To sell soap and cosmetics, understanding the rules of making claims about your products is key. These rules and regulations, created by the FDA (Food and Drug Administration), are put in place for the safety of consumers. Soap and cosmetics should not make claims that could confuse the product with a drug. The FDA regulates and defines cosmetics, drugs and soap differently. It can be a little tricky to understand these definitions and what type of claims are appropriate for cosmetics, drugs and soap.
It’s important to first understand the difference between a cosmetic and a drug, as defined by the FDA. According to the FDA website, the law defines a cosmetic as:
“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, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.”
In contrast, the law defines a drug as:
“The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].”
To summarize this statement, a cosmetic is a product that is used to beautify, or alter the appearance. A drug is a product intended to diagnose, treat or prevent a disease. A product is also considered a drug when it is intended to affect the function of the body.
It is possible for a product to be considered both a drug and a cosmetic. This happens when a product has two intended uses. The FDA uses dandruff shampoo as an example. Dandruff shampoo cleanses the hair like a cosmetic, but treats dandruff like a drug. Products that are considered both a drug and cosmetics must comply with requirements for both drugs and cosmetics.
You may be wondering ,”where does soap fit into all this?” Soap is defined in its own special category by the FDA. According to the FDA website, a product is defined as soap 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 the product meets these requirements, it is regulated by the Consumer Product Safety Commission, not the FDA. If you claim your soap does anything to beautify or alter ones appearance, it is then considered a cosmetic and is regulated by the FDA. For example, if you say your soap moisturizes the skin, it is considered a cosmetic.
Depending on what your product claims to do, it could be considered a drug, cosmetic, soap, or a combination of these categories. Drugs are required to be approved by the FDA, while cosmetics and soap are not. So for example if you were to say that your soap or cleanser helps treat acne, it is no longer considered only soap. It’s now considered a drug as well and would require FDA approval. If you say that your soap is moisturizing and will treat acne, it is now considered both a cosmetic and a drug. Click here to read more about the different approval laws and regulations of drugs, cosmetics and soap.
When a product is represented solely as soap, it is regulated by the Consumer Product Safety Commission, not the FDA.
Sometimes, it can be tricky to determine what type of claims are appropriate for cosmetics and soap, rather than drugs. This is because some beauty concerns like aging, acne and rosacea require altering the function of ones body. In general, when describing the function of your products, you should avoid terms such as treat, cure and heal. Common claims for soaps, cosmetics, moisturizers and more that would classify the product as a drug are listed below.
- The product claims to prevent or fight the aging process. This includes helping with wrinkles, age spots, and firmness. Specific claims might include increasing collagen production, decreasing melanin production, increasing cell turnover, reviving skin cells and treating aging.
- The product claims to prevent or fight acne. This includes helping with pimples, cystic acne or acne scars. Specific claims might include reducing the frequency of breakouts, reducing the production of oil or sebum, decreasing the size of pores, unclogging pores, and killing bacteria.
- The product claims to prevent or fight eczema or rosacea. This includes helping reduce redness, rashes and broken blood vessels. Specific claims might include reducing broken vessels, curing or treating redness and curing/healing irritated skin.
- The product claims to provide SPF sun protection, or heal sunburned skin. This includes protection from UVA/UVB rays, healing sunburns or sun rashes. Specific claims might include claiming a specific amount of SPF protection in a product, or claiming it to be healing from sun related skin problems.
So, what type of terms are acceptable for cosmetics in order for them to not be classified as a drug? Terms that are acceptable for cosmetics do not refer to a product curing, treating or preventing a health condition. Acceptable terms include claiming the product is moisturizing, conditioning, calming, skin-loving, deodorizing, cleansing, beautifying and hydrating. Now you might be thinking, “Doesn’t the term moisturizing imply that the product is altering the function of ones body?” This topic is tricky! The term moisturizing does not claim to cure, prevent, diagnose or treat a disease. By including “skin moisturizers,” in the group of products approved as cosmetics by the FDA (see the the statement above), moisturizing the skin is considered beautifying. The function of the body remains the same. Keep in mind, if you make any claims about your soap it is considered a cosmetic.
The FDA takes several things into consideration when establishing the intent of the product. According to the FDA’s website, they look at how the product is advertised. This includes advertising online and other promotional materials. The FDA also considers the consumer perception and the ingredients that are considered to be drugs by the public. This means it’s important to consider how your product is labeled, as well as how it’s described online and other promotional materials.
If you are looking for more information on FDA regulations of cosmetics, drugs and soap, check out the FDA’s website for Cosmetics Laws & Regulations. If you have questions, the FDA does respond to emails (we have tested this several times!), click here to get their contact info. This page is full of links to various articles including the Federal Food, Drug and Cosmetic Act, as well as the Fair Packaging and Labeling Act. It’s so important to make yourself familiar with these laws when making and selling soap.
