USADA Launches “Supplement Safety Now” Site

Posted By elissa on Dec 15, 2009 | 5 comments

The U.S. Anti-Doping Agency has a new site dedicated to its latest crusade: getting supplements containing “designer steroids” and illegal stimulants off the market.  Called “Supplement Safety Now,” the organization (a non-governmental agency responsible for implementing the World Anti-Doping Agency guidelines in the US), is currently lobbying Congress for substantial changes in how the FDA regulates dietary supplements.

Specific Proposals

Pre-Market Enhancements

• All dietary supplement companies should be required to register as “dietary supplement companies” so that the Food and Drug Administration (FDA) can identify them.
• Dietary supplement companies should provide the FDA with a comprehensive list of all dietary supplements they manufacture with a copy of the master formulas and product labels.
• 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.

Post-Market Enhancements

• 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 Drug Enforcement Agency (DEA) should be given emergency scheduling power for steroids and the criteria for scheduling steroids under Schedule III of the Controlled Substances Act (CSA) 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.

Although USADA CEO Travis Tygart apparently assured a range of trade group representatives that his only interest was in going after “bad actors,”   Council for Responsible Nutrition president and CEO Steve Mister was skeptical.

Council for Responsible Nutrition (CRN) President and CEO Steve Mister also offered general support of common goals, but asked Tygart if FDA and FTC were given all the resources needed and actually enforced existing regulations, from serious adverse event reports (SAERs) and NDIs to GMPs (good manufacturing practices), and if DEA were given power to easily schedule controlled substances, would that not accomplish the initiative’s goal.

After the call, Mister noted while CRN firmly believes the existing regulatory framework is adequate to ensure supplements are safe for consumers, the group agrees with some aspects of the USADA plan, such as the need for clarification from FDA on the NDI notification process, as well as FDA enforcement to punish companies who do not submit NDI notifications.

I’ve been seeing something like this coming for some time now.  I’ll be keeping an eye out to see what happens to these proposals and how the industry receives them.