Claims Substantiation

Presented by Paula Brock, PhD., EAS Independent Consultant

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, PhD.

Dr. Paula Brock, PhD, has 20 years of experience in pharmacology and toxicology of drugs and dietary supplements, specializing in clinical and preclinical research, neuroscience, analytical pharmacology, molecular biology, and personalized medicine. More recently, she has focused on US and international regulations on dietary supplements, drug-herb interactions, and adverse event investigations. She has a bachelor’s in chemistry and pharmacy, master’s in clinical investigation, and PhD in pharmacology and toxicology. Dr Brock has held director to senior director positions in the industry. She has contributed to several scientific publications and received awards from the HHMI, APFE, ASPET and others.