Dietary Supplement Regulatory Compliance in the United States Labeling Product Claims
Overview: 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 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 An update on FDA’s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011) will also be discussed.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.
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.
Areas Covered In the Session:
Dietary Supplement Overview
What is a dietary supplement?
Supplements vs. Pharmaceuticals/OTC Drugs/Conventional Foods
FDA Structure regarding Dietary Supplements
History of Dietary Supplement Regulation
Early History & DSHEA
Code of Federal Regulations
Company & Facility Registration
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
Display Panels & Layout
Supplement Facts Panel Requirements
Health vs. Disease vs. Structure/Function claims
Notification of labeling claims to FDA
Dietary Supplement Labeling Act
FDA vs. FTC jurisdiction & enforcement
Expressed vs. Implied Claims
Disclosures & Claim Substantiation
Questions & Answers
Who will benefit:
Executives of Dietary Supplement companies
Regulatory Compliance Professionals
Quality Assurance Professionals
Dietary Supplement Manufacturers
Dietary Supplement Distributors
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.
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