12 May 2021 Jae Haroldsen

The multibillion-dollar dietary supplement industry covers every aspect of a person’s health from natural products to aid sports performance to necessary micronutrients for improved cognitive functioning.

For the safety and wellbeing of the public, the Food and Drug Administration (FDA) regulates dietary supplements products’ labeling to give consumers clear and accurate information regarding the contents of the supplement and their associated claims. The FDA regulates health, nutrient content, and structure/function claims in the following ways.

 

Health Claims

Health claims show a relationship between an ingredient in a dietary supplement and a reduced risk of a health-related condition or disease. An example of a health claim for a calcium supplement is: Lifelong adequate calcium may reduce the risk of osteoporosis.

A supplement’s health claim can be determined from the FDA in one of the following three ways.

1990 Nutrition Labeling and Education Act (NLEA) - The FDA issues regulations authorizing health claims for given supplements after reviewing and evaluating the scientific evidence for a clear substance/disease relationship. The FDA provides numerous health claims for known substance/disease relationships on their Authorized Health Claims site.

1997 Food and Drug Administration Modernization Act (FDAMA) - FDAMA allows companies to submit a supplement health claim for FDA approval. This claim must include an authoritative statement by 1) a scientific body of the US government responsible for public health protection or nutrition research or 2) the National Academy of Sciences (a private, non-profit organization of the country's leading researchers) regarding the evidence of the health claim. Submitted health claims may be used 120 days after submission to the FDA unless the submission does not include all the required information.

Surmounting Scientific Evidence - The FDA’s interim procedures for a health claim for dietary ingredients in the labeling of Conventional Food and Dietary Supplements Product fall into play when there is surmounting scientific evidence for a health claim, but the evidence falls short of FDA requirements. If the FDA finds a supplement’s ingredients evidence credible and can be quantified to prevent misleading consumers, they will issue a letter to specify the health claim’s language and the circumstances for which it can be used.

 

Nutrient Content Claims

The amount of a nutrient in the supplement establishes the nutrient content claim. Most nutrient content claims apply only to those ingredients that have an established Recommended Daily Value (RDV). Daily Values (DV) are given as a percentage on labels for dietary supplements in relation to the nutrient’s RDV. RDV and DV are governed under the NLEA. For Example, if a supplement contains 200% calcium, it means it contains 2,000 mg of calcium per serving based on calcium’s RDV.

 

Structure/Function Claims

A structure or function claim describes the role of a nutrient to affect the structure or normal role in the human body. For example, a structure claim for calcium would be: Calcium builds strong bones.

The Dietary Supplement Health and Education Act of 1994 (DSHEA) regulates dietary supplement labels’ claims of general well-being and disease claims related to nutrient deficiency.

However, since the FDA does not specifically approve or disapprove of structure or function claims, DSHEA requires a “disclaimer” on the labeling notifying the consumer that the claim has not been evaluated by the FDA. Also, when using a structure or function claim, DSHEA requires a “disclaimer” on the label stating, “this product is not intended to diagnose, treat, cure, or prevent any disease.”

The FDA prosecutes companies selling dietary supplements without proper labeling or with fraudulent label claims. Origin Nutraceutical works to help our clients build a trustworthy, high-quality brand that conforms with all labeling requirements and claims. Give us a call today!

(This article is intended to provide general information regarding FDA’s labeling requirements for dietary supplement products. In this article, Origin Nutraceutical is not providing legal advice for dietary supplement labeling.)

The content of Origin Nutraceutical’s website is for information only, not advice or guarantee of outcome. Information is gathered and shared from reputable sources; however, Origin Nutraceutical is not responsible for errors or omissions in reporting or explanation. No individuals, including those taking Origin Nutraceutical products, should use the information, resources or tools contained within to self-diagnosis or self-treat any health-related condition. Origin Nutraceutical gives no assurance or warranty regarding the accuracy, timeliness or applicability of the content.

Sources:

“Label Claims for Food and Dietary Supplements.” US Food and Drug Administration. 2018. https://www.fda.gov/food/food-labeling-nutrition/label-claims-food-dietary-supplements

“Label Claims for Conventional Foods and Dietary Supplements.” US Food and Drug Administration. 2018. https://www.fda.gov/food/food-labeling-nutrition/label-claims-conventional-foods-and-dietary-supplements

Granato, Heather. “Developing Appropriate Substantiation Supplement Claims.” National Product Insider. 2020. https://www.naturalproductsinsider.com/claims/developing-appropriate-substantiation-supplement-claims

“Questions and Answers on Dietary Supplements.” US Food and Drug Administration. 2019. https://www.fda.gov/food/information-consumers-using-dietary-supplements/questions-and-answers-dietary-supplements