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EAPA Litigation

Under the Enforce and Protect Act, CBP investigates whether a company is evading particular antidumping and countervailing duty orders. Litigation on determinations made under the relatively new statute have centered on due process protections for respondents, CBP's evidentiary basis for its decisions and the interplay of decisions made on the scope of the applicable AD/CVD orders from both CBP and the Commerce Department. The Court of Appeals for the Federal Circuit issued a key decision for all EAPA cases in Royal Brush Manufacturing v. United States, when it found CBP to have violated a respondent's due process protections by failing to provide it with access to the business proprietary information used in the proceeding. 

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FDA Threatens to Block Imports from Two Indian Drug Companies for CGMP VIolations
August 23, 2013 by Brian Feito|FDA

The Food and Drug Administration threatened two Indian drug companies with refusal of their products at the border for violations of current good manufacturing practice requirements. FDA told Posh Chemicals in a warning letter Aug. 2 that active pharmaceutical ingredients (APIs) from its facility in Hyderabad may face import alert and detention without physical examination unless CGMP violations are corrected (here). And in a warning letter sent Aug. 9, FDA told Sentiss Pharma (formerly Promed Exports) that it will continue to refuse finished pharmaceuticals already subject to DWPE from the company’s Khera Nihla Village facility for uncorrected CGMP violations (here).

FDA Warns Two Food Companies of Compliance Problems, Will Assess Reinspection Fees
August 23, 2013 by Brian Feito|FDA

The Food and Drug Administration warned two foreign food companies that it may refuse admission to some of their products after finding violations of FDA regulations. The agency sent warning letters to Grant's Smokehouse of the United Kingdom on July 8 (here), and Waterwheel Premium Foods of Australia on July 26 (formerly Philemon) (here). Because Grant’s violations were “materially related to food safety,” FDA said it’s going to charge the company’s U.S. agent for any required reinspection.

Consumer Groups Push U.S. Agencies to Recommend Global Ban on Animal Drugs Banned in the U.S.
August 22, 2013 by Claire Yan|FDA

Three consumer groups wrote letters to the U.S. Department of Agriculture, the U.S. Trade Representative and the Food and Drug Administration, asking them to support international standards that would globally prohibit animal drugs that are banned in the U.S. The Consumers Union (CU), Center for Science in the Public Interest, and the Food Animal Concerns Trust (FACT) raised concerns that drug residues in foods like imported seafood pose a risk for both U.S. and foreign consumers.