Custom Manufacture :The Modernization of Cosmetics Regulation Act (MoCRA) has brought significant changes to the U.S. cosmetics industry, introducing the concept of a Responsible Person to oversee regulatory compliance. For companies importing, distributing, or selling cosmetics in the USA, understanding the duties of the MoCRA Responsible Person is crucial.
At HCP Wellness, we are a MoCRA-registered cosmetic manufacturer, skincare manufacturer, and toothpaste manufacturer in the USA, helping importers, distributors, and retailers comply with these regulations while offering cost-effective solutions tailored to your budget.
What is a MoCRA Responsible Person?
Under MoCRA, the Responsible Person is defined as the manufacturer, packer, or distributor whose name appears on the product label. They ensure that products meet U.S. regulatory standards, including safety substantiation, labeling, and adverse event reporting. This role can be fulfilled inside or outside the U.S., or delegated to a qualified authorized agent.
HCP Wellness acts as your MoCRA Responsible Person, helping USA importers, distributors, and retail chains maintain compliance and avoid regulatory issues.
Duties of the MoCRA Responsible Person
The responsibilities of the Responsible Person under MoCRA include:
1. Cosmetic Product Listings
All cosmetics marketed in the U.S. must be listed with the FDA, including:
• Product type and category
• Ingredients (fragrances, flavors, colors)
• Facility registration number
• Responsible person contact details
At HCP Wellness, we maintain accurate FDA product listings for all our manufacturing clients, whether for toothpaste, skincare, or cosmetics, ensuring full compliance with MoCRA.
2. Safety Substantiation
MoCRA requires proof of product safety, which can include studies, tests, and expert analyses. The FDA may request documentation to verify safety.
Our in-house R&D team at HCP Wellness ensures all formulations are thoroughly tested and documented, giving USA importers and distributors confidence in safe, high-quality products.
3. Cosmetics Product Labeling Requirements
The Responsible Person ensures labels include:
• Domestic contact details for adverse event reporting
• Fragrance allergen warnings
• Professional use disclaimers (if applicable)
HCP Wellness provides private label and custom formulation services with MoCRA-compliant labels, helping supermarkets, malls, and distributors sell products confidently in the U.S.
4. Adverse Event Reporting & Recordkeeping
Serious adverse events must be reported to the FDA within 15 business days. Records must be maintained for 3–6 years depending on business size.
We support our clients with complete adverse event management and documentation, making HCP Wellness an ideal contract manufacturing partner for U.S. cosmetics, skincare, and toothpaste brands.
5. Voluntary Product Recalls
If a product is misbranded or adulterated, the Responsible Person may need to initiate a voluntary recall.
With HCP Wellness, USA distributors and importers benefit from full regulatory support, including recall management when necessary.
Difference Between FDA and EU Responsible Person
While both FDA and EU require a Responsible Person, the EU requires a person located within the EU to oversee compliance. The FDA allows the role to be handled from outside the U.S. through authorized agents, giving flexibility to international brands.
HCP Wellness bridges this gap for USA-based sales, ensuring your products meet all MoCRA compliance requirements without hassle.
How HCP Wellness Supports USA Importers and Distributors
At HCP Wellness, we go beyond compliance:
• MoCRA-registered and MoCRA-compliant manufacturing for cosmetics, skincare, and toothpaste
• Custom formulations and R&D support to create products per your specifications
• Private label, third-party, and contract manufacturing solutions
• Assistance with product listings, labeling, safety substantiation, and adverse event reporting
• Support for budget-specific cosmetic manufacturing for mall chains, supermarkets, and distributors in the USA
Whether you’re launching a new toothpaste brand, expanding your skincare line, or supplying cosmetics to supermarkets, HCP Wellness is your trusted USA contract manufacturer and MoCRA responsible partner.
Navigating MoCRA compliance can be complex, but with the right partner, it becomes seamless. HCP Wellness provides end-to-end support, from custom product formulation to MoCRA registration and responsible person services, helping USA importers, distributors, and retail brands safely and efficiently bring high-quality cosmetics, skincare, and toothpaste products to the market.
