FDA is issuing new regulations that allow importation of prescription drugs from Canada. Under the final rule, FDA may approve “Section 804 Importation Programs” (SIPs) sponsored by a state, tribal or territorial governmental entity. The registered wholesaler or pharmacy identified by the SIP as the importer could then import the specified drug from an FDA-registered, Health Canada-licensed wholesaler that buys the drug directly from its manufacturer. The final rule is set for publication in the Oct. 1 Federal Register, and takes effect Nov. 30.

A multinational engineering company will pay more than $22.2 million to resolve a False Claims Act whistleblower lawsuit related to the evasion of customs and antidumping and countervailing duties. Germany-based Linde GmbH and its U.S. affiliate, Linde Engineering North America, allegedly misrepresented the nature, classification, and valuation of imported merchandise, as well as the applicability of free trade agreements, so as not to pay tariffs, the Department of Justice said in a Sept. 25 news release.

While some individual companies in the medical and protective equipment sector testified that advantaging U.S. production will prevent shortages in the next pandemic, trade groups generally emphasized that stockpiling is the best solution, and that production needs to be globalized for the lowest risk. All were testifying across two days this week to the International Trade Commission, which was tasked with investigating the U.S. production and trade in goods needed for COVID-19 pandemic response, and supply chain challenges revealed in the crisis.

A hotly contested racketeering lawsuit involving antidumping duties on garlic imports from China has reached an end, after Harmoni International opted to drop its case before the Central California U.S. District Court Sept. 16. Lawyers for the defendants in the case claimed victory for their clients, and all Americans, in a news release emailed the following day. Harmoni’s lawyer tells a different tale, saying the case had largely wrapped up and it was no longer in his client’s financial interest to continue.

The Court of International Trade should use a case management approach for the numerous Section 301 tariff lawsuits similar to the one used for litigation over the harbor maintenance tax (HMT), the Department of Justice said in a Sept. 23 filing. That should include the selection of a “test case” and a stay of all other cases involved, DOJ said. The filing marks DOJ's first since HMTX Industries filed suit to force refunds of Section 301 tariffs paid on lists 3 and 4 goods from China (see 2009110005).

House Ways and Means Committee Trade Subcommittee Chairman Earl Blumenauer, D-Ore., cast doubt on Congress voting to renew the Generalized System of Preferences trade benefits program before it expires, and on passing a new Miscellaneous Tariff Bill to cover imports in 2021 and 2022. He told an online audience at the Washington International Trade Association Sept. 23 that it's too soon to say whether a vote would be possible.

Importers and domestic producers predictably clashed over the Commerce Department’s recently proposed changes to its antidumping and countervailing duty regulations (see 2008120037), in comments recently submitted to the agency. While domestic industry urged Commerce to move forward with the changes, importers challenged proposed changes to liquidation timelines in scope inquiries, as well as tighter deadlines that they said make it harder to defend from AD/CVD cases.

International Trade Today is providing readers with the top stories from Sept. 14-18 in case they were missed. All articles can be found by searching on the titles or by clicking on the hyperlinked reference number.

FDA is proposing new record-keeping requirements for foods it deems high-risk, as part of its ongoing implementation of the Food Safety Modernization Act. The agency’s proposed rule would require entities at key points in the supply chain to keep records of certain high-risk foods as they move through the supply chain, and also to more general records of their traceability record-keeping program. Comments on the proposed rule, which is set for publication Sept. 23, are due Jan. 21, 2021.

Whether the deadline has passed for court challenges to lists 3 and 4 of Section 301 tariffs of goods from China continues to be in question, lawyers following the case have said. While some have pegged the deadline to Sept. 21 based on a two-year statute of limitations from when the List 3 tariffs were published in the Federal Register (see 2009160056), other factors remain in play. Filing sooner rather than later is seen as preferable, the lawyers said.