The Dynamics of the Cosmetics Industry in Response to the Extension of MoCRA Facility and Product Registration Deadlines
The U.S. Food and Drug Administration (FDA) announced on November 8th that it would extend the facility and product registration deadline of the Modernization of Cosmetics Regulation Act (MoCRA) from the original date of December 29, 2023, to July 1, 2024.
This extension has brought a sigh of relief for many cosmetics companies. MoCRA is legislation aimed at enhancing the safety and transparency of the U.S. cosmetics market. It covers not only facility and product registration regulations but also includes aspects such as product safety verification, labeling regulations, manufacturing and quality control, reporting and management of adverse events, and recall procedures.
While this deadline extension provides the industry with additional time to prepare for regulatory compliance, it's essential to note that not all compliance deadlines for regulations included in MoCRA have been extended. Therefore, the industry still needs to remain vigilant about regulatory compliance. In particular, companies dealing with eye makeup products, which are not exempt from facility and product registration regulations, should be especially cautious.
This extension allows the industry more time to adapt to the regulatory changes introduced by MoCRA, but companies should continue to prioritize full compliance with all relevant regulations to ensure the safety and transparency of their cosmetic products in the U.S. market.
-The Introduction of MoCRA Brings Positivity to the Industry, Yet Stirs Confusion
The cosmetics industry has generally shown a positive response to the introduction of MoCRA (Mindful Cosmetics Regulation and Safety Act). The FDA's implementation of this regulation aligns with consumer demands for stricter regulations, contributing to the enhancement of the safety of cosmetics. While there have been voluntary registration programs such as 'VCRP (Voluntary Cosmetic Registration Program),' these were considered optional regulations for companies. Persistent dissatisfaction and concerns about safety have led to a growing consumer demand for safe products, including the rise of 'Clean Beauty' products.
-Regulatory Confusion and Issues Related to 'Eye Makeup Products
However, at the current juncture, detailed guidelines or prominent compliance cases regarding MoCRA are not clear, leading to ongoing confusion within the industry. In particular, regulations concerning 'Eye Makeup Products' are causing uncertainty. MoCRA includes a provision exempting small businesses with an annual average total cosmetic sales in the U.S. of less than $1 million over the past three years from regulation. However, this exemption applies only to products that directly contact the eyes, and the lack of clear criteria for determining which products fall under this category is causing confusion.
-The FDA's Response and Insufficient Guidelines yet
o alleviate the confusion, the FDA organized a virtual public hearing on MoCRA, and in November, they released guidelines summarizing the key aspects of MoCRA. However, the industry still faces uncertainty as additional detailed guidelines and grace periods have not been announced. In particular, companies dealing with 'Eye Makeup Products' are preparing for regulatory changes, leading to concerns that some businesses might consider discontinuing the production of these products.
How should beauty companies prepare?
Currently, stakeholders in the cosmetics industry are formulating strategies to comply with the Mindful Cosmetics Regulation and Safety Act (MoCRA). Experts emphasize preparing for legal compliance with the original deadline of December 29th. Despite the six-month extension, as the compliance deadline for regulations other than facility and product registration has not been prolonged, companies still need to actively prepare for compliance.
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