On December 12, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On December 9, 2011, 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 has updated its frequently asked questions document to clarify the intent behind its November 25, 2011 notice seeking expedited approval by the Office of Management and Budget of a proposed information collection related to an Economic Hardship Fee Reduction Guidance. FDA explains that the notice was meant to indicate its intent to issue the guidance for FY 2012 hardship reductions requests. It adds that this Economic Hardship Fee Reduction Guidance is separate and distinct from FDA's development of a proposed set of FY 2013 guidelines in consideration of the burden of fee amounts on small businesses.
The Natural Resources Defense Council announced that the Food and Drug Administration has committed to decide by March 31, 2012 whether the chemical Bisphenol A, or BPA, which NRDC claims causes brain damage in developing babies, infants and young children, should be banned from use in packaging for food and drinks. The agency agreed to address the use of BPA as part of a settlement reached on December 7, 2011 with NRDC.
On December 8, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On December 7, 2011, 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 announcing a December 19, 2011 public meeting and seeking comments on proposed recommendations it has developed with the regulated community toward a draft Generic Drug User Fee Act. The draft legislation would authorize FDA to collect user fees related to human generic drugs and use them for the human generic drug application review process and associated submissions, to conduct related inspections (particularly of foreign manufacturers), and to engage in other related activities for fiscal years 2013-2017.
The Food and Drug Administration has issued its Biennial report to Congress on the Food Emergency Response Network, which is an integrated, secure laboratory system for Federal, State, and local government agencies engaged in food safety and defense activities. The report, which is required by the Food Safety Modernization Act (FSMA), states that FERN plays a critical role in food safety and defense by integrating these food-testing laboratories into a network that is able to detect, identify, respond to, and aid in the recovery from emergencies involving biological, chemical, or radiological contamination of food.
The Food and Drug Administration announced that at its request, on December 6, 2011, U.S. Marshals seized raw materials imported by Infinity Marketing Group, Inc. containing ephedrine alkaloids, a large family of pharmacological compounds called sympathomimetics banned by FDA since 2004 for use in dietary supplements. The seizure took place in Rancho Dominguez, California. FDA states that it coordinated with U.S. Customs and Border Protection, Immigration and Customs Enforcement, and the Drug Enforcement Administration to identify and remove these potentially dangerous products, worth more than $70,000, from the marketplace.
On December 6, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: