Why Should You 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 90 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 An update on FDA’s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011) will also be discussed.
At the conclusion of this 75 minute presentation, there will be a 15 minute Q&A session with the speaker.
Areas Covered in the Seminar:
- 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 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.
- Questions & Answers.