The cGMP Kit

In July 2007, the FDA promulgated comprehensive "cradle to grave" regulations that govern every aspect of the manufacture, holding, and distribution of dietary supplements.

In its rule, FDA admits that the regulations:

• may result in the elimination of over 100 dietary supplement companies
• will likely increase the cost of dietary supplements
• will likely decrease demand for dietary supplements
• will likely create costly new barriers to market entry

Moreover, the FDA admits that the regulations will impose the greatest economic burden on very small (20 or fewer full time employees) and small (500 or fewer employees) dietary supplement companies.

We commissioned Dr. Steve Hanke, former Senior Economist on President Reagan's Council of Economic Advisers, to evaluate the economic impact of the regulations and he predicts the burden will be approximately ten-fold higher than FDA has predicted.

These regulations impose costly obligations on the industry and focus primarily on process rather than outcomes. They mandate new testing, master manufacturing records, complaint records, disposition records, and new procedures to ensure the identity, purity, strength, and composition of dietary supplements. They mandate compliance with education, training, and experience requirements for quality control personnel and supervisors.

Failure to comply with the regulations is deemed "adulteration" without need for proof that products present an actual risk of illness or injury to the public.

The FDA is implementing these regulations in a tiered fashion, requiring companies of 500 employees or more to come into compliance in July of 2008, of between 20 and 499 employees to come into compliance in July of 2009, and of between 1 and 20 employees to come into compliance in July of 2010. Whether your company manufactures, holds, or distributes dietary supplements, early achievement of compliance is well-advised.

Get Informed about cGMP and Your Compliance

1. Emord & Associates held a three-hour teleconference one business day after adoption of the rules. You may obtain a copy of the three-hour conference on CD from the firm by calling 202-466-6937.
2. Emord & Associates has created a Compliance Kit, including detailed checklists, for your use in achieving compliance with the new cGMPs. You may obtain a copy of the Compliance Kit from the firm by calling 202-466-6937.
3. Emord & Associates offers on-site audits to evaluate compliance and assist in modifying operations to ensure compliance. You may schedule an on-site audit from the firm by calling 202-466-6937.