On December 29, 2022, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as part of the 2023 omnibus spending bill. This legislation is the first major update to the U.S. Food and Drug Administration’s (FDA) authority over cosmetic products since 1938.
Clean beauty brands and industry advocates including trade associations have been lobbying for increased regulation at the federal level for years in an effort to increase consumer safety and transparency in cosmetic formulations. In the absence of meaningful federal legislation, states including California, Washington, and New York have enacted cosmetics legislation in previous years.
MoCRA imposes several new requirements for cosmetic manufacturers and brands, including the following:
The passing of MoCRA lays out a framework for the future, and now it falls upon the FDA to turn that framework into actual rules and regulations that beauty brands and manufacturers will follow. At this stage, the FDA is leaning heavily on beauty industry advocates to develop rules to implement the law that are fair and equitable across all-sized companies without undue burden.
To help you understand the specifics of law as it stands now, how it may be interpreted in the future, and what potential problems may arise, BeautyMatter spoke with industry experts on how upcoming regulation changes may impact the beauty industry.
Product and facilities registration
Two provisions of the law that are supposed to take effect by the end of 2023 are product and facilities registration. Regarding product registration, there's already a voluntary product registration procedure in place with FDA.
“Our proposal would just go ahead and change that from being voluntary to being mandatory,” says Don Frey, President and CEO of the Independent Beauty Association (IBA). “This system is already set up, and people are already familiar with it, so it wouldn't be a lot of additional work for many organizations.”
Each product must be registered separately, which will be a bigger burden upon submission for larger brands with a wide product assortment. Every time a brand launches something new, it will have to be registered with the FDA.
Similarly, any facility that manufactures personal care or cosmetics products will need to be registered with the FDA by the end of the year. Many cosmetic manufacturing locations already comply with this because there’s a nearly identical type of facility registration in place for OTC drugs, which includes sunscreens and some acne products.
IBA is trying to propose that the FDA use the same kind of registration process that's already in place for OTC drugs and expand it to be used for cosmetic manufacturers as well.
“The issue with that is there are different organizations within FDA, sort of like divisions of a company,” said Frey. The OTC drugs are in one division of the FDA and cosmetics are in another. “The challenge for FDA is to allow some cross-pollination between their various divisions,” said Frey.
Good manufacturing practices (GMP)
The FDA has provided guidance on good manufacturing practice standards since 1997, but now those standards are going to be universally mandated by law. According to Ian Ginsberg, President of C.O. Bigelow Apothecaries, this won’t be a huge change for brands that already have a wide distribution.
“Frankly, a lot of us selling globally are doing all this work anyway,” Ginsberg tells BeautyMatter. “We always manufacture to the highest and safest standards.
Dr. Robb Akridge (aka Dr. Robb), CEO and founder of OPULUS Beauty Labs, has already acted on ensuring his company is compliant with GMP regulations.
“I've already given the GMP guidance that currently exists from the FDA to the person who manages production to use as a way to set up our production line,” says Dr. Robb. “If we're already at that level, we won't have to be playing catch up when it actually becomes official.”
Safety testing and serious adverse event documentation
Safety testing will now be required for cosmetic products, but at this point, it’s unclear what those requirements will entail.
“My concern about this bill overall is there's a lot of open-ended questions,” said Dr. Robb. “We don't know how they're going to define safety testing.”
“I could see the FDA taking the view that the current Cosmetic Product Safety Report in the EU cosmetics product information file (PIF) is meeting this requirement,” says Orveon’s Chief Science Officer Mike Wong. “In the worst case, the FDA chooses to actually create its own regulatory scheme that doesn’t align with any other jurisdiction and thereby creates a divergence in the requirements around the world, making it more difficult and costly for companies to manage their compliance requirements globally.”
In addition to safety testing, MoCRA is also requiring mandatory adverse event submissions within specific timeframes. Serious adverse events (which refer to “rashes, second- or third-degree burns, significant hair loss, or alternation of appearance”) must be reported to the FDA within 15 business days after the consumer reports the event to the brand or manufacturer. Additionally, package labeling must include contact details for adverse event reporting to make it more clear for consumers how to notify brands of such a reaction. Brands are required to maintain those records in the event that the FDA comes to inspect the facility.
“That's common sense,” says Dr. Robb. “If you're having a product that's causing people not to be able to breathe or something similar, you better report it and get the product corrected or off the market.”
Regulations surrounding talc and PFAS in cosmetics
MoCRA stops short of banning two heavily debated ingredients in cosmetics: talc and PFAS. Instead, the law directs the FDA to issue regulations that establish and require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetics. The FDA has one year to establish this new regulation.
