FDA (U.S. Food & Drug Administration) Guidelines and Regulations for Soap
Soap is in a different category than cosmetics (body care products). The FDA says soap is exempt from the provisions for cosmetics must but you must go by the FDA's definition of soap. To be classified as soap, you can not make any cosmetic claims about your soap on the soap label. If you say the soap is moisturizing, that is a claim for cosmetics and your soap is now a cosmetic. You now must follow the guidelines and regulations for cosmetics. Basically what soap does is clean and that is the only claim you can make about your soap. See below highligted words for the FDA's defintion of a cosmetic.
Statements below are directly quoted from the FDA website: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm
And what if it's "soap"?
Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word. Products that meet the definition of "soap" are exempt from the provisions of the FD&C Act because -- even though Section 201(i)(1) of the act includes "articles...for cleansing" in the definition of a cosmetic -- Section 201(i)(2) excludes soap from the definition of a cosmetic.”
How FDA defines "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].
If a cleanser does not meet all of these criteria...
If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:
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 or moisturizing,
it is regulated as 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 to cure, treat, or prevent disease or to affect the structure or any function of the human body,
it is regulated as a drug.
If a product --
• 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,
it may be identified in labeling as soap, but it is regulated as a cosmetic.
How does the law define a cosmetic?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.
Soap is in a different category than cosmetics (body care products). The FDA says soap is exempt from the provisions for cosmetics must but you must go by the FDA's definition of soap. To be classified as soap, you can not make any cosmetic claims about your soap on the soap label. If you say the soap is moisturizing, that is a claim for cosmetics and your soap is now a cosmetic. You now must follow the guidelines and regulations for cosmetics. Basically what soap does is clean and that is the only claim you can make about your soap. See below highligted words for the FDA's defintion of a cosmetic.
Statements below are directly quoted from the FDA website: http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm
And what if it's "soap"?
Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word. Products that meet the definition of "soap" are exempt from the provisions of the FD&C Act because -- even though Section 201(i)(1) of the act includes "articles...for cleansing" in the definition of a cosmetic -- Section 201(i)(2) excludes soap from the definition of a cosmetic.”
How FDA defines "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].
If a cleanser does not meet all of these criteria...
If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:
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 or moisturizing,
it is regulated as 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 to cure, treat, or prevent disease or to affect the structure or any function of the human body,
it is regulated as a drug.
If a product --
• 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,
it may be identified in labeling as soap, but it is regulated as a cosmetic.
How does the law define a cosmetic?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.
2 comments:
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alj
Thank you for your comments.
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