Claims Substantiation for Dietary Supplements: A Scientific and Legal Approach

By Paula Brock, Ph.D., MSCI, 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.

Whether implied or explicitly stated, claims about health benefits or safety need to be substantiated with “competent and reliable evidence.” A clearer definition of “competent and reliable evidence” has recently been provided in the updated FTC guideline. The evidence depends on several factors including the type of product and the type of claim. In general, four attributes of the evidence must be considered:

1. Type of evidence
   • Unbiased evidence. Are there any personal or financial conflict of interest for the evidence being used?
   • Expertise: Are the data obtained from studies conducted by experts in the field?
   • Science: Anecdotal evidence such as testimonials from consumers or even doctors are not considered to be competent and reliable evidence since it isn’t based on scientific data.
2. Quality of the evidence
   • Randomized human clinical trials are the highest quality evidence and are expected for substantiation. However, epidemiological studies are accepted depending on the type of ingredient and claim. Animal and in vitro data alone are rarely sufficient. It will depend on the claim when human studies aren’t feasible.
   • Even high-quality studies need to be analyzed for sample size, duration, outcome measures, placebo, blinding, and statistics and assessed by someone with the right scientific expertise.
   • Public health recommendations, monographs, books and other similar sources: The references within those sources need to be evaluated for the same parameters mentioned above.
3. Quantity
   • Amount of evidence that is sufficient for substantiation is not specified. However, demonstration that the results were replicated by a separate group of scientists add to the evidence. Quality is more important than quantity.
   • Totality of evidence. It is important to evaluate the breadth of evidence available for the claim as opposed to pick and choose the evidence that supports the desired claim.
4. Relevance of the evidence
   • Provide a discussion of how the study dose relate to the ingredient amount in the product.
   • Is the product ingredient the same as the ingredient used in the study? For botanicals, the plant part(s) as well as extraction methods are considered.
   • Is the evidence from a product with a mix of ingredients? How does it apply to a single-ingredient product?
   • Topical use studies don’t substantiate orally administered products.
   • Study population. Are the study participants diagnosed with severe/rare diseases? How would the claim benefits apply to the general population?
   • Outcome measure. Does the outcome measure of the study support the claim for the product?

Other aspects pointed out in the FTC substantiation guidance: 1. Disclose the claims properly; 2. Provide disclosure of important information about the evidence (e.g., the effects only observed in athletes or safety issues with long-term use); 3. Discuss ingredients’ interactions for products with multiple “active” ingredients in relation to efficacy and safety.

EAS Consulting Group provides services such as developing claims, claim substantiation documentations, safety and toxicity assessments, and study designs to support the dietary supplement industry and other stakeholders.