Are you ready for the next big thing in cosmetics regulation? The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has arrived, reshaping the landscape of cosmetic oversight in the United States. This groundbreaking legislation, enacted on December 29, 2022, represents a pivotal moment in the history of cosmetics regulation, with the aim of strengthening consumer safety and enhancing the integrity of the industry. Here's everything you need to know about MoCRA.
Key Provisions and Deadlines: MoCRA's Impact on Cosmetics
As MoCRA takes centre stage, it brings with it a series of obligations and deadlines that will reshape the cosmetic industry in the United States. Are we ready to meet these new requirements? Let's take a closer look at the key provisions and deadlines.
MoCRA focuses primarily on the regulation of cosmetic products, which are defined as "a preparation of cosmetic ingredients with a qualitatively and quantitatively defined composition for use in a finished product". It does not cover over-the-counter (OTC) medicines that make cosmetic claims, such as anti-dandruff shampoos, moisturisers/make-up marketed with sun protection claims, etc. Instead, these products are subject to OTC drug regulations. However, it is worth noting that certain provisions of MoCRA relating to fragrance allergen disclosure and professional use labelling remain applicable in these cases.
1. Facility Registration (Deadline: December 29, 2023)
Under MoCRA, all existing cosmetic facilities must register with the U.S. Food and Drug Administration (U.S. FDA) by December 29, 2023. New facilities must complete their registration within 60 days of commencing operations or by February 27, 2024, whichever is later. Moreover, these registrations must be renewed every two years, ensuring ongoing compliance. A draft guidance on registration and listing of cosmetic product facilities and products can be found here.
2. Product Listing (Deadline: December 29, 2023)
Responsible persons (RPs), which include manufacturers, packers, or distributors whose names appear on cosmetic product labels, are required to list each cosmetic product and its ingredients with the U.S. FDA by December 29, 2023. For products introduced to the market after MoCRA's enactment, the RPs must submit product listings within 120 days of marketing or within 120 days of December 29, 2023, whichever is later. Additionally, RPs must update this information annually, promoting transparency and accuracy.
3. Safety Substantiation (Deadline: December 29, 2023)
Ensuring the safety of cosmetic ingredients and intended product use is a fundamental responsibility of RPs under MoCRA. They must maintain adequate safety substantiation for their products or have their product safety evaluated by a qualified expert before the impending deadline of December 29, 2023. Products lacking safety substantiation will be considered misbranded and adulterated, reinforcing the commitment to consumer safety. More resources on cosmetics safety substantiation can be found here.
4. Labelling (Deadline: December 29, 2024)
MoCRA imposes several labelling requirements with the primary goal of enhancing consumer information and safety. Cosmetic product labels must now prominently display a domestic address, domestic phone number, or electronic contact information where Responsible Parties (RPs) can receive adverse event reports. Additionally, there is a new mandate to clearly label fragrance allergens. According to MoCRA, the U.S. FDA is tasked with the responsibility of issuing the list of fragrance allergens within a period of eighteen months from the enactment of the legislation, and the final ruling will be issued precisely one hundred and eighty days after the public comment period concludes. Furthermore, for professionally used cosmetics, it is obligatory to feature a conspicuous statement indicating that these products are exclusively intended for use by licensed professionals, while still adhering to the existing cosmetic labelling requirements.
5. Cosmetic Good Manufacturing Practices (Deadline: December 29, 2025)
The introduction of Good Manufacturing Practises (GMPs) is a crucial aspect of MoCRA. These practices, aligned with national and international standards, are designed to protect public health by preventing the adulteration of cosmetic products. MoCRA empowers the U.S. FDA to inspect facilities and access records, ensuring GMP compliance. Within two years of enactment, the FDA will publish a Notice of Proposed Rulemaking for Cosmetic GMP, with the final ruling due within three years after enactment.
6. Adverse Event Reporting
RPs are required to promptly report any "serious adverse event" related to a cosmetic product to the U.S. FDA within fifteen working days of receiving the report. Additionally, for one year after the initial submission, RPs must provide new, and material medical information related to the initial report within fifteen working days of receipt. This ensures that adverse events continue to be monitored and reported with RPs required to keep records for six years.
7. Records
Under MoCRA, the U.S. FDA now possesses the authority to conduct in-person audits of various records related to cosmetic products if there are concerns about serious health issues or adverse events associated with the product or its ingredients.
8. Mandatory Recall Authority
In cases where the U.S. FDA determines a reasonable probability that a cosmetic is adulterated, misbranded, or poses serious adverse health consequences or death, the FDA can compel RPs to cease distribution or initiate a recall voluntarily, further bolstering consumer protection.
Conclusion
A new era of safety and transparency in the cosmetics industry is set to begin with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). As the deadlines approach, industry stakeholders and consumers alike must prepare for these transformative changes, ultimately contributing to safer and more reliable cosmetic products for all.
Read Less
