Structure/Function Claims Under DSHEA: What Indian Brands Get Wrong

Structure/function claims are the workhorse of US supplement marketing — and the place where Indian brands most often step over the line without realising it. The rules are specific, and the difference between a permitted claim and an implied disease claim can come down to a single word.

What a structure/function claim is

A structure/function claim describes the role of a nutrient or ingredient in maintaining the normal structure or function of the body — for example, "calcium supports strong bones" or "helps maintain healthy immune function". It does not claim to diagnose, treat, cure, or prevent a disease. That boundary is the entire point.

The three obligations brands forget

• Substantiation: the claim must be truthful, not misleading, and supported by competent and reliable scientific evidence held before the claim is made — not assembled after a challenge.
• The FDA disclaimer: structure/function claims must carry the statement that the claim has not been evaluated by the FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease.
• FDA notification: the manufacturer must notify the FDA of the claim within the required window (generally within 30 days of first marketing the product with that claim).

The disease-claim trap

The most common error is drifting into an implied disease claim. Referring to a specific disease, using before/after imagery, citing a condition, or borrowing drug-like language can convert a permitted structure/function claim into an unlawful disease claim. Words like "treats", "cures", "prevents", or naming a diagnosed condition are red flags.

Build the evidence file first

The safest sequence is: decide the claim, assemble the substantiation, confirm it is a structure/function claim and not a disease claim, add the disclaimer, and file the FDA notification. Brands that market first and document later are the ones that receive warning letters.

Frequently Asked Questions