Since the Dietary Supplement Health and Education Act (DSHEA) was passed in 1994 an ongoing debate existed around the FDA’s ability to properly enforce Good Manufacturing Processes (GMP). In June of 2007 the FDA responded by updating the final rule on cGMP (Current Good Manufacturing Processes) for companies involved in manufacturing, packing, labeling and holding of dietary supplements. The FDA’s final rule establishes the needed cGMP’s to ensure quality for all of the aspects of dietary supplements. The FDA’s final rule also includes requirements for establishing quality control procedures, designing, and constructing manufacturing plants, and testing ingredients and finished products. The new FDA standards went into effect in June of 2008 for larger companies, 500 employees or more. The majority of the companies that fall into the smaller category, 20 to 499 employees, were given until June of 2009 to comply. Companies with 20 employees or less have a looming deadline of June 2010.

Key elements of the FDA’s final rule include that each dietary ingredient used in a supplement will be required to meet 100% identity testing, such that manufacturer will be required to conduct at least one test or examination to verify the identity of any component that is a dietary ingredient. Well-established principles of cGMP require process controls for each step of the manufacturing process as early in the production as possible. It’s not considered effective or acceptable to only rely on the testing of the end product to guarantee the consumers are receiving a quality dietary supplement. Manufacturers will also be required to confirm the identity of other components. The rule is relevant to all dietary supplements offered or sold in the United States, so that even foreign firms will be required to meet the new manufacturing standards. The final rule is relevant only to dietary supplements and not to dietary ingredients.

The FDA admits they may have trouble reviewing all of the dietary supplement manufacturers this year. The agency’s manager of the Division of Dietary Supplements, Brad Williams, said “it’s impossible for us to get to everybody this year, but our plan is to do a substantial number, like as many as 200 firms this fiscal year.” There was a 16% decline in FDA investigators from 2003 to 2006. Given the number of supplement manufacturers, the FDA has increased their presence by teaming with other government agencies and hiring of over 1,000 new agents to meet the new standards.

Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs proclaims, “the FDA will not tolerate companies that fail to provide adequate safeguards.” Supplement brands with manufactures that are not able to meet the cGMP are experiencing difficulties receiving continued products. While it’s not published, approximately 36 dietary supplement manufactures in the U.S. have been shut down since June of 2008 due to the new standards. According to Jeff Golini of All American Pharmaceuticals, “The FDA is now taking a purely objective approach with their reviews of dietary supplement manufacturers. A ‘check the box’ list is no longer acceptable; meaning you must be able to not only show that a policy exists, but prove it.” As a first step supplement manufacturers will need to familiarize themselves with the new guidelines and compare them to their current operating procedures before being subject to an FDA review. Additional information on the FDA’s final rule for dietary supplement manufacturers can be found at: http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformation/RegulationsLaws/ucm110858.htm

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