How Do I Get FDA Approval on My Cosmetic Product?

Did you invent a type of cosmetic product, and want to know what the process is for getting approval from the Food and Drug Administration?

Before researching the approval process, it’s important to determine if the FDA considers your invention a cosmetic product, or some other type of product, like a drug.

Is My Product Considered a Cosmetic?

The FDA defines cosmetics based on how they’re meant to be used.

The Federal Food, Drug and Cosmetic Act (also known as the FD&C Act) describes cosmetics as articles “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” (from the FD&C Act, sec. 201(i)).

This description covers products including:

  • Skin moisturizers
  • Perfumes
  • Lipsticks
  • Fingernail polish
  • Eye and facial makeup
  • Cleansing shampoos
  • Permanent waves
  • Hair color
  • Deodorant
  • Any substance meant to be used as a component of a cosmetic product

What About Soap?

Did you notice that soap is missing from the list above?

What you consider soap and what the FDA considers soap may be very different things.

Will your product be marketed and labeled for use as a skin moisturizer, or to make the body smell pleasant, or prevent body odor? If so, then the FDA considers it a cosmetic.

The FDA doesn’t consider a product soap unless:

  • it’s marketed and labeled to be used for cleaning only – not for any other purpose;
  • it’s made mostly of “alkali salts of fatty acids” (this is what you get after you combine fats or oils with an alkali such as lye, which is the traditional method of making soap); AND
  • the only material in the product that actually cleans are the alkali salts of fatty acids. If there’s any other ingredient in the product that also cleans, the product is not regulated by the FDA as soap (although you can still use the word “soap” on the label).

The FDA does not regulate soap as defined above. The Consumer Product Safety Commission (CPSC) does.

Could My Cosmetic Product Be Considered a Drug by the FDA?

You might think you’ve invented a cosmetic product, but there’s a possibility that the FDA might consider your invention a drug, and drugs are regulated differently than cosmetics.

If your product is meant to prevent or treat disease, such as by treating skin conditions or killing germs, the FDA will consider it a drug.

Can My Product Be a Cosmetic AND a Drug?

Yes, it’s possible that the FDA might consider your product both a drug and a cosmetic. In that case, your product would have to meet the FDA’s requirements in both categories of products.

How Does Getting Cosmetics Approved by the FDA Work?

You might be surprised to learn that cosmetic products and ingredients (except for color additives) do not require approval by the Food and Drug Administration before they go on the market. (You can learn more about color additives and the FDA here.)

That also means it’s not necessary for cosmetic products to undergo testing. However, if the FDA ever becomes aware that your product has caused an adverse reaction in a user, it will likely collect samples of your product and analyze it to see if it may be unsafe.

So, cosmetic products don’t require approval by the FDA (except for color additives) and cosmetic products don’t need to be tested before going to market. Sounds like you don’t need to worry much about the FDA, right? Well, the FDA does concern itself with cosmetic products in other ways that are important for you to know about:

  1. Adulterated or Misbranded Cosmetics. The FD&C Act prohibits the marketing of “adulterated” or “misbranded” cosmetics when selling cosmetics and/or transporting them across state borders. You’ll find more information here.
  2. Enforcing Laws. Even though the FDA does not require premarket approval of cosmetics, if a cosmetic product is not in compliance with the law, the FDA can take legal action to enforce compliance.
  3. Compliant Labeling. While the FDA doesn’t require testing or premarket approval of cosmetic products, it does regulate the labeling of cosmetics. All cosmetics distributed within the United States must meet very specific labeling requirements, which you can read more about here.

As the inventor or creator of a cosmetic product, it’s important to familiarize yourself with all FDA requirements that pertain to you. Visit the FDA website’s section on cosmetics for more information.

P.S. Don’t wait to protect your cosmetic product idea with a patent. Lock down the exclusive rights to sell your unique product by getting it patented. We can help you patent your cosmetic invention, and we can help you trademark your brand name, too. The Patent Professor® is an intellectual property law firm. We specialize in patents and trademarks and work with individual inventors and small startups in all 50 states. Call us at 1-877-Patent-Professor (1-877-728-3687) for a 100% free and confidential consultation.

This article is not intended to present complete guidance on issues pertaining to the intersection of cosmetics and the FDA. Since this article was written, FDA policies, guidelines and regulations may have changed. Please consult the FDA website for the most current information relevant to cosmetic products.

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