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What goes wrong

A claim moved the product into another regime

Updated

On this page8
The characteristic failure on this shelf is a sentence that changed which agency you answer to, written by somebody who was not thinking about agencies.

Cosmetic to drug

An after sun gel that says it heals, a moisturizer that claims an SPF, a self tanner that mentions protection. Each is now a drug product with testing and panel requirements it does not meet, and the product on the shelf has not changed at all.

Cosmetic to pesticide

A botanical body oil that says it keeps mosquitoes away is a pesticidal claim, and the product becomes a pesticide. This one surprises people most because the EPA is not an agency a cosmetic maker expects to meet.

Exempt repellent to unregistered pesticide

A minimum risk product that claims protection from disease-carrying insects has broken the condition the exemption depends on. It is then an unregistered pesticide rather than an exempt one, which is a materially different position.

Sunscreen with a prohibited word

A properly tested sunscreen can still fail on its label by using waterproof, sweatproof or sunblock, which the regulation names directly. Everything about the product can be right and the label still wrong.

It almost always happens off the label

The label gets reviewed; the website, the market stall sign, the listing copy on a marketplace and the reply to a customer question do not. That is where these claims live and where they are quoted from.

The fix is a written claim list

Everything you intend to say, checked once against the three regimes, before anything is published. It is the same control the supplements property arrives at, because it is the same class of failure.

Audit what is already live

Most makers reading this have a website and a year of posts, and the claims in them were written before anybody thought about agencies. Going through what is published now is uncomfortable and it is the highest-value afternoon available.

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.