Cosmetics regulation in the USA is regulated by the Food and Drug Administration (FDA). Two laws are applicable to cosmetic products, the Federal Food, Drug and Cosmetic Act (FD&C Act), which describes the regulatory standards for cosmetics, and the Fair Packaging and Labelling Act (FPLA). Apart from these two laws, which apply across all the unites states, there are also state-specific regulations, such as the California Proposition 65 (Prop 65).
How to classify a cosmetic product according to cosmetics regulation in the USA
FD&C Act defines cosmetics 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”.
We can bear in mind that certain personal care products, which are considered as cosmetics in Europe, are considered as over-the-counter drugs (OTC) in the USA. Some examples are the sunscreen products, anti-cavity toothpaste, anti-dandruff shampoo, etc.
Also, the claims of a products can determine whether the product can be considered as a cosmetic or not.
General requirements to sell cosmetics in the USA
Cosmetics have to be safe for their intended use, but no specific tests or documents are required to demonstrate the safety of both the ingredients and the final product. The manufacturers shall be responsible for the safety of their products.
Labelling of cosmetics is important in order to ensure the compliance with the legislation. Cosmetic products must be properly labelled. Products whose label does not comply with the regulation, or misbranded cannot be put on the sold and might be removed from the market.
With the new MoCRA, labels must include:
- US address.
- US phone number or electronic contact information of the Responsible Person in case of any adverse events.
- Fragrance allergens if they are present in the cosmetic product.
What’s new with MoCRA?
Last December 22nd, 2022, the US President Joe Biden signed into law the Modernization of Cosmetics Regulation Act (MoCRA). This new act amends Chapter VI of the FD&C Act and establishes new regulation for cosmetics products sold in the USA.
Among the new requirements to be considered at cosmetics regulation in the USA, some of which will come into force at the end of this year (December 29th, 2023), there are the following:
- Mandatory product listing for cosmetics sold in the USA
- Mandatory compliance with the Good Manufacturing Practices (GMP’s)
- Mandatory FDA Registration for cosmetic facilities
- Mandatory declaration of fragrance and essential oil allergens on the label
- Mandatory reporting of serious adverse effect to the FDA
- Mandatory safety substantiation and record keeping
- New regulations on PFAS, talc and Asbestos
- Prohibition of animal testing
- New labelling requirements for professional use products
SHAPYPRO is constantly monitoring the updates of MoCRA and shall provide the clients with all the relevant information so they can prepare for the upcoming deadlines. For further information, do not hesitate to contact us:
Discover the 4 key steps to register a cosmetic product sucessfully in our ebook. Download it for free here!