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MoCRA Regulation
Modernization of Cosmetics Regulation Act of 2022
The United States recently enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), expanding the U.S. Food and Drug Administration's (FDA) regulatory authority over the cosmetics industry. MoCRA requires the FDA to establish comprehensive new regulations for companies that manufacture and distribute cosmetics in the US.
Many regulations come into force as early as 2023.
Prepare now to comply with new US FDA requirements for cosmetics companies.
What does MoCRA mean for cosmetics companies?
MoCRa introduces new provisions that affect the entire life cycle of cosmetic products, from manufacturing to marketing, resulting in increased scrutiny and stricter compliance requirements for cosmetic companies.
These new requirements include:
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Facility registration;
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Cosmetic product listing;
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Adverse events reports;
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Adherence to Good Manufacturing Practices (GMP) issued by the FDA;
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Record keeping, including adverse event and safety substantiation records;
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New labelling requirements which include the addition of a domestic contact information, fragrance allergen declaration and specific labelling requirements for cosmetic products for professional use.
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We will help:
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Properly register cosmetic factories with the FDA as soon as possible
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Act as a US agent for cosmetics brands based outside the US
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Send and manage cosmetic product listings
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Provide updates as FDA implements additional MoCRA guidelines
Do not know where to start? Pharmilab is the ideal partner to help your brand comply with new obligations in the USA.