Let’s Set the Record Straight – Cosmetics are Regulated

Let’s Set the Record Straight – Cosmetics are Regulated

I frequently see statements in the press that in the United States cosmetics are not regulated and this is simply NOT TRUE. While the FDA does not require premarket approval of cosmetics there are regulations governing the safety of cosmetics in the Federal Food, Drug, and Cosmetic Act. cosmetic regulations

The FDA has published regulations explicitly prohibiting or restricting some ingredients. This listing, however, is not to be considered a complete listing of all materials that should be avoided in cosmetics. The FD&C Act specifically prohibits the sale of cosmetics that are deemed adulterated or misbranded. Section 601(a) of the FD&C Act states that a cosmetic is deemed adulterated:

If it bears or contains any poisonous or deleterious (harmful) substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual…

Furthermore, according to the Code of Federal Regulations Section 740.10(a):

Each ingredient used in a cosmetic product and each finished cosmetic product shall be adequately substantiated for safety prior to marketing. Any such ingredient or product whose safety is not adequately substantiated prior to marketing is misbranded unless it contains the following conspicuous statement on the principal display panel: Warning – The safety of this product has not been determined.

These regulations state that is the responsibility of the manufacturer of cosmetics to substantiate the safety. For this reason, cosmetic manufacturers employ toxicologists to evaluate ingredients prior to use and conduct numerous safety tests for intended use and anticipated human exposure on finished goods. Additionally, substantiation of safety also includes preservative efficacy and stability testing. Enforcement actions can and are taken against products that are misbranded or adulterated. The actions provided by the FD&C Act include recalls, seizure of product, injunction (judicial order) against the manufacturer or distributor to prevent further shipment of the product, or prosecution of an individual or the company responsible for the violation.

More information about what constitutes an adulterated or misbranded cosmetic can be found on the FDA’s website.

Kelly Dobos is a cosmetic chemist and expert in both skin care and make-up product formulation. She has the coolest job and a passion for teaching others the smartest ways to express their creativity through cosmetic chemistry.


  • Kelly,
    I see that firms understand that cosmetic products and colors are regulated, but they don’t believe personal care products are cosmetics. A bigger debate is on the rise of where tattoo inks and permanent make up shall fit within the system. FDA just recently made new policy statements.

    Recently, we see more and more action by the Agency against firms using city water, instead of purified water in their products.

    Thanks for posting.

    Courtland Imel Reply
    • The FDA is also very clear that personal care products are cosmetics.
      According the US Food and Drug Administration (FDA) the term cosmetic means
      articles intended to be rubbed, poured, sprinkled or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and articles intended for use as a component of any such articles; except that term shall not include soap.
      Tattoos and permanent makeup are regulated on the state level in the US.

      Kelly Dobos Reply

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