FDA should audit supplement testing labs for GMPs – podcast

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.