Cosmetic

The FDA regulates cosmetics; however, the FDA’s legal authority over cosmetics is different from other products regulated, such as drugs, biologics, and medical devices. Under FDA’s Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetics must not be “adulterated” or “misbranded.” For example, they must be safe for consumers when used as directed in their labelling or under customary conditions of use, and they must be properly labelled and not mislead consumers. Companies and individuals who market cosmetics have a legal responsibility for the safety and labelling of their products.

In addition to these requirements, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) imposes new requirements on companies that manufacture and distribute cosmetics in the U.S. 

New requirements include:

1

Mandatory FDA registration of cosmetics facilities

2

Compulsory product listings for all cosmetics marketed in the U.S.

3

Adherence to FDA Good Manufacturing Practices

4

Adverse event reporting

5

Record-keeping (including safety substantiation)

6

Declaration of fragrance allergens.

MoCRA also gives the FDA new records access and mandatory recall authority.

Diaz Trade Consulting assists companies with all aspects of FDA and MoCRA compliance. DTC submits Cosmetic Product Ingredient Statement (CPIS) filings, registration of cosmetic facilities, and cosmetic product listings. DTC also provides claim and labeling review and ingredient statement filing services on behalf of cosmetic companies. 

Whether you are an individual, small enterprise, or Fortune 500 company, DTC can help you navigate the FDA regulations applicable to your cosmetics products.

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