Regulations

MoCRA Is in Effect

The Modernization of Cosmetics Regulations Act (MoCRA) is effective today.

It’s MoCRA in America. Facility registration and product listings under the Modernization of Cosmetics Regulations Act went into effect today, July 1.

The Personal Care Products Council noted its member companies continue to work diligently to meet all MoCRA deadlines. In a statement, PCPC noted that member companies have long provided more product information than was required by law, MoCRA’s facility registration and product listing requirement increases ingredient and manufacturing transparency.

More Deadlines Loom

“As now mandated by federal law, all cosmetics brand owners must list each product marketed in the U.S. with the FDA, including its ingredients and where it is manufactured. All facilities manufacturing cosmetic products for distribution in the US must also be registered by the deadline,” said PCPC.

“Cosmetics companies have been collecting the required information for the last several months and submitting it to the FDA’s Cosmetics Direct electronic platform to meet the July 1 deadline. Companies are also working to update product labels as needed to meet the Dec. 29, 2024, deadline for new product labels to include the contact information of the responsible person (i.e., the manufacturer, packer or distributor) for reporting adverse events.

“PCPC and our member companies continue to engage with and share industry’s perspectives with the FDA as it works to implement MoCRA. PCPC has submitted comments in response to all of the FDA’s public consultations on MoCRA implementation to date, including the Agency’s GMP public meeting and the registration and listing program.”

MoCRA In Review

On  December 29, 2022: President Joe Biden signed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Here are key headlines topics and guidelines related to MoCRA, as reported by Happi.com

March 2023

Prepare for the Modernization of Cosmetics Regulation Act

November 2023

FDA Delays MoCRA Enforcement

December 2023

FDA Delays Implementation of MoCRA (Dec. 11, 2023)

FDA Issues Updated Instructions for Serious Adverse Event Reporting (December 15, 2023)

FDA’s MoCRA Electronic Submission Portal is Open (December 18, 2023)

January 2024

More Submission Tools for Facility Registration & Product Listing Are Available

March 2024

PCPC Commends MoCRA Funding (March 15, 2024)

April 2024

Navigating MoCRA: Recent Updates and Key Strategies for Compliance

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