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Cosmetic products are defined by the FD&C Act as: “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 such term shall not include soap” (FD&C Act, sec. 201[i]).
A formula compliance review is essential for cosmetic products because they must comply with ingredient restrictions, prohibitions, and color additive requirements.
Color additives, except for coal tar hair dyes, require FDA approval before they can be used in cosmetics. Failure to meet US color additive requirements can result in a product being considered adulterated. Color additives may only be used for the approved intended uses.
Our team of US cosmetic regulatory experts can assist you in ensuring that your product is classified correctly as a cosmetic, that your formula complies with regulations, and that there are no prohibited substances in the mixture.
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