U.S. MoCRA REGISTRATION
The Modernization of Cosmetics Regulation Act (MoCRA) mandates registration for manufacturers, processors and distributors of cosmetic products.
LOOKING TO SELL COSMETICS IN THE U.S.?
United Safety Agents (USA) specializes in assisting cosmetic manufacturers, processors, and distributors to achieve MoCRA compliance.
Cosmetic Facility
Product Listing
FDA Registration
MoCRA compliance includes a mandatory two-part registration with FDA.
USA SERVICES
As U.S. Agent, USA will ensure MoCRA compliance.
Product Listing Registration
Facility Registration
Cosmetic Label Assessment
PRODUCT LISTING REGISTRATION
for cosmetic distributors
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PRODUCT REGISTRATION
USA will submit an Initial Product Listing Registration and Amended Registrations.
USA will act as your company's U.S. Agent.
2. CERTIFICATE
Once FDA approves your Product Listing Registration, you will receive a Certificate indicating your MoCRA compliance.
3. ADVERSE REPORTING
Have a Serious Adverse Event?
USA will assist you through the process of reporting event with FDA.
FACILITY REGISTRATION
for cosmetic manufacturing and processing facilities
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FEI NUMBER
Does your Facility have an FEI number? If not, no problem.
USA will help to obtain one at no additional cost.
2. FACILITY REGISTRATION
USA will submit an initial Facility Registration and Amended Registrations.
USA will act as your Facility's U.S. Agent.
3. CERTIFICATE
Once FDA approves your Facility Registration, you will receive a Certificate indicating your MoCRA Compliance.
COSMETIC LABEL ASSESSMENT
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COSMETIC LABEL ASSESSMENT
FDA requires cosmetic labels to be truthful, not misleading, and compliant with U.S. regulations. USA ensures your label meets FDA labeling requirements.
2. PROP 65 ASSESSMENT
Affirm your cosmetic ingredients meet the State of California's Prop 65 mandate.
USA will provide ongoing monitoring confirming product compliance.
MoCRA is mandatory. MoCRA has broadened the FDA's regulatory authority over the cosmetic industry with the intention of protecting the public's health and confirm consumer confidence by placing safety measures on all cosmetics sold in the United States. MoCRA requires Facility Registration, Product Listing Registration, Serious Adverse Event Reporting, Records Maintenance, adds to Labeling Requirements, and establishes GMPs.
Failure to meet these requirements falls into the Prohibited Acts under Section 301 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 331).
