With a population of more than 330 M people, and valued at 85€ billion euro at retail sales price in 2021, the USA is one of the largest markets for cosmetic products in the world. The USA represents a market full of opportunities where the consumer has a high purchasing power.
Under the USA cosmetics regulation, we will need to check if your product can be considered as a cosmetic or as an OTC (Over the Counter) product.
In the USA, the definition of a cosmetic will depend mainly on its intended use, and not only on its composition. For the FDA, the main purpose of a cosmetic is modifying the appearance of the skin.
You should be aware that cosmetic products were regulated in the USA by the U.S. food and drug administration (FDA), but in December 2022, the congress approved the modernization of cosmetics regulation act (MoCRA) giving the FDA authority to create stricter regulations regarding cosmetics. The new regulation will come into force in Dec 29, 2023.
First step is to make a revision of the formula of your product. In the USA, there is only a list of 11 ingredients which are banned.
Otherwise, FDA regulates cosmetic colorants.
In US all color additives are required to be listed by FDA and there are two categories: color additives that are subject to FDA’s batch certification process and others which are exempt from the certification.
There is some key information that must appear in the packaging of the product such as name, identity, net quantity, direction of use, warnings, ingredients declaration…
Our safety assessors will analyse and evaluate your products to inform you about any change or modifications that may apply.
The VCRP (Voluntary Cosmetic Registration Program) is no longer valid due to MOCRA update. FDA is currently developing a new system for the mandatory notification and product listing to be used by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the USA.
Our goal is to provide you support to sell your cosmetic products in any US state, but if you consider to sell your products in California, you must know that this state has its’ own regulation.
The specific regulations that apply to this state are:
In December 2022, the Congress approved the Modernization of Cosmetics Regulation Act (MoCRA), giving the FDA authority to create more strict regulations regarding cosmetics. The new MoCRA requires companies to register their manufacturing facility with the FDA and the Responsible Person to list (register) each cosmetic product sold in the American market. See more
The definition of “responsible person” refers to the individual or entity that produces, packages, or distributes a cosmetic product and whose name is displayed on the product label as specified by section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. The “responsible person” assumes responsibility for various tasks, including registering the cosmetic product, reporting adverse events, providing safety validation, creating labels, and maintaining documentation of fragrance allergen disclosures.
Cosmetic products must be safe for human use and properly labeled. They must also comply with FDA regulations regarding the ingredients used in their manufacture.
The FDA prohibits the use of certain ingredients in cosmetic products, including toxic substances such as lead and mercury, as well as certain chemicals that have been associated with health issues such as cancer or allergies.
Banned ingredients list: https://www.fda.gov/cosmetics/cosmetics-laws-regulations/prohibited-restricted-ingredients-cosmetics
The FDA conducts inspections of cosmetic product manufacturing facilities and can order the removal of any product that does not meet its requirements from the market. It can also conduct laboratory testing to ensure that products meet safety standards.
Yes, cosmetic products must be properly labeled with clear and accurate information about the ingredients and safety warnings.
If a cosmetic product does not meet FDA requirements, it can be removed from the market and manufacturers may face civil or criminal penalties.
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