Dietary Supplement Claims and Labeling

Why Should You Attend:

Dietary Supplements are one of the fastest growing food product categories in the United States, especially with a growing number of consumers taking an active role in the maintenance and promotion of health. While the product category was created and defined by Congress, the US Food & Drug Administration (FDA) has the authority to oversee claims and labeling of dietary supplements. The expansion of product offerings in this category has been met by an increase in FDA monitoring and enforcement. It is therefore important for dietary supplement companies to ensure their product labels and accompanying claims are fully compliant with applicable statutes and regulations.

This 90 minutes session is designed for dietary supplement companies, and is focused on helping those companies develop product labels and claims that comply with applicable statutory and regulatory requirements. Functional groups that have regulatory, legal, marketing, product development consumer relations, external relations, or clinical research responsibility will benefit from the information shared in this webinar.

At the end of this webinar, the speaker will handle your specific questions related to the topic.

Areas Covered in the Webinar:

• Product classification.
• Statutory definition of Dietary Supplement.
• Compare and contrast with other FDA product classifications.
• FDA oversight of Dietary Supplements.
• Key FDA offices; senior officials and managers.
• Applicable statutes, regulations and guidances.
• Dietary Supplement labeling.
• FDA requirements for Principal Display Panel.
• FDA requirements for Supplement Facts box.
• Other statutory and regulatory labeling requirements.
• Types of dietary supplement claims.
• Unqualified health claims.
• Qualified health claims.
• Structure-Function claims.
• Nutritive value claims.
• Claim substantiation.
• Clinical and nonclinical studies.
• Truthful and non-misleading advertising.
• FDA and FTC standards.
• Enforcement trends
• Audit readiness / documentation.

Who Will Benefit:

• Regulatory affairs
• Marketing
• Professional Relations
• External Relations
• Consumer Relations
• Product Development
• Clinical Research
• Legal
• Internal Auditors
• Quality Assurance
• Risk Management

Instructor Profile:

Dr. Bradley Johnson, Ph.D., is Owner and Principal of BN Johnson Consulting, LLC, and brings more than 20 years of corporate technical and management experience to this Compliance Online training event. In his consumer product career, Bradley has managed regulatory resources to support upstream innovation and post-market compliance of many conventional foods, dietary supplements, OTC drugs, cosmetics and medical devices. His areas of expertise include regulatory strategy & option analysis, regulatory support for research, development and commercialization (including formulation, packaging, quality, stability, claims, labeling, advertising), as well as support for product recalls, site inspections, and new supplier evaluations. He is also skilled in regulatory team building and capability development, negotiation with regulators, and crisis management.

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