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.

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