ALS Summarizes New Rules Regulating Cosmetics in the United States

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David Klowden


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United States
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david.klowden@alsglobal.com

(1888PressRelease) A global leader in testing, ALS Limited has released a report to help the cosmetics industry understand and respond to important new changes to cosmetics regulations in the USA codified in the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

ALS, a leading global testing company, has released a report to help manufacturers, importers, marketers, and distributors of cosmetics products for the USA market understand the sweeping set of amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act known as the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The first major update to the FD&C since it established USA cosmetics regulation in 1938, MoCRA was enacted in December 2022 and its phased roll-out is underway.

ALS has published the report to help stakeholders in the cosmetics industry to understand the repercussions of MoCRA. Non-compliance with the Act’s stringent rules governing ingredients, manufacturing processes, documentation, testing, inspection, and certification of cosmetics products could place companies at risk given the FDA’s enhanced enforcement powers—including the new legal authority to require a mandatory recall of cosmetics.

Cosmetics industry stakeholders are advised to review the ALS report, Navigating MoCRA: A Comprehensive Overview of the Modernization of Cosmetics Regulation Act (alsglobal.com/mocra-report), which distills from the legislation its key requirements, provisions, and milestones that will impact the industry in upcoming months and years.

The report covers these important topics in MoCRA:

Adverse events reporting—MoCRA requires manufacturers to monitor and report adverse events associated with the use of their products.

cGMP requirements—manufacturers must adhere to current Good Manufacturing Practices (cGMP) requirements to ensure that their products are safe and effective.

Facility registration and product listing—all facilities manufacturing or processing cosmetics in the US are now required to register their facilities with the FDA and provide complete ingredients lists for their products.

FDA recall authority—if the FDA determines that a cosmetic product may be adulterated or misbranded, MoCRA gives it the legal authority to require a mandatory recall.

Small business accommodations—MoCRA allows several exceptions for small businesses, including a longer compliance period and exemptions from some regulations.

Immediate ramifications—the recent frequency of facility audits by the FDA and the issuance of warning letters to cosmetics manufacturers from the FDA, as well as warning letters from the Federal Trade Commission (FTC) underscore the urgency of understanding these changes. ALS’ report provides details about the FDA warnings and discusses other apparent ramifications of the enactment of MoCRA.

An industry leader in cosmetics safety and efficacy testing, ALS is helping the cosmetics industry navigate these changes and ensure compliance with the Act. ALS also provides stakeholders with product and ingredient reports, recommendations to help meet cGMP requirements, and resolution of non-compliance issues. To learn more about the changing regulatory landscape, read the ALS report on MoCRA (alsglobal.com/mocra-report). If you have any questions or would like further information call 310 214-0043.

About ALS Limited
A global leader in testing, ALS provides comprehensive testing solutions to clients in a wide range of industries around the world. Using state-of-the-art technologies and innovative methodologies, our dedicated international teams deliver highest-quality testing services and personalized solutions supported by local expertise. The ALS mission is helping our clients leverage the power of data-driven insights for a safer and healthier world.

https://www.alsglobal.com/