It’s important not to assume that using only ingredients from plants will make your products safe. The laws and regulations that FDA enforces do not have definitions for “natural” or “organic.” The same requirements apply to your product no matter whether the ingredients are plant, animal, mineral, or synthetic. What if my ingredients are “natural” or “organic”? To learn more, see “ Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).” For more information, you can contact FDA’s Center for Drug Evaluation and Research (CDER), Division of Drug Information, Small Business Assistance, at If it’s both a cosmetic and a drug, it must meet the requirements for both cosmetics and drugs. You will need to register your firm and list your products with FDA. It must comply with the regulations (called “monographs”) for certain categories of non-prescription drugs or requirements for new drug approval. If it’s a drug, it’s regulated by FDA.To learn more, see “ Fact Sheet for Small Businesses and Homemade Cosmetics,” and the resources listed on that page. You don’t need to register your company or file your product formulations with FDA, although we do encourage you to participate in our Voluntary Cosmetic Registration Program. It is your responsibility to make sure your product is safe for consumers when it is used as intended, and to make sure it is properly labeled. Neither the product nor its ingredients need approval by FDA, except for any color additives it contains. If it’s a cosmetic, it’s regulated by FDA.Please direct questions about requirements for these products to CPSC. If your product meets the regulatory definition of soap, it’s regulated by the Consumer Product Safety Commission (CPSC), not by FDA.How are different “soap” products regulated? You can read the entire regulation at 21 CFR 701.20. You still can use the word “soap” on the label. Or, if the product is intended to treat or prevent disease, such as by killing germs, or treating skin conditions, such as acne or eczema, it’s a drug. If it is intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user’s body, it’s a cosmetic. How it's intended to be used: To be regulated as soap, it must be labeled and marketed only for use as soap. If the product contains synthetic detergents, it’s a cosmetic, not a soap.
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