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25 years of DSHEA: A GMP auditor’s perspective – podcast

EAS Consulting’s Tara Lin Couch remembers supplement manufacturing before GMPs were issued as the “wild wild west.”

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.

With Sandy Almendarez, editor in chief, INSIDER, Couch discusses:

  • How the requirement of DSHEA to meet 100 percent of label claims at the end of shelf life upended formulations, packaging size and testing methods
  • How the “c” in cGMPs doesn’t mean the regulation changes, but it does mean processes to follow GMPs must adapt with technology advancement
  • How still, even with the Food Safety Modernization Act (FSMA), the regulations don’t place enough safety and quality burdens on raw material suppliers.

This podcast was recorded at SupplySide East in Secaucus, New Jersey, in April 2019.

Links and Resources:

Got feedback? Email Sandy at [email protected], or tweet to @NatProdINSIDER using the hashtag #INSIDERPodcast.

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