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FDA Schedules Entry Processing Outage Jan. 20-21
January 17, 2024 by Noah Garfinkel|FDA

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.

FDA Posts Filing Tips for Electronic Nicotine Delivery System Products
January 17, 2024 by Noah Garfinkel|FDA

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.

New and Revised FDA Import Alerts for Jan. 10
January 11, 2024 |FDA

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:

FDA Considering End to Uses of Four Solvents in Color Additives
January 10, 2024 |FDA

The FDA is proposing to end the use of four chemical solvents under its color additive regulations, it said in a pair of notices released Jan. 10. In one notice, the agency said that it filed a petition to remove provisions from the regulations for ethylene dichloride, methylene chloride and trichloroethylene. In the other, the FDA said it filed a petition to remove benzene, as well as other uses of ethylene dichloride, methylene chloride and trichloroethylene. The petitions say the chemicals have been found to cause cancer. Comments are due March 11.

FDA Announces New Tools, Forms for Cosmetics Facility Registrations
January 10, 2024 |FDA

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).