Robert J. Russell 2012 - Dietary Supplement Regulatory Compliance in the United States: Labeling, Product Claims & Updates from the FDA

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 An update on FDA’s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labelling Act (both introduced in 2011) will also be discussed.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

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

-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 Should Attend?

- Executives of Dietary Supplement companies

- Regulatory Compliance Professionals

- Quality Assurance Professionals

- Dietary Supplement Manufacturers

- Dietary Supplement Distributors

- Sales/Marketing Personnel

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