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What goes wrong

A deodorant claimed to stop sweat

Updated

On this page9
The product stayed the same and the statute changed, which is the commonest failure in this category.

How it happens

A natural deodorant works well, a customer says it keeps them dry, and that becomes the marketing line. "Keeps you dry", "stops sweat", "no more wet patches" are all claims about reducing perspiration.

What it creates

An unapproved drug. An antiperspirant is a drug product that reduces the production of perspiration, and a product represented as doing that is one whether or not it contains a monograph active.

And the monograph is not then satisfied

No listed active at a permitted concentration, no antiperspirant identity statement, no Uses phrase from the menu, no four warnings, no Drug Facts panel. The claim brings all of that and the product has none of it.

The honest claims are still good ones

Controls odor, lasts through the day without reapplying, no baking soda, no aluminum, gentle on skin. All specific, all about odor or composition, and none of them a statement about sweat production.

"Aluminum free" is a composition claim and it is fine

It is also a useful one, because the monograph actives are aluminum compounds. Saying what is not in the product is a different act from claiming what the product does to a gland.

Check the reviews you quote

A customer testimonial about staying dry, reproduced on your own site, is your claim once you publish it. That is the route by which careful label copy gets undone by a marketing page.

Audit everything, not just the label

Listings, the website, social posts, email, influencer briefs. The label gets reviewed and the rest does not, which is the same finding four other properties here reach under four other statutes.

Write the claim rules down for whoever writes copy

One page listing what may and may not be said, with the reason beside each. The label gets lawyered and the Instagram caption does not, and the caption is where this actually happens.

References

21 CFR 350.3, the definition: "Antiperspirant. A drug product applied topically that reduces the production of perspiration (sweat) at that site." law.cornell.edu
21 CFR 350.50, Labeling of antiperspirant drug products. Paragraph (a) requires the product to be identified as an antiperspirant; (b)(1) gives the Uses statement as a choice of one of three verbs and one of five nouns; (b)(3) and (b)(4) tie duration and "extra effective" claims to 20 percent and 30 percent sweat reduction; (c) sets four verbatim warnings; (d) sets the direction "apply to underarms only". law.cornell.edu
21 CFR 350.10, Antiperspirant active ingredients, a closed list with maximum concentrations calculated on an anhydrous basis excluding buffer components: aluminum chloride up to 15 percent in an aqueous nonaerosol solution, the chlorohydrates and chlorohydrex glycols up to 25 percent, and the aluminum zirconium compounds up to 20 percent, with USP-NF atomic ratios where applicable. law.cornell.edu
Written from the federal monograph, not from a formulation bench. Whether a given product is a cosmetic or a drug turns on its ingredients and its claims, and that is a determination with consequences; nothing here substitutes for getting it right for a specific formula and label.