Additionally, the FDA is required to assess the use, safety, and risks associated with PFAS in cosmetics and publicly publish its findings by December 29, 2025. This directive is in conflict with an existing state law in California that bans the use of PFAS in cosmetics altogether.
“One of the things that we want to really push for is to make sure that there's as much harmonization of these rules and regulations,” says Frey regarding differing state and federal laws.
“There were certain preemptions that were built into the bill, but the one preemption that we had hoped for that wasn't in the bill has to do with the ability of states to regulate individual raw materials or individual ingredients within products. As you start to have these different states with various laws, they can start to conflict with each other.”
Potential problems
In addition to the lack of federal preemption, how the FDA interprets and implements the guidelines set forth by MoCRA might lead to other issues. For example, if the GMP standards are updated in a way that differs from the standards established in other countries, it could end up making it more difficult for brands to be globally compliant.
“In an absolute worst-case scenario, it could mean that the paperwork is so incompatible that you can't manufacture one batch and have it be used for both the US and exported to the EU and UK,” says Frey.
This means brands would have to maintain separate SKUs, and the accuracy of their forecasting becomes problematic because they can't necessarily shift inventory from one geography to another.
The same goes for packaging. “There's a lot of laws happening right now associated with packaging that can affect how you'd have to label the product or how much PCR has to be in the product,” says Frey. “Where those laws start to be in conflict, that, again, could create a situation where you could have a product that in order to comply with, say, a Washington law is not compliant with a California law, or vice versa.”
“We're looking for ways to try and make sure that you can have free trade across the various states and not have laws that prevent you from selling one product across all 50 states,” says Frey.
Increased costs
With increased regulation comes an increase in cost in order for the FDA to enforce regulations and for brands to be compliant. Before MoCRA, the cosmetics industry was one of the least-regulated industries in America. Larger brands that are sold internationally often already have a regulatory affairs person whose responsibility it is to ensure compliance across different countries. Now, smaller brands are going to have to have a regulatory affairs person much earlier in their business-building journey.
“I worry for small to medium-sized business that the bar is going to be so high when it comes to paperwork and fees, because FDA is going to have to charge fees at some point along the line,” says Dr. Robb. “Is it going to be too much of a burden on those manufacturers that they'll have to pass that cost on to the brands? The smaller companies are going to have trouble keeping up,” says Dr. Robb.
This increase in costs can hamper innovation, according to Ginsberg. “I do get concerned about over-regulation because it’s going to cost a lot of unnecessary money, " he says. “There’s a lot of great innovation that comes out of this industry, and you don’t want to stifle this.
Dr. Robb has similar concerns. “A lot of innovation doesn't come from large companies; it comes from small brands that create novel things,” he says. “I'm just worried that it's going to basically suppress innovation in small companies.”
What’s next for the beauty industry
The FDA is facing a number of important decisions regarding the implementation of MoCRA. Additionally, the timing is very tight for the agency to clarify the definitions and processes associated with this newly passed law. The federal agency is working with IBA and other beauty industry advocates to provide feedback and help identify ways to implement the law to ensure consumer safety in such a way that doesn't overburden and add excess cost to companies.
Frey told BeautyMatter that the IBA has already met with the regulatory agency to set forward a timeline to ensure that anyone who wants to have a hand in crafting these new regulations has the chance to make their voice heard.
“The FDA and Congress do listen when people make these comments, so it's important for us to make sure that our members are mobilized and ready to know when comments are coming up, and explain to them what the implications are of the various rules and regulations so that they can make up their own minds as to how they feel about them,” says Frey. That's the most important thing: to make sure that as we go through this process that the rules and regulations reflect the wishes of the companies as well as the wishes of the lawmakers.”
“The small guys should get involved, come to the table, and help shape the framework for the future. Now is your chance to speak up,” echoes Ginsberg. “I’m cautiously optimistic that [the FDA] will come up with something that works for everyone.”
Beauty brands are currently under no obligation to make any changes to their production, but it’s important to be aware of what’s coming down the pike as it relates to cosmetic ingredients and safety testing. Many of these laws are set to take effect at the end of 2023, so there’s still time to at least get on the right path while the specifics of the law are being ironed out.
“The updated FDA regulations will allow the industry to create a more level playing field for all companies involved in the beauty space,” says Wong. “Overall, I feel pretty optimistic about the potential that these new regulations could provide, but without the full details from the FDA, the full impact remains to be seen.”
Staying informed of these changes on your own can be really difficult. Trade associations like IBA play an ever-increasing role in the policy-making process and are a great resource to make sure your voice is heard. This is the first major update to cosmetics regulations in decades, so if you haven’t been involved in regulatory reform in the past, it’s not too late to start.
“I think many companies got very complacent,” says Frey. “Business as usual is not going to be the case going forward. People need to be aware that there's going to be some changes and they have to adapt to those changes.”
