48% of companies importing cosmetics to the top 25 U.S. retailers remain non-compliant with the Cosmetic Regulatory Modernization Act of 2022 (MoCRA), according to a report from new regulatory compliance firm Registrar Corp. got it. As FDA enforcement efforts intensify in the coming months, this lack of compliance could have significant implications for brands, retailers, and the broader cosmetics industry.
Cosmetics Design spoke with Ashley Dear Zuaiter, Senior Manager, Cosmetic Regulatory Affairs, and Registrar Cosmetics Design to gain further insight into the report’s findings and the potential impact on manufacturers and suppliers of cosmetics and personal care products. We spoke to Coop President David Lennertz.
Compliance Gap: Registration and Product Listing
Lennertz highlighted that the main compliance gaps identified are related to “the lack of FDA registration and the lack of FDA product listing, both of which are requirements under MoCRA.” These gaps highlight key areas where companies should focus on meeting regulatory requirements.
A Registrar Corporation analysis of cosmetics companies selling to the top 25 U.S. retailers revealed that approximately 135,000 imported products still do not comply with MoCRA requirements. Compliance rates also vary by retailer type.
According to the Registrar Corp. report, pharmacy chains had the highest compliance rate at 54%, followed by grocery chains at 41%, department stores at 38%, and general merchandise chains the lowest at 32%. .
“Our analysis shows that retailers are having a hard time ensuring that the cosmetics on their shelves are actually FDA-compliant,” Lennertz said. Although 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 major challenges facing the cosmetics industry is “the lack of FDA customs enforcement of cosmetics imported into the United States,” Zuaiter said. Without customs verification mechanisms, companies face little pressure to comply.
In response, we spoke with an FDA spokesperson to clarify the agency’s role in import oversight. “Imported cosmetics must be subject to the same laws and regulations that apply to domestically manufactured cosmetics, including MoCRA requirements,” the spokesperson explained.
“FDA works closely with U.S. Customs and Border Protection (CBP) to monitor imported products,” it said, adding that “imported cosmetics are subject to inspection by CBP upon entry.”
It also said that “foreign cosmetics that appear to be adulterated or of a counterfeit brand may be refused entry into the United States.” As a result, “they must be compliant and destroyed or reexported,” the spokesperson concluded. “Import denials are posted on FDA’s website and updated monthly.”
“There is currently no way to check whether a company is compliant for registration or listing,” Zuaiter said, adding, “If these stop gaps are not in place, there is no way to put pressure on companies to rush into compliance. No,” he explained.
The FDA spokesperson also emphasized FDA’s approach to enforcement. “In general, FDA takes a risk-based approach to compliance and enforcement,” which means “not all imported goods are inspected upon entry,” the agency said.
Additionally, “MoCRA includes defined conditions and exemptions that limit certain requirements from broad scope.” According to the spokesperson, “Furthermore, FDA generally As the day progresses, we intend to ‘educate before regulating’ whenever appropriate and feasible.”We believe that most cosmetic products on the market in the United States are safe. ”
Retailers driving compliance
Despite these challenges, retailers are actively promoting compliance efforts with their suppliers. “Retailers have taken their own actions by sending letters and requirements about the new MoCRA compliance to their brands that they sell in their stores,” Zuaiter explained.
“Many retailers already have requirements from the FDA, such as labeling regulations, and more recently, state regulations as well,” she added.
Raj Shah, CEO of Registrar Corp., emphasized in the company’s report that retailers may ultimately refuse to stock non-compliant products. “With FDA enforcement now increasing, we expect retailers to put pressure on cosmetic brands to comply or risk removal from shelves,” he said.
Registration and publication priority
For companies still struggling with MoCRA compliance, Zuaiter recommended prioritizing registration and product listing to avoid potential confusion and fines. “Registration and listing is the first thing every property and brand should focus on,” she advised.
She also highlighted the importance of addressing adverse event reporting, which remains a challenge for many brands. “Receiving, record-keeping and reporting of adverse events appears to be the biggest struggle for brands, as most companies are not equipped to deal with them,” Zuaiter said.
He said existing consumer complaint departments are often ill-equipped to manage medical and personal information, resulting in “misinformation, delays in reporting to the FDA, and more serious problems such as recalls and facility shutdowns.” He explained that this has led to “good results.”
Impact on supply chains and industry relationships
High levels of non-compliance can have far-reaching implications for the industry in the short term, particularly regarding supply chain relationships and product offerings. “Facilities are the driving force behind compliance, as responsible parties must register their facilities to list their products,” Zuaiter said.
He also noted that FDA enforcement at Customs may increase, putting pressure on companies to meet compliance requirements. “It is also expected that the FDA will put in place a system to check products as they enter the United States, which will put even more pressure on industry to comply,” she said.
Resource burden on regulatory teams
As the cosmetics industry continues to navigate the complexities of MoCRA compliance, companies must ensure their regulatory teams have sufficient resources to manage these new requirements.
“The burden is on regulatory teams and resources can be quickly depleted,” Zuaiter warned. Brands that fail to meet these obligations risk losing their distribution network and damaging their reputation in an increasingly competitive market.
For additional information on importing cosmetics, an FDA spokesperson recommended the following FDA resources:
The spokesperson also urged interested parties to follow FDA’s social media handle @FDACosmetics on X (formerly Twitter); Cosmetics News and Events | FDA Visit our webpage to stay up to date on MoCRA developments.
