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

This 90 minute 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.

Why Should You Attend:

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 Seminar:

• 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 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.
• 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