According to a new regulatory compliance company Registrar Corp. report, 48% of companies importing cosmetics to the top 25 US retailers remain non-compliant with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This lack of compliance could have significant implications for brands, retailers, and the broader cosmetics industry as FDA enforcement efforts ramp up in the coming months.
CosmeticsDesign spoke to Ashley Dia Zuaiter, Senior Manager of Regulatory Affairs Cosmetics, and David Lennarz, President of Registrar Corp., to gain further insights into the report’s findings and their potential implications for cosmetics and personal care product manufacturers and suppliers.
Compliance gaps: Registration and product listings
Lennarz emphasized that the primary compliance gaps identified were related to “a lack of FDA registrations and a lack of FDA product listings, both of which are requirements under MoCRA.” These gaps highlight critical areas where companies should focus on meeting regulatory requirements.
Registrar Corp.’s analysis of cosmetics companies selling to the top 25 US retailers revealed that approximately 135,000 imported products are not yet compliant with MoCRA requirements. Compliance rates also varied across different types of retailers.
According to Registrar Corp.’s report, pharmacy chains demonstrated the highest compliance rate at 54%, followed by grocery chains at 41%, department stores at 38%, and general merchandise chains with the lowest compliance rate at 32%.
“Our analysis indicates that retailers are struggling to ensure the cosmetics products on their shelves are in fact FDA compliant,” Lennarz said. While retailers themselves are not directly responsible for compliance under MoCRA, consumers expect the products they purchase to meet FDA safety standards.
Challenges in FDA enforcement
One of the key challenges facing the cosmetics industry is “the lack of FDA enforcement at customs for cosmetics entering the United States,” said Zuaiter. Without verification mechanisms at customs, companies face little pressure to comply.
In response, we spoke to an FDA spokesperson, who clarified the agency’s role in monitoring imports. “Imported cosmetics must comply with the same laws and regulations, including MoCRA requirements, that apply to those produced domestically,” the spokesperson explained.
“FDA works closely with U.S. Customs and Border Protection (CBP) to monitor imports,” and “imported cosmetics are subject to examination by CBP at the time of entry,” they added.
Additionally, they shared that “foreign cosmetics that appear to be adulterated or misbranded may be refused entry into the United States.” As a result, “they must be brought into compliance, destroyed, or re-exported,” and “import refusals are listed on FDA’s website and are updated monthly,” the spokesperson concluded.
Zuaiter added that “there is currently no way to verify if a company is compliant with registration and listings,” explaining that “there is no pressure on companies to rush to become compliant without these stop gaps in place.”
The FDA spokesperson also emphasized the agency’s approach to enforcement. “In general, FDA has a risk-based approach to compliance and enforcement.” This means that “not all imported products are examined at the time of entry,” they said.
In addition, “MoCRA contains defined terms and exemptions that limit certain requirements from broad applicability.” According to the spokesperson, “Further, FDA generally intends to ‘educate before we regulate’ as appropriate and feasible as the various effective dates for MoCRA provisions are met. We believe that most cosmetics on the market in the United States are safe.”
Retailers pushing for compliance
Despite these challenges, retailers are proactively pushing their suppliers toward compliance. “Retailers have taken action on their own in sending letters and requirements to their brands that sell into their stores about the new MoCRA compliance,” Zuaiter explained.
“Many retailers already have FDA requirements such as labeling regulations as a requirement,” she added, “and more recently have adopted state regulations as well.”
Registrar Corp.’s CEO, Raj Shah, emphasized in the company’s report that retailers may eventually refuse to stock non-compliant products. “As FDA enforcement now ramps up, we expect that retailers will press on the cosmetics brands to get compliant or risk being removed from their shelves,” he said.
Prioritizing registration and listings
For companies still struggling with MoCRA compliance, Zuaiter recommended prioritizing registration and product listings to avoid potential disruptions or penalties. “Registration and listings are the first thing all facilities and brands should focus on,” she advised.
She also highlighted the importance of addressing adverse event reporting, which remains a challenge for many brands. “Adverse event receiving, record keeping, and reporting appears to be the largest struggle for brands since most are not set up to handle adverse events,” Zuaiter said.
She explained that existing consumer complaint departments are often unequipped to manage medical and personal information, leading to “misinformation, delays in reporting to FDA, and more serious consequences such as recalls and facility suspensions.”
Impact on supply chain and industry relationships
The high level of non-compliance could have broad implications for the industry in the near term, particularly regarding supply chain relationships and product offerings. “Facilities are the driver to push compliance, as they need to be registered in order for Responsible Persons to list their products,” Zuaiter said.
She also noted the potential for increased FDA enforcement at customs, which could pressure companies to meet compliance requirements. “We also anticipate FDA having a system in place to be able to check products as they come into the United States, which will put more pressure on industry to become compliant,” she said.
The resource strain on regulatory teams
As the cosmetics industry continues to navigate the complexities of MoCRA compliance, companies must ensure that their regulatory teams are adequately resourced to manage these new requirements.
“The burden falls on regulatory teams, which can deplete resources very quickly,” Zuaiter warned. Brands that fail to meet these obligations risk losing their distribution networks and damaging their reputations in an increasingly competitive market.
For additional information on importing cosmetic products, the FDA spokesperson recommended visiting FDA’s resources, including:
The spokesperson also encouraged stakeholders to follow the FDA’s social media handle @FDACosmetics on X (formerly Twitter) and subscribe to email updates via the Cosmetics News & Events | FDA web page to stay informed about MoCRA developments.
