Federal law does not require cosmetic products and ingredients (aside from color additives) to have FDA approval before going to market. However, some specific laws and regulations must be followed when it comes to FDA cosmetics registration. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) are the laws under which cosmetics are regulated.
Miami, FL -- (SBWIRE) -- 08/18/2021 -- The FD&C Act states that cosmetics should be intended for use 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" (FD&C Act, sec. 201(i)) Products that fall under this category are perfumes, moisturizers, nail polish, makeup, shampoos, hair coloring, deodorant, and any other product intended to be a type of cosmetic (not including soap). The FDA prohibits any adulterated or misbranded cosmetics from being available for commerce. Ingredients must be marketed on a retail basis for consumers.
The FDA's authority over cosmetic products is different from that of drugs, FDA device registration, and other FDA-regulated products. Cosmetics and their ingredients are not required to have FDA premarket approval, but the FDA can pursue action against products that are not in compliance with the law, as well as the firms or individuals who violate the law.
Companies have a legal responsibility to make sure all of their cosmetic products are safe. The FDA does not require specific tests to prove the safety of the products or ingredients, and companies are not required to share their safety information with the FDA. However, the FDA advises manufacturers to use safety standards with testing and ingredients when manufacturing products, "the safety of a product can be adequately substantiated through (a) reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic, and (b) performance of any additional toxicological and other tests that are appropriate in light of such existing data and information." (Federal Register, March 3, 1975, page 8916).
This update is provided to you by UReg FDA Registrations. We provide FDA registration services to a wide range of clients to help them remain compliant with the many laws and regulations associated with the FDA. For more information, please visit us online.