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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-hour teleconference with its clients to explain the regulations. That teleconference is now available on CD from the firm for the price of the teleconference, $350. In it Emord partners Jonathan W. Emord and Andrea Ferrenz explain each of the regulatory strictures and answer client questions. For a copy of the CD set contact Emord & Associates at 202-466-6937. Emord & Associates has also created a Compliance Kit with checklists that companies in the manufacturing, holding, and distribution businesses may use to guide them in their compliance efforts. For a copy of the $500 Compliance Kit, contact Emord & Associates at 202-466-6937. Finally, the firm will perform cGMP audits for clients to identify areas of potential non-compliance and advise on means to achieve compliance before FDA performs its own compliance audits of firms. To schedule an audit, contact Emord & Associates at 202-466-6937.