From—DSHEA Ten Years Later: Now What?

Source: Nutrition Business Journal, San Diego, CA, reprinted with permission.
Originally published in January 2004
by Loren Israelsen and Thomas D. Aarts

Strategy #1: Resolve Major Controversies

The "Unregulated Industry" Issue, as illustrated by Ephedra

We 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.

Congressional 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.

The "Drugs as Dietary Supplements" Issue, as illustrated by Andro

The 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.

Any 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 Olympic organizations.

Terry 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."

The Quality Issue, as illustrated with GMP regulation

The industry must make early and significant progress in responding to FDA's unacceptable good manufacturing practices (GMPs) proposal.

An 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.

The Safety Issue, as illustrated by Adverse Event Reports (AERs)

The time has come for industry to support measures that provide FDA and qualified health professionals with pertinent information on Adverse Event Reports.

The 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.

Source

Loren Israelsen and Thomas D. Aarts. "DSHEA Ten Years Later: Now What?" Nutrition Business Journal, January 2004. Reprinted with permission of the authors.