Modernization of Cosmetics Regulations Act (MoCRA)

Briefing Notes
How to cite: Modernization of Cosmetics Regulations Act (MoCRA). Beauty SciComm Group. August 25, 2023. Accessed February 26, 2024. https://beautyscicomm.com/mocra/

This briefing note is to review what we currently know about the Modernization of Cosmetics Regulations Act (MoCRA), with perspectives from Meredith Petillo of Independent Beauty Association, Craig Weiss of Consumer Product Testing, and Dr Simone Swafford of Vogue Regulatory Consulting.

Meredith Petillo, Senior Director of Technical Regulatory Affairs at Independent Beauty Association

What’s happening?

U.S. federal cosmetics regulatory oversight is getting the most significant overhaul since the Food, Drug & Cosmetic Act was enacted in 1938.  A massive federal spending omnibus bill was passed in December 2022 which included MoCRA, the Modernization of Cosmetics Regulations Act of 2022 (text of the law starts on page 1389).  Several provisions of this new law go into effect beginning December 29, 2023, and other sections will come into effect in subsequent years.  

What does it all mean?

First, cosmetics and personal care companies need to know about these regulatory changes.  Next, they must learn about and understand the contents of MoCRA and the obligations that cosmetics stakeholders must meet. Finally, companies should assess their businesses and implement any changes or new processes to comply with those obligations. 

What will the impact be?

The impact will vary depending on the brands’ and manufacturers’ current levels of compliance.  There will be some heavy lifting for all brands and manufacturers this year due to the (still pending at the time of writing) launch of an entirely new facility registration and product listing portal.  It is a level playing field, though, because all companies will need to input their information into this new system (as FDA elected not to transfer data from the now-shuttered Voluntary Cosmetics Registration Program (VCRP) portal).  In addition to the registration and listing requirements, companies should conduct a gap analysis to identify their obligations in other areas.  Adverse event reporting may be a new process for some cosmetics brands, especially those that do not currently make OTC drug products.  Labels may also need to be updated with new information.  Although brands currently implement labeling updates as a part of usual business practices, the timing for compliance could create but an industry-wide update to almost all products, which will be a significant effort. 

What do we know? What do we NOT know?

It is important to keep in mind that the passage of MoCRA was not the end of the regulatory journey;  it’s just the beginning.  Although MoCRA is the new law, FDA is now tasked with creating supplemental regulations and guidance to help industry comply.  

  • We know facility registration and product listing will need to be completed by December 29, 2023. We do not know when the registration portal will be open.  
  • We know GMPs will be mandatory, but we do not yet know the details of what will be included in those GMPs (and FDA has 2 years to publish a proposal, and another year after that to finalize). 
  • We know that serious adverse event reporting will be mandatory. 
  • We know products will need to be labeled with fragrance allergens, but the specific fragrance allergens have not been identified yet.  

It is important to stay up-to-date with FDA’s progress in MoCRA implementation and to act on credible information. There is much speculation circulating in the industry from various sources, so it is important to confirm the accuracy of any information before making business decisions related to MoCRA compliance.  Monitoring communication directly from FDA is very important, and trade associations working directly with FDA to support implementation are also reliable sources of status information related to MoCRA. 

Craig Weiss, Co-President of Consumer Product Testing

What’s happening?

At present, there are a huge number of unknowns and there is a lot of possible misinformation circulating.  We won’t have a clear idea until the regulations are promulgated. There are a few things we can glean from the law; the cosmetic industry is now more heavily regulated than it has ever been, the safety standard appears to be elevated and most of the FDA’s voluntary requests of the past will be mandatory under MoCRA.  While the systems for registrations and listing is being built the law does proscribe the information necessary, so the information can be gathered.  SAE is to be reported to the FDA’s Med Watch and AE’s will need to be collected, trended, retained, and follow through resolution.  I see many companies offering responsible person services, which may be a bit premature as without the regulations, it is difficult to know exactly what makes sense or is allowed to be contracted out.

What does it all mean?

Until the regulations are promulgated it is difficult to say, but I do believe that it will be slightly more difficult to offer new products to market.

What will the impact be?

The additional responsibilities required by MoCRA will put small to medium companies under stress to comply with the anticipated regulations.  This stress will cut across the entire industry and supply chain, from ingredient manufacturers to finished product companies and everyone in between.  These responsibilities may also impact innovation in both ingredients and finished products. 

Simone Swafford, Ph.D. of Vogue Regulatory Consulting

What’s happening?

There are two key activities that either have happened or are happening right now of which everyone should be aware. 

On June 1st, the FDA held a virtual listening session to consult cosmetics manufacturers, including smaller businesses, contract manufacturers, consumer organizations, and other experts to inform FDA’s efforts in developing regulations to establish good manufacturing practices (GMPs) for facilities that manufacture, or process cosmetic products distributed in the United States. If you were unable to attend the session, the deadline to submit comments is July 3, 2023. 

Currently, the FDA is seeking public comments regarding MoCRA labeling requirements, facility registration, and product listing. This is an important opportunity for everyone including industry to provide input to the FDA. The deadline for comments is  June 30, 2023. 

What does it all mean? 

It means the FDA is actively working on its end to fulfill its obligations under  MoCRA. 

What will the impact be?

The impact is not yet known. There is a lot of speculation as to which pathways the agency may take to satisfy the different regulatory requirements mandated by MoCRA. For example, in terms of GMPs, is the FDA going to adopt the International  Standardization Organization Standard (ISO) standard 22716:2007 or make the current draft guidance document law? According to the FDA’s website on May 3rd, the FDA  stated that they intend to withdraw or revise and reissue the draft guidance as appropriate, based on the GMP rulemaking required by the Modernization of  Cosmetics Regulation Act of 2022 or MoCRA. 

What do we know? What don’t we know?

What we do know is that the Voluntary Cosmetic Registration Program or VCRP will not be the system used to fulfill the cosmetics establishment registration and product 

listing required by MoCRA. The FDA stopped accepting and processing submissions to the voluntary registration program for cosmetics establishments and products and is developing a program for submission of the facility registrations and product listings. They will provide further updates on its forthcoming availability.  

What we don’t know is everything else!