Justia Government & Administrative Law Opinion Summaries

Amarin markets Vascepa®, a prescription drug consisting of eicosapentaenoic acid in ethyl ester form, synthetically produced from fish oil, intended to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. Vascepa® is the only FDA-approved purified ethyl ester E-EPA product sold in the U.S. Amarin filed a complaint with the International Trade Commission (ITC) under 19 U.S.C. 1337 (Tariff Act), alleging that certain companies were falsely labeling and deceptively advertising their imported synthetically produced omega-3 products as “dietary supplements,” where the products are actually “new drugs” under the Food, Drug, and Cosmetic Act (FDCA) that have not been approved for use in the U.S. Amarin claimed that their importation and sale was an unfair act or unfair method of competition because it violates the Lanham Act, 15 U.S.C. 1125(a), and the Tariff Act “based upon" FDCA standards. The FDA urged the Commission not to institute an investigation and to dismiss Amarin’s complaint, arguing that the FDCA prohibits private enforcement actions and precludes any claim that would “require[] the Commission to directly apply, enforce, or interpret the FDCA.” The ITC and Federal Circuit agreed.Amarin’s allegations are based entirely on FDCA violations; such claims are precluded by the FDCA, where the FDA has not yet provided guidance as to whether violations have occurred. Although Amarin claimed violations of the Tariff Act, its claims constituted an attempt to enforce the FDCA. View "Amarin Pharma, Inc. v. International Trade Commission" on Justia Law

Mid Continent Nail requested that the Department of Commerce initiate a third administrative review of its anti-dumping duty order covering certain steel nails from China. Mid Continent did not serve the request directly on Suntec, a Chinese exporter and producer named in the antidumping order and in the request. When Commerce actually initiated the review about a month after receiving the request, it published a notice in the Federal Register, as provided in 19 U.S.C. 1675(a)(1). Despite that publication, however, Suntec did not participate in the review. Because of a lapse in its relationship with the counsel who had been its representative for years in the steel-nail proceedings, Suntec remained unaware of the review until Commerce announced the final results. The Court of International Trade declined to set aside the results of the review as applied to Suntec. The Federal Circuit affirmed, holding that Suntec had failed to demonstrate that it was substantially prejudiced by the service error as to the request for the review because the Federal Register notice constituted notice to Suntec as a matter of law and fully enabled Suntec to participate in the review. View "Suntec Industries Co., Ltd. v. United States" on Justia Law

OFAC is authorized to impose civil penalties against any person who exports goods to a third party who it has reason to know intends to send them to Iran. At issue was whether OFAC must also show that the goods actually ended up in Iran. The DC Circuit held that the government need not make that showing and affirmed the district court on that ground. However, the court held that OFAC did not adequately explain parts of its determination that the exporter in this case had reason to know that its shipments would be sent on to Iran. Therefore, the court affirmed the district court's order granting the government defendants' motion for summary judgment as to OFAC's determination that Epsilon's 34 shipments to Asra International between August 2008 and March 2011 violated section 560.204 of the Iranian Transactions and Sanctions Regulations. The court reversed as to OFAC's determination that Epsilon's five shipments to Asra International in 2012 violated the same regulation. The court remanded with instructions. View