Is your product a cosmetic, an OTC drug, or regulated as both? Answer 4 questions based on the FDA's official classification criteria under the FD&C Act.
Select the category that best describes your product:
Some categories are automatically regulated as OTC drugs by FDA — regardless of how they are marketed. If your product belongs to one of these, you will receive an immediate result.
Question 2 of 4
What claims does your product make?
FD&C Act §201(i) — Cosmetic Definition
Which best describes the claims on your label and marketing?
The key distinction: cosmetics "cleanse, beautify, promote attractiveness, or alter appearance." Drugs "affect the structure or function of the body." Claims — not just ingredients — primarily determine classification.
Question 3 of 4
Does your product contain any recognized OTC drug-active ingredients?
21 CFR Parts 333, 347, 352, 358
Does your formulation include any of these OTC drug-active ingredients?
Certain ingredients are drug actives regardless of claims. Their presence alone can trigger drug classification even if the product is marketed as a cosmetic.
Question 4 of 4
What is the primary intended use of the product?
FDA Guidance — Is It a Cosmetic, a Drug, or Both?
How would a consumer understand the primary purpose of this product?
FDA looks at the entire context — label, advertising, website, and consumer perception — to determine intended use. If consumers would reasonably believe the product treats a condition, it may be regulated as a drug.
Classification Complete
Your Cosmetic vs. Drug Classification
For informational purposes only. Classification depends on the totality of evidence including all claims, ingredients, and consumer perception. Always consult a qualified regulatory specialist for a binding determination on your specific product.