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A Freedom of Information Act (FOIA) request found 58 percent of supplement manufacturers aren't living up to the full expectations of GMPs (good manufacturing practices) set forth by FDA nine years ago. The numbers are improving compared to past years, but, per FDA inspections, failure to set specifications is still the most common citation.

A Freedom of Information Act (FOIA) request found 58 percent of supplement manufacturers aren’t living up to the full expectations of GMPs (good manufacturing practices) set forth by FDA nine years ago. The numbers are improving compared to past years, but, per FDA inspections, failure to set specifications is still the most common citation.

In this episode, Sandy Almendarez, editor in chief, and Josh Long, legal and regulatory editor, INSIDER discuss:

  • GMP inspection data from fiscal year 2015, including the number of inspections, the number of form 483 issued, and the number of companies that were reinspected.

  • Why the nature of violations and the reinspection data are the most important aspects of these numbers.

  • If FDA is using its authority properly to ensure the supplement market is safe for consumers.

 

Links and Resources:

 

Got feedback? Email Sandy Almendarez at [email protected] or Josh Long at [email protected], or tweet to @NatProdINSIDER using the hashtag #INSIDERpodcast.

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.

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a special focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year ‘Jake the Snake’ Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

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