NCBFAA Seeks Clarity on FDA's Upcoming Cosmetics Registration and Listing Requirements
The National Customs Brokers & Forwarders Association of America sought more clarify from the FDA on a recently issued draft guidance document on upcoming registration and listing requirements for cosmetics facilities and products, in comments submitted to the agency on Sept. 1.
The NCBFAA asked the FDA to confirm that the registration number will not be required as part of the import documents "processed at entry into the U.S." The NCBFAA also sought clarification on the definition of facility, which in the notice is defined as "any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States." The NCBFAA asked if that means an importer must register only if the "the importer manufactures or processes cosmetics."
The NCBFAA also pointed out that the Modernization of Cosmetics Regulation Act (MoCRA), which set the registration and listing requirements, requires a "responsible person" who isn't located in the U.S. to "designate a US agent" when registering and submitting its product. The NCBFAA wanted to know how the FDA would validate that the U.S. person has agreed to be the agent, the comments said.
The NCBFAA asked whether or not the current de minimis policy, which allows cosmetic products under $800 to enter the U.S. without providing FDA data, will continue.
The NCBFAA also asked whether the FDA would have a system in place for cosmetics registration by "opening moment" on Oct. 1. The FDA said in its guidance document that it "intends to make the new electronic submission portal available for submitting registration and product listing information ... in October 2023."