25 years of DSHEA: a GMP auditor’s perspective - podcast

The Dietary Supplement Health and Education Act of 1994 (DSHEA) gave FDA the authority to issue cGMP (current good manufacturing practice) requirements for dietary supplements, which the agency did in 2007. Tara Lin Couch, Ph.D., senior director of dietary supplement and tobacco services, EAS Consulting, remembers the issuance of cGMPs as a major disruptor of supplement manufacturing, even for those brands that previously followed pharmaceutical GMPs. In this podcast, Couch discusses the transition from pre-GMPs to post-GMPs, how manufacturing has become more sophisticated in the past 25 years and that DSHEA’s biggest omission was not including raw material suppliers.