Yesterday, the U.S. Food and Drug Administration (FDA) announced a six-month delay in implementing the Cosmetic Facility Registration and Cosmetic Listing requirements issued under the Cosmetic Modernization Regulatory Act (MoCRA). This delay was implemented to provide sufficient time for industry members to submit the necessary information and comply with the previously published draft. guidanceRegarding MoCRA regulatory standards.
As previously reported by CosmeticsDesign, MoCRA is the most significant amendment to U.S. cosmetics law in more than 80 years, outlining a dramatic overhaul of the FDA’s authority to regulate consumer cosmetics.
These changes include mandatory adverse event reporting and a requirement that cosmetic manufacturing and processing facilities must register with the FDA.Renew your registration every two years”, and specifies that product listings must be submitted to FDA by a designated “responsible person.”Provides up-to-date information, including product ingredients every year”
Before MoCRA was enacted, cosmetics were voluntarily registered with the FDA through the Voluntary Cosmetic Registration Program (VCRP), but this program was discontinued by the organization in March of this year. ”As a result of facility registration and product listing authorities mandated MoCRA”
And in August of this year, FDA issued the draft guidance linked above that provides recommendations for industry organizations to comply with the new facility registration and product listing requirements.
The following month, the FDA opened a commentary period for its newly developed electronic filing portal, Cosmetics Direct. This portal is intended to replace the VCRP as a portal for companies to submit documents required for facility registration and product listing requirements under MoCRA.
Additionally, FDA has created paper forms (Forms FDA 5066 and 5067) that can be used for the same purpose. As detailed in yesterday’s announcement,FDA anticipates that electronic submissions, technical assistance documents, and paper submission forms will be available in early December 2023.”
To learn more and understand more about Guidance issued yesterdayCosmetics Design spoke with attorney Kelly Bonner, an associate at Duane Morris LLP, about the FDA’s decision, including important deadlines for MoCRA compliance. He focuses on litigation risks and regulatory issues affecting businesses in the cosmetics and personal care industry, as well as cross-jurisdictional legal and regulatory issues. Complex commercial disputes involving FDA-regulated products and consumer branded products.
What are the key takeaways from today’s guidance?
Kelly Bonner (KB): As of today’s announcement, FDA does not intend to enforce MoCRA’s requirements related to cosmetic facility registration and cosmetic listing. July 1, 2024.
FDA’s announcement does not change the statutory deadlines for registration and listing. That means the FDA won’t enforce them until July 1, 2024. Therefore, there is effectively a grace period of 6 months.
This delay is intended to provide additional time for industry to comply with these requirements and is in response to industry concerns regarding the need for additional time.
What does this mean in a practical sense?
KB: First, if your company is in a hurry to register its facilities and list its products by the deadline of December 29, 2023 at the latest, this means a “breather”. FDA has heard and is responding to industry concerns.
Second, today’s guidance simply postpones the date by which FDA will enforce MoCRA’s product listing and facility requirements. July 1, 2024– Does not remove the obligation to comply with MoCRA.
FDA has notified that it will be ready to accept registration and listing information by the statutory deadline. December 29, 2023And we encourage businesses to meet that deadline if possible.
Companies should continue to work to identify responsible parties and gather all the information required by MoCRA and the draft guidance issued by the FDA earlier this year.
What are the new important deadlines?
KB: July 1, 2024is the new enforcement deadline for product listings and facility registrations. However, FDA expects to be able to accept product listings and facility registration information by the following deadlines: December 29, 2023.
What am I missing?
KB: FDA has not advised whether it intends to delay implementation of the commercial product labeling requirements effective December 29, 2023 under MoCRA.
Similarly, the FDA said that this delay in enforcement announcement may result in companies having difficulty maintaining records of adverse events, reporting serious adverse events to FDA, or maintaining records demonstrating adequate safety. , does not advise whether the statutory effective date of December 29, 2023 will change. Businesses must be prepared to meet these deadlines.
