How the FDA (Federal Government Agency) Defines "Soap"
First, understand that "soap" is exempt from FDA regulation, but it must be just that, soap. To qualify as soap, the vast majority of ingredients must be fatty acids and an alkali. In addition, it must be labeled, sold, and represented solely as soap. Lastly, its purpose is to clean the human body. You cannot state that it moisturizes the skin, exfoliates, cures, or any other such claims. To say it moisturizes, makes your soap a cosmetic; to say it relives itchy skin, makes it a drug. All drugs must be approved by the FDA. This is a costly project, to obtain FDA drug approval. It takes years of testing, and lots of money.
Here is my interpretation of FDA cosmetic regulations. By no means should this article replace your own research and study of the actual FDA regulations. The information is presented to help you to decide whether you want to branch out into the realm of cosmetic manufacturing or, simply to stick to making soap.
Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when
- The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and
- The product is labeled, sold, and represented solely as soap [21 CFR 701.20].
NOTE: Melt and pour, cold and hot process soaps falls into the FDA category termed "soap" as long as no claims are made that the soap has moisturizing properties, healing properties, beautifying or age reducing properties, cures; treats; or prevents disease. If your label or advertising makes any of these claims, your "soap" is deemed a cosmetic or drug by FDA standards and all these claims must meet FDA approval. Best bet is to keep it simple and list ingredients only on the label. Though the FDA does not require an ingredient label on "soap", buying consumers appreciate the information.
When is a soap considered a cosmetic?
If a product
- consists of detergents or
- primarily of alkali salts of fatty acids and
- is intended not only for cleansing but also for other cosmetic uses, such as beautifying, deodorizing or moisturizing,
- it is regulated as a cosmetic and must meet all FDA requirements for a cosmetic; the label must list all ingredients.
Soap may also be regulated as a cosmetic if:
- is intended solely for cleansing the human body and
- has the characteristics consumers generally associate with soap,
- does not consist primarily of alkali salts of fatty acids
- In this case, is regulated as a cosmetic and must meet all FDA requirements for a cosmetic; the label must list all ingredients. For more information about FDA cosmetic guidelines visit http://www.cfsan.fda.gov/~dms/cos-toc.html.
When is soap considered a drug?
If a product
- consists of detergents or
- primarily of alkali salts of fatty acids and
- is intended not only for cleansing but also to cure, treat, or prevent disease or to affect the structure or any function of the human body. Examples include antibacterial, antiperspirant, or anti acne. If any of these claims are made it is regulated as a drug and the label must list all active ingredients and meet all FDA requirements for a drug.
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* Denise Marks is the president of Nouveau Designs LLC which offers one of the most extensive selection of quality soap supplies and on the Net. She is an experienced soap maker and owner of one of the largest soap mold manufacturing companies worldwide. Visit GoPlanetEarth.com for a complete listing of soap making supplies.
