As a manufacturer and producer of cosmetic products sold to the US market, it’s vital you sit up and take notice of the Modernization of Cosmetics Regulation Act otherwise known as MoCRA.
MoCRA is the first major update to cosmetics regulations since the Federal Food, Drug, and Cosmetic Act (FDCA) appeared over 80 years ago. Enacted on 29th December 2022, MoCRA will come into force as of 29th December 2023.
The premise of these changes is to give the Food & Drug Administration (FDA) greater oversight of the activities of cosmetics manufacturers as well as greater powers to mandate adverse event reporting and standardise labelling and testing in certain areas.
The end goal is of course increased safety for consumers and clearer routes for resolution in the event of issues. Something we should be wholly supportive of as an industry.
What do cosmetics companies need to know about MoCRA?
There are a number of requirements that will need to be addressed in good time:
Registration of production facilities
If you are the owner or operator of a facility that manufactures or processes cosmetic products you will need to register with the FDA now and every two years going forwards. If you’re responsible for only labelling, external packaging or storage, this requirement does not apply. Registration will need to take place by 29th December 2023 for all existing facilities and no more than 60 days after production activity starts in a facility that commences after that date.
Additional obligations for Responsible Persons
Responsible Persons (i.e. manufacturers, packers or distributors of a cosmetic product whose name appears on the label, as set forth under the Fair Packaging and Labeling Act) will need to submit a list to the FDA containing all cosmetic products for which they are responsible, including ingredients and information about where they were manufactured.
All labels will need to be updated to include not only the name of the RP but also a domestic address and telephone number via which they can receive adverse event reports. Once received, the RP is obligated to record the adverse event and submit to the FDA within 15 days. The RP must maintain all records for a period of 6 years.
What constitutes a reportable adverse event?
MoCRA provides specific details on what constitutes a reportable event. It includes infections or “significant disfigurement,” such as “serious and persistent rashes, second- or third- degree burns, significant hair loss, or persistent or significant alteration of appearance[, other than as intended, under conditions of use that are customary or usual.”
We are working on the assumption that the FDA will continue to use MedWatch for mandatory submissions as it has done for voluntary cosmetics adverse event reporting to date.
One final key consideration for RPs will be the obligation to maintain records supporting “adequate substantiation” that a cosmetic product is safe. Where this is not possible, for example in the case of Coal-Tar Hair Dye, the product will be considered adulterated under a newly created adulteration provision within the FDCA Coal-Tar Hair Dye subsection. This requires the RP to maintain additional records and ensure the product abides by a number of legal stipulations such as adequate precautionary labelling.
What can we expect from the FDA during this time?
MoCRA brings with it a number of new responsibilities for the FDA itself, meaning we can expect more changes or at least guidance from them across the coming years.
Mandating Good Manufacturing Processes
The FDA must issue mandatory current Good Manufacturing Practice (GMP) regulations for cosmetics, that are consistent with national and international standards. The FDA’s current draft guidance for cosmetic GMP leverages elements from ISO 22716, so we can only expect that future cosmetic GMP regulations will do the same.
Getting serious on fragrance allergen labelling
The FDA must determine which fragrance allergens need to be disclosed on a cosmetic’s label. And then regulate this. We can expect this to be implemented not later than 18 months after the date of enactment of the Modernization of Cosmetics Regulation Act of 2022.
Greater powers of recall
MoCRA grants the FDA the authority to order a mandatory recall of a cosmetic product if it determines that the cosmetic product is likely to cause serious adverse health consequences or death.
Introducing regulations re talc
The FDA have a responsibility to put in place regulations to establish standardised testing methods for detecting and identifying asbestos in talc-containing cosmetic products.
It’s worth noting there are some exemptions to these rules depending on company size and or the mix of drugs / cosmetics being produced in a facility.
Stay up-to-date on regulations
At ADSL we believe one of the most important things we can do for our partners and clients, is to keep up-to-date with new rules and regulations that come into force not just in the UK and the US, but across the world. So we can offer advice, guidance and best practice examples to make sure they don’t get caught out by something they simply weren’t aware of. Sign up to our email newsletter adslaboratories.com/#newsletter-popup
Find out more about ADSL’s cosmetic development and testing work at In-Cosmetics 28-30 March, Stand AA11.