Acne Treatment or Prevention

A product with the intended use to treat or prevent acne is a drug. “Acne” includes blackheads, whiteheads, pimples, and acne blemishes.

If you make any claims that make the consumer think that the intended use of the product is to treat or prevent acne, then the product is a drug. That may include sideways references in your label or labeling such “acne-prone” or “blemishes” or “skin inflammation.”

OTC Acne Products

There are non-prescription acne treatment products on the market that look like cosmetics. Do not be deceived – these are over-the-counter drugs [link to OTC article]. In order to qualify, they must meet the OTC Monograph for topical acne drug products, using only approved ingredients, label claims, directions, and warning statements.

Reality vs Regulation

Clean skin (good old soap and water) is known to help prevent acne and there are natural ingredients that have shown effectiveness is preventing or treating acne.

Be that as it may, only products which meet the OTC monograph for acne treatment or prevention may be promoted and sold as acne treatment or prevention.

Also keep in mind that even if you could get the ingredients and make a product that meets the requirements, in order for the product to be legally marketed it must be manufactured in a facility that is registered as a drug manufacturer with the FDA and in which follow drug good manufacturing practices as contained in federal regulations are followed. It is likely there are state-level drug manufacturing registration and licensing requirements.