Naming, and the claims that come with it

In this category the words are regulated more tightly than the product, and a product name can itself be a claim.

The claim is the regulated part

DSHEA permits structure/function claims: statements that a nutrient affects the structure or function of the body. "Supports immune function." "Helps maintain healthy joints."

It does not permit disease claims: that a product treats, prevents, cures or mitigates a disease. Those make the product an unapproved drug.

The distinction is not about evidence. A well-evidenced disease claim is still a disease claim.

Structure/function and the disclaimer

A structure/function claim requires two things: substantiation, meaning competent and reliable evidence you hold, and the DSHEA disclaimer stating that FDA has not evaluated the statement and the product is not intended to diagnose, treat, cure or prevent any disease.

The disclaimer must appear wherever the claim appears, not only on the label. Missing it is a common failures in the category and it is a sentence.

What crosses the line

Naming a condition. Using words like treats, cures, prevents, heals. Implying a drug effect through imagery or comparison. Citing research about a disease in a way that implies the product addresses it.

And product names: "Immune Defense" is structure/function shaped; "Cold Fighter" is a disease claim in a brand name and it is on every tub you print.

Auditing everything

Claims attach wherever they appear: label, website, marketplace listing, email, social post, influencer copy, and customer reviews you repost or feature.

The reposted testimonial is the usual failure. A customer writing that your product cured their condition becomes your claim the moment you amplify it, disclaimer or not.

Write down what you will and will not say, and give it to anybody who writes for you.

References