Distinguish cosmetics from therapeutic claims

1. 1

   Core concept

   FDA evaluates intended use through labeling, advertising, consumer expectations and sometimes ingredients. Claims to diagnose, treat or prevent disease, or affect the body's structure or function, can make a product a drug. For example, sunscreen, acne therapy and eczema treatment claims raise a different regulatory pathway than basic beautifying or cleansing.

2. 2

   Apply the concept

   Create a claims inventory including product page, packaging, influencer briefs, hashtags and customer-service scripts. Mark statements as appearance, sensory, substantiated cosmetic performance, or likely drug/therapeutic claim. Have qualified counsel review uncertain wording before marketing.

3. 3

   Professional decision-making

   Changing 'treats acne' to 'helps acne' does not necessarily resolve intended-use problems. Evidence must support truthful cosmetic claims; an attractive disclaimer does not neutralize prominent drug claims.

4. 4

   In practice

   • Review every claim on your label, website and social posts, because FDA looks at intended use across all of them.
   • Flag words that suggest treating or preventing disease, such as 'cures', 'treats acne' or 'antibacterial'.
   • Remember that adding 'not a drug' doesn't change how a disease claim is viewed.
   • Know that products like sunscreens and acne treatments follow drug rules in the U.S.
   • When unsure, get advice from a regulatory professional before launch.
5. 5

   Case study

   A product listing calls a facial wash 'antibacterial acne treatment' and says 'not a drug' at the bottom.

   Think about what you would do, then show the recommended response

   Intended-use signals remain drug-related. Halt that wording and seek regulatory review instead of relying on the footer.

6. 6

   Your practice task

   Claims risk register with source evidence, reviewer, decision and approved replacement wording. Check yourself: All consumer-facing channels included. Claims separated by likely regulatory classification. No claims approved automatically by the student.

7. 7

   Common misconception

   Cosmetic claims cannot be made lawful by simply adding 'for educational purposes' to marketing.

8. 8

   Check yourself

   1. Does writing 'not a drug' on a label make a treatment claim acceptable?
   2. Name two claims that may make a product a drug.
   3. Where does FDA look to judge a product's intended use?

   Show the answers

   1) No. Intended use is judged by the claims as a whole. 2) Examples: 'treats acne', 'cures eczema', 'prevents infection'. 3) Labeling, advertising, websites, social media and how consumers understand the product.

Checked against the official sources listed below on November 9, 2026. Educational only: not medical, legal or regulatory advice, state-approved training, or certification.