The Food and Drug Administration is extending until May 10 the period for comments on whether to adopt a regulatory definition for “natural” food, it said (here). The agency began its inquiry in November, after mostly backing away from establishing a definition in the 1990s (see 1511100069).
On Dec. 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 alerted drug compounders and manufacturers of the continued risk of chemical contamination for shipments from Tianjin, China, following the rejection of two shipments of drugs after finding them contaminated with hydrogen cyanide. According to FDA’s Dec. 22 release (here), the agency’s increased surveillance following two explosions at the Port of Tianjin in August resulted in the detection of the contamination in shipments of drugs from Tianjin Tianyao Pharmaceuticals Co., Ltd. As a result, the contaminated shipments were stopped and “will not be allowed into the United States, said FDA.
On Dec. 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Dec. 18 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 Dec. 16 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.
On Dec. 17 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 proposing changes to its regulations on sunlamp products in an effort to improve consumer safety and align U.S. requirements with international standards. In one proposed rule (here), FDA would adopt elements of the International Electrotechnical Commission’s International Standard 60335-2-27, bringing U.S. regulations in line with current science and allowing manufacturers to comply with a single set of standards. The proposed rule would also subject manufacturers of ultraviolet (UV) lamps intended for use in sunlamps to the same recordkeeping and reporting requirements as sunlamp manufacturers, and set new technical requirements for sunlamps.
The Food and Drug Administration recently posted to its website a diagram (here) outlining which data elements are required for filing in the Automated Commercial Environment, broken down by commodity. The diagram includes data elements required for all types of goods, as well as elements required specifically for foods, drugs, devices, biologics, tobacco and animal drugs and devices.