Review intended use before treating a claim as cosmetic

Collect the complete claim context

Review the product name, label, directions, website, marketplace listing, social posts, images, testimonials, comparison language, and any material supplied to retailers or influencers. Consider express wording and the message reasonably conveyed by the presentation as a whole. Keep the exact text and screenshot or artwork version with the review record.

1. Describe the cosmetic purpose: identify the cleansing, beautifying, attractiveness, or appearance-related function actually intended.
2. Flag treatment or prevention language: references to disease, symptoms, inflammation, infection, healing, or prevention need classification review.
3. Flag body-function language: claims about changing structure or function can point beyond cosmetic use even when the product is applied topically.
4. Review directions and audience: use instructions, duration, dose-like language, professional positioning, and target users can add intended-use evidence.
5. Check ingredients and presentation together: an ingredient name alone does not decide classification, but formula, claims, route, and consumer understanding can interact.

Do not solve a classification issue with a disclaimer

A qualifier must be clear, close, and consistent with the main message, but a disclaimer cannot reliably erase an otherwise drug-oriented intended use. Likewise, avoiding one prohibited word does not make the overall presentation cosmetic. If classification is unresolved, keep the claim out of the release queue until the product and regulatory pathway are reviewed.

Worked claim review example

Fictional example: a serum label says “repairs eczema and stimulates collagen production,” while a nearby line calls the product a cosmetic. The disease-treatment and body-function messages still require classification review; the word “cosmetic” does not cancel them. Collect the label, product name, directions, website, marketplace listing, images, testimonials, formula, and substantiation before deciding the pathway.

A team might consider appearance-focused wording, but no replacement claim should be copied from this example or treated as approved. The revised message must accurately describe the intended cosmetic effect, match the evidence, and be reviewed again in its full presentation. Keep both the rejected and revised versions in the release record.

Official starting points

• FDA: Is It a Cosmetic, a Drug, or Both?
• FDA Cosmetic Labeling Claims
• 21 U.S.C. 321 — Definitions

Continue the label review