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.
About the Presenters
Tara Lin Couch, Ph.D.
Senior Director of Dietary Supplement and Tobacco Services
Dr. Tara Lin Couch is a Ph.D. Analytical / Organic Chemist with exceptional analytical abilities and over 25 years of diverse laboratory and regulatory experience in academic, field, contract, and manufacturing environments. She is a sought-after expert on issues pertaining to Quality Control in pharmaceutical, dietary supplement and tobacco manufacturing facilities including the establishment of specifications and the development of well-organized, sophisticated laboratories. As a Senior Director for EAS Consulting Group, Dr. Couch has assisted numerous companies with the development, improvement, and implementation of strong Quality Systems that are scientifically sound, efficient, practical, and compliant with all FDA regulations. She also performs mock FDA inspections, gap-analyses, and contractor facility audits. In addition, Dr. Couch provides GMP and laboratory training via seminar, webinar, and on-site presentations.
Senior Director of Food Consulting Services
Allen Sayler is the Senior Director for Food Consulting Services at EAS. Mr. Sayler had been an independent consultant for EAS since 2012 and promoted in 2017. His expertise in the areas of food processing, particularly in the area of dairy processing, infant formula, bakery products, food additives, botanical products and food packaging as well as GSFI Third-Party Certification programs such as Safe Quality Foods (SQF) has been of great value to EAS clients. Allen has spent more than 30 years as a food processing and regulatory expert, with half of the time serving the industry and the other have as a state and federal government employee. For twelve of those years, he served as vice president of regulatory affairs and international standards at the International Dairy Foods Association. Prior to that, his government career included working on dairy standards and grading programs at the Dairy Division of USDA’s Agricultural Marketing Service, FDA’s Milk Safety Branch – including a stint as acting chief of the branch and ten years as Assistant Dairy Commissioner for the North Dakota Department of Agriculture. Prior to joining EAS full time, he was a Managing Partner of the Center for Food Safety & Regulatory Solutions. His international experience includes representing the US food processing industry at the Codex Committees on Food Additives, Food Labeling, Food Hygiene and Milk & Milk Products.
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