Labeling

The warning most makers have not read

On this page9

What 740.10 requires What makes it unnecessary The conspicuousness rule applies to it Which means it cannot be hidden Small packages have a route, not an exemption Why this page exists What substantiation looks like in practice Do it before the artwork, not after References

"Warning--The safety of this product has not been determined." On the principal display panel, in bold, on a contrasting background.

What 740.10 requires

A cosmetic whose safety has not been adequately substantiated carries that warning, and it goes on the principal display panel where a buyer will see it.

What makes it unnecessary

Substantiating the safety of the product. MoCRA already requires the responsible person to maintain records supporting adequate safety substantiation derived from scientifically robust methods, so the work that removes this warning is work you owe anyway.

The conspicuousness rule applies to it

Warnings appear prominently and conspicuously compared with the other words, statements, designs and devices on the label, in bold type on a contrasting background, in letters not less than 1/16 inch.

Which means it cannot be hidden

Not set in the same weight as the ingredient list, not reversed out of a busy photograph, not tucked under the fold of a wrap label. The standard is that an ordinary individual is likely to read and understand it under customary conditions of purchase and use.

Small packages have a route, not an exemption

Where a package is too small to meet the requirements, the regulation contemplates a petition to the Commissioner for an alternative. That is a process, and it is not the same as the requirement not applying.

Why this page exists

Because it is the requirement most likely to be missed entirely. A maker who has carefully built an ingredient list and a net quantity statement can still be shipping a product that should be carrying this sentence and is not.

What substantiation looks like in practice

MoCRA asks for records derived from scientifically robust methods, and does not require animal testing. For a small range built from well characterised cosmetic ingredients at conventional use levels, the work is documentary: what is in it, at what concentration, with what support for each of those being safe at that level on that part of the body.

Do it before the artwork, not after

If the answer turns out to be that the safety is not substantiated, the front panel needs a sentence it was not designed around, in bold, on a contrasting background, at a minimum type size. That is a layout change rather than a text change, and it is cheaper to discover before the print run than after it.

References

21 CFR 740.10, the warning for a cosmetic whose safety has not been adequately substantiated, which must appear on the principal display panel: "Warning--The safety of this product has not been determined." law.cornell.edu

21 CFR 740.2, conspicuousness of warning statements: they shall appear "prominently and conspicuously as compared to other words, statements, designs, or devices and in bold type on contrasting background", in letters not less than 1/16 inch in height, and so as to be "likely to be read and understood by the ordinary individual under customary conditions of purchase and use". law.cornell.edu

FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Facility registration renewed every two years; product listing by the responsible person with annual updates; records supporting adequate safety substantiation derived from scientifically robust methods; serious adverse events reported within 15 business days, with new medical information received within one year reported within a further 15 business days. Certain small businesses are exempt from GMP, registration and listing, except for products that contact mucous membranes, are injected, are intended for internal use, or alter appearance for more than 24 hours. fda.gov

Written from the FD&C Act and 21 CFR parts 701 and 740, and from the catalog as it stood on 17 October 2026. Whether a particular product is a cosmetic or a drug turns on its claims and its ingredients, and that determination has consequences; nothing here substitutes for getting it right for a specific formula and a specific label.