On Jan. 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration issued its weekly Enforcement Report for Jan. 24 that lists the status of recalls and field corrections for food, drugs, biologics and devices. The report covers both domestic and foreign firms.

On Jan. 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Jan. 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration issued a draft guidance document intended to help animal food facilities develop food safety plans to comply with FDA’s Food Safety Modernization Act preventive controls for animal food regulations. The draft guidance includes information on the biological, chemical and physical hazards in the manufacturing, processing, packing and holding of animal food; the components of a food safety plan; and the importance of each component. It also details how to conduct a hazard analysis and develop a food safety plan, and identify and apply preventive controls, as well as how to comply with monitoring, verification and record-keeping requirements under the regulations. Comments on the draft guidance are due July 23, FDA said.

Exporters of dairy products to the European Union must sign up for a new electronic list by March 1 or else lose the ability to ship to the EU, the Food and Drug Administration said in a constituent update. On that date, FDA is fully transitioning to Dairy Listing Module, created in 2016 (see 1607260035), for EU dairy products, it said. Exporter lists for Chile and China have already transitioned to the electronic system, FDA said. “All currently listed firms that have not applied in DLM by” March 1 “will be removed from the EU dairy list and will not be able to obtain the export certificates necessary to ship dairy products to the EU.”

The Food and Drug Administration's Import Trade Auxiliary Communication System is down due to ongoing "emergency maintenance," CBP said in a CSMS message. "If documents or availability information need to be submitted while ITACS is down, they can be submitted to the local FDA office at the port of entry via that office’s preferred alternate communication method."

On Jan. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On Jan. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Laser products that conform to comparable sections of International Electrotechnical Commission standards do not have to also comply with certain Food and Drug Administration regulations on laser products, FDA said in a draft guidance document issued Jan. 19. Many of the FDA standards duplicate provisions of the international IEC standards, and the “IEC standards would provide adequate protection of the public health and safety for laser products similar to FDA’s performance standards,” the agency said. FDA eventually intends to harmonize its standards with the IEC requirements, it said. In the meantime, “FDA does not intend to consider whether laser products are in compliance with certain sections of 21 CFR 1040.10 and 21 CFR 1040.11 if the manufacturer conforms to the comparable sections of the IEC Standards: IEC 60825-1 Ed. 3.0 and IEC 60601-2-22 Ed. 3.1,” as listed in the guidance document. FDA in 2007 issued similar guidance related to earlier editions of the IEC performance standard.