This week, FDA gave the cosmetic industry an early holiday gift when it issued a Compliance Policy on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under MoCRA for 6 months after the December 29, 2023 statutory deadline, or until July 1, 2024. FDA advised this delayed enforcement is intended to assist industry in submitting facility registration and product listing information.
Additionally, owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or facilities that first marketed a cosmetic product after December 29, 2022, now have until July 1, 2024 to comply with the registration and listing requirements.
As we published in our News & Insights article this week, we anticipated FDA providing industry this additional time, as the new Cosmetic Direct system is still pending official launch.
While cosmetic businesses now have an additional 6 months with which to comply, we recommend still getting relevant information in order as the new date will be here before you know it. This includes the FDA Establishment Identification Number, a list of all brands and products in addition to product category, and a list of ingredients in the cosmetic product, including any fragrances, flavors or colors, with each ingredient identified by the regulation name or by the common or usual name. Check out our prior Insights articles here and here for more information.
For businesses that believe they meet the small business exception, we recommend keeping a regulatory rationale on file.
For any questions on U.S. cosmetics compliance and enforcement, including MoCRA, cosmetics labeling and substantiation, import compliance, recalls, FDA inspections and more, please contact us at email@example.com.