Claims Substantiation Seminar

It is required in the United States that manufacturers and other advertisers of dietary supplements such as distributors, retailers, and endorsers, have adequate substantiation that the claims made about their products are “truthful and not misleading”. The Federal Trade Commission (FTC) released an update of their substantiation guideline in December 2022. Combined with the FTC guideline, the Food and Drug Administration (FDA) guidelines and regulation provide the framework for claims and claims substantiation for U.S. dietary supplements.

This two-hour training will be a scientific dive into the regulatory requirement of claims substantiation. Several topics including the following will be discussed along with real case examples: which types of evidence are available and where to find them; what are high quality and low quality evidence; when is the evidence irrelevant to the claim being made; and how to write claims that can be substantiated.

About the Instructor

Paula Brock, Ph.D., MCSI 

Works directly with EAS’ Senior Director, Labeling, Cannabis and Claims Consulting Services to assure client satisfaction and project management. She collaborates with EAS consultants and clients to provide excellence in service. Dr. Brock facilitates food, dietary supplement, and cosmetic label compliance reviews, develops marketing materials for FDA and FTC compliance, including claims substantiation. She provides scientific services such as clinical study design, data analysis, herb-drug interaction studies, product formulation, safety and efficacy of ingredients, ingredient monograph writing, safety opinions, adverse event investigations, and develops claims and slides for marketing purposes. She serves as GRAS and NDI expert panelist.