Do I need FDA approval before selling a natural haircare product in the US?

Haircare products marketed as cosmetics (shampoos, conditioners, styling products) do not require FDA pre-market approval but must comply with the FD&C Act and the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which mandates facility registration, adverse event reporting, and safety substantiation. Products making drug claims — such as treating hair loss or dandruff — are regulated as OTC drugs and require separate FDA compliance. An experienced cosmetic chemist can help you stay on the right side of that line.