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NEW YORK Here’s the breakdown: Two government officials representing the Food and Drug Administration and the Drug Enforcement Agency joined Travis Tygart of the U.S. Anti-Doping Agency (the body responsible for keeping performance-enhancing drugs out of U.S. Olympic athletes), Daniel Fabricant of the Natural Products Association and Richard Kingham, a litigator specialized in food/drug law, before a panel of senators — less to inform the Senate around the problem of steroids sold as dietary supplements, and more to be grilled by those senators as to why those products are actually on any market.
The senators were Sens. Orrin Hatch, R-Utah, and Arlen Specter, D-Pa., who played a sort of good cop/bad cop routine. Hatch was the good cop, at least as the dietary supplement industry goes, as he defended the legislation governing the regulation of dietary supplements that he helped draft some 15 years ago. Specter played the bad cop — questioning the regulatory priorities of the two governing bodies present, while raising the thought of adding more regulations to the FDA and/or DEA already-underutilized toolbox.
Following the hearing, dietary supplements emerged as the unwilling participants in all of this talk around performance enhancing supplements. You almost had to wonder why Fabricant was present, except to politely remind everyone that the dietary supplement manufacturers who actually distribute product through mass-channel retailers actually fought for (as in not against) such additional regulations as certified good manufacturing practices or mandated serious adverse event reports, and as such are not likely to field illegal products.
At stake in all of this is whether or not legitimate dietary supplement players ought to seek premarket approval, a condition that if ever really implemented, would decimate any future innovation in the almost $6 billion mass-channel business (according to the latest Nielsen Company figures). It’s also a condition that wouldn’t actually do much to pull those steroid drugs masquerading as supplements off the market, unless you expect those well-respected criminals to actually file an NSA (new supplement application) that contained ingredients that would not only land their consumers in the hospital, but would also land them in jail if ever actually discovered in the trunks of their cars.
The alternative, proposed by Hatch, is to place more resources behind enforcement of the laws on the book, as opposed to creating new laws that would more likely cripple legitimate manufacturers as actually inhibit outliers from selling steroids.