The National Customs Brokers & Forwarders Association of America said the FDA needs to address a few remaining issues in its recently issued guidance document on upcoming cosmetics registration and product listing requirements.
A scheduled FDA upgrade of its import operations database will lead to an outage from 10 p.m. Jan. 20 to 5 a.m. Jan. 21 EST, CBP said Jan. 17. This will affect the Interoperability Web Service (IWS), the FDA Import Trade Auxiliary Communications Systems (ITACS) and prior notice applications, except the Prior Notice System Interface (PNSI), the agency said in a CSMS message.
The FDA posted a document showing the information needed "for successful filing of Electronic Nicotine Delivery System (ENDS) products," CBP said in a CSMS message Jan. 17. The information needs to be provided to the customs broker on the shipment in order to avoid a delay of an FDA admissibility determination, CBP said. "*Please share this resource with your customs broker," the FDA said.
On Jan. 10, the FDA posted new and revised versions of the following Import Alerts (after not having posted new ones for a number of days) on the detention without physical examination of:
The FDA on Jan. 8 announced the availability of new ways to submit cosmetic facility registrations and cosmetic product listings that will be required from foreign and domestic facilities beginning in July 2024. One is a new electronic submission method using a structured product labeling tool, as mandated by the Modernization of Cosmetics Regulation Act of 2022, which created the cosmetics registration requirements. FDA Forms 5066 and 5067 are also now available as a tool to provide cosmetic product facility registration and product listing information to the FDA. “While electronic submission is not required, FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency,” the FDA said. The original deadline for submission of cosmetics facilities was the end of 2023, but FDA extended it in November (see 2311080085).