Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States

Why Should You Attend:

Your organization has developed a truly innovative dietary supplement and wants to advertise its benefits broadly through multiple media channels. As a regulatory professional, you need to make sure that all efficacy claims used in advertising and labelling are compliant and do not draw unwanted attention from the Federal Trade Commission and the Food and Drug Administration.

The Federal Food, Drug, and Cosmetic Act requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim has substantiation that the claim is truthful and not misleading. Additionally, the FTC Act strictly prohibits unfair or deceptive acts or practices.

The FTC has brought several enforcement actions against dietary supplement companies, and in some cases levied multi-million-dollar fines and penalties for violative advertisements. Simply put, any advertisement for your product must be “truthful and not misleading”. To meet this requirement, the FTC has stated that product efficacy claims must be substantiated by “competent and reliable scientific evidence”. But how do you know if your scientific evidence meets FTC’s expectations. This course provides strategies to: 1) identify claims; 2) characterize and rank the different types of claims; and 3) determine the level of scientific evidence needed to substantiate different types of claims.

• Is your dietary supplement substantiation “unhealthy” for your organization?
• Are your dietary supplement claims based on competent and reliable scientific evidence?
• How does FTC’s “competent and reliable scientific evidence” standard apply to your dietary supplement claims?
• Does the FTC have your dietary supplement claims in its cross-hairs? Learn effective strategies to substantiate product claims and minimize risk.

Areas Covered in the Webinar:

• Regulatory requirements for substantiating dietary supplement claims for advertising and labeling
• Identifying different types of dietary supplement claims
• Competent and Reliable Scientific Evidence
• How to characterize/rank product claims
• Risk-based approach to scientific substantiation
• Scientific evidence recommendations (based on risk)
• Qualifying claims
• Linking scientific evidence to finished products
• Linking scientific evidence to botanical extracts

Who will benefit:

• Regulatory Affairs Professionals
• Corporate Counsel
• Legal Affairs
• Technical/Scientific Affairs Professionals
• Research & Development
• Marketing/Product/Brand Management
• Copy/Technical Writers
• CEOs

Travis Austin MacKay
Director of Regulatory Affairs, Plexus Worldwide

Travis MacKay is the Director of Regulatory Affairs for Plexus Worldwide, a leading direct sales company with a range of products dedicated to helping others obtain health and happiness. He currently oversees international regulatory compliance activities driving strategic direction focused on claims development and substantiation strategy, product development and commercialization, international formulation considerations, and quality testing & validation.

Travis has 20 years of quality and regulatory experience, including prior regulatory affairs leadership positions within well-respected, global consumer product companies. He has a passion for mentoring regulatory professionals to develop robust compliance systems that keep business moving forward.

Travis Graduated from the University of Utah in 2002 with a B.S. in Behavioral Science and Health (Human Health Emphasis). He is a fly-fishing enthusiast, a college football fan, an exercise junky, and a lover of classic cars. He escapes the noise by spending time with his family in the outdoors of beautiful Arizona.

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