Ten Years Later: Now What?
Nutrition Business Journal, San
Diego, CA, reprinted
Originally published in January 2004
by Loren Israelsen and Thomas
#1: Resolve Major Controversies
"Unregulated Industry" Issue, as illustrated by Ephedra
must have a satisfactory political and regulatory solution to ephedra
by April 2004. FDA's action of December 30, 2003 to ban ephedra
is a key event that the industry should not oppose. Litigation to
challenge FDA's decision to ban ephedra would be ill advised and
would drag the ephedra issue into 2005.
sentiment against ephedra is an issue that can prompt many members
to vote in favor of anti-DSHEA legislation. Unfortunately, the controversy
surrounding the safety of ephedra has become a lightning rod that
has galvanized considerable congressional concern about other herbs
and dietary supplements. Many key congressional players, plus members
of the media, health professionals and others are looking at all
herbs and supplements through the distorted looking glass of ephedra.
Unfairly, but perhaps understandably, ephedra has become the unwitting
poster child of the herbal industry.
"Drugs as Dietary Supplements" Issue, as illustrated by Andro
Anabolic Steroid Control Act of 2003 (S.1780 - the Biden/Hatch bill)
should be a top industry priority with a goal to remove the steroid
precursor issue before the 2004 Olympic games begin in September.
supplement doping scandals this year could ignite an anti-DSHEA
debate in the Congress, fully supported and led by the U.S. Anti-Doping
Agency (USADA) and the Coalition for Steroid Precursor and Ephedra
Regulation (CASPER - www.casper207.com) and other international
Madden, the CEO of USADA testified before a Senate Committee Hearing
on Dietary Supplements on October 26, 2003, where he stated, "Today
American consumers can walk into their corner nutrition store and
buy products containing Androstenedione. After professional athletes
acknowledged that they had used Androstenedione, sales of these
supplements in the United States dramatically increased. This phenomenal
demand, particularly among teenagers, led to the mass marketing
of other steroid precursors. Now the nutrition shelves and the Internet
are flooded with products containing these steroid precursors. Further,
the manufacturers of these substances attempt to take advantage
of DSHEA by touting these substances as natural and implying in
their advertising that natural equals safe."
Quality Issue, as illustrated with GMP regulation
industry must make early and significant progress in responding
to FDA's unacceptable good manufacturing practices (GMPs) proposal.
economic analysis on small business should be a top priority in
order to demonstrate FDA's utter failure to correctly assess the
economic impact of the GMP rule on the supplement industry. This
analysis should clearly articulate consumers' loss of access to
products that would result from soaring costs to produce small lot
and specialty products.
Safety Issue, as illustrated by Adverse Event Reports (AERs)
time has come for industry to support measures that provide FDA
and qualified health professionals with pertinent information on
Adverse Event Reports.
supplement industry must recognize that for supplements to become
more fully accepted by the general public, there must be ways to
help ensure confidence in their overall safety, and this means,
at least in part, developing a process of monitoring the potential,
and possibly inevitable, cases of adverse responses to some supplements
and provide a pro-active way of dealing with this issue.
Israelsen and Thomas
D. Aarts. "DSHEA Ten Years Later: Now What?" Nutrition
Business Journal, January 2004. Reprinted with permission of