Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates

Instructor: James Russell 
Product ID: 702154
  • Duration: 90 Min

recorded version

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Read Frequently Asked Questions

This training will review the dietary supplement regulations in the USA and explain how to verify that your products are compliant with the most recent regulations and provisions. It covers the FDA regulatory structure and considerations for manufacturing, labeling and advertising dietary supplements.

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 An update on FDA’s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labeling Act (both introduced in 2011) will also be discussed.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

  • 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/Distributor 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.
  • Current Events
  • Questions & Answers.

Who Will Benefit:

This course will be beneficial to the following personnel in Dietary Supplement manufacturing companies:

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

Instructor Profile:

Mr. Russell, is the Director of Regulatory Affairs and Business Development for RJR Consulting Inc, a leading global regulatory consulting company servicing the Life Science and Consumer Products industries. Mr. Russell has 14 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 supply chain, regulatory, device business strategy and product data quality. Mr. Russell is also a participating member of the Regulatory Affairs Professionals Society (RAPS) and associate member of the Consumer Healthcare Products Association (CHPA).

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