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FDA should audit supplement testing labs for GMPs – podcastFDA 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

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

editor in chief, Informa

Sandy Almendarez entered the natural products industry in 2009 when she joined Virgo Publishing (now Informa Exhibitions) as an assistant editor. Since then, she's worked her way up to editor in chief where she writes, edits and manages content for INSIDER. Under Sandy’s direction, INSIDER has won editorial awards from Folio: every year since 2014, including B2B Editorial Team of the Year in 2015.

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