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What goes wrong

A claim with no testing behind it

Updated

On this page9
Two of the available claims are tied to a percentage you have to have measured.

The two numbers

Standard effectiveness is 20 percent sweat reduction over a 24-hour period, and it unlocks "all day protection", "lasts all day", "lasts 24 hours" and "24 hour protection". Extra effectiveness is 30 percent and unlocks "extra effective".

They are thresholds, not adjectives

The regulation defines the words by the measurement, so using them without the data is not an exaggeration, it is a claim the monograph specifically conditions. That is a different kind of problem from puffery.

How it happens

A competitor says "24 hour protection" so it reads as standard category language. It is standard category language for products that have the data, which is not visible from the outside.

The base Uses phrase needs no number

Decreases, lessens or reduces underarm dampness, perspiration, sweat, sweating or wetness. That is the required statement and it is available without an effectiveness claim, which is worth knowing before anybody reaches for the bigger words.

And there is a stay on part of it

The limitation of the enhanced duration claim to 24 hours was stayed in 2004 until further notice. A stayed provision is exactly the thing to check in its current form rather than from a summary like this one.

Cosmetic deodorants have no such claims available

Because the claims are about sweat and a cosmetic deodorant does not act on sweat. "Lasts all day" on a cosmetic deodorant is ambiguous at best and an antiperspirant claim at worst.

Decide the claim set before the artwork

What you can prove determines what you may print, and the testing is not something that can be arranged after a print run. That sequence is the whole of the control.

Borrowed language is the mechanism

Nobody invents "24 hour protection"; they copy it from a product that has the data. Treating competitor labels as a template rather than as evidence of somebody else's testing is the specific habit to break.

References

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
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.