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What you may say

The line: function, not disease

Updated

On this page7
One sentence separates a supplement from an unapproved drug: a structure/function claim describes an effect, a disease claim names a condition.

What is allowed

A statement about how an ingredient affects the structure or function of the body. Supports a normal function. Helps maintain something already healthy. Describes a role an ingredient plays in ordinary physiology. The statement has to be truthful, not misleading, and substantiated before you make it.

What is not

Anything that says or implies the product treats, prevents, cures or mitigates a disease. Naming a condition is the obvious version. The subtle versions do the same work without the word: describing symptoms, naming a drug class, or putting the product next to a disease in a way a reader joins up themselves.

Implication counts

This is where people get caught. An image, a product name, a customer testimonial you republish, a list of conditions on a blog, an answer in a comment thread. If the overall impression is that the product treats something, the claim has been made regardless of how the label is worded.

It applies everywhere, not just the label

Your website, your social posts, your emails, your market stall sign, anything a customer reads. Keeping the panel immaculate and writing freely elsewhere is the most common version of this mistake and it does not work.

Substantiation comes first, not after

The rule is that you hold substantiation that the statement is truthful and not misleading at the time you make it. Writing the claim and looking for support later is backwards, and the certification in the notification asks you to say you have it.

When in doubt, describe less

A narrower claim you can defend is worth more than a broad one you cannot. The category rewards restraint, which is an uncomfortable thing to tell somebody who believes in their product.

References

21 CFR 101.93, Certain types of statements for dietary supplements, which carries the disclaimer word for word and the requirement to notify FDA within 30 days of first marketing a product bearing a structure/function statement. law.cornell.edu
Written from federal regulation, not from a laboratory and not from a lawyer. The claims rules here are specific and strictly enforced, and the difference between a permitted statement and a drug claim is narrower than it looks. Treat anything here as a starting point for advice on your own label rather than as clearance for it.