The Food and Drug Administration is extending until Jan. 31 the period of biennial registration renewal for foreign and foreign food facilities, it said in an update to its Q&A on food facility registration. FDA said it is taking this action because of the delay in beginning the period of registration renewal, which was required to start by Oct. 1, but did not begin until Oct. 22. The guidance said FDA is “exercising enforcement discretion” for food facilities that register during the Jan. 1-31 period, and encouraged facilities to register early.
In a June 14 warning letter recently posted to its website, the Food and Drug Administration said Chinese drug manufacturer Shijiazhuang Pharma Group Zhongnuo Pharmaceuticals Co. Ltd.’s products may not be allowed entry into the U.S. until the company renews its registration. Zhongnuo had previously been notified of its lapsed registration in an FDA letter dated March 26, but the FDA said it continued to find imports of Zhongnuo’s drugs even though the company hadn’t registered in 2011 or 2012. FDA said Zhongnuo is required to submit registration information annually by electronic means for each foreign establishment it owns or operates that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the U.S. Failure to register is a prohibited act under Section 301(p) of the Food, Drug and Cosmetic Act.
The U.S. International Trade Commission released “The Year in Trade 2011,” its annual overview of the previous year's trade-related activities. The Year in Trade 2011 includes complete listings of antidumping, countervailing duty, safeguard, intellectual property rights infringement, and section 301 cases undertaken by the U.S. government in 2010. In addition, the 2011 report covers:
The Office of the U.S. Trade Representative has determined to waive certain discriminatory purchasing requirements with respect to goods and services covered by Chapter 17 of the U.S.-Korea Free Trade Agreement (KORUS), which will enter into force on March 15, 2012.
The Office of the U.S. Trade Representative has released the President's 2012 Trade Policy Agenda and 2011 Annual Report. The President’s Trade Policy Agenda for 2012 offers a survey of how the Administration will support exports and two-way trade, enforcement of U.S. rights in a rules-based trading system, and through bolstered international trade relationships. It also outlines how the U.S. will partner with developing countries to expand opportunity, U.S. trade enforcement activities, among other topics.
The Food and Drug Administration has issued an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Anneri Izurieta for a period of 30 years from importing articles of food or offering such articles for importation into the U.S. FDA bases this order on Ms. Izurieta's conviction of six felony counts under Federal law for conduct relating to the importation into the U.S. of dairy products. The order is effective January 13, 2012.
On October 6, 2011, Congressman Mike Turner (R-OH) introduced the Trade Law Enforcement Act (H.R. 3112), which he states would utilize a Commerce Department complaint process to provide U.S. companies with a lower cost, less complex path to the USTR's initiation of a Section 301 investigation on market access barriers.
U.S. Trade Representative Kirk states the U.S. has submitted information to the World Trade Organization identifying nearly 200 subsidy programs that it says China has failed to notify as required under WTO rules. Information was also submitted on 50 subsidy programs in India not previously notified.
The Office of the U.S. Trade Representative has issued a notice requesting written comments from the public concerning Paraguay’s implementation of the U.S.-Paraguay MOU on Intellectual Property Rights, and additional actions that Paraguay should take, if any, to improve the protection and enforcement of intellectual property rights.
The Food and Drug Administration has made available two presentations on the Food Safety Modernization Act (FSMA) -- one provides an overview of the new law, and the other focuses on its import safety provisions, which FDA states are the most groundbreaking shift of the FSMA. Both also list the implemented FSMA provisions.