Drug vs. Cosmetic Claims

If you plan to sell your products, it’s important to research the Food and Drug Administration (FDA) regulations first. They’re put in place for consumer safety and they dictate what goes on your label. The regulations apply to soap, cosmetics, and drugs.

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First, let’s go over the difference between the three.

To meet the FDA's regulatory definition of soap, a recipe needs three things.

  • It has to be made of fats/oils and an alkali like lye.
  • Those ingredients are the only things that cleanse. Most store-bought soap has added synthetic detergents, so it's classified as a cosmetic instead of soap. 
  • It must be labeled and marketed only as soap meant to cleanse. If it's labeled as moisturizing, nourishing, deodorizing, etc., it's considered a cosmetic. If there are claims that it treats any skin conditions like acne or eczema, it's considered a drug.

True soap is regulated by the Consumer Product Safety Commission. There are no labeling requirements, but we recommend following cosmetic regulations so your customers know exactly what they’re putting on their skin. Learn more in the How to Label Products article.

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Cosmetics

The FDA defines cosmetics 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.” That includes:

  • Moisturizer
  • Lipstick
  • Fingernail polish
  • Eye/face makeup
  • Shampoo
  • Conditioner
  • Hair colors
  • Deodorants

These are regulated by the FDA. The products and the ingredients you use don’t need to be approved by them, and you don’t need to register the products or your business. They do need to be properly labeled and safe for consumers to use. 

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Drugs

The FDA defines drugs 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.” That includes:

  • Hand sanitizer
  • Sunscreen
  • Skin products that treat acne
  • Dandruff shampoo
  • Anti-aging products
  • Products that treat eczema or rosacea 

Drugs are also regulated by the FDA. You have to register your business and submit the list of products to the FDA for approval.

While it may seem pretty straightforward, those classifications can change based on the claims you make. For instance, if you say soap does anything other than cleanse, it’s no longer classified that way. If it’s moisturizing, it’s a cosmetic. If it treats acne, it’s a drug.

The same goes for cosmetics. If you claim a lotion is anti-aging or protects against UV rays, it’s now considered a drug and must follow those regulations. If you say it’s moisturizing and treats eczema, it’s now considered a drug and a cosmetic.

If you want your product to be listed as soap or a cosmetic, we recommend sticking with terms that beautify the skin. That includes gentle, calming, moisturizing, hydrating, smoothing, skin loving, cleansing, and conditioning. 

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The claims you make apply to the product label, as well as any advertising or marketing. That includes your website, social media, etc. Even language like “thought to help with acne” or “may help acne-prone skin” may be considered making a claim. 

We always recommend erring on the side of caution when it comes to making claims about your products. Stick to descriptors like moisturizing, smoothing, etc. It’s best to be safe when it comes to your small business!

Additional resources

FDA
CSPS
Soap and Cosmetic Labeling by Marie Gale
Good Manufacturing Practices for Soap and Cosmetic Handcrafters by Marie Gale