This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling, and advertising dietary supplements.
Why Should Attend
With the FDA beginning to take a stronger stance on Dietary Supplement enforcement, it is important for companies to verify that their products comply with the latest regulations and provisions.
This 120-minute training will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations. We will also cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labeling, and acceptable marketing claims. An update on the FDA’s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011) will also be discussed.
2.0 RAC CREDITS
RAPS - This course has been pre-approved by RAPS as eligible for up to 2 credits towards a participant's RAC recertification upon full completion.
Agenda
Dietary Supplement Overview
- What is a dietary supplement?
- Supplements vs. Pharmaceuticals/OTC Drugs/Conventional Foods
Regulatory Structure
- FDA Structure regarding Dietary Supplements
- Industry Groups
History of Dietary Supplement Regulation
- Early History & DSHE
- Code of Federal Regulations
Manufacturing/Distributor Considerations
- Company & Facility Registration
- GMP Requirements
Dietary Ingredients
- What qualifies as a dietary ingredient?
- Old dietary ingredients vs. New dietary ingredients
- New Dietary Ingredient Notification (NDIN)
- Updated New Dietary Ingredient Guidance from FDA
Labeling Considerations
- Display Panels & Layout
- Supplement Facts Panel Requirements
- Labeling Claims
- Health vs. Disease vs. Structure/Function claims
- Disclaimers/Substantiation
- Notification of labeling claims to the FDA
- Dietary Supplement Labeling Act
Advertising Considerations
- FDA vs. FTC jurisdiction & Enforcement
- Expressed vs. Implied Claims
- Disclosures & Claim Substantiation
- Testimonials
Current Events
Questions & Answers
Speakers
Travis Austin MacKay,
Plexus WorldwideTravis MacKay is the Director of Regulatory Affairs for Plexus Worldwide, a leading direct sales company with a range of products dedicated to helping others obtain health and happiness. He currently oversees international regulatory compliance activities driving strategic direction focused on claims development and substantiation strategy, product development and commercialization, international formulation considerations, and quality testing & validation.
Travis has 20 years of quality and regulatory experience, including prior regulatory affairs leadership positions within well-respected, global consumer product companies. He has a passion for mentoring regulatory professionals to develop robust compliance systems that keep business moving forward.
Travis Graduated from the University of Utah in 2002 with a B.S. in Behavioral Science and Health (Human Health Emphasis). He is a fly-fishing enthusiast, a college football fan, an exercise junky, and a lover of classic cars. He escapes the noise by spending time with his family in the outdoors of beautiful Arizona.
Who Should Attend
This course will be beneficial to the following personnel in Dietary Supplement manufacturing companies:
- Executives of Dietary Supplement companies
- Regulatory Compliance Professionals
- Quality Assurance Professionals
- Dietary Supplement Manufacturers
- Dietary Supplement Distributors
- Sales/Marketing Personnel
