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Structure/Function Claims vs Disease Claims: What Supplement Labels Can Say

This content is for informational purposes only and does not constitute medical advice. Statements about dietary supplements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease. Individual results may vary — consult your healthcare provider before starting any supplement. Full disclaimer

A structure/function claim describes how a nutrient supports normal body processes — for example, 'calcium supports...

A structure/function claim describes how a nutrient supports normal body processes — for example, 'calcium supports strong bones.' A disease claim says a product can diagnose, mitigate, or address a specific illness, which U.S. dietary supplements are not permitted to make. That legal line is why supplement labels carry the FDA disclaimer.

Key Takeaways

  • Structure/function claims describe how an ingredient supports normal body processes, like 'calcium supports strong bones.'
  • U.S. supplements may not claim to diagnose, mitigate, or address a specific illness — those are disease claims reserved for approved drugs.
  • The FDA disclaimer on the label signals a structure/function claim, not an FDA-reviewed medical claim.
  • Beyond the label, the FTC requires health claims in advertising to rest on competent and reliable scientific evidence.
  • Watch for disease claims disguised as a product name, image, or before-and-after — they imply a medical benefit without stating it.

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Why Supplement Labels Are Worded So Carefully

In the United States, dietary supplements are regulated under a 1994 law, the Dietary Supplement Health and Education Act (DSHEA). Under it, the FDA does not approve supplements for safety or effectiveness before they're sold, and there are strict limits on what a label may claim [1]. Understanding two categories of claim helps you read labels with clear eyes.

Structure/Function Claims (Allowed)

A structure/function claim describes how an ingredient affects the normal structure or function of the body. Examples:

  • 'Calcium supports strong bones.'
  • 'Fiber helps maintain regularity.'
  • 'Antioxidants support immune health.'

These are permitted *without* FDA pre-approval — but they can't promise to fix a medical problem, and they must be truthful and not misleading.

The Required Disclaimer

Any supplement making a structure/function claim must carry this FDA disclaimer on the label:

> '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.'

If you see that sentence, it's a signal the claim above it is a structure/function claim — not an approved medical claim.

Disease Claims (Not Allowed on Supplements)

A disease claim states or implies that a product can diagnose, cure, mitigate, treat, or prevent a disease. For a dietary supplement, those claims are off-limits — they would make the product an unapproved drug in the eyes of the FDA. Watch for disguised versions, too: a product name, an image, or a 'before and after' can imply such a claim without saying it outright.

Advertising Has Rules Too

Beyond the label, the Federal Trade Commission (FTC) requires that health claims in advertising be backed by 'competent and reliable scientific evidence' [2]. So even a legal-sounding label claim still has to be substantiated to be advertised.

What This Means for You

  • A structure/function claim ('supports,' 'helps maintain') is a softer, legally limited statement — not proof of a medical benefit.
  • The FDA disclaimer tells you the claim above it wasn't reviewed by the FDA.
  • Any supplement promising to address a specific illness is crossing a legal line — a reason for caution, not confidence.

Frequently Asked Questions

What's the difference between a structure/function claim and a disease claim?

A structure/function claim describes how an ingredient supports normal body processes, such as 'supports immune health.' A disease claim says a product can address a specific illness. Supplements may make the first kind, with a disclaimer, but not the second.

Why do supplements carry the 'has not been evaluated by the FDA' disclaimer?

Because the claim above it is a structure/function claim, which the FDA does not review before sale. The disclaimer is required to make clear the statement isn't an FDA-approved medical claim.

If a label says a supplement 'supports' something, does that mean it works?

Not necessarily. 'Supports' and 'helps maintain' are legally limited structure/function wording, not evidence of a medical benefit. To judge whether an ingredient does anything, look at the actual studies behind it, not the label phrasing.

Can a supplement legally say it cures or prevents an illness?

For a dietary supplement, no — claiming to address a named medical condition would make it an unapproved drug under U.S. rules. A product implying that, directly or through images and testimonials, is a red flag worth heeding.

References

  1. U.S. Food and Drug Administration (2022). Dietary Supplements: Structure/Function Claims and the Dietary Supplement Health and Education Act (DSHEA). U.S. Food and Drug Administration.
  2. U.S. Federal Trade Commission (2022). Health Products Compliance Guidance. U.S. Federal Trade Commission.