THE NEW CGMPS FOR DIETARY SUPPLEMENTS THREATEN 1/3 OF THE DIETARY SUPPLEMENT INDUSTRY WITH DESTRUCTION
On June 22, 2007, FDA promulgated the most extensive regulations governing any of its regulated licensees, the cGMPs for dietary supplements. In an 820 page final rule, FDA imposed “cradle to grave” regulations on every aspect of the manufacture, holding, and distribution of dietary supplements. By FDA’s own admission, the regulations will eliminate approximately 140 dietary supplement companies, will increase the cost of dietary supplements, will decrease the availability of dietary supplements, and will create new, costly barriers to entry into the dietary supplement marketplace. Dire as those admitted consequences are, an economic study commissioned by Emord & Associates from the former chairman of President Reagan’s Council of Economic Advisors, Steve Hanke, predicts the regulations will result in far greater economic harm to the industry, resulting in the destruction of as much as 1/3 of the companies in the field. The regulations fall hardest on small (500 employees or less) and very small (20 employees or less) companies which represent over 80 percent of all companies in the field.
One business day after the regulations were published in the Federal Register, Emord & Associates held a three-