Applicable legislation

The legal authority that regulates cosmetics in the USA is the US Food and Drug Administration (FDA). The two most important laws applicable to cosmetic products in the USA are the Federal Food, Drug and Cosmetic Act (FD&C Act), which prescribes the minimum regulatory standards for cosmetics and applies across all 50 states, and the Fair Packaging and Labelling Act (FPLA). Certain states (most notably, California) have, however, also applied some state-specific regulations that can be more stringent than the FD&C Act, such as the California Proposition 65 (Prop 65).

What type of products are cosmetics?

Cosmetics products are defined by the FD&C Act as: “Articles intended to be rubbed, poured, sprinkled, or sprayed on or 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]).

It is important to note, however, that products intended for therapeutic use (products used to treat or prevent diseases or those that affect the structure or function of the body) are classified as drugs or medical devices, even if they also affect appearance. Certain personal care products are also regulated as food supplements, consumer products or over-the-counter (OTC) drugs.

Claims made regarding a certain product can often determine how the product is going to be classified.

Requirements

Cosmetic products placed on the market in the USA do not need product registration/FDA pre-market approval, with the exception of colour additives. However, the FDA can pursue enforcement actions against products that are not compliant with the legislation, either when products are already on the market or when cosmetic products are imported into the country.

Cosmetic products have to be safe for their intended use but the legislation does not require a specific set of tests or documents to demonstrate the safety of individual products or ingredients. It is up to the cosmetics’ manufacturer to determine how they will prove the safety of their products.

Cosmetic products must also comply with the ingredient restrictions, prohibitions and allowable colourants.

Labelling is a very important part of ensuring compliance with the relevant legislation. Products that are improperly labelled, deceptively packaged or otherwise misbranded are prohibited and can be removed from the market.

As mentioned, there is no pre-market approval for cosmetic products. The cosmetic firms are, however, encouraged to participate in the FDA’s Voluntary Cosmetic Registration Program (VCRP), which is an online registration system where manufacturers, distributors and packers can register their facility and provide certain information about the cosmetic products they are selling in the USA.

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