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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:
DSHEA author reflects on law’s impact and future–Scott Bass, partner, Sidley Austin
Orrin Hatch reflects on DSHEA—Former U.S. Senator
25 years of DSHEA: A GMP auditor’s perspective—Tara Couch, Ph.D., senior director of dietary supplement and tobacco services, EAS Consulting
DSHEA turned supplement manufacturing from the ‘wild west’ to sophistication—Robin Koon, executive vice president of sales and marketing, Best Formulations
DSHEA 2.0 should better define ‘supplement’—Mark Potocnjak, CFO at Herbally Yours Inc.
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