What regulatory or advertising standards govern cognitive claims for dietary supplements in the U.S.?
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Executive summary
Cognitive claims for dietary supplements in the United States are governed primarily by the Dietary Supplement Health and Education Act (DSHEA) and the Federal Food, Drug, and Cosmetic Act as implemented by the FDA, with advertising overseen by the Federal Trade Commission (FTC); manufacturers may make certain “structure/function” or qualified health claims about brain function so long as they follow DSHEA notification and disclaimer rules and avoid drug claims that would trigger the drug approval pathway [1] [2] [3]. The FTC requires that advertising claims be truthful, not misleading, and substantiated by “competent and reliable scientific evidence,” and the FDA’s guidance on substantiation aligns with that standard while reserving enforcement discretion in some borderline cases [4] [5] [6].
1. The legal architecture: DSHEA, the FD&C Act and agency split of labor
Congress created the modern statutory framework for supplements in DSHEA , which treats supplements as a category of food under the FD&C Act and authorizes certain label claims while prohibiting the marketing of supplements as drugs without FDA approval [1] [6]; FDA has primary authority over labeling and what constitutes a “drug” versus a supplement and maintains rules for health, qualified health, and structure/function claims [2] [7]. Advertising outside the label—television, online ads, infomercials—falls mainly to the FTC, which enforces truth-in-advertising standards under the FTC Act, coordinating with FDA under a liaison agreement [4] [8].
2. What kinds of cognitive claims are allowed, and which cross the line into drugs
Manufacturers may use structure/function claims that describe how a product affects the structure or function of the body—examples include claims that a supplement “supports memory” or “promotes cognitive function”—but such claims must be truthful, not misleading, and carry the statutory disclaimer “This statement has not been evaluated by the Food and Drug Administration,” and the maker must notify FDA of the claim [1] [3] [2]. Health claims that assert a relationship between a substance and reduced risk of a disease (for example, claims about dementia or cognitive decline) are subject to a higher FDA standard and often require either an FDA-authorized health claim based on “significant scientific agreement” or a “qualified” health claim with an evidentiary disclaimer and possible enforcement discretion [7] [9].
3. Evidence standards: “competent and reliable” science and FDA/FTC guidance
The FTC’s standard for advertising substantiation is “competent and reliable scientific evidence,” a phrase that guides what studies and data advertisers must possess before making claims [10] [4], and FDA says it intends to apply a standard consistent with the FTC when assessing the substantiation of dietary supplement claims and offers guidance on what sorts of evidence are appropriate [5]. Where scientific consensus exists, FDA’s “significant scientific agreement” standard under NLEA/NLEA-derived guidance will support stronger health claims; where evidence is emerging but not definitive, FDA may permit qualified claims if accompanied by clear disclosures describing the uncertainty [6] [7] [9].
4. Enforcement, practical limits, and competing interests
In practice, manufacturers do not need premarket approval to sell supplements or their cognitive claims, which places the burden on FDA and FTC to police the market through post-market enforcement such as warning letters, recalls, and litigation; FDA can remove unsafe or misbranded products and the FTC can pursue deceptive advertising, but resource constraints and the volume of products complicate enforcement [3] [8]. Industry groups emphasize compliance and voluntary standards—such as NSF/ANSI 173 for ingredient/label integrity—but also lobby for flexible enforcement and self-regulation, creating a tension between consumer-protection advocates who urge stricter FDA intervention and trade groups urging less prescriptive regulation [11] [12] [13].
5. Bottom line for cognitive claims and the information gap
A cognitive claim framed as “supports memory” or “promotes brain health” can be lawfully used as a structure/function claim provided the manufacturer has substantiation, files the required notification, and includes the FDA disclaimer; stronger claims tying a supplement to preventing or treating cognitive disease require either FDA-authorized health claims or qualified language backed by substantial evidence and subject to enforcement scrutiny [1] [5] [7]. Reporting and guidance documents make clear the standards but also expose gaps—no premarket approval, uneven enforcement, and a high evidentiary bar for disease-risk claims—so consumers and clinicians must read labels and advertising claims critically and look for independent verification such as third‑party testing or peer‑reviewed clinical evidence when a product promises cognitive benefits [3] [11] [8].