Dietary Supplements and FSMA Compliance – Fallacy or Fact?

Presented by Tara Lin Couch, Ph.D. & Allen Sayler

In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of products, called “Dietary Supplements”, which are regulated by the FDA as a subcategory of foods. Since DHSEA, the Food Safety Modernization Act (FSMA) of 2011 was passed, and as a category of foods, dietary supplements are now subject to seven major regulations to support enforcement of FSMA.

One of the most important of these regulations being 21 CFR 117, Current Good Manufacturing Practice (cGMP) and Hazard Analysis and Risk-Based Preventative Controls for Human Food (PCHF), which requires, among other things, that a Preventive Controls Qualified Individual (PCQI) develop a food safety plan. Another FSMA requirement is the need for a Foreign Supplier Verification Program (FSVP) when dietary ingredients and dietary supplements are sourced internationally, (estimated to be over half of all dietary supplement ingredients). Unfortunately, the dietary supplement industry is plagued by lack of compliance with these critical FSMA requirements and the FDA is beginning to crack down on firms with increased enforcement actions.

How does the dietary supplement industry, including raw material manufacturers and dietary ingredient suppliers, dietary supplement manufacturers, and dietary supplement brand owners referred to as Own Label Distributors (OLDs) avoid enforcement actions? What aspects of FSMA’s Preventive Controls for Human Foods, 21 CFR 117, apply to dietary supplements and what about other FSMA responsibilities like FSVP?

Join EAS Consulting Group’s FSMA and Dietary Supplement experts Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services and Allen Sayler, Senior Director for Food Consulting Services for an overview of the FSMA regulation and a deeper dive into those aspects which specifically apply to dietary supplements. Learn the crucial steps to compliance, including what must be included in a dietary supplement written and documented program as well as the FDA FSMA FSVP requirements applicable to dietary ingredients and dietary supplements sourced from outside the US.

Dietary Supplement OLDs, manufacturers and dietary ingredient suppliers all have an obligation to protect public safety and ensure compliance with all the applicable regulations. Understanding these FSMA requirements and their role in the supply-chain are key to ensuring compliance.