McCain's bill redundant, lawyers say

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.

Possible impact on health clubs Functional Ingredients talked with Stuart Goldman, former sports writer and current managing editor of sister publication Club Industry (www.clubindustry.com). FI: Is the health club industry taking the issue of steroid use seriously? SG: The health club industry is making a concerted effort toward a health and wellness model. Even one of the most famous bodybuilding gyms in the industry, Gold's Gym, is moving in this direction. Gold's Gym once had the slogan 'Serious Fitness.' Now, its slogan is 'Know Your Own Strength.' Several smaller, low-cost gyms, such as Planet Fitness, Anytime Fitness and Snap Fitness, are designed for gym goers to get in, get their workout done, and get out. The image of a seedy sweatbox that the industry had years ago is slowly fading away. There are clubs in the industry that sell supplements in their pro shops. Although this is part of a club's ancillary revenue, the bulk of a club's revenue is generated through obtaining and retaining memberships. Clubs are not dependent on revenue from supplements to survive. Any changes, however, to make supplements more legitimate will help clubs appear more legitimate to the masses. There are those members who are ardent bodybuilders and use supplements. If they choose to obtain steroids or other performance-enhancing drugs, they likely will find a way to find them outside of the club. FI: Will Sen. McCain's bill be effective in controlling illegal steroid sales? SG: There are athletes out there who will do anything to gain an advantage. A bill such as the one John McCain introduced last week will only make athletes go the extra mile to do what they feel they need to do to stay in the game and enhance their performance. If they used to go to supplement stores for supplements, they then turned their attention to the Internet. If the Internet will not be sufficient if and when this bill passes, there will be other forms of communication and service providers for athletes to get what they feel they need.