The Modernization of Cosmetics Regulation Act (MoCRA) creates a comprehensive, uniform national framework for cosmetics regulation. The Act provides the safety reassurances consumers expect and deserve, according to executives at the Personal Care Products Council (PCPC). The legislation helps the science-driven beauty industry remain innovative and provide consumers with the variety of products they trust and use every day. 

MoCRA was enacted on Dec. 29, 2022, but the legislation was years in the making. PCPC went on the journey from the first step.  Happi recently sat down with PCPC’s Lisa Powers, EVP-public affairs and communications; Karin Ross, EVP-government affairs; and Tom Myers, EVP-legal and regulatory affairs, to discuss MoCRA and the impact it will have on manufacturers and suppliers in the cosmetics industry.

Ross noted that the industry was advocating for reform for many years; but the opportunity to enact change came in November 2021, when Senators Patty Murray (D-WA) and Richard Burr (R-NC) created a true bipartisan dialogue.

“There had been no changes to the FD&C Act since 1938,” noted Ross. “Our members have gone above and beyond the law for years. But MoCRA makes voluntary measures mandatory. It levels the playing field, and gives FDA more power and enhances its regulatory authority.”

At the same time, regulators continue to seek input from industry. According to Myers, FDA is developing rules and regulations on issues such as labeling and good manufacturing procedures.

“We want to shape FDA’s perspective on key issues,” said Myers. “We are working with our members to ensure that the industry’s perspective is heard.”

For example, in early discussions regarding cosmetics regulation reform, small companies balked at onerous regulations that could be costly. Through compromise, companies with $1 million or less in sales, don’t have to comply with mandatory GMPs, nor must they register their facilities.

Of course, multinationals and many other companies have followed GMPs, as well as ISO standards for years. With mandatory registration for larger companies, it gives FDA a better understanding of where cosmetics manufacturers are operating and the scope of those operations.

For years, cosmetics industry detractors have decried the lack of oversight on manufacturers. They note that the European Union bans more than 1,400 dangerous chemicals from cosmetics. In contrast, the US bans only 20.

Myers was quick to note that ingredients on the EU include an array of chemicals, including motor oil, that would never be found in cosmetics.

“The cosmetics industry is proud of its safety record,” added Myers. “We are the safest product category regulated by FDA.”

MoCRA and Consumers

Consumers crave information. PCPC executives maintain the cosmetics industry has done just that, with label disclosures and informative websites. As a result, consumers won’t see a significant change in communication, since most MoCRA-mandated changes will be between FDA and manufacturers.

“I do hope it (MoCRA) will give consumers even greater confidence in our products,” added Myers.

Powers noted that PCPC has an array of analytical tools at the consumer’s disposal. For example, the website, www.cosmeticsinfo.org  provides information on how cosmetics are regulated in the US and globally and reviews many of the product categories available to consumers.

“We have seen an increase in engagement and impressions for www.cosmeticsinfo.org,” noted Powers. “We’re putting even more support behind our content.”

One issue that MoCRA doesn’t address is animal testing. The industry has been committed to not testing on animals for decades. But animal testing wasn’t addressed in MoCRA because it was not in the version that passed in the Senate Health Committee. But the PCPC executives were quick to point out that industry supports the Humane Cosmetics Act, which generally prohibits the animal testing in the evaluation of cosmetic products, and it prohibits the sale or transport of cosmetics developed using animal testing, subject to civil penalties.

Few Dissenters

PCPC represents 90% of the products available on the US cosmetics market. And while every member was not in on minute details of the Act, overall members were very supportive of modernizing the FD&C Act, according to the PCPC executives.

“Certainly, we spent a lot of time educating members,” recalled Myers. “Our members are innovative and the law didn’t keep pace with innovation.”

Powers noted that MoCRA represents a diverse group of people coming together in the spirit of compromise.

“Leadership got everyone to the table,” recalled Ross. “There are things that not everyone agreed on, but that’s to be expected when you have a diverse group of stakeholders.”

One issue that wasn’t discussed by PCPC members is implementation costs. Myers noted that such discussions could have antitrust issues. But given the support the Act has received from industry, companies look at MoCRA as a good thing for every company.

For now, PCPC is working on an implementation plan.

“We are helping our members comply with MoCRA,” said Ross.

That’s because there is a bit of uncertainty surrounding the Act in regard to product registration and product listing. There is also a question of whether FDA will continue using the voluntary platform or create a new one? Another question: will GMPs be based on international standards or will FDA start from scratch?

“There are some unknowns, so we are talking to FDA during the implementation phase to get some dialogue going,” added Myers. “The deadline is aggressive, but we are firmly committed to making sure we keep it rolling, be a good partner and communicate our perspective to FDA.”

Clearly, there are obstacles to overcome regarding MoCRA, but the PCPC executives are enthusiastic about the measure.

“It is a good thing for industry. Everyone came to the table in the spirit of compromise,” noted Ross. “Now we have a lot of work to do as we pivot to implementation.”


For more on MoCRA, be sure to read the April issue of Happi.