and legislators-- acting in a
conscientious alliance with consumers at the grassroots
level-- have moved successfully to bring common sense
to the treatment of dietary supplements under regulation
and law." The White House press release concluded by
saying "in an era of greater consciousness among people
about the impact of what they eat on how they live and
how long they live, it is appropriate that we have finally
reformed the way Government treats consumers and supplements
in a way that encourages good health."
notes that herbs are not consumed for a nutritional
purpose and often are marketed with therapeutic claims.
was the fallout?
until proven guilty: While the FDA can pull
drugs that are harmful, it has no mechanism to pull
drugs for no efficacy. This has led to a number of useless
supplements that make veiled or sometimes bold claims
of efficacy (such as increasing the size of body parts).
U.S. congressional investigators said they could not
directly establish a link between ephedra and reported
health problems, including heart attacks, seizures,
strokes and deaths. But the U.S. Food and Drug Administration
has proposed a tough new label for ephedra products
that warns about potential side effects. Herein lies
a good part of the problem - unless these products are
a part of a controlled study, it is very difficult to
make a direct link between a pharmaceutical product
and an adverse drug reaction.
Bad: There were too many ways this process can
be abused. If a new dietary supplement ingredient is
introduced, the manufacturer must have evidence of safety
and must supply this evidence to FDA 75 days before
marketing the product. This evidence is usually much
less than is required for a pharmaceutical. Obviously
ephedra is a good indication of how drugs can fall through
Good: In the past, FDA has repeatedly attempted
to define dietary supplements as drugs or food additives
and subsequently remove them from the market. The legislation
makes it clear that these products may not be regulated
as food additives or drugs under most circumstances.
making the transition to Supplements?
trend seen of late is when pharmaceuticals enter clinical
trials and then exit to emerge as supplements. The usual
claim is that the trials were of poor design or other
issues prevented the FDA from approving our drug, but
we are proud to offer it as a supplement. I guess this
is a little better, since there is some rigorous safety
testing, but the potential for misuse here is enormous...
should be done?
opinion: At a minimum supplements that are not
a normal part of a diet should have to go through a
trial similar to a Phase I clinical trial (dose escalation)
and not allowed to put claims on the labels unless they
prove efficacy in a controlled study.
sites for more information:
Heart Association: http://www.americanheart.org/presenter.jhtml?identifier=3010681