Cosmetic Facility Registration, Product Listing, Record-Keeping, Recall Readiness, and Labeling and Substantiation Compliance for Lasting Radiance
Hear ye hear ye! Implementation deadlines and compliance dates for the new Modernization of Cosmetic Regulation Act (MoCRA) requirements, aimed at strengthening FDA’s regulation of cosmetic product safety in over 80 years, are around the corner. And we must say, prepping and priming for compliance is critical to avoid any disruptions in trade, and to stay ahead of the curve.
In this first part of our upcoming series of articles on cosmetics, we’ll discuss which parties must comply, important compliance dates, and action items for cosmetic companies that start now.
Who is Subject to MoCRA?
The new cosmetic requirements are generally imposed on a “Responsible Person”. MoCRA defines this party as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product. In layman’s terms, this party is typically the company listed on the cosmetic product label.
However, there are certain exemptions that apply to small businesses whose average gross annual sales in the US of cosmetic products for the past three years is less than $1,000,000 USD, adjusted for inflation, and who do not engage in the manufacturing or processing of the following:
- Cosmetic products that regularly come into contact with the mucus membrane of the eye under conditions of use that are customary or usual
- Cosmetic products that are injected
- Cosmetic products that are intended for internal use
- Cosmetic products that are intended to alter the appearance for more than 24 hours
Small businesses, minus the above exceptions, are exempt from facility registration and product listing.
What is Facility Registration and Product Listing?
Manufacturers and processors must register their facilities with the FDA, and renew their registration every 2 years. Additionally, business must list products and ingredients with the FDA, and provide updates annually. FDA has stated the compliance date for facility registration and product listing will be December 29, 2023. The agency anticipates issuing further guidance and instruction on the facility registration process.
Facilities and operations that are exempt from the definition of a facility requirement registration include establishments solely involved in labeling, relabeling, packaging, repackaging, holding and/or distributing cosmetic products that are used solely in research or evaluation, not offered for retail sale and cosmetic ingredient manufacturers (not finished products). Small businesses, as defined above, are exempt from facility registration and product listing requirements unless they engage in the manufacturing or processing of the above-listed products.
FDA is authorized to suspend facility registration if the agency determines that a cosmetic product manufactured by that facility has a reasonable probability of causing adverse health consequences and believes other products may be similarly affected. With a suspend facility registration, the facility is not authorized to introduce any cosmetic products into commerce until the registration is reestablished.
At this time, we recommend identifying whether your facility is required to register, or whether your facility or operations are exempt. We also recommend identifying for registration the following: facility’s name, physical address, email address, and telephone number; US agent of the facility and contact information if a foreign facility, all brand names under which cosmetic products are manufactured or processed in the facility are sold, and the product category or categories and the responsible person for each category. We’ll be monitoring further guidance on the cosmetic registration and product listing process.
Who is Responsible for Reporting Adverse Events and What Record-keeping Requirements Apply?
Under the new requirements, all companies are required to report serious adverse events associated with use of cosmetic products in the U.S. within 15 business days after receiving the report. The adverse event report must include a copy of the cosmetic label, and the Responsible Person is required to report material updates that it learns of related to the adverse event for one year following submission of the report. Additionally, FDA also has authority to request information relating to flavor, or fragrance ingredients, if it has reasonable grounds to believe that such ingredients caused or contributed to the adverse event. The Responsible Person must submit the requested information within 30 days of the request.
We recommend organizing data now, including procedures for intaking, reviewing and processing an adverse event.
In terms of record-keeping, businesses are required to maintain records of any health-related adverse events associated with the use of its cosmetic product for 6 years and report to FDA any serious adverse events no later than 15 days after receiving the report.
Labeling and Safety Substantiation
Responsible persons must ensure and maintain records supporting adequate product safety substantiation by December 29, 2023. Additionally, MoCRA requires that businesses identify contact information through which the responsible person can receive adverse event reports. Professional cosmetic product labels that are not intended for sale to consumers must be marked “For Professional Use Only” and must also comply with other cosmetic labeling requirements. Once FDA issues the fragrance allergen rule, expected December 29, 2024, labels will also be required to identify each fragrance allergen.
Mandatory Recall Authority
FDA now has authority to order a mandatory recall if the Agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded, and the use of or exposure to such cosmetic will cause serious adverse health consequences or death. Before issuing the order, FDA must provide the Responsible Person with an informal hearing and an opportunity to voluntarily cease distribution and recall the product. Additionally, MoCRA provides specific consumer notification requirements for recalled products, including specific information for press releases and recall execution.
Concluding Note
We recommend companies review internal procedures for reporting adverse events, and develop and/or review procedures (SOPs) including Recall procedures and procedures for record development and maintenance. We also recommend companies review product labeling to ensure compliance with US FDA requirements, develop and maintain product substantiation files, and begin identifying and collecting requisite data for cosmetic facility registration and product listing, to ensure lasting radiance.
For any questions on MoCRA and FDA regulatory compliance for cosmetics and personal care products, including assistance with facility registration or product listings, assistance with the development of operating procedures, labeling or substantiation review, or other product compliance or enforcement matters, please contact us at info@garg-law.com.
