The warning

The string

On this page12

Where it comes from What triggers it Which is a different logic from most warnings So the route around it is substantiation The section has an exception paragraph Those are described here and not quoted The string itself is 59 characters And it goes in bold on a contrasting background Which is the real design constraint And it has to survive the label being read at arm's length Part 740 is cosmetic labeling References

"Warning--The safety of this product has not been determined."

Where it comes from

A section headed "Labeling of cosmetic products for which adequate substantiation of safety has not been obtained". The heading is the trigger, stated plainly.

What triggers it

A cosmetic product whose safety has not been adequately substantiated. The warning is the consequence of an absence rather than of a hazard.

Which is a different logic from most warnings

Most warning statements follow from something known about a product. This one follows from something not known.

So the route around it is substantiation

Not better typography and not a larger container. The statement goes away when the underlying work has been done.

The section has an exception paragraph

It sets out when the warning is not required, turning on safety having been substantiated previously, new information not demonstrating a hazard, and adequate studies being underway.

Those are described here and not quoted

Because the only verbatim rendering obtained was of the warning string and the section heading. A paraphrase labeled as a paraphrase beats a quote that is not one.

The string itself is 59 characters

Including the dash and the full stop. Which with the 1/16 inch minimum is what makes the panel arithmetic concrete.

And it goes in bold on a contrasting background

Prominently and conspicuously as compared to other words, statements, designs or devices. So it cannot be set quietly in the small print.

Which is the real design constraint

A 59-character sentence, bold, contrasting, at a fixed minimum height, on a container that may be 1.06 inches across. That is a layout problem with no dial to turn.

And it has to survive the label being read at arm's length

Likely to be read and understood by the ordinary individual under customary conditions of purchase and use. Which is a standard about a person in a shop, not about a magnifying glass.

Part 740 is cosmetic labeling

Whether a particular topical is a cosmetic or a drug is a determination not made here, and a product making therapeutic claims is assessed under a different scheme.

References

21 CFR 740.10, headed "Labeling of cosmetic products for which adequate substantiation of safety has not been obtained." A product without adequate substantiation of safety must bear the statement "Warning--The safety of this product has not been determined." Paragraph (b) of the section sets out when the warning is not required, turning on safety having been substantiated previously, new information not demonstrating a hazard, and adequate studies being underway. Part 740 is cosmetic labeling, and whether a particular topical is a cosmetic or a drug is not determined here. law.cornell.edu

21 CFR 740.2(a): "A warning statement shall appear on the label prominently and conspicuously as compared to other words, statements, designs, or devices and in bold type on contrasting background to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use, but in no case may the letters and/or numbers be less than 1/16 inch in height, unless an exemption pursuant to paragraph (b) of this section is established." law.cornell.edu

The warning statement runs to 59 characters including the dash and the full stop. The minimum letter height is 1/16 inch. The smallest container in this group is 1.0625 inches in diameter, which gives a side wall circumference of about 3.3 inches, and diameter is recorded on 97 of the 106 containers with a median of 2.37 inches. No fit is computed from those numbers, because character width is a property of the typeface and we do not publish one.

Written from 21 CFR 740.2 and 740.10 and from the catalog as it stood on 19 October 2026. Part 740 is cosmetic labeling; whether a particular topical is a cosmetic or a drug is a determination not made here, and nothing on these pages addresses whether a cannabinoid is permitted in a cosmetic or what any state requires. The 1/16 inch minimum is stated as the regulation states it and no fit is computed, because character width depends on a typeface we do not publish. Availability figures are a single snapshot.