The long-awaited reform, part of the Consolidated Appropriations Act, 2023, will advance cosmetic product safety and innovation
Under MoCRA there are new requirements for ‘responsible persons’ and for facilities manufacturing cosmetics
The Consolidated Appropriations Act, 2023 was signed into law by President Biden at the end of last year and included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
Within MoCRA is a long-awaited update to the US’ cosmetics laws, amending Chapter VI of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Proposed reforms were originally put forward in a bill in 2015 by co-sponsors Democratic Senator Dianne Feinstein and Republican Senator Susan Collins.
Lezlee Westine, President and CEO of the Personal Care Products Council (PCPC), said of the signing: “This truly historic moment took over a decade, bringing together a diverse group of stakeholders to support a contemporary approach to cosmetics oversight and further strengthen consumer trust in the products they use every day.
She noted that the “landmark legislation” would not have been possible without the commitment of Chairwoman Patty Murray, Ranking Member Richard Burr, Chairman Frank Pallone Jr and Ranking Member Cathy McMorris Rodgers.
“We entered this process advocating for well-crafted, science-based federal reforms to enhance our industry’s ability to innovate and to modernise regulation that has largely been unchanged for 80 years,” added PCPC Executive Vice President of Government Affairs Karin Ross.
“These members of Congress guided that process. Thanks to their leadership, the Food and Drug Administration (FDA) will have the necessary tools to ensure consistent regulation of cosmetics and personal care products.”
The Fragrance Creators Association also voiced its support of MoCRA.
“This will create a modern cosmetics regulatory framework – including for fragrances in cosmetics products – designed to advance sound science, safety, innovation and consumer confidence,” said Farah K Ahmed, the association’s President & CEO.
“We thank Senators Murray, Burr, Collins and Feinstein and Representatives Pallone and McMorris Rodgers, and their tireless staffs for championing this legislation.”
However, Ahmed added: “While we are pleased that cosmetics regulations are now coming in-line with the needs of the 21st century, we remain concerned that future individual state actions could negatively impact competition, limit innovation, and cause consumer confusion.
“Fragrance Creators looks forward to engaging with the Food and Drug Administration to ensure a strong federal role and proper implementation of the cosmetics modernisation provisions as related to fragrance.”
Under MoCRA there will be new requirements for ‘responsible persons’ and for facilities manufacturing cosmetics and personal care.
All existing facilities, domestic and foreign, which manufacture or process a cosmetic product for distribution in the US must register with the FDA no later than one year after the enactment of MoCRA, which was on 29 December 2022.
Following the deadline, new businesses will have 60 days after beginning manufacturing to register with the FDA.
And facility registrations must be renewed every two years.
MoCRA also ushers in mandatory reporting requirements for serious adverse events following the use of a cosmetic product in the US, as well as stronger recall authority for the FDA when quality or safety risks are associated with a cosmetic product.