In December 2023, the United States Food and Drug Administration (FDA) ushered in a new era for the cosmetics industry with the release of its final guidance on Registration and Listing of Cosmetic Product Facilities and Products in USA as required by Modernization of Cosmetics Regulation Act (MoCRA). This comprehensive guidance encompasses crucial information on the registration and listing of cosmetic product facilities and products. Among the ground breaking initiatives is the introduction of Cosmetics Direct, an electronic submissions portal designed to streamline the registration process.
Cosmetics Direct: A Revolution in Submission Processes
The FDA has unveiled Cosmetics Direct, an innovative electronic submissions portal that aims to simplify the registration and listing of cosmetic product facilities and products. Functioning as an FDA Structured Product Labeling (SPL) authoring tool, Cosmetics Direct facilitates the creation, validation, and submission of SPLs without the need for the Electronic Submissions Gateway (ESG). This user-friendly tool supports the submission of essential data for registration of cosmetic product facilities and cosmetic product listing, providing the FDA's Office of Cosmetics and Colors (OCAC) with valuable insights into manufacturers, processors, and market-available cosmetic products.
Other Submission Alternatives: Expanding Your Options
In addition to the Cosmetics Direct platform, the FDA provides alternative avenues for submitting essential information related to cosmetic product facilities and products. Exploring these options allows stakeholders flexibility in adhering to regulatory requirements.
SPL-formatted Submissions through ESG: As an alternative to Cosmetics Direct, stakeholders can transmit Structured Product Labeling (SPL)-formatted submissions directly through the FDA's Electronic Submissions Gateway (ESG). This approach, which includes applying for a free ESG account, enables the submission of data in the SPL format. The process may take one to three weeks, providing an alternative route for those familiar with ESG.
Paper Forms - Traditional Yet Functional: For those preferring a more traditional approach, the FDA has developed paper forms, namely FDA Form 5066 and 5067. These forms serve as an alternative submission tool and are accessible on the FDA's official website. This option ensures accessibility for stakeholders who may prefer or require a non-electronic conventional method while ensuring compliance with regulatory standards.
Flexibility with SPL Authoring Software: Users have the flexibility to utilize SPL authoring software, including Xforms, to transmit SPL-formatted submissions. This allows stakeholders to choose software that aligns with their preferences and systems. The FDA emphasizes that the ESG system or any SPL authoring software, including Xforms, may be employed for SPL-formatted submissions.
ESG Integration: For those accustomed to the Electronic Submissions Gateway (ESG), Cosmetics Direct allows users to transmit submissions seamlessly through the ESG. This flexibility accommodates varying user preferences, ensuring a smooth transition for stakeholders familiar with the ESG system.
Registration of Facilities: Understanding the Requirement under Modernization of Cosmetics Regulation Act (MoCRA)
Section 607(a)(1) of the FD&C Act mandates the registration of facilities engaged in manufacturing or processing cosmetic products for distribution in the United States. Notably, contract manufacturing facilities necessitate only a single registration, even if producing for multiple responsible persons.
Product Listing: Navigating the Modernization of Cosmetics Regulation Act (MoCRA) Compliance
Section 607(c) of the FD&C Act mandates the submission of cosmetic product listings by responsible persons. Exemptions exist for small businesses and cosmetic products subject to both cosmetic and drug regulations under chapter V of the FD&C Act. Essential details required for product listing include the facility registration number, responsible person information, cosmetic category, and a detailed list of ingredients.
Key Information for Registration under Modernization of Cosmetics Regulation Act (MoCRA)
For both facility registration and product listing, specific information is paramount. This includes details such as the owner/operator's information, facility details (name, address, contact information), brand names, product categories, and type of submission (initial, amended, biennial renewal). Optional information like parent company name, DUNS Number, and additional contact information is encouraged.
FEI - a Key Step in Cosmetic Facility Registration
The facility registration number, also known as the FDA Establishment Identifier (FEI), plays a pivotal role in the registration process for cosmetic product facilities. In order to initiate the registration, facility owners or operators must first obtain an FEI number. Typically, requests for the issuance of FEI numbers associated with the registration of cosmetic product facilities undergo processing within 7-10 business days. It is important to note that if a facility has previously been assigned an FEI number in connection with other business dealings with the FDA, the same FEI number should be utilized, and there is no need to request a new one. However, for entities without an assigned FEI number, a request can be submitted to email@example.com. This request should include comprehensive details such as
Legal firm name
Alternate firm names
Designated mailing address
Contact information for the designated person,
A list of activities conducted at the specific location,
Any registration numbers associated with other FDA centers,
Former names of the firm, and previous addresses linked to the firm.
Foreign Facilities and U.S. Agents:
Foreign facilities must designate a U.S. agent for registration purposes. The U.S. agent should be physically present in the U.S., excluding mailbox or answering machine services.
Renewal and Update Processes:
Facility registrations and product listings require periodic renewal and updates. Biennial renewal for facilities and annual updates for product listings ensure that information stays current. FDA provides an abbreviated renewal process for unchanged registrations and listings.
Compliance Policy and Enforcement Timeline for Modernization of Cosmetics Regulation Act (MoCRA)
While the FDA issued a compliance policy deferring enforcement of cosmetic product facility registration until July 1, 2024, responsible persons and facilities are encouraged to comply with the outlined timelines for initial registration, amendments, and renewals.
Registration of Drug-Cosmetic Combination Products –
When a cosmetic product doubles as a drug, it is exempt from the listing requirements stipulated in section 607 of the FD&C Act. Similarly, a facility engaged in the manufacturing or processing of cosmetic products with drug attributes is not obligated to fulfill the registration requirement. Notably, the registration and listing of cosmetic product facilities, even those involved with drugs, follow the streamlined electronic submission process, which is the same as that employed for establishing and listing drugs with the FDA. This unified approach facilitates a smoother and more efficient process for entities dealing with both cosmetics and drugs, ensuring seamless compliance with registration and listing regulations.
Exemptions from Registration under Modernization of Cosmetics Regulation Act (MoCRA)
Certain entities, such as laboratories performing research, development or evaluation / testing of cosmetic products, might be exempt from registration. On the other hand the laboratories that test cosmetics for batch release are subject to registration requirements. Importers need to comply with registration and listing requirements if they meet the criteria of a facility or responsible person. The facilities intended for storage of cosmetics alone are also exempted from registration. The facilities involved in manufacturing or processing cosmetic ingredients alone are exempted from registration. The small business exemptions are not applicable for facilities involved in manufacturing and processing of cosmetic products regularly in contact with mucus membrane of eye, injectable cosmetics, intended for internal use and those which alter the appearance for 24 hours.
The FDA's latest guidance marks a significant milestone in ensuring the safety and transparency of cosmetic products in the U.S. market. Stakeholders in the cosmetics industry must familiarize themselves with these guidelines, leverage tools like Cosmetics Direct, and adhere to registration and listing requirements to contribute to a safer and more regulated cosmetic landscape.
End-to-End Support with Artixio:
Navigating the regulatory landscape can be complex, and ensuring compliance is paramount. For comprehensive end-to-end support and management, consider reaching out to Artixio. Our experts are well-versed in FDA regulations and can guide you through the entire process, from registration to product listing. Contact us today for a seamless and compliant journey in the cosmetics industry.