Cosmetic regulations in the USA

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

their intended use, taking into consideration claims, consumer perception and ingredients. A product can be classified as a cosmetic, a drug, or even both.

Cosmetic products sold in the USA have to be safe and compliant with

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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.

The USA legislation has specific rules on where certain information has to appear on the label of the cosmetic product. In order to place the information where it should be, it is important to know the terms, such as the outer container and inner container. The outer container has a principal display panel (PDP), and information panels (IP), whereas the inner container has a front

panel and information panels. In order to comply with the labelling requirements, it is important to know which information has to be listed on certain panels. Additionally, for certain information, it is important to use the correct size of the lettering and to place it on the specific location of the packaging as required by the regulation. The following information has to appear on the principal display panel (PDP) i.e. the surface that is visible under customary conditions of sale. • Product name. • Product identity (the nature or use of the product). It can be expressed using a common or usual name of cosmetics, a descriptive name, illustration, or in cases where the nature of cosmetic is obvious, a fanciful name. • Net quantity of contents: using US customary units (fl., gal., fl. oz, oz., lb., etc.) • § 740.10 warning. If the safety of the product hasn’t been substantiated, the label has to include the following warning: ‘Warning – The safety of this product has not been determined’.

Other information that needs to appear on the label. • Ingredient list: ingredients must be listed in descending order by concentration. Those ingredients with a concentration below 1% can be listed in any order after those with a concentration above 1%. Colour additives should be listed at the end and should be named as designated by the FDA (for example, D&C Green No. 5). Perfumes and flavours have to be listed as ‘fragrance’ and ‘flavor’. • Directions for safe use (where relevant). • Warning statements: if the use of products requires any warnings, they have to be listed on the label. • Name and place of business: the name and address of the manufacturer, packer or distributor. • Country of origin (for imported products). • Batch number (not a requirement but it is a common practice to include it). • The expiry date (not a requirement but cosmetic firms are responsible for the safety of their products).

All required labelling information must be in English. The only exception is products distributed solely in a USA territory where a different language is predominant,

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such as Puerto Rico.

Although cosmetics sold in the USA do not require approval by the FDA, manufacturers, distributors or packers are encouraged to participate in the FDA’s Voluntary Cosmetic Registration Program (VCRP). VCRP is an online postmarket reporting system, which means that the products can be registered only after they are already being sold in the USA. It should be added that the VCRP does not apply to cosmetics for professional use only or products, which are not for sale (e.g. hotel samples, free gifts, etc.).

It is important to note that some states have additional state cosmetic regulations, such as Prop 65 in California. Prop 65 includes the list of chemicals which are known to cause cancer, birth defects or other reproductive harm. If products sold in California contain any of those ingredients, they need to include a ‘clear and reasonable’ warning on the labels.

Tjaša Grum has a Bachelor’s degree in Cosmetic Science and a Master’s degree in Biochemistry from the University of Ljubljana, Slovenia. She is a Regulatory Consultant at CE.way Regulatory Consultants Ltd, which offers regulatory and testing services for cosmetic products. tjasa@ceway.eu