During the week of May 19-25, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:
On May 23 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 is allowing more time for comments on its proposed revisions to nutrition facts labeling for food (here) and (here). FDA’s proposed rules would revise the information required on nutrition facts labels and require that manufacturers keep records on added sugar, the amount of dietary fiber, and certain vitamin contents (see 14022713). FDA is also proposing to increase recommended serving sizes to bring them into line with current eating habits, and would require an additional column of nutrition information for packages that contain more than one serving but could be consumed in one sitting. Comments are now due Aug. 1.
On May 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Cheese Importers Association of America (CIAA) urged the Food and Drug Administration not to paint with too broad a brush as it devises its list of high-risk foods subject to increased recordkeeping requirements. In comments dated May 21 submitted in response to FDA’s proposed criteria for designating high risk foods, the CIAA said the agency shouldn’t use overly broad product categories that would lump safe products in with foods that actually are high-risk.
The Food and Drug Administration is extending until July 30 the period for comments on its proposed rule on the sanitary transportation of human and animal food. The proposed regulations issued under the Food Safety Modernization Act in February would apply to shippers, receivers, and carriers that transport human or animal food by truck or rail, including parties engaged in the international shipment of food in some circumstances (see 14020301). If an international shipper or carrier is subject to the rule and fails to comply, the food shipment would be refused entry into the U.S., said FDA in its proposed rule. FDA is extending the deadline because of requests from industry. Under a court settlement, FDA’s final rule on sanitary transportation is due March 31, 2016.
The Food and Drug Administration told a fish importer that it may begin refusing admission to its products because of violations of hazard analysis and critical control point (HACCP) and acidified food regulations. In a warning letter dated May 13, FDA said Ridgewood, New York-based Maharaja Foods Importers failed to take steps to ensure its shelf stable glass-packed pickled tuna in oil complies with HACCP requirements. The agency also said that an inspection of an entry of Maharaja’s pickled tuna revealed that the foreign exporter didn’t register as an acidified food manufacturer. FDA said that, unless corrected, it may begin refusing shipments imported by Maharaja at the border. It also said it may collect fees to cover the costs of reinspection.
The Food and Drug Administration issued its weekly Enforcement Report for May 21 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration said it may refuse imports from pharmaceutical manufacturers in India and Germany, in separate warning letters sent to the companies in April and May. FDA said an inspection of a Sun Pharmaceutical Industries manufacturing facility in Gujarat, India turned up violations of CGMP requirements for both finished pharmaceuticals and active pharmaceutical ingredients (APIs) (here). It also told SANUM-Kehlbeck that an inspection of the pharmaceutical manufacturer’s facility in Hoya, Germany found violations of CGMP requirements for both finished pharmaceuticals and APIs, as well as a failure by the company to register with FDA (here). The agency told both companies that their drug products are subject to refusal of admission because of the violations.
On May 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: