USADA Launches Supplement Safety Now Initiative

COLORADO SPRINGS, COThe U.S. Anti-Doping Agency launched its new Supplement Safety Now initiative, an effort to clean the retail and online marketplace of rogue manufactures and the products they pedal that often contain designer steroids, stimulants or pharmaceuticals. In partnership with the NFL, NBA, MLB, US Olympic Committee (USOC) and other pro and amateur sporting bodies, USADA said it will urge Congress to alter the existing regulatory framework to provide more pre-and post-market enhancements of dietary supplement oversight.

Among the objectives, according to USADA CEO Travis Tygart, is a suggestion to have all dietary supplement companies register with FDA, including a list of all products and ingredients. In addition, he said there should be tighter new dietary ingredient (NDI) protocol, as well as changes to the Controlled Substances Act to allow the Drug Enforcement Agency (DEA) to more easily and quickly schedule new controlled substances, in order to keep up with the rapid pace at which new designer steroids are invented and marketed. Despite these recommendations, Tygart insisted USADA does not feel a wholesale reset of DSHEA is necessary to accomplish the goals of this Supplement Safety Now initiative.

On a teleconference to announce the initiative, Tygart was sure to distinguish the bad actors from the legitimate supplement industry, but said these rogues, who used to operate underground, are now  selling their products in mainstream retail stores and online. To prove his point, just this week USADA went on Amazon.com and purchased a product containing a designer steroid, but marketed as a dietary supplement, P-Plex, from Cutting Edge Labs (CEL).

Loren Israelsen executive director of United Natural Products Alliance, which represents numerous supplement companies, was on the call and offered his groups support for the greater goal of Supplement Safety Now, saying it is important to expose companies that manufacture or market adulterated products.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 initiatives 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.

It is important to reiterate that laws are only as good as the regulatory agencys determination and ability to enforce them, he said, noting some of the recommendations made under Supplement Safety Now, while well-intended, may not be very effective. For example, while CRN supports a registry of products with FDA, we do not believe that companies that are illegally contaminating products would bother to register. We believe that the best way to catch these offenders is to give the Drug Enforcement Administration (DEA) and FDA more resources to enforce the laws already in place and to show these criminals that there are penalties to breaking the law.

John Gay, executive director and CEO of the Natural Products Association (NPA) agreed, Simply putting more laws on the books for the bad guys to continue to ignore is not the answer. He said there is much NPA and USADA can do together to put the bad actors out of business, but indicated NPA believes more enforcement of existing laws should be the focus of such efforts. Boosting enforcement also proves a quicker way to get rogue companies out of the marketplace versus the much longer process of trying to pass new legislation and write new regulations that still may not be enforced.

In addition to this problem of potentially dangerous substances available readily and easily to the athletes, the  public and children, another problem with supplements, according to Tygart, is many feature inaccurate labeling of ingredients, either containing something not listed or containing too little or too much of an ingredient. MLB Executive Vice President for Labor Relations Rob Manfred and NFL VP of Law & Labor Policy Adolpho Birch were also on the call and expressed their concern that their players can not trust any retailer and any product not on the approved list of supplements maintained by the leagues dietary supplement safety programs. When asked about NFLs partnership with NSF International for the testing of products from companies wishing to be approved for NFL players use, Birch said the ongoing program offers a safe harbor for NFL players who want to be certain of the safety and legality of supplements they use. The problem is it is simply impossible to give accurate advice on the millions of products out there that are not a part of our program, he said.

According to NSF, MLB the MLB Players Association, the NFL, the NFL Players Association, Professional Golfers Association of America (PGA), Ladies Professional Golf Association (LPGA), and the Canadian Centre for Ethical Sports (CCES) have all chosen NSF to help verify the products their athletes use are safe and free of banned substances. While the independent lab offered general support for Supplement Safety Now, NSF Chief Scientific Officer Lori Bestervelt, Ph.D., noted, To be clear, products containing steroids and steroid precursors are not supplements, they are illegal drugs masquerading as dietary supplements. These dangerous and illegal products pose a significant public health risk and more stringent enforcement and independent surveillance is needed to better safeguard consumers.

More detailed information on Supplement Safety Now is available at the programs dedicated Web site.