Food and Drug Administration Commissioner Margaret Hamburg will travel to India Feb. 10-18 for meetings intended to strengthen cooperation between FDA and Indian regulators. During the trip, which will include visits to Delhi, Cochin, and Mumbai, Commissioner Hamburg will meet with Indian policy and government leaders involved in the regulation of medical and food products exported to the U.S., said FDA in its press release. Currently, India is the second largest exporter of finished drug products and the eighth largest exporter of food products to the United States, it said.
On Feb. 4 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On Feb. 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
During the week of Jan. 27 - Feb. 2, 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 Jan. 31 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 asking for comments by April 7 on its criteria for designating a list of high-risk foods that will eventually be subject to increased recordkeeping requirements. Under the Food Safety Modernization Act, FDA’s must base its list on criteria that include the severity of past outbreaks, the likelihood of contamination, and the likelihood that contaminated food will cause illness. According to an update from FDA's Center for Food Safety and Applied Nutrition (here), the agency plans to put together its list of high-risk foods by the time it issues an upcoming proposed rule on recordkeeping requirements for high-risk foods.
The Food and Drug Administration is increasing civil monetary penalty amounts for violations of the Food, Drug and Cosmetic Act to adjust for inflation. Instead of going through the normal notice-and-comment process, FDA is implementing the across-the-board increase through a direct final rule here). The rule also allows FDA staff other than the Office of Chief Counsel to authorize civil monetary penalty complaints against tobacco retailers. The new provisions are set to take effect June 18, unless FDA gets adverse comment in response to a concurrent proposed rule by April 17 (here), in which case it will withdraw the direct final rule and follow normal notice-and-comment procedures.
The Food and Drug Administration is extending until March 31 the comment period on its Food Safety Modernization Act proposed rule on animal food. The proposal would set current good manufacturing practices and hazard analysis and risk-based preventative controls requirements for animal feed and pet food (see 13102519). Comments were originally due Feb. 26, but FDA is giving commenters more time to consider new CGMP requirements, as well as the relationship between the animal food rule proposal and the Foreign Supplier Verification Program, it said.
On Jan. 30 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 said it will hold another two meetings during the comment period of its proposed rule on intentional adulteration of food to explain the proposal and get feedback from the public. The meetings will be held in Chicago on Feb. 27, and on March 13 in Anaheim, Calif. The proposed rule on intentional adulteration of food, required under the Food Safety Modernization Act, would require food facilities that are required to register with FDA to address hazards that may be intentionally introduced by acts of terrorism (see 13122017). FDA already said one public meeting on the rule will be held on Feb. 20 in College Park, Md.