Yesterday, the US Food and Drug Administration (FDA) announced a six-month delay in enforcement of its cosmetic product facility registration and cosmetic product listing requirements issued under the Modernization of Cosmetics Regulation Act (MoCRA). The delay has been implemented to provide industry members adequate time to submit required information and comply with previously issued draft guidance for MoCRA’s regulatory standards.
As CosmeticsDesign has previously reported, MoCRA is the most significant update to US cosmetics law in over 80 years, and outlines a dramatic overhaul of the FDA’s authority to regulate cosmetics products for consumers.
These changes include mandatory adverse event reporting, as well as the requirements that cosmetics manufacturing and processing facilities must register with the FDA “and renew their registration every two years,” and that product listings must be submitted to the FDA by designated ‘responsible person, “including product ingredients, and provide any updates annually.”
Prior to MoCRA’s enactment, cosmetic products were voluntarily registered with the FDA through the Voluntary Cosmetic Registration Program (VCRP), but this program was suspended by the organization in March of this year “as a result of the facility registration and product listing authorities mandated by MoCRA.”
Then, in August of this year, the FDA issued the above linked draft guidance for industry organizations to provide recommendations for adherence to the new facility registration and product listing requirements.
The following month, the FDA opened a commentary period for its newly developed draft electronic submission portal, Cosmetics Direct, which is intended to replace the VCRP as a portal to companies to submit necessary documentation for facility registration and product listing requirements under MoCRA.
Additionally, the FDA is making paper forms (Forms FDA 5066 and 5067) available for the same purposes. As detailed in yesterday’s announcement, the “FDA anticipates that electronic submission, technical assistance documents, and paper submission forms will be available in early December 2023.”
To learn more about, and better understand the guidance issued yesterday by the FDA, including important deadlines for MoCRA compliance, CosmeticsDesign spoke to attorney Kelly Bonner, an associate at Duane Morris LLP who focuses on litigation risk and regulatory issues affecting businesses in the cosmetics and personal care industries, as well as cross-jurisdictional and complex commercial disputes involving FDA-regulated 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 product facility registration and cosmetic product listing until July 1, 2024.
FDA’s announcement doesn’t change the statutory deadlines for registration and listing– it means that FDA won’t enforce them until July 1, 2024. So, essentially, a six month grace period.
This delay is intended to provide industry additional time to comply with these requirements, and responds to industry concerns about the need for additional time.
What does this mean in practical terms?
KB: First, if your company was rushing to register facilities and list products by no later than the December 29, 2023 deadline, this means, “Breathe.” FDA has heard industry concerns, and is responding to them.
Second, today’s guidance simply pushes back the date on which FDA will enforce MoCRA’s product listing and facility requirements to July 1, 2024 – it doesn’t remove the obligation to comply with MoCRA.
FDA has advised that it will be ready to accept registration and listing information by the statutory deadline of December 29, 2023, and encourages companies to meet that deadline if they are able to do so.
Companies should still be working to identify their responsible persons and gather all of the information required by MoCRA and the draft guidance released by FDA earlier this year.
What are the new important deadlines?
KB: July 1, 2024 is the new enforcement deadline for product listing and facility registration; however, FDA expects to be able to accept product listing and facility registration information by December 29, 2023.
What’s missing?
KB: FDA has not advised whether it intends to delay enforcement of professional product labeling requirements, which, under MoCRA, come into effect on December 29, 2023.
Likewise, FDA has not advised whether this delayed enforcement announcement changes the December 29, 2023 statutory effective date for companies to maintain records of adverse events, report serious adverse events to FDA, or maintain adequate safety substantiation records. Companies should still prepare to comply with these deadlines.