Cosmetic products sold in the USA are regulated by the Food and Drug Administration (FDA). Applicable legislation includes Federal Food, Drug and Cosmetic Act (FD&C Act) and Fair Packaging and Labeling Act (FPLA). In addition, there are also some state-specific regulations, as example the California Proposition 65 (Prop 65).
Definition of Cosmetics Product
The FD&C Act defines cosmetics 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)].
Cosmetic product in the USA are defined by their intended use, taking into consideration claims, consumer perception and ingredients. A product can be classified as a cosmetic and a drug or both.
Cosmetic companies have to ensure the safety and legal compliance of their products. The product should be properly labelled and marketed as well as not include any prohibited ingredients and in case of restricted ingredients, comply with the relevant restrictions. In case the product contains colour additives, those colors have to be found on the list of approved colour additives for use in cosmetics.
The USA regulations do not provide specific requirements on how to demonstrate safety of the products and its ingredients. This remains in hands of the manufacturers as they can choose how they will substantiate the safety of their products.
Cosmetics products must comply with the labelling requirements laid down by the FD&C Act and the FPLA and it is important to comply with these requirements and make sure that the labels include only cosmetic claims. Otherwise, the product may be considered misbranded by the FDA and removed from sale.
Cosmetic products do not require pre-market approval by the FDA. The only exception are colour additives which require pre-approval by the FDA.
FDA maintains the Voluntary Cosmetic Registration Program (VCRP) and encourages companies to participate in it. It is important to note that the registration of the cosmetic product can be done only after the product is already being sold in the USA. However, after the products enter the USA market, companies can participate in VCRP with information about their activities and cosmetics.
The VCRP does not apply cosmetic products that are not sold for a fee and only cosmetic products used for professional purposes.
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