FDA should audit supplement testing labs for GMPs – podcast

Supplement testing labs haven’t been among facilities audited for GMP compliance, but Alkemist Labs’ Elan Sudberg says the tide is changing.

Sandy Almendarez, VP of Content

July 17, 2019

The Dietary Supplement Health and Education Act of 1994 (DSHEA) created a regulatory need for supplement safety testing, but the GMPs (good manufacturing practices), issued in 2007, set a fire in the industry to partner with supplement testing labs that meet high quality standards. Yet, without FDA audits of third-party labs for GMP compliance, labs may not be feeling the burning desire to fully comply with regulations.

Elan Sudberg, CEO of Alkemist Labs, a contract testing laboratory specializing in plant authentication, said FDA should be conducting more audits of supplement testing labs to ensure compliance. A recent warning letter sent to ABC Testing may signal the start of this welcome trend.

In this podcast, Sudberg discuses lab audits and other aspects of DSHEA that affect labs operations, including:

  • How demand for quality testing increased after GMPs were issued.

  • How GMPs it still leave too much room for interpretation allowing for a gaping hole for “willful ignorance.”

  • The ways DSHEA and GMPs could be updated to improve quality.

Listen to how others in the supplement supply chain work with DSHEA in this series of podcasts that celebrate the law’s 25th anniversary:

About the Author(s)

Sandy Almendarez

VP of Content, Informa


• 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 Natural Products Insider and Food and Beverage Insider, the education programming for the health and nutrition trade shows SupplySide East and SupplySide West, 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!


Speaker credentials

Resides in

  • Phoenix, AZ


  • Arizona State University


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