The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a significant milestone in the regulation of cosmetic products in the United States. This comprehensive legislation, enacted to enhance consumer safety, imposes a series of requirements and obligations on cosmetic companies, facilities, and responsible persons within the industry. MoCRA not only expands the authority of the U.S. Food and Drug Administration (FDA) but also introduces new regulations that affect the entire lifecycle of cosmetic products, from manufacturing to marketing.
What MoCRA Means for Cosmetic Companies
One of the fundamental requirements under MoCRA is mandatory FDA registration for all facilities involved in the manufacturing or processing of cosmetic products intended for distribution in the United States.
Existing facilities must complete their registrations no later than December 29, 2023, while new facilities must register within 60 days of marketing their products or by February 27, 2024, whichever is later. These registrations will necessitate renewal every two years.
MoCRA requires manufacturers, packers, or distributors whose names are featured on a cosmetic product’s label to provide the FDA with comprehensive details about the product’s ingredients.
For cosmetic items launched after MoCRA became effective, these responsible individuals must submit their product listings within 120 days of the product’s introduction to the market or by December 29, 2023, whichever date is later. Additionally, they are obligated to provide annual updates for their product listing information.
Cosmetic Good Manufacturing Practices (GMPs)
Facilities engaged in cosmetic product production will be obliged to adhere to GMPs established by the FDA. These GMPs align with international and national standards and aim to ensure the safety and quality of cosmetic products.
The FDA has a window of up to two years from the passage of MoCRA to issue a Notice of Proposed Rulemaking concerning Cosmetic GMP, and it is anticipated that the final decision will be made within three years after MoCRA becomes law.
Records Access, Inspections, and Safety Substantiation
Individuals in charge must ensure the safety of their cosmetic products by overseeing the ingredients and intended usage. They are required to maintain sufficient safety evidence for their products or seek evaluation of their product’s safety by a qualified professional. Products lacking such safety documentation will be deemed as improperly labelled and contaminated.
MoCRA has implemented new guidelines concerning the labelling of cosmetic products. These guidelines entail the necessity of including a domestic phone number, electronic contact, or domestic address on the product label for receiving adverse event reports from a responsible person. Furthermore, the label must now include information about fragrance allergens.
MoCRA requires the FDA to compile a list of fragrance allergens within 18 months of the law’s implementation, with the ultimate decision being issued 180 days after the conclusion of the public comment period. In the case of professional cosmetics, there is a stipulation necessitating a prominent statement specifying their intended use exclusively by licensed professionals and their compliance with established cosmetic product labelling standards.
Adverse Event Reporting
Responsible individuals are required to promptly notify the FDA of any significant negative incidents linked to a cosmetic product, known as “serious adverse events,” within 15 business days of receiving the report. Furthermore, if new and substantial medical information related to the initial report arises within a year, it must also be reported within 15 business days. These adverse event reports need to be retained for six years, though certain small businesses are exempt and must keep records for three years.
The FDA is now empowered to carry out on-site inspections of a range of documents pertaining to cosmetic products, especially when there are concerns regarding significant health issues or adverse events linked to the product or its components.
Mandatory Recall Authority
In cases where the FDA establishes that a cosmetic item is tainted or inaccurately labeled, and there is a significant likelihood of severe health issues or even fatalities, the FDA is empowered to compel the responsible party to halt distribution or prompt a voluntary recall.
Small Businesses Exemptions
Small businesses in the US, with average gross annual cosmetic product sales of less than $1 million over the past three years (adjusted for inflation), and not involved in manufacturing or processing certain types of cosmetic products, are exempt from complying with GMP, facility registration, and product listing requirements. However, this exemption does not apply to cosmetic products that fall into specific categories:
- Cosmetic products designed for use near the eye’s mucous membrane in customary conditions.
- Cosmetic products meant for injection.
- Cosmetic products intended for internal use.
- Cosmetic products designed to modify one’s appearance for a period exceeding 24 hours under typical circumstances, without the need for consumers to remove them as part of their routine.
Mandatory Compliance with Regulatory Asbestos Detection (MoCRA) mandates that the FDA, within a year of its enactment or within 180 days after the conclusion of the public comment period on the proposed regulation, must establish and enforce standardized testing procedures to detect and identify asbestos in cosmetic products containing talc.
PFAS in Cosmetics
Within three years of the Act’s enactment, the FDA is obligated to evaluate and furnish scientific evidence regarding the safety and utilization of Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) in cosmetic products.
The Modernization of Cosmetics Regulation Act of 2022 represents a significant step forward in enhancing the safety and oversight of cosmetic products in the United States. By expanding the FDA’s authority and imposing new requirements on cosmetic companies, MoCRA aims to protect consumer health and ensure that cosmetic products meet stringent safety and quality standards. Cosmetic companies must proactively prepare for compliance with MoCRA to meet the new regulatory obligations and ensure the continued availability of their products in the U.S. market.
As a leading regulatory consulting organization, DDReg has supported its customers for cosmetic product registration and compliance for the US market. The team is well-versed with the Cosmetics Regulation Act. It also brings experience in the pharmacovigilance and cosmetic product safety domain. Read our previous take on Enhancing the Safety of Cosmetic Products.
References and Further Reading
- US FDA. Modernization of Cosmetics Regulation Act of 2022. United States Food and Drugs Administration. 2023
- US FDA. News Release: FDA Issues Draft Guidance for Registration and Listing of Cosmetic Product Facilities and Products. United States Food and Drugs Administration. 2023
- US FDA. Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry. United States Food and Drugs Administration. 2023