WASHINGTON—As of today, June 25, the third and final category of dietary supplement companies—small firms with less than 20 employees—are legally required to comply with mandatory good manufacturing practices (GMPs) for dietary supplements. Large- and medium-sized companies came under compliance requirements the past two years, and now the whole industry is required to follow the regulation.
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), called this a historic day for the dietary supplement industry and its consumers. “Full implementation of the GMP regulations that we fought so hard for should put to rest any skepticism that our industry is not regulated,” he said. “Clearly, there are stringent manufacturing standards that our entire industry must adhere to and we expect that after three years of preparation for implementation, manufacturers are prepared to embrace GMP compliance as another illustration of an industry committed to its consumers.”
CRN joined many industry insiders in calling for FDA to commit to inspections and enforcement of the GMPS. “Industry worked hard to get GMPs and we now expect FDA to make complete use of the standards by holding the industry to them,” he said. “Full implementation of the GMPs, coupled with FDA attention to industry compliance, will help to weed out bad actors from our legitimate industry and assure that consumers are being protected.”
The trade group also reiterated its support for the Dietary Supplement Implementation and Enforcement Act of 2010, which calls for additional funds for FDA to fully implement and enforce the Dietary Supplement Health and Education Act of 1994 (DSHEA). Introduced by Senators Tom Harkin (D-Iowa) and Orrin Hatch (R-Utah), the bill would provide FDA with additional resources over five years to energize its enforcement of DSHEA, including GMP inspections.