Marketing Claims for Cosmetics
The words you use determine whether your product is a cosmetic or a drug
The Fine Line Between Cosmetic and Drug
The FDA defines cosmetics as products intended to "cleanse, beautify, promote attractiveness, or alter the appearance." The moment you claim your product does something therapeutic - treats, heals, prevents, or affects the structure/function of the body - it becomes a drug requiring FDA pre-market approval.
The Critical Understanding
It's not your formula that determines classification - it's your CLAIMS. Two identical products can be classified differently based solely on what the manufacturer says about them. Customer perception, shaped by ALL your marketing communications, determines intended use.
Cosmetic (Regulated, No Pre-Approval)
- Cleansing
- Beautifying
- Promoting attractiveness
- Altering appearance
Drug (Requires FDA Approval)
- Treating or preventing disease
- Affecting body structure or function
- Healing, curing, mitigating
- Therapeutic effects on skin/body
This guide references FDA documents including "Is It a Cosmetic, a Drug, or Both?". Your product can even be BOTH a cosmetic AND a drug simultaneously if it makes both types of claims - requiring compliance with both sets of regulations.