USADA develops 'Supplement Safety Now' initiative

COLORADO SPRINGS, Colo. A little more than two months following a Senate hearing on steroids in supplements, just about every professional sports organization in the United States and the U.S. Olympic Committee have partnered under the umbrella of the United States Anti-Doping Agency to challenge rogue companies masquerading steroids as supplements, the USADA announced Wednesday.

However, the USADA joint effort is not altogether industry friendly, as the new effort, called “Supplement Safety Now,” will be pushing for more regulation — most notably regulation that would require retailers of dietary supplements to help police the supplement industry.

“Most Americans are unaware that dangerous drugs are intentionally being sold as dietary supplements in retail and Internet stores across America, and that current laws allow for these products to get into the hands of our children too easily,” stated USADA CEO Travis Tygart.

“These unscrupulous supplement manufacturers intentionally exploit loopholes in the federal regulations by selling products containing drugs and marketing them as ‘safe’ and ‘legal.’ Congress needs to act now to close these loopholes,” added Robert Manfred, Jr., EVP labor relations at MLB.

“[The Council for Responsible Nutrition] believes that the current regulatory framework is more than adequate to support the objectives of ensuring consumers' access to safe supplement products — if the laws are enforced,” stated Steve Mister, CRN president and CEO, in response to the announcement. There are enhancements to the current laws being recommended by Supplement Safety Now that CRN supports, Mister noted, such as clarification around the New Dietary Ingredient notification process from the Food and Drug Administration, which regulates supplements. CRN also supports enforcement actions taken against any companies that do not submit with NDI notifications. “These actions, along with rigorous inspections of manufacturing facilities under existing Good Manufacturing Practices, would help ensure that all new ingredients entering the market are safe, if used correctly,” Mister said.

“[However], some of the recommendations made under 'Supplement Safety Now' — which are well-intended — may not be very effective,” Mister cautioned. Instead, both FDA and the Drug Enforcement Agency should be afforded greater resources to enforce the laws that are already on the books, Mister suggested.

Specifically, Supplement Safety Now is advocating the following:

• All dietary supplement companies should be required to register as “dietary supplement companies” so that the FDA can identify them;
• Dietary supplement companies should provide a 75-day pre-market notice to the FDA not only for New Dietary Ingredients, but for all products containing steroids (including hormones, pro-hormones and hormone analogues) and must establish that the product is safe under its intended use;
• Dietary supplement companies should be required to maintain a substantiation file that is available on request to the FDA;
• Distributors and retailers of dietary supplements should obtain evidence of compliance from the manufacturers and licensors that all pre-market requirements have been complied with or bear responsibility for the products they sell as if they were the manufacturer;
• Supplement companies should be required to report all adverse events not just “serious adverse events” requiring hospitalization, surgery or death;
• The FDA should be given the power to unilaterally prohibit sales and initiate immediate recall of any product that has not followed all pre-market requirements or when the FDA determines that there is a reasonable probability that the product poses a safety risk or contains an ingredient that will ultimately be scheduled as a controlled substance;
• The DEA should be given emergency scheduling power for steroids and the criteria for scheduling steroids under Schedule III of the Controlled Substances Act should be modified to better address the current reality of designer steroids;
• As was done in 2004, Congress should immediately amend Section 102 of the CSA to schedule the 20 or more designer steroids that have been identified but not yet scheduled as controlled substances;
• Dietary supplement companies should be prohibited from advertising that any product performs like a steroid, is named similarly to a steroid, affects the structure of the body or touts the fact that a product may soon be declared illegal.

The professional sports leagues that have joined USADA include the NFL, MLB, NBA and NHL.