Justia International Trade Opinion Summaries

Articles Posted in US Court of Appeals for the District of Columbia Circuit
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Acting under the Export Control Reform Act of 2018 (ECRA) the Department of Commerce has maintained a so-called Entity List to restrict designated foreign parties from receiving United States exports.   Plaintiff, Changji Esquel Textile Co, operates a spinning mill in Xinjiang. The United States has determined that China abuses the human rights of Uyghurs and other religious or ethnic minorities in Xinjiang, including imprisonment and forced labor. Changji and its parent company filed a lawsuit alleging that the Department, in adding Changji to the Entity List, violated ECRA and its implementing regulations, the APA, and the Due Process Clause. They moved for a preliminary injunction on the theory that the alleged ECRA and regulatory violations were ultra vires. The district court denied the motion on the ground that Plaintiffs are not likely to succeed on this claim.   The DC Circuit affirmed. The court explained that to prevail on an ultra vires claim, Plaintiff must establish three things: “(i) the statutory preclusion of review is implied rather than express; (ii) there is no alternative procedure for review of the statutory claim; and (iii) the agency plainly acts in excess of its delegated powers and contrary to a specific prohibition in the statute that is clear and mandatory.   The court explained that the canons invoked by Plaintiffs can resolve statutory ambiguity in close cases, but they do not allow the court to discern any clear and mandatory prohibition on adding entities to the List for human-rights abuses, particularly given the breadth of section 4813(a)(16) and the deference owed to the Executive Branch in matters of foreign affairs. View "Changji Esquel Textile Co. Ltd. v. Gina Raimondo" on Justia Law

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The Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 321(g) regulates homeopathic drugs. A 1988 FDA guidance document outlined the circumstances in which the FDA intended to exercise its discretion not to enforce the full force of the FDCA against homeopathic drugs. In 2019, the FDA withdrew the guidance document, explaining that the homeopathic drug industry had expanded significantly and it had received numerous reports of “[n]egative health effects from drug products labeled as homeopathic.” The FDA then implemented a “risk-based” enforcement approach and added six of MediNatura’s prescription injectable homeopathic products to an import alert, notifying FDA field staff that the products appeared to violate the FDCA.The D.C. Circuit affirmed the dismissal of MediNatura’s challenges. When a product is detained under an import alert, the importer is given notice and an opportunity to be heard, so the import alert was non-final agency action. The court declined to enjoin the withdrawal of the 1988 guidance, noting the public’s strong interest in the enforcement of the FDCA. Requiring the FDA to keep in place a guidance document that no longer reflects its current enforcement thinking, particularly in light of present public health concerns related to homeopathic drugs, is not in the public interest. View "MediNatura, Inc. v. Food and Drug Administration" on Justia Law