On June 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 announced the reclassification of blade-form endosseous dental implants as Class II medical devices subject to special controls. The dental implants were previously classified in Class III and required premarket approval. The reclassification will take effect July 18; Although the devices will no longer need FDA approval, the devices will still be subject to premarket notification requirements, as well as certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling..
The Food and Drug Administration threatened Chinese and India drug makers with import refusal in two recent warning letters. In a letter dated June 10 (here), FDA told Tianjin Zhongan Pharmaceutical of China that it needs to correct violations of current good manufacturing practice (CGMP) requirements or else face an import alert on its active pharmaceutical ingredients (APIs). In a separate letter dated June 16 (here), FDA told Apotex Pharmachem India that it will continue to refuse imports of APIs from the company, also for violations of CGMP requirements.
The Food and Drug Administration may refuse imports of pharmaceuticals from a Spanish company for failure to pay generic drug user fees, it said in a warning letter dated June 2. According to FDA, Leon-based generic drug manufacturer Antibioticos did pay fees required by the Generic Drug User Fee Amendments of 2012 (GDUFA) for fiscal years 2013 and 2014. As a result, FDA has put Antibioticos on its GDUFA Arrears List (here), and says it may put the company on import alert and refuse imports of generic drugs exported by Antibioticos.
On June 17 the Foreign Agricultural Service posted the following GAIN reports:
Hong Kong has agreed to lift restrictions on imports of beef and beef products from the U.S., said the U.S. Department of Agriculture on June 17. A ban on U.S. beef had been in place since a 2003 outbreak of bovine spongiform encephalopathy, but Hong Kong has been gradually removing restrictions since. Subject to certain conditions, Hong Kong will now lift its last remaining restrictions effective June 16. Previously, only deboned beef from all cattle and bone-in beef from young cattle could be shipped from the U.S. to Hong Kong. Similar restrictions on U.S. beef in Mexico, Uruguay, Ecuador and Sri Lanka have also been lifted this year, said USDA.
The Commerce Department will lead a trade promotion mission to Egypt, Jordan and Israel in 2015 for exporters of healthcare equipment, it said on June 17. During the trade mission, U.S. healthcare companies will receive market briefings and meet with potential business partners. The mission, which will take place May 16-21, 2015, also includes an optional stop in the West Bank city of Ramallah. Applications may be submitted until March 13, 2015, and will be reviewed on a rolling basis.
The Court of International Trade has put liquidation on hold for entries in 2011-12 of frozen fish fillets from Vietnam exported by eight companies, while it considers a challenge to the final results of an antidumping duty administrative review. CIT’s preliminary injunction prevents liquidation of any unliquidated entries of frozen shrimp entered between Aug. 1, 2011 and July 31, 2012 that were exported by the following companies: An Giang Fisheries Import and Export Joint Stock Company; Asia Commerce Fisheries Joint Stock Company; Cuu Long Fish; Hiep Thanh Seafood; International Development and Investment Corporation; NTSF Seafoods; QVD Food Company; and Southern Fishery Industries. The companies are challenging the AD duty rates they were assigned in April (see 14040412).
A listing of recent antidumping and countervailing duty messages from the Commerce Department posted to CBP's website June 17, along with the case number(s) and CBP message number, is provided below. The messages are available by searching for the listed CBP message number at http://adcvd.cbp.dhs.gov/adcvdweb.
Potential changes to labeling rules under California’s Proposition 65 would increase compliance costs for both labelers and downstream companies in the supply chain, according to a letter dated June 12 from nearly 140 companies. A “pre-draft” of proposed regulatory changes issued by the California Office of Environmental Health Hazard Assessment (OEHHA) in March would do away with standard safe harbor language that many companies use on labels, adding costs for labelers and uncertainty for downstream companies over whether a product is in compliance with labeling requirements, said the letter. And as currently written, the draft changes would also eliminate protections for upstream companies like manufacturers, which may have the effect of forcing manufacturers to label all of their products, regardless of whether they’re sold in California.