FDA Standards for Making Health Claims for your Dietary Supplements

September 8, 2015 By

shutterstock_163244129Companies marketing dietary supplements aim to make claims for their products in order to help successfully market their products/product lines. As such, claims being made for dietary supplements are a key to business strategy. Marketing teams may brainstorm claim options for their dietary supplements and if a scientific/regulatory expert is available on staff, the claims may be reviewed with respect to the evidence on-hand for the product or relevant ingredient. However, often this is not the case, and the evidence may not be assessed from a scientific and regulatory perspective. In fact, a simple PubMed search with X ingredient and the effect/outcome can generate many hits which might not be strictly reviewed to see if the dietary supplement claim in question is supported. Which begs the question – what evidence meets the FDA standards for making health claims for your dietary supplements?

Substantiating Claims with the FDA

Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 343(r)(6)), a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim is required have substantiation for the claim that is truthful and not misleading. In the Act, there is no mention of the type of evidence that is required for substantiation for dietary supplement claims. However, the FDA has provided some guidance as to their current thinking for substantiation for dietary supplement claims under the Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403 (r)(6) of the Federal Food, Drug and Cosmetic Act, Dec 2008. This guidance document indicates the FDA’s stance for evidence: “Although there is no pre-established formula as to how many or what type of studies are needed to substantiate a claim, we, like the FTC, will consider what the accepted norms are in the relevant research fields and consult experts from various disciplines.”

The Right Evidence for your Health Claims

With this said, the FDA stipulates as to what types of evidence may substantiate a claim:

  • Human studies: Intervention studies (note: “randomized, double-blind, parallel group, placebo-controlled trials offer the greatest assessment of a relationship between a dietary supplement and outcome”).
  • Human studies: Observational studies (includes Case reports, Case-series studies, Case-control studies, Cohort studies, Cross-sectional studies, Time-series studies, and Epidemiological studies.

Importantly, the FDA also stipulates as to what types of information are useful as background to support a claim (but alone may not be adequate to substantiate a claim):

  • Animal studies
  • In vitro studies
  • Testimonials and other anecdotal evidence
  • Meta-analysis
  • Review articles
  • Comments and Letters to the Editor
  • Product monographs

The FDA’s guidance document is not legally binding, but rather provides the FDA’s current thinking on evidence for dietary supplement claims. Therefore, the right type of evidence is not clear-cut and what is ‘scientifically sound and reliable’ evidence may be different depending on the nature of the claim and the message it conveys to consumers.   Therefore, it is very important for companies to be confident in their claim substantiation in order to prevent any hassle down the road with the FDA or FTC.

We’re Here to Help

The bottom line is: if you do not have an expert in-house (with a regulatory and scientific background), be sure to have the efficacy evidence reviewed or even provided by an outside party, who can help your team apply the FDA standards for making health claims for your dietary supplements to the evidence you have gathered.

dicentra can assist in reviewing evidence for Dietary Supplement Claims to ensure that you have the right type of evidence and substantiation documentation on-hand for Dietary Supplements for the US market.

FDA Consultant dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. Our on-staff professionals include food safety and quality control experts, former government officials, medical doctors, engineers and toxicologists to handle all of your needs. Contact us at info@dicentra.com or at 1-866-647-3279.


The Federal Food, Drug, and Cosmetic Act (the Act). (21 U.S.C. 343(r)(6)). Available at:

Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403 (r)(6) of the Federal Food, Drug and Cosmetic Act, Dec 2008. Available at: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm073200.htm