Industry Seeks FDA Flexibility Around MoCRA Registration And Listing; Attorneys Discuss
August 16, 2023, HBW Insight
Jessica O'Connell's commentary was featured in an HBW Insight article about recent guidance provided in the Modernization of Cosmetics Regulations Act, specifically related to draft guidance on registration and listing requirements, key challenges facing industry, and how the agency may proceed.
Jessica believed that "while MoCRA’s facility registration requirement is not expected to be particularly burdensome, the product listing requirement is. “Especially for companies that have a large volume of products, without seeing the system and understanding how information needs to be put into the system, in what format, and all of those other things, it’s hard for companies to prepare right now,” she said.
Jessica believes the agency will be receptive to industry’s concerns. “This isn’t an industry that’s been sitting on its heels, not getting ready to comply,” she said. “It’s challenging to get ready to comply if they can’t see the system, so I think it would be very reasonable to extend the compliance date by some period of time needed to give everyone a chance to do this.”
In addition, Jessica believed the agency’s approach could parallel what has happened for foods. She pointed to the FDA’s food facility registration guidance, which has been revised seven times since 2003.
The FDA’s most recent update in 2018 provided clarity on changes that came with the Food Safety Modernization Act of 2011, which amended food facility registration requirements under the Food, Drug and Cosmetics Act. “It has kind of evolved as FDA has learned what companies have questions about,” Jessica said.
According to Jessica, it has taken time for the FDA and industry to really understand what issues require clarification. “And that really comes from industry’s experience using a system and FDA’s experience reviewing submitted information. Based on this, I’d expect FDA to consider updating the [cosmetics registration and listing] draft guidance over the next few years to address questions similar to how FDA approached this in the food facility registration space,” she said.
She also expects some portion of stakeholder comments to be asking for guidance on issues the FDA has not touched on yet at all.
“I mean, that draft guidance in itself is pretty basic,” she said.
Jessica advises stakeholders to identify in their comments to the FDA the information required for product listing that they see as vulnerable trade secrets.
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