Healthy INSIDER Podcast 13: FDA GMP Numbers Tell Story of Supplement Compliance

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

VP of Content, Informa

Summary

• 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!

Awards:

Speaker credentials

Resides in

  • Phoenix, AZ

Education

  • Arizona State University

Contact:

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 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).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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