US Dietary Supplements Certification Includes the below Courses.
- Training #1 Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations (2 hrs)
- Training #2 US Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labelling Issues and FDA Updates (2 hrs)
- Training #3 Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States (3hrs)
Training Agenda
Training #1 Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations
- Compliance and what you can do to protect yourself and your company.
- Tips on how to market dietary supplements that benefit health
- Regulations governing the promotion and advertising of dietary supplements
- Types of claims FDA allows will be discussed, e.g., Qualified Health Claims, Structure/Function Claims and Nutrient Content Claims
- Risk-based approach to efficacy substantiation
- Enforcement actions and what to expect if government is investigating your firm
- How FDA and FTC regulations intertwine
- Real world examples of acceptable versus unacceptable product claims
Training #2 US Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labelling Issues and FDA Updates
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 FDA.
- Dietary Supplement Labeling Act.
Advertising Considerations
- FDA vs. FTC jurisdiction & enforcement.
- Expressed vs. Implied Claims.
- Disclosures & Claim Substantiation.
- Testimonials.
Current Events
Questions & Answers.
Training #3 Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States
- Regulatory requirements for substantiating dietary supplement claims for advertising and labeling
- Identifying different types of dietary supplement claims
- Competent and Reliable Scientific Evidence
- How to characterize/rank product claims
- Risk-based approach to scientific substantiation
- Scientific evidence recommendations (based on risk)
- Qualifying claims
- Linking scientific evidence to finished products
- Linking scientific evidence to botanical extracts
- Regulatory requirements for substantiating dietary supplement claims for advertising and labeling
- Identifying different types of dietary supplement claims
- Competent and Reliable Scientific Evidence
- How to characterize/rank product claims
- Risk-based approach to scientific substantiation
- Scientific evidence recommendations (based on risk)
- Qualifying claims
- Linking scientific evidence to finished products
- Linking scientific evidence to botanical extracts
- Regulatory requirements for substantiating dietary supplement claims for advertising and labeling
- Identifying different types of dietary supplement claims
- Competent and Reliable Scientific Evidence
- How to characterize/rank product claims
- Risk-based approach to scientific substantiation
- Scientific evidence recommendations (based on risk)
- Qualifying claims
- Linking scientific evidence to finished products
- Linking scientific evidence to botanical extracts
Course Provider
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
