USA - FDA Requirements

Legislation in the USA

Under U.S. cosmetics regulation, it’s crucial to determine whether your product qualifies as a cosmetic or an OTC (Over the Counter) product, based on its intended use rather than composition. Traditionally, the FDA defines cosmetics as products that modify the skin’s appearance. 

However, with the passage of the Modernization of Cosmetics Regulation Act (MoCRA) by Congress in December 2022, the FDA now has enhanced authority to enforce stricter cosmetics regulations, effective from December 29, 2023.

How to submit FDA in the USA?

For more details on the Modernization of Cosmetics Regulation Act (MoCRA), including its implications and new requirements starting December 29, 2023.


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:

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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