When a cosmetic becomes a drug
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Intended use is the test
A product intended to affect the structure or function of the body, or to treat or prevent a condition, is a drug. A product intended to cleanse or beautify is a cosmetic. The intention is read from what you say, so your own copy determines your category.
The sentences that move it
- Heals, repairs, treats, cures, or prevents anything.
- Names a condition: sunburn, eczema, bites, rashes.
- Claims an SPF, which is a sunscreen claim and therefore a drug claim.
- Claims to repel insects, which moves it to the EPA rather than to drug status.
SPF on a moisturizer is the common one
Adding a sun protection claim to a cosmetic makes it a sunscreen drug product with everything that entails, including the testing. A great many products carry both propositions and they are drugs, which is the correct and expensive answer.
Testimonials do it too
Republishing a customer saying a gel healed their burn adopts the claim. That is the same mechanism the supplements property describes, operating under a different statute, and it catches the same people.
Before and after imagery carries meaning
A photograph showing a condition improving makes a claim no sentence had to make. If the image implies treatment, the implication is the claim.
Write the claims first
Decide what you intend to say, check which category that puts you in, and then formulate and package for that category. Doing it in the other order is how a cosmetic business discovers it has built a drug.
A product name can carry the claim
Calling something a burn gel or a bite treatment puts the claim in the one place you can never edit later without rebranding. Names are chosen early and reviewed last, which is the wrong way round for exactly this reason.
Check the whole impression, not the sentences
The test reads the overall impression a buyer takes away, so a clean sentence next to a suggestive image can still make the claim. Reviewing copy line by line misses it; looking at the finished page catches it.