FDA Regulation, Soaps & Lotions
Mar 03 2022
We provide safety and regulatory information about soaps and lotions.
Lotions, soaps, and other cleansers may be regulated as cosmetics or as other product categories, depending on how they are intended to be used.
Cleansing products, many of which are marketed as “soap,” may be cosmetics or drugs regulated by FDA, or consumer products regulated by the Consumer Product Safety Commission, depending on how they are made or how they are intended to be used. For example, soaps and cleansers marketed as “antibacterial” are drugs.
Lotions intended to make people more attractive are cosmetics. But, if they’re intended to affect the structure or function of the body, or for a therapeutic purpose, such as treating or preventing disease, they’re drugs, or sometimes they may be both cosmetics and drugs. For example, sunscreen products are drugs under U.S. law. So are skin protectants, skin bleaches, and treatments for skin conditions such as acne, eczema, or rosacea.
Some lotions are both cosmetics and drugs, and must meet the requirements for both categories. Lotions that are intended both to moisturize the skin and protect users from the sun are just one example.
To learn more about the differences, see “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).”
Frequently Asked Questions on Soap
FDA often receives questions from soap makers about how their products are regulated. Here is information to help small-scale soap producers understand the laws and regulations they need to know about.
What’s the regulatory definition of soap?
Whether a product is a “soap” in the traditional sense, or is really a synthetic detergent, helps determine how the product is regulated. So, let’s take a look at how “soap” is defined in FDA’s regulations;
To meet the definition of soap in FDA’s regulations, a product has to meet three conditions :
What it’s made of: To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye.
What ingredients cause its cleaning action: To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap. You still can use the word “soap” on the label.
How it's intended to be used: To be regulated as soap, it must be labeled and marketed only for use as soap. 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. 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. You still can use the word “soap” on the label.
You can read the entire regulation at 21 CFR 701.20.
How are different “soap” products regulated?
If your product meets the regulatory definition of soap, it’s regulated by the Consumer Product Safety Commission (CPSC), not by FDA. Please direct questions about requirements for these products to CPSC.
If it’s a cosmetic, it’s regulated by FDA. Neither the product nor its ingredients need approval by FDA, except for any color additives it contains. 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. 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. To learn more, see “Fact Sheet for Small Businesses and Homemade Cosmetics,” and the resources listed on that page.
If it’s a drug, it’s regulated by FDA. It must comply with the regulations (called “monographs”) for certain categories of non-prescription drugs or requirements for new drug approval. You will need to register your firm and list your products with FDA. For more information, you can contact FDA’s Center for Drug Evaluation and Research (CDER), Division of Drug Information, Small Business Assistance, at CDERSmallBusiness@fda.hhs.gov.
If it’s both a cosmetic and a drug, it must meet the requirements for both cosmetics and drugs. To learn more, see “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?).”
What if my ingredients are “natural” or “organic”?
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. It’s important not to assume that using only ingredients from plants will make your products safe. To learn more, see “‘Organic’ Cosmetics” and “Product Testing.”
Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients. Rather, FDA has consistently advised
manufacturers to use whatever testing that is deemed necessary to ensure
the safety of their products and ingredients.
Firms may substantiate safety in a number of ways.
Our services allow manufacturers to spend more time developing their products
rather than searching for distributors, negotiating contracts, and learning regulations.
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