FDA Updates Rules for Structure-Function Claims on Dietary Supplements

By Cynthia Gomez

The U.S. Food and Drug Administration issued updated guidance that spells out expectations for structure-function claims on dietary supplement labels. Officials provided fresh examples of acceptable and unacceptable phrasing. The document reinforces boundaries that separate these claims from disease claims, which remain off limits.

This clarification arrives as the agency steps up attention on immune support statements and cognitive health language that often appear in marketing. Regulators want labels to stay truthful and not mislead buyers. [1]

The FDA groups label claims into four main categories. Authorized health claims, qualified health claims, nutrient content claims, and structure-function claims each carry distinct requirements. [1]

Structure-function claims describe effects on normal body processes. A product may state that it “helps maintain healthy bones” or “supports immune function.” Yet the same product cannot claim it “reduces arthritis pain” or “prevents the flu.” Such statements would classify the item as an unapproved drug. [1][3]

Every structure-function claim must display a standard disclaimer. The exact wording reads: “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.” Manufacturers place this text near the claim. [3]

Manufacturers must hold competent and reliable scientific evidence before marketing any structure-function claim. They keep this evidence on file and can be asked to produce it during an FDA review. The agency does not pre-approve supplements or their labels. [2]

Recent enforcement has targeted products with overstated immune or brain-health claims that stray into disease territory. The new examples in the guidance aim to reduce such violations.

What this means

The updated guidance gives companies concrete language models to follow. It highlights the line between describing normal body functions and implying disease treatment. For consumers, labels may become more consistent, though the same wide variety of products and claims will remain on store shelves.

Key takeaways

• Dietary supplements cannot claim to diagnose, mitigate, treat, cure, or prevent disease because such language classifies them as unapproved drugs. [1]
• Structure-function claims require the precise FDA disclaimer stating that the agency has not evaluated the statement. [3]
• Companies must keep competent and reliable scientific evidence on file before using any structure-function claim. [2]
• The FDA does not review or approve dietary supplement labels prior to marketing. [2]
• Guidance documents reflect the agency’s current thinking on compliant practices but do not create new legal obligations. [1][4]

Limitations

FDA guidance documents represent the agency’s current thinking but are not legally binding regulations. They do not cover every possible claim scenario or international regulations. Rapidly evolving product formulations such as novel botanicals may prompt future clarifications. The materials align with existing rules for products sold inside the United States.

FAQ

What constitutes a structure/function claim versus a disease claim on dietary supplements?
Structure-function claims describe how a nutrient affects normal body structure or function. Disease claims suggest the product can diagnose, treat, cure, or prevent a specific disease and are not allowed on supplements. [1][3]

What scientific substantiation is required for claims under the updated FDA guidance?
Manufacturers must possess competent and reliable scientific evidence that supports the claim. This evidence stays on file and may be requested by the FDA. [2]

What disclaimers are required on dietary supplement labels making structure/function claims?
The label must include the statement: “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.” [3]