The FDA, with assistance from the FTC, has become increasingly aware of the large amount of dietary supplements that have come onto the market since the passage of the Dietary Supplement Health and Education Act in 1994. A growing public demand for supplements, along with a relatively relaxed pre-market approval process, has resulted in a flurry of companies creating and marketing their own dietary supplements in the United States. With 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 live, interactive webinar 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 labelling and acceptable marketing claims. An update on FDA’s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labelling Act (both introduced in 2011) will also be discussed.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.
I. Dietary Supplement Overview
? What is a dietary supplement?
? Supplements vs. Pharmaceuticals/OTC Drugs/Conventional Foods
II. Regulatory Structure
? FDA Structure regarding Dietary Supplements
? Industry Groups
III. History of Dietary Supplement Regulation
? Early History & DSHEA
? Code of Federal Regulations
IV. Manufacturing Considerations
? Company & Facility Registration
? GMP Requirements
V. 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
VI. Labeling Considerations
? Display Panels & Layout
? Supplement Facts Panel Requirements
? Labeling Claims
o Health vs. Disease vs. Structure/Function claims
? Notification of labeling claims to FDA
? Dietary Supplement Labeling Act
VII. Advertising Considerations
? FDA vs. FTC jurisdiction & enforcement
? Expressed vs. Implied Claims
? Disclosures & Claim Substantiation
VIII. Questions & Answers
Who Should Attend?
- Executives of Dietary Supplement companies
- Regulatory Compliance Professionals
- Quality Assurance Professionals
- Dietary Supplement Manufacturers
- Dietary Supplement Distributors
- Sales/Marketing Personnel
Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry.
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