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The claim check, before anything is published

Updated

On this page9
Run every sentence you intend to publish through four questions. Any one of them can move you to a different agency.

One: does it claim an SPF or sun protection?

If yes, the product is a sunscreen drug product, with testing, a Drug Facts panel and the prohibited words. There is no light version of this answer and it applies to a moisturizer as much as to a sunscreen.

Two: does it claim to repel or control a pest?

If yes, the product is a pesticide and the agency is the EPA, through registration or the minimum risk exemption. Repelling counts even though nothing is killed.

Three: does it claim to treat, heal or prevent anything?

If yes, the product is a drug regardless of what else it is. Naming a condition, describing a symptom or showing a before and after all count, because intended use is read from the whole impression.

Four: if exempt, does it mention disease?

A minimum risk repellent may not claim to control disease-transmitting organisms. This is the single condition most likely to be broken, because it removes exactly the claim the product most wants to make.

Check everything, not just the label

Website, listings, advertisements, stall signage, emails and replies. The label is the part that already gets reviewed; the rest is where these claims actually appear.

Write the answers down

One list of every claim with the category it implies, approved before publication. It is the same register the supplements property describes, and here it has to cover three regimes rather than one.

Run it again whenever anything changes

A reformulation, a new product name, a seasonal campaign or a new marketplace listing each reopen the question. The check is cheap to repeat and the failure it prevents is not.

Decide who is allowed to publish

The common failure is somebody answering a customer helpfully on a Saturday. Agreeing in advance who may write about the product, and what the standard replies are, is part of the control rather than an administrative nicety.

References

21 CFR 201.327, Over-the-counter sunscreen drug products; required labeling based on effectiveness testing. Paragraph (g) makes “sunblock”, “sweatproof” and “waterproof” false or misleading; paragraph (a)(2) permits only “Water Resistant (40 minutes)” or “(80 minutes)”; paragraph (d)(2) carries the Skin Cancer/Skin Aging Alert. law.cornell.edu
40 CFR 152.25, Exemptions for pesticides of a character not requiring FIFRA regulation, including the minimum risk exemption: active ingredients named with their percentage by weight, inert ingredients by their designated names, company name and contact information, and no claim to control disease-transmitting organisms. law.cornell.edu
21 CFR 701, Cosmetic Labeling, for the products on this shelf that are cosmetics rather than drugs or pesticides. law.cornell.edu
Written from federal regulation, not from a formulation lab. A sunscreen is an OTC drug and an insect repellent is a pesticide, and both carry requirements that a cosmetic does not. Nothing here clears a specific label, and the difference between a cosmetic claim and a drug claim is narrower than it looks.