It’s officially six months until cosmetics manufacturers, brands and processors have to adhere to legislation introduced under the Modernization of Cosmetic Regulations Act (MoCRA), here’s everything you need to know about the new legislation
You may have heard mumblings of the acronym MoCRA – for good reason. The legislation is the biggest reform to cosmetics regulation in the United States in over eight decades.
The new rules – which come into force on the 29th December 2023 – apply to any brand distributing into the US, including British businesses exporting to the territory.
British beauty brands must learn how to adhere to the new expectations surrounding registration, adverse event reporting, labelling and safety substantiation, to ensure that brands are still able to access the $430 billion market.
What is MoCRA?
The Modernization of Cosmetic Regulations Act was introduced by President Biden as part of the Food and Drug Omnibus Reform Act of 2022 (FDORA). There are 10 key areas of legislation that are set to be rolled out from the end of 2023 over two years.
Introduced to increase consumer safety, the legislation gives the US Food and Drug Administration greater powers to mandate adverse event reporting and standardise labelling and testing in certain areas.
How should British brands prepare for MoCRA rules?
There are four key areas that brands exporting to the US will need to think about after the 29th December. These are:
- Adverse Event Reporting: Your brand’s responsible person will be required to report serious adverse events associated with the use of cosmetic products in the U.S. to the FDA within 15 business days. Adverse events must be reported via the FDA’s MedWatch platform.
- Facility Registration: Manufacturers and processors must register their facilities with the FDA and renew their registration every two years. If the FDA finds that manufacturers are creating products that may cause adverse effects, they have the authority to suspend facilities.
- Product Listing: Each marketed cosmetic product exported to the US must be listed with the FDA, including product ingredients, and provide any updates annually.
- Safety Substantiation: A responsible person is required to ensure and maintain records supporting adequate safety substantiation for their products. The contact details of this person will have to be printed on the label of cosmetic products, including address, phone number, and web address.
Does MoCRA give the FDA more regulatory power?
Short answer – yes.
The FDA will have increased authority to ‘access and copy certain records related to a cosmetic product, including safety records,’ and ‘recall cosmetics (that are) adulterated or misbranded… which could cause serious adverse health consequences or death’.
This is why it is increasingly important for UK brands exporting to the US to ensure their safety records are up to date throughout the lifecycle of their products.
Are any businesses exempt from MoCRA?
Most small businesses will be exempt from MoCRA. For example, small businesses are fully exempt from facility registration and product listing submission if their average gross annual sales for the previous 3-year period is less than $1,000,000 and do not make any of the following:
- cosmetics that come in contact with mucus membranes of the eye
- cosmetics that are injected
- cosmetics that are intended for internal use
- cosmetics that intend to alter the appearance for more than 24 hours
You can find out more about exemptions here.
The FDA is yet to introduce a registration system for cosmetics under the new legislation, once this is launched the British Beauty Council will update MoCRA-related communications.
Interested in learning more about trading outside of the UK? Visit the British Beauty Council’s Trade Hub.
