The biggest amendment of the U.S. Cosmetics Law since 1938

What Beauty Brands Need to Know about the Modernisation of Cosmetics Regulation Act (MoCRA)

The US cosmetics market is one of the biggest worldwide, and it is facing a major revolution in regulatory affairs. At the end of 2022, the US government issued the Modernisation of Cosmetics Regulation Act (MoCRA) of 2022, which will apply as of December 29, 2023.  

MoCRA is the most significant amendment to the federal law on cosmetic products since 1938. It will reinforce the power of the FDA (Food and Drug Administration) over state governments, and it will have a huge impact on beauty brands. In this transition period, it is essential to have a knowledgeable partner at your side who can guide you through the compliance process, ensuring your products meet the latest regulatory requirements.

What are the changes for manufacturers of cosmetic products according to MoCRA?

The main changes introduced by MoCRA are the following:

  • Registration of facility for manufacturers and processors (US and non-US) with FDA — A US Agent must perform the registration of non-US facilities;
  • Product listing — A responsible person must list each marketed cosmetic product with the FDA, including product ingredients, and provide updates annually, if any;
  • According to MoCRA, the FDA will issue a regulation on Good Manufacturing Practices (GMP) consistent with national and international standards for the cosmetic manufacturing process.
  • Each cosmetic product must have documents to substantiate its safety, such as tests, studies, and analyses;
  • Serious adverse events associated with the use of a cosmetic product in the United States must be reported by the responsible person to the FDA. Moreover, the responsible person must keep records of serious adverse events;
  • Voluntary and mandatory recall by the FDA for cosmetic products that can cause serious adverse health consequences. As a further measure, the FDA can suspend the facility registration;
  • Allergens labelling — The FDA will propose a rule in the near future.  

Lastly, MoCRA also intends to strengthen the federal power in the area of cosmetics. Hence, it prevents States to establish requirements that differ from the federal law regarding the abovementioned points. In fact, the United States is a federation, and each state can enact its own cosmetics law, as California has done with Preposition 65 and New York with the restrictions on 1,4-Dioxane and other ingredients.   

How can Obelis help you?

New laws bring challenges but also opportunities. If you want to extend your business to the United States or ensure that your products already on the US market meet the MoCRA requirements by December 2023, Obelis can help you!

Our team of regulatory affairs professionals will advise you on the applicable requirements and guide you on the compliance process in the United States.

Are you expanding your business to the United States or want to ensure that your products, which are already in the US market, comply with the MoCRA requirements?

Contact us today to know more!

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