The Food and Drug Administration issued its weekly Enforcement Report for July 27 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.

The Food and Drug Administration set potential fiscal year 2017 fees for import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA if a firm fails to comply with a mandatory recall order, though it still isn't invoicing for services associated with the fees, FDA said in a notice (here). The agency set FY 2017 fees of $221/hour for domestic services and $285/hour if foreign travel is required. The fees are effective Oct. 1.

The Food and Drug Administration is delaying until July 26, 2018, the compliance date for type size front-of-pack labeling requirements and calorie disclosure requirements for certain gums, mints and roll candy products in glass-front machines under vending machine regulations it issued in 2014, FDA said (here). FDA’s final rule established requirements for calorie declarations for certain food from vending machines operated by a person engaged in the business of owning or operating 20 or more vending machines. Under the final rule, vending machine operators do not have to declare calorie information for a food if a prospective purchaser can view certain calorie information on the front of the package, in the nutrition facts label on the food, or in a reproduction of the nutrition facts label on the food subject to certain requirements.

On July 27 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

On July 26 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 “does not anticipate additional large-scale sampling of raw milk cheese” based on the results of a recently completed sampling program that found few samples contaminated with harmful bacteria, it said (here). After testing over 1,600 samples of imported and domestic cheese (see 1503110026), the agency found a contamination rate of less than 1 percent for salmonella, listeria and shiga-toxin producing E. coli, it said. However, FDA plans to “continue to utilize its Domestic and Imported Cheese Compliance Program for routine sampling of cheeses” due to continuing concerns over listeria in raw milk cheese. Meanwhile, of 1,600 samples of imported and domestic hot peppers and cucumbers collected under a sampling program FDA began in November (see 1511250010), FDA has tested 452, finding 13 tested positive for salmonella. “This testing is still underway and no conclusions can be drawn at this time,” FDA said.

Dominic Veneziano, director of the Food and Drug Administration’s Division of Import Operations, retired in mid-June, an FDA spokesman said. Veneziano had led FDA’s import operations division since 2005.

On July 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 a draft guidance document outlining format requirements for unique device identifiers, it said in a notice (here). The draft guidance, “Unique Device Identification System: Form and Content of the Unique Device Identifier” (here), describes “the two forms of a UDI,” clarifies the content of the UDI, and discusses “the order of the data in a UDI and UDI carrier.” FDA’s UDI rule started taking effect in September 2014 (see 13092020). The next effective date is Sept. 24, 2016, when FDA will require UDIs on the labels and packages of class II devices, data submissions for class II devices, and direct marking of certain class III devices, according to the FDA website (here).

The Food and Drug Administration launched a new electronic system for U.S. manufacturers and producers of milk products to register for lists of establishments approved for export, it said July 25 (here). Companies interested in exporting to Chile, China and the EU can use the new electronic FDA Unified Registration and Listing Systems (FURLS) Dairy Listing Module (DLM) to apply for inclusion on the applicable list for one or more of these countries, update listing information and reapply for lists as necessary, the agency said. Beginning July 25, new applications and biennial updates for currently listed firms will be processed using the DLM. To ensure a smooth transition, U.S. manufacturers and processors of milk products that are currently listed on the Chile, China or EU milk product lists should submit a new application via the DLM, FDA said. Firms currently listed on the milk product list for Chile are due for a biennial update in September 2016, it said.