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.”

Sandy Almendarez, VP of Content

April 18, 2019

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.

About the Author

Sandy Almendarez

VP of Content, Informa

Summary

• Well-known subject matter expert within the health & nutrition industry with more than 15 years’ experience reporting on natural products.

• She cares a lot about how healthy products are made, where their ingredients are sourced and how they affect human health.

• She knows that it’s the people behind the businesses — their motivations, feelings and emotions — drive industry growth, so that’s where she looks for content opportunities.

Sandy Almendarez is VP of Content for SupplySide and an award-winning journalist. She oversees the editorial and content marketing teams for the B2B media brands SupplySide Supplement Journal and SupplySide Food & Beverage Journal, the education programming for the health and nutrition trade shows SupplySide Connect New Jersey and SupplySide West, the education program SupplySide Fresh for industry newcomers and community engagement across the SupplySide portfolio. She is a seasoned content strategist with a passion for health, good nutrition, sustainability and inclusion. With over 15 years of experience in the health and nutrition industry, Sandy brings a wealth of knowledge to her role as a content-focused business leader. With specialization in topics ranging from product development to content engagement, creative marketing and c-suite decision making, her work is known for its engaging style and its relevance for business leaders in the health and nutrition industry.

In her free time, Sandy loves running, drinking hot tea and watching her two kids grow up. She brews her own “Sandbucha” homemade kombucha; she’s happy to share if you’re ever in Phoenix!

Awards:

Speaker credentials

Resides in

  • Phoenix, AZ

Education

  • Arizona State University

Contact:

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