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FDA Delays Implementation of MoCRA

Enforcement of the far-reaching cosmetic regulations underscores the Administration’s desire to get it right the first time.

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By: TOM BRANNA

Chief Content Officer

The cosmetics industry has been waiting for federal regulation reform— it will have to wait a bit longer. As reported in Happi, implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has been postponed for six months. The compliance date has moved from Dec. 29, 2023 to July 1, 2024.

The US Food and Drug Administration (FDA) calls MoCRA “the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.”

And rightly so.

For example, MoCRA gives FDA access to certain records related to a cosmetic product, including safety records. MoCRA also gives FDA the authority to order a mandatory recall if the responsible party refuses to do so voluntarily. MoCRA establishes new requirements for industry including adverse event reporting, facility registration (updated every two years), product listing (updated annually) and safety substantiation. MoCRA also requires that industry comply with regulations that FDA will establish for Good Manufacturing Practices, fragrance allergen labeling requirements, and standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

With that kind of depth and weight, it makes sense to make sure every facet of MoCRA is working smoothly. That includes the launch of Cosmetic Direct, FDA’s electronic submission portal.

Read More: Prepare for the Modernization of Cosmetics Regulation Act


Beauty industry trade groups, with multinational and independent members, applauded the postponement.

At the time of the announced postponement, the Personal Care Products Council said it:

“Supports the U.S. Food and Drug Administration’s (FDA) announcement to exercise enforcement discretion on Modernization of Cosmetics Regulation Act’s (MoCRA) facility registration and product listing compliance deadline for six months.”

PCPC provided feedback to the FDA on the development of an efficient electronic submission program and recognizes that the FDA’s development of Cosmetics Direct is ongoing.


MoCRA will put an emphasis on Good Manufacturing Practices.
“PCPC will continue to offer feedback to the FDA on the agency’s implementation of MoCRA and is encouraging member companies to prepare for registration and listing. PCPC has shared FDA’s instructions with member companies on obtaining an FDA-assigned Establishment Identifier (FEI) number for each facility that is manufacturing or processing cosmetic products, as needed,” said the Council.

PCPC has also shared information with member companies to help facilitate communications between companies that intend to coordinate their registration and listing activities.

Meanwhile, the Independent Beauty Association (IBA), which represents many small- and medium-sized businesses, said it appreciates the announcement of FDA’s decision to delay enforcement of MoCRA Facility Registration and Product Listing requirements until July 1, 2024. According to IBA, the six-month enforcement delay will help ensure companies of all sizes are able to properly comply with the new registration and listing requirements. In a statement, IBA said it supports FDA’s tireless work since MoCRA’s passage in December 2022 and values the accessibility of the offices of Drs. Bumpus and Katz to hear the voice of small business,” said IBA in a statement. “Our members’ top priority is getting this right and IBA’s priority is to be a resource for our members and the FDA as MoCRA implementation progresses. We were grateful to have a seat at the table and applaud the FDA for listening to the concerns of independent beauty brands.”

IBA has an open survey for companies to get input on MoCRA and encourages an open dialogue as the release date gets closer.

More recently, IBA President and CEO Don Frey told Happi that IBA appreciates FDA’s recent announcement regarding the delayed enforcement of the Cosmetic Product Listing and Cosmetic Facility Registration components of MoCRA to July 1, 2024. 

“In our discussions with FDA, they indicated that they wanted to allow industry a full six months to allow for quality data entry recognizing the volume of information that companies will have to input.  This is particularly important for smaller companies with limited regulatory or legal resources allowing them adequate time to fully comply,” said Frey. “We understand the FDA has limited resources which has affected the opening of the portal, but we are reassured that they are not launching with a system that could result in errors in data integrity as they balance the desire to comply with MoCRA’s timing provisions.”


One Manufacturer’s View of the MoCRA Delay



Industry supports MoCRA, despite delays. That’s because the Act promises to level the playing field when it comes to good manufacturing practices. At the same time, MoCRA may deter states from passing legislation on their own— which would create a patchwork of regulations, according to Chad Conger, SVP-technology, Cohere Beauty.

“We expect that with the support from the Personal Care Product Council, Independent Beauty Association and others, this will help to bring the fractured approaches into one platform,” he said.

Conger noted that in the past 10 years, the beauty industry has been overwhelmed by dubious claims, “no-no lists” and “free from” promises.

“MoCRA is a welcome addition,” agreed Erin Delatorre, regulatory compliance manager, Cohere Beauty. “It levels the playing field for companies like ours that operate using Good Manufacturing Practices (GMP)

Cohere Beauty is a new contract manufacturer, formed from the strategic merger of Marianna Beauty, Arizona Natural Resources, Health Specialty Inc and Contract Filling Inc. Cohere offers research and development capabilities (including more than 100,000 formulas); four production sites and 30 production lines. The Cohere Beauty Salon is the company’s internal testing laboratory.

For his part, Conger said he was pleased to see FDA take its time to get the portal set up correctly.

“That demonstrates there is a thought process in place,” he explained. “And the opportunity for discussion and comments.”

Conger told Happi that MoCRA could put a strain on manufacturers who may not produce products using ideal manufacturing processes.

“MoCRA will help raise the quality of the industry in general, help the cream rise to the top and weed out any bad actors that are in the industry,” he said.

For companies that may be struggling with MoCRA mandates, there are places to turn for help.

For example, during the annual meeting and showcase of the Society of Cosmetic Chemists in December, Registrar Corp will exhibit at booth 215. In addition, Registrar will offer 30-minute seminars on MoCRA compliance on Tuesday, December 12 and Wednesday, December 13. To learn more, click here

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