Marketing Claims for Soap
What you say about your soap determines how the FDA classifies it
Your Words Determine Your Product's Legal Status
The FDA doesn't regulate "true soap" - but the moment you make certain claims about what your soap does, it becomes either a cosmetic (FDA regulated) or a drug (requires pre-market approval). The determining factor isn't your ingredients - it's what you say about your product.
The Critical Rule
Customer perception - shaped by ALL your communications - determines how the FDA classifies your product. This includes your product name, label text, website copy, social media posts, blog articles, customer testimonials you share, and even how you respond to customer questions. One therapeutic claim anywhere can turn your exempt soap into a regulated drug.
True Soap (Not Regulated)
Made from fatty acid alkali salts (lye + oils) and marketed ONLY for cleansing. No cosmetic or drug claims.
Cosmetic Soap (Regulated)
Makes claims about beautifying, moisturizing, or altering appearance. Must follow FDA cosmetic regulations.
Drug (Requires Approval)
Makes claims about treating, preventing, or curing conditions. Requires FDA pre-market approval.
This guide is based on FDA resources including "Is It a Cosmetic, a Drug, or Both?" and "Soap - FDA's Interpretation of the Term". Links to these official documents are provided in the FDA Resources tab.