Business Tips
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Cosmetic regulations in the
USA For South African beauty brands wanting to export their products in the USA, Tjaša Grum provides an introduction into the regulatory framework of that region Photo by Sharefaith from Pexels
In terms of legislation and product classification, cosmetic products sold in the USA are regulated by the US Food and Drug Administration (FDA). They must comply with the Federal Food, Drug and Cosmetic Act (FD&C Act) and Fair Packaging and Labelling Act (FPLA). In addition, there are also some state-specific regulations, such as California Proposition 65 (Prop 65). The definition of a cosmetic product in the USA is different than in the EU, which means that some products may be cosmetics in the EU but not in the USA. 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’. It is important to add that the definition of a cosmetic product excludes soap. Cosmetic products in the USA are defined by
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Cosmetic products 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, a drug, or even both.
their intended use, taking into consideration claims, consumer perception and ingredients. A product can be classified as a cosmetic, a drug, or even both.
Product composition and safety Cosmetic products sold in the USA have to be safe and compliant with
the relevant regulations. Similar to Canada, the US regulations do not provide specific requirements on how to demonstrate the safety of the product and its ingredients. This remains in the hands of the manufacturers; they can choose how they will substantiate the safety of their products. The product should also be properly labelled as well as not include any prohibited ingredients and in the case of restricted ingredients, comply with the relevant restrictions, which are published by the FDA. It is important to add that although cosmetic products do not require pre-market approval by the FDA, all colour additives, other than colouring materials intended for use as coal-tar hair dyes, must be approved by the FDA in order to be used in cosmetic products. If the cosmetic product contains colour additives, those have to be found on the list of approved colour additives for use in cosmetics, which can be found on the FDA’s website.