June 25, 2010 –  Today marks the date by which small businesses, meaning dietary supplement manufacturers with less than 20 employees, must be compliant with the current Good Manufacturing Practices (cGMPs) for dietary and nutritional supplements. It has been nearly 16 years since the Dietary Supplement Health and Education Act (DSHEA) was passed. DSHEA contained a provision requiring that FDA establish and enforce cGMPs, and while drafts were presented for comment over the years, it was not until 2007 that the cGMPs were finally approved, along with a three phase process for enactment, the final phase taking effect today.

The supplement industry has been heavily criticized over the years, with allegations that it is unregulated and questions as to whether dietary supplements are safe. News stories depicting an industry wrought with contaminated products, supplements spiked with drugs, and product recalls have all contributed to a negative view of the industry, particularly by members of Congress. While the cGMPs are sure to have a significant financial impact on small business and the industry as whole, they should also serve to improve consumer confidence in dietary supplements, as these regulations impose new, stringent compliance criteria that address the problems that have damaged the reputation of the industry with a focus on quality control, record keeping and documentation.

Understandably, even with the three phase approach to effectuating the new GMPs, small businesses are still scrambling to come into compliance and cope with voluminous documentation requirements and additional expenses. No longer should we see raw materials, purchased from unknown foreign suppliers, being used in the manufacture of dietary supplement products, relying solely on a Certificate of Analysis. The cGMP requirements such as Vendor Certification, Document Control Procedures and Identity Testing are new compliance measures that make it clear… Times they are a-changin’!