In a recent announcement on November 8, 2023, the FDA communicated a deferment in the enforcement date for cosmetic facility registration and product listing, pushing it to July 1, 2024. The rationale behind this decision, as stated by the FDA, is to afford the regulated cosmetic industry additional time for alignment with the evolving requirements of the MoCRA.
In other words, the US Food and Drug Administration (FDA) shared some good news for the cosmetics industry. They decided to give companies an extra six months before enforcing rules about registering cosmetic facilities and listing products under the Modernization of Cosmetics Regulation Act (MoCRA). This delay is to make sure companies have enough time to give the FDA the needed info and follow the guidelines they provided in a draft earlier.
It's the most important update to US cosmetics law in 80 years. Some of the new rules include reporting any bad reactions to cosmetics and making sure places that make cosmetics register with the FDA every two years. Also, the people making these products need to share details like ingredients, and they have to update this information each year.
Before MoCRA, companies could choose to tell the FDA about their cosmetic products through a program called the Voluntary Cosmetic Registration Program (VCRP). However, the FDA stopped this program in March because MoCRA said they had to.
In August, the FDA gave advice to companies on how to follow the new rules for registering facilities and listing products. They also introduced a new online portal called Cosmetics Direct to replace the old VCRP. This portal lets companies submit all the necessary info for MoCRA. The FDA is also providing paper forms for the same purpose. According to the announcement, all these tools should be ready by early December 2023.
What is the main point from today's guidance?
The FDA does not intend to enforce MoCRA's requirements concerning cosmetic product facility registration and product listing until July 1, 2024. It's important to note that this announcement does not change the statutory deadlines for registration and listing; instead, it signifies that the FDA will not enforce these requirements until July 1, 2024, essentially providing a six-month grace period. The delay is aimed at giving the industry extra time to meet these requirements and is a response to concerns raised by the industry regarding the need for additional time.
What is the important date to post?
July 1, 2024: the new enforcement deadline for product listing and facility registration
December 29, 2023: The FDA expects to be able to accept product listing and facility registration information.
As we understand, it's not surprising that the FDA needs more time to get everything ready for the new rules (MoCRA). They're being open about it, saying they'll be ready to receive registration and listing info by December 29, 2023, and they want companies to try to meet that deadline if possible. But we'll have to wait and see if their online system is really ready in time.
While we wait, check out the rough drafts of the paper forms for registering your facility and listing cosmetic products. It'll give you an idea of the info you'll need to gather. You can also find a quick summary of what you need to do for registration and listing.
Other requirements are still effective December 29, 2023
The delay in cosmetic registration and listing will likely be a relief for cosmetic companies worldwide. However, it's crucial to understand that this postponement doesn't impact other MoCRA requirements set to take effect on December 29, 2023:
Companies must comply safety dossiers for their products, encompassing tests, studies, or any other evidence necessary to substantiate the claim that a cosmetic product is safe when used as directed on the labels or other provided instructions.
December 29, 2023
Serious Adverse Event Reporting
Companies must have a system for receiving, addressing, and promptly reporting serious adverse events related to their products.
December 29, 2023
Mandatory Recall Authority
The FDA will have the authority to mandate the removal of cosmetics from the market if there is a reasonable likelihood that they could lead to significant adverse health consequences or death.
December 29, 2023
Similarly, the FDA has not indicated whether the delayed enforcement announcement alters the statutory effective date of December 29, 2023, for companies to retain records of adverse events, report serious adverse events to the FDA, or maintain sufficient safety substantiation records. Therefore, companies should continue to prepare themselves for compliance with these deadlines.
We hope you find this information beneficial. Feel free to reach out with any questions regarding safety substantiation, adverse event reporting, or other aspects of cosmetic regulations.
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