Embracing the Future: Responsible Person & US Agent in the Era of MoCRA 

On December 29th, 2022, the cosmetic industry witnessed a groundbreaking change in regulatory requirements (21 U.S.C., Sec. 321-392), the most substantial update since 1938. This legislation, known as MoCRA, brings forth fresh obligations and signals a significant shift in how cosmetic products are overseen in the USA introducing the US Agent. 

MoCRA grants the FDA increased powers for surveillance, inspection, and intervention to safeguard public health, including the authority to suspend facility registrations and order product recalls. Notably, this aligns the US approach to cosmetics regulation more closely with European law principles. 

FDA Drafts Guidance for MoCRA Cosmetic Registration and Listing 

The US Food and Drug Administration (FDA) has issued draft guidance aimed at aiding “responsible persons” in fulfilling the requirements for submitting cosmetic manufacturing facility registrations and product listings as mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). These requirements apply to all cosmetic manufacturers and private labelers, irrespective of their prior involvement in voluntary programs. The submission window is set between October and December 2023. 

Cosmetic Product Listing: 

MoCRA defines “responsible persons” as individuals like manufacturers, packers, distributors, or importers, whose names appear on cosmetic product labels. Exemptions from these listing requirements include small businesses and certain products classified as both over-the-counter drugs and cosmetics. A comprehensive listing submission entails details such as the product’s labeled name, its cosmetic category as per FDA standards, a complete ingredient list encompassing fragrances, flavors, or colors, the product listing number (if previously assigned), facility registration numbers, contact information for the responsible person, and specification of the submission type, whether it’s an initial submission, an annual update, or an abbreviated renewal. Additional voluntary information includes the parent company’s name (if applicable), the business type, an image of the product label, a link to the product webpage, clarification on whether the cosmetic product is for professional use only, the Data Universal Numbering System (DUNS) number associated with the label address, Unique Ingredient Identifiers (UNIIs), and contact information for individuals related to the listing. 

Facility Registration: 

Entities not involved in cosmetic manufacturing or processing are exempt from registration. Facility registrations should encompass key details like the facility owner/operator’s information, the facility’s particulars, product categories, brand names, responsible persons for each cosmetic product, and the type of submission. Registration deadlines vary, with facilities already engaged in cosmetic manufacturing by December 29, 2022, having until December 29, 2023, to register. Facilities commencing operations after December 29, 2022, must register within 60 days of initiation or by February 27, 2024, whichever comes later. Registration updates are obligatory within 60 days of any changes or cancellations, and all registrations must be renewed biennially. 

Electronic and Paper Submission: 

FDA is developing an electronic submission portal utilizing structured product labeling, set to launch in October 2023. This electronic submission is favored by the FDA, although a paper form option will also be available. A pilot program for testing the electronic portal is currently open until August 22, 2023. 

The Role of the US Agent 

Representing Beyond Borders 

While the Responsible Person need not be physically present in the USA, foreign Responsible Persons must designate a US Agent to represent them on US soil. But what does the US Agent do? 

Deciphering the US Agent’s Role 

Lessons from Established Sectors 

The FDA’s stance on the US Agent’s precise role under MoCRA remains forthcoming. However, insights from other FDA-regulated industries like food, pharmaceuticals, and medical devices provide valuable guidance. Essentially, the US Agent serves as a legal entity or individual capable of efficiently communicating with the FDA and other stakeholders while dutifully fulfilling the legal obligations of the Responsible Person, executed within the United States. 

The Responsibilities of the Responsible Person (and their US Agent) 

Unpacking MoCRA’s Demands 

Here, we delve into the comprehensive obligations stipulated by MoCRA for both the Responsible Person and their US Agent: 

1. Safety Records (Sec. 608) 

• Maintaining records that substantiate the safety of cosmetic products. 

• Ensuring accessibility of these records to regulatory authorities when required. 

2. Adverse Event Management (Sec. 605) 

• Recording Adverse Effects and Serious Adverse Effects around the clock. 

• Reporting Serious Adverse Events to the FDA within 15 business days. 

• Maintaining updated Adverse Events records, the retention period being 3 or 6 years, contingent on business size. 

• Cooperation and readiness for FDA record inspections. 

3. Fragrances and Flavors 

• Providing competent authorities with information on fragrances and flavors in case of Serious Adverse Events. 

4. Labeling Compliance 

• Ensuring product labels feature accurate contact details, enabling consumers to report Adverse Events via regular mail, email, or telephone. 

5. Product Listing (Sec. 607 (c)) 

• Listing cosmetic products and committing to annual updates. 

6. Label Accuracy 

• Ensuring precise labeling of cosmetic products, especially concerning fragrance allergens, pending FDA identification. 

7. FDA Interaction 

• Handling FDA inspections and inquiries efficiently. 

• Assisting in market withdrawals or recalls when necessary. 

8. General Compliance 

• Upholding compliance with all other provisions outlined in MoCRA. 

In Conclusion: Navigating the Roles of the Responsible Person and US Agent 

In summary, comprehending the roles of the Responsible Person and the US Agent is pivotal in navigating MoCRA’s intricacies. The Responsible Person is the entity responsible for bringing products to market, regardless of their physical location. In contrast, the US Agent, detailed in the establishment registration, operates within the USA and stands ready 24/7 for Adverse Events reporting, inquiries, health emergencies, controls, and inspections. Together, they form an integral part of MoCRA compliance, safeguarding the cosmetic industry’s future in the United States.

 

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