Some of the dust has settled Sen. McCain (R-AZ) introduced the Dietary Supplement Safety Bill of 2010 (DSSA). Now that the industry's legal experts have had a chance to scrutinize the language, the question has become, "Is this about tighter regulations for legitimate companies or closing loopholes used by criminals?"
"It seems that the bill's backers were not aware of existing regulatory controls that have yet to reach their true potential," says Daniel Fabricant, vice president of scientific and regulatory affairs for the Natural Products Association.
"Many supplement companies agree with (Utah Republican) Sen. (Orrin) Hatch's point at a Senate Hearing this past fall that DSHEA and the Anabolic Steroid Control Act of 2004 provide FDA and DEA, respectively, with sufficient authority to bring strong enforcement actions—including criminal charges—against companies that ignore current laws when they sell products that contain illegal or undeclared steroids or hormones," says attorney Susan Brienza of law firm Patton Boggs.
Redundancy is common theme. "This legislation is largely pointless. It contains numerous provisions that would unduly burden those parts of industry that are concerned with compliance while having no impact on companies that are already selling illegal steroid products, says Marc Ullman, Esq, Ullman, Shapiro and Ullman.
For some of the bill's redundancies and possible burdens, consider these provisions:
Facility Registration — Both the proposed Senate FDA Food Safety and Modernization Act (S510), expected to pass in 2010, and the Bioterrorism Act already requires food manufacturers to register with FDA. The penalties for noncompliance under the proposed bill could be steep. It calls for a penalty of "not more than twice the gross profits or proceeds derived from the manufacture, packaging, holding, distribution, labeling or license of the dietary supplement."
This bill could place the onus on retailers, distributors and packers to verify that manufactures are indeed registered. The definition of retailer isn't clear, which means this responsibility could extend to include health clubs, practitioners and even convenience stores that sell dietary supplements. (See the Health Club sidebar, below.)
Accepted Dietary Ingredients — The bill would create a list of ingredients deemed acceptable by Health and Human Services, rather than the grandfather clause already in DSHEA, which the industry still waits to see. "This model appears to be moving closer to the EU system and appears to be very restrictive given the safety record of the supplement industry," says Michelle C. Jackson of Venable LLP.
Recall and Adverse Event Reporting — The bill gives FDA recall authority, even though this is already addressed in S510. Another potentially cumbersome issue is the bill strikes out the word serious from adverse events, meaning FDA would be required to keep up with a constant flood of reports, whether valid or not. "We do not believe that requiring manufacturers to report all adverse events—not just serious adverse events—would do anything to protect consumers. Instead, it could do the opposite by stretching the Agency beyond its limits. FDA itself has stated that this would overburden the Agency and would not help protect consumers," says Steve Mister, President and CEO of the Council for Responsible Nutrition.
The timing of the bill, introduced prior to the Olympics and the Major League baseball season, is curious since both have been arenas for the abuse of illegal performance-enhancing drugs. "If you look at this seriously, it is apparent that USADA (US Anti-doping Agency) is backing this initiative at the behest of Major League Baseball (and the other sports leagues), providing a smokescreen for a bunch of crybaby baseball players (and other professional athletes) who don't want to take responsibility for their own actions," says Ullman. Crying in baseball? Read more in coming weeks.