Do I need FDA approval to sell a private label glycolic acid body scrub?

A glycolic acid body scrub does not require FDA pre-market approval if it is sold and marketed as a cosmetic — meaning its labeled purpose is to cleanse, exfoliate, or beautify skin, not to treat a disease or alter a body function. The FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which does not require pre-market approval for cosmetics, only for drugs.

However, if your marketing claims cross into drug territory — phrases like 'treats keratosis pilaris,' 'reverses sun damage,' 'treats hyperpigmentation,' or 'stimulates cell renewal at the dermal layer' — the FDA may classify the product as an OTC drug, which requires an NDA (New Drug Application) or compliance with an OTC drug monograph. That is an entirely different regulatory pathway with vastly different testing, labeling, and manufacturing (cGMP, not cosmetic GMP) requirements. Stick to cosmetic claims: 'exfoliates,' 'smooths the look of rough skin,' 'brightens skin appearance.'

MoCRA, which took full effect in 2024, added significant new requirements for cosmetics sold in the US. Your manufacturing facility must be FDA-registered (facilities had a December 2023 deadline for initial registration). Each product must be listed with the FDA, including its ingredient list. Serious adverse event reports must be submitted within 15 business days. And if your product is manufactured at a facility that also handles OTC drugs, additional segregation requirements apply. Confirm your manufacturer is already compliant with MoCRA registration before signing a contract — it is now a condition of legal market access, not an optional credential.

For California specifically, Prop 65 is a separate state-level requirement. If any ingredient in your fragrance blend, colorant system, or preservative is on California's Prop 65 list, you must provide a compliant warning on the label for products sold in California. Many glycolic acid scrubs use fragrance compounds (certain musks, for example) that appear on the Prop 65 list at detectable concentrations. Ask your manufacturer to run a Prop 65 screen on the finished formula.

For Canadian sales, Health Canada classifies AHA-containing cosmetics under the Cosmetic Regulations under the Food and Drugs Act. Products must be notified to Health Canada within 10 days of first sale. Glycolic acid concentration and labeling are reviewed against the Cosmetic Ingredient Hotlist.

For EU sales, the EU Cosmetics Regulation (EC) No 1223/2009 applies. Glycolic acid in rinse-off products is restricted to 10% at a minimum pH of 3.5 for consumer products, with a mandatory on-pack warning for AHA concentrations above 10%. A Cosmetic Product Safety Report (CPSR) prepared by a qualified EU safety assessor is required before any EU sale, and the product must be notified in the EU's CPNP (Cosmetic Products Notification Portal) by a Responsible Person established in the EU or in a country with a mutual recognition agreement post-Brexit.

The bottom line: no pre-market FDA approval, but a meaningful compliance checklist. Working with a manufacturer who understands MoCRA registration, Prop 65, and can direct you to a safety assessor for EU expansion is worth the extra sourcing effort. AJ Cosmo Labs lists manufacturers who have demonstrated regulatory literacy so founders aren't navigating this alone.