USADA's New Supplement Safety Initiative

USADA held a teleconference today on its new initiative, called Supplement Safety Now, which aims to help rid the market of designer steroids and contaminants masquerading as legal dietary supplements. USADA CEO Travis Tygart said the problem has two layers: 1. spiking of products with designer steroids, stimulants or pharmaceuticals; and 2. products not containing what they say they contain on the label. He said while it is impossible to totally eliminate all rogue players, who used to operate only in the shadows, the growing availability of such adulterated/contaminated products in retail stores and online is dangerous to athletes and the public. In fact, he was sure to often mention this problem is not only for elite athletes, but also for children. As an alarming example, he said his group purchased just this week from Amazon.com a product—P-Plex from Cutting Edge Labs (CEL)—that contained designer steroid and was marketed as a dietary supplement.

A little short on details of the initiative, Tygart did say while USADA does not believe a wholesale reset of DSHEA is necessary, they and their Supplement Safety Now partners—NBA, NFL, MLB, USOC and other sporting bodies— are going to urge Congress to adjust the existing “ineffective” regulatory framework for dietary supplements. Among these proposals are pre- and post-market “enhancements” to the Food Drug and Cosmetic Act (FDCA); a tighter new dietary ingredient (NDI) regulation; and amendment to the Controlled Substances Act (CSA) to combat the creation speed of new designer compounds.

Tygart was sure to often note the problems were due to bad actors and not the legitimate industry, as far as the adulteration goes, but he also cited studies and surveys as indication the problem of label-vs.-contents is not just with a small band of fly-by-nighters. Likewise, he assured USADA and partners want to work with the supplement industry to rid the market of bad actors—and Loren Israelsen of Utah Natural Products Alliance (UNPA) chimed in with his group’s support of this goal—but there seemed to be no definitive agreement between those parties on how to best accomplish this goal. In fact, while I found Tygart’s careful positioning pretty balanced and well-targeted, he confused me with his reply to a question by Steve Mister, Council for Responsible Nutrition (CRN). When after voicing support for the general effort, including better scheduling of steroids by DEA, Mister asked if more resources for and better enforcement by FDA and FTC would solve these adulteration and contaminant problems within existing regulatory framework, the USADA chief replied, “The safety of our kids shouldn’t depend on resources given to FDA and the enforcement [by the agency].” OK, if pre-and post-market requirements are expanded, which agency will get those responsibilities and costs? FDA. So, the agency will need more funding and more resources (manpower) directed towards dietary supplements. This would have the safety of our children dependent on FDA resources and funding.

In Tygart’s defense, there is no easy answer to this, and it definitely is in the industry’s best interest to rid the market of rogue players. However complex, a couple things stand out from all this debate: none of the existing or proposed regulations (pre-/post-market “enhancements”, GMPs, NDIs, SAERs, etc.) will be effective until FDA adequately enforces said regulations; and Congress needs to undo the handcuffs on DEA that restrict them from scheduling new controlled substances, which are being created at an alarmingly fast rate. I also agree with Loren’s suggestion that more companies like Amazon.com, CEL and others need to be called out on their dangerous, illegal and illegitimate products and marketing. I also agree with Tygart’s assertion that such rogue manufacturers should face more civil and criminal penalties, but then someone has to enforce those to make them work. All comes back to the same problem, enforcement. That's where the efforts should focus and where the government should change its approach.