The US Modernization of Cosmetics Regulation Act of 2022 was signed into law at the end of 2022 and there have been many articles online highlighting the contents. Notably, sections 605, 607, 608 and 609 are added to the Food, Drug and Cosmetic Act (FDCA). These provisions are now part of the FDCA whereas additional provisions will require further regulatory publications from the Food and Drug Administration (FDA) in the coming years (e.g. GMP). However, what is clear is that nothing is yet clear! As you will see below, the detail of many requirements is not yet known but we can begin to prepare and plan whilst we await full clarity.
FDCA Section 605: Adverse Event Recordkeeping and Serious Adverse Event Reporting
Section 605 introduces requirements for adverse event recording and reporting. Taking effect from 29 December 2023, the FDA has not yet defined the process for reporting.
FDCA Section 607: Mandatory Facility Registration and Product and Ingredient Listing
Each establishment that manufactures or processes cosmetic products for US distribution, whether the facility is located in the US or overseas, must register with FDA. Overseas facilities will be required to name a US agent on their registration.
Existing facilities must register within one year (29 December 2023) but the FDA has not yet produced information on how to register.
Responsible Persons (manufacturer, packer, or distributor who appears on the product label) must list their product, its ingredients and place of manufacture with the FDA.
Existing products must be registered within one year (29 December 2023) but the FDA has not yet produced information on how to register.
FDCA Section 608: Cosmetic Safety Substantiation
Section 608 establishes a requirement for Responsible Persons to ensure, and maintain records supporting, “adequate substantiation” showing that a cosmetic product is ‘safe’.
‘Adequate substantiation’ is not currently defined but as UK and EU businesses already carry out robust safety assessments we hope that these will be able to form the basis of a body of evidence for this requirement, as is currently the case.
This provision applies from 29 December 2023.
FDCA Section 609: Cosmetic Labelling and Fragrance Allergen Transparency
Professional products will need to be clearly labelled that they are for use by licenced professionals only and such products will need to carry all aspects of cosmetic and FPLA labelling, including a list of ingredients (by 29 December 2023). In the past, professional products have not been required to carry a list of ingredients.
Details through which the Responsible Person can receive reports of adverse events must be included on the pack by 29 December 2024. This can be achieved through the inclusion of a website on the labelling, or a domestic address or telephone number.
MoCRA introduces the need to include fragrance allergens on pack but the FDA has not yet defined the list of allergens for inclusion.
What should you be doing now?
In our view, it will take the FDA several years to implement and enforce the new law with some aspects requiring rulemaking proceedings that will be technical and complicated. However, companies are advised to prepare where it is possible to do so. For example:
What products do you supply to the US?
Which manufacturers/facilities produce which products?
How do you currently receive and record adverse events occurring in the US?
Will any modifications be needed to your current labelling to accommodate a US address or website?
Do you sell professional products that will need to be relabelled?
Do you currently list the EU fragrance allergens on your US packaging? This provision is coming in Canada too - something to keep in mind also!
Training staff on new requirements.
Monitoring for FDA confirmation of new laws and processes.
Building new/revised SOPs for adverse event processing.
However, it is important to keep in mind that we are currently still awaiting clarification from the FDA on many aspects of MoCRA and during this time, we would advise businesses to be aware of companies selling services that, potentially, may not be needed (particularly for those who are already compliant in EU/GB markets).
Written by Amanda Isom