Modernization of Cosmetics Regulation Act of 2022 (MoCRA)-A comprehensive guide

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#MoCRA is a law that expands the #FDA’s authority to regulate #cosmetics in the US. It aims to ensure the safety of cosmetic products that many consumers use daily.

On average, people use 6 to 12 cosmetics products daily, including #makeup, #nailpolishes, #shavingcream and other #grooming products, #perfumes, #face and #bodycleansers, #haircare products, #moisturizers, and other #skincare products.

➡ KEY TERMS IN MoCRA:

✅Adverse Event: Any health-related event associated with the use of a cosmetic product that is adverse.

✅ Facility: Any establishment (including an establishment of an #importer) that #manufactures or processes cosmetic products distributed in the #UnitedStates.

✅ Responsible Person: The manufacturer, #packer, or #distributor of a cosmetic product whose name appears on the label of such cosmetic product.

✅ Serious Adverse Event: An adverse event that results in serious health consequences.

➡ MoCRA provides new authorities to FDA including:

✅ Records Access

✅ Mandatory Recall Authority

➡ MoCRA establishes the following new requirements for industry:

✔ Adverse Event Reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days.

✔ Facility Registration: Manufacturers and processors must register their facilities with FDA and renew their registration every two years.

✔ Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.

✔ Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products.

✔ A responsible person is required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers can use relevant safety data that is already available to support the safety of their products.

✔ Animal testing is not a requirement for marketing a cosmetic product.

➡ MoCRA also requires that industry comply with regulations that FDA will establish for:

✅ Good Manufacturing Practice (#GMP) requirements for facilities that manufacture cosmetic products.

✅#Fragrance#allergen labeling requirements.

✅ Standardized #testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

#food#drugs#cosmetics#medicaldevices#auditor#leadauditor#facilityregistration#productlisting #responsibleperson #gapanalysis #riskassessment #trendingnow #trendingpost #consultants #qualitycompliance #regulatorycompliance #qa #qc #rq #irca #cqi

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