Live Webinar on:

Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA

Thursday, September 06, 2012 duration : 01:00 to 02:30 PM EDT

DESCRIPTION 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 An update on FDAs draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labelling Act (both introduced in 2011) will also be discussed . Agenda: 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

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Pricing Live ( Single registration ) : $189.00 Group ( Max 10 Attendee): $249.00 On Demand (Recording available):$289 Get Training CD : $449

Play Back - Unlimited views $319

-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 Claim -Health vs. Disease vs. Structure/Function claims -Disclaimers/Substantiation -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 -Testimonials VIII. Questions & Answers

Who will benefit

- Executives of Dietary Supplement companies - Regulatory Compliance Professionals - Quality Assurance Professionals - Dietary Supplement Manufacturers - Dietary Supplement Distributors - Sales/Marketing Personnel

About Speaker Mr. Russell is the Director of Regulatory Affairs and Business Development for RJR Consulting Inc, a leading global regulatory consulting firm servicing the Life Science and Consumer Products industries. Mr. Russell has 13 years of experience in the Life Science field, encompassing foods, dietary supplements, medical devices and pharmaceuticals. James joined RJR Consulting in 2009 to assist companies with their global regulatory, manufacturing and distribution needs. Prior to RJR, Mr. Russell worked for a large life science distribution company with organizational responsibilities including regulatory, supply chain, business strategy and product data quality. Mr. Russell currently teaches on a variety of regulatory topics and is a participating member of the Regulatory Affairs Professionals Society (RAPS).

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