§9.2 Structure/Function Claims

• Jurisdiction: United States
• Publication year: 2022

§9.2 Structure/Function Claims

When passing DSHEA, Congress was aware that dietary supplement manufacturers often used "claims" of statements on the labels or labeling of the supplement in support of its benefits.⁸

Section 6 of DSHEA allowed dietary supplement manufacturers to make statements about a supplement in the following circumstances:

• the statement claims a benefit to a nutrient deficiency disease and discloses the rate of that disease in the United States;
• the statement describes the role of a nutrient or dietary ingredient to affect the structure or function of the human body;
• the statement refers to the mechanism by which a nutrient or dietary ingredient maintains such structure or function; or
• the statement describes the general well-being resulting from consumption of a nutrient or dietary ingredient.⁹

These statements are referred to as "structured/function" claims.¹⁰ Whereas the Act defined "drugs" as being articles intended to affect the "structure or . . . function of the body,"¹¹ it was Congress' specific intent that these claims would not give dietary supplement drug status.¹² To make these statements legally, manufacturers are required to:

• have substantiation that the statement is truthful and not misleading;¹³
• insert the disclaimer on the label or labeling that "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.";¹⁴ and
• notify the Secretary no later than thirty days after the first marketing of the dietary supplement that the statement is being made.¹⁵

An example of a structure/function claim was given in the Congressional Record as,

"Calcium builds strong bones."¹⁶

The FDA promulgated regulations for implementation of DSHEA structure/ function claims. 21 CFR §101.93, published in the Federal Register, sets forth the notification method for structure/function claims as,

Not later than 30 days after the first marketing a dietary supplement containing structure/function claims, the manufacturer, packer, or distributor (collectively "manufacturer") shall notify the FDA at the Office of Special Nutritionals;¹⁷

The notification shall include:¹⁸

(1) the name and address of the manufacturer;
(2) the text of the statement;
(3) the name of the dietary ingredient or supplement;
(4) the name of the dietary supplement (including brand name) on whose label or labeling the statement appears;
(5) certification

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