The new law on cosmetic products starts applying in the United States on December 29, 2023. The Modernisation of Cosmetics Regulation Act (MoCRA) is the major update to the US federal law on cosmetics since 1938. MoCRA includes many terms that might sound unfamiliar or complex. Some terms already exist in another cosmetics legislation, but sometimes have a different meaning in the MoCRA context. However, with the right guidance, understanding MoCRA requirements will become easy also for economic operators new to the American regulatory world.
Definition of cosmetic under the US law
The Federal Food, Drug, and Cosmetic (FD&C) Act defines as a cosmetic a product applied to the human body or introduced into the body to clean it, change its appearance, or improve its aspect. Essentially, the intended purpose of the product defines its classification as a cosmetic. Based on this definition, brand owners can determine whether their product fall under the MoCRA scope or not. Interestingly, soaps and sunscreens are not classified as cosmetics in the United States.
What is an US Agent and when do you need one?
For foreign cosmetic manufacturers, the US Agent is one of the major changes introduced by MoCRA. The US Agent is an in-country representative that facilities based outside the United States must have to enter the US market.
Responsible Person in the United States
The Responsible Person is the brand owner and is accountable for compliance. In other words, the Responsible Person is the name that appears on the labels. Among other things, the Responsible Person have to take care of the following activities:
- Products and facilities registration with the FDA
- Adverse events recording and evaluation
- Serious adverse events reporting
- Holding of safety substantiation dossier
- Compliance with Good Manufacturing Practices (GMP) and labelling requirements
- Communication with the FDA, including fragrance disclosure
Safety substantiation to prove cosmetics safety
MoCRA foresees that brand owners have to provide documentation that evidences the safety of their product. The new law does not specify which documents or tests have to substantiate the product safety. However, the brand owner has to adequately justify why the documentation provided is enough to prove the product safety.
When do you need to register as a facility?
Within end of December 2023, any facility that manufacturers or processes cosmetics must register with the FDA. This applies to each facility – located in the US or outside the US – that manufacturers or processes product distributed on the US market. Therefore, also when a facility produces cosmeticsfor another company, the facility must be registered with the FDA. Notably, small business can be exempted from the facility registration if they do not manufacture certain types of cosmetics, such as cosmetics intended for internal use.
Learn more about MoCRA in our free COSlaw Tutorials:
- Responsible Person USA vs EU
- Product Registration
- MoCRA vs EU Cosmetics vs OTC Drugs
- Fragrance Allergens
- Asbestos and PFAS in Cosmetics
- Cosmetics for Professional Services
- Adverse events
- FDA Access to Records
- Responding to FDA Request for Ingredients
- Mandatory Recalls and Facility Suspension
With decades of experience in global regulatory affairs, Obelis can help both brand owners and facilities comply with MoCRA.
If you appoint Obelis USA as your US Agent, we will assist you with the above and ensure you meet all regulatory requirements for selling cosmetic products in the United States.
Simona Varrella
Publications department
06.10.2023
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