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ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
+1 855-510-2240
MOCRA

 

Modernization of Cosmetics Regulation Act

 

MOCRA

The FDA announced the launch of Cosmetics Direct for electronic Registration and Listing of Cosmetic Facilities and Products, on December 18, 2023.

Indeed, the Modernization of Cosmetics Regulation Act (MoCRA) significantly expands FDA’s rulemaking and enforcement authority over cosmetics, and creates substantial new compliance obligations for manufacturers, packers, and distributors of cosmetics intended for sale in the United States.

The U.S. Food and Drug Administration stopped accepting and processing submissions to the voluntary registration program for cosmetics establishments and products.

COSMETIC ESTABLISHMENT REGISTRATION

Any firm that manufactures or packages cosmetics must submit an establishment registration.

This includes contract manufacturers or packers of a cosmetic, as well as foreign cosmetic product establishments whose products are exported for sale in the United States.

Below are your new options:

FDA has the authority to suspend a facility’s registration if the agency determines that a cosmetic product manufactured or processed by the registered facility and distributed in the United States has a reasonable probability of causing serious adverse health consequences or death to humans, and the agency has a reasonable belief that other products manufactured or processed by the facility may be similarly affected because of a failure that cannot be isolated to a product or products, or is sufficiently pervasive to raise concerns about other products manufactured in the facility.

If a facility’s registration is suspended, it is a prohibited act to distribute or sell (or otherwise introduce or deliver into commerce) in the United States cosmetic products from the facility.

Finally, the U.S. Food and Drug Administration (U.S. FDA) will not complete a registration or provide a registration number until ITB HOLDINGS LLC confirms it has agreed to serve as the U.S. Agent for a foreign facility or establishment.

Modernization of Cosmetics Regulation Act (MoCRA) SERVICE


FACILITY
REGISTRATION

$350.00

ANNUAL SERVICE FEE
178
Voluntary Cosmetic Registration Program (VCRP)

Total registered companies and listed formulations  since September 20, 2018:

  • Number of active accounts: 6,061
  • Number of active cosmetic establishment registrations: 3,459
  • Number of labelers that have filed product formulations: 1,533
  • Number of filed products: 21,761
  • Number of product formulations discontinued: 1,969
  • Number of product formulations rejected: 2,215

Total registered companies and listed formulations  since September 20, 2018:

  • Number of active accounts: 6,061
  • Number of active cosmetic establishment registrations: 3,459
  • Number of labelers that have filed product formulations: 1,533
  • Number of filed products: 21,761
  • Number of product formulations discontinued: 1,969
  • Number of product formulations rejected: 2,215
U.S. Cosmetics Imports

The American market recorded an increase of 28%. With more than €2.3bn of sales, the United States climbed to first place on the podium of countries importing French cosmetics, ahead of China.

Also, the first importer of Italian cosmetics is the United States. As expected, 2024 will be a record year for the cosmetics industry.

Imported cosmetics are subject to examination by CBP at the time of entry. Foreign cosmetics that appear to be adulterated or misbranded may be refused entry into the United States. They must be brought into compliance, destroyed, or re-exported.

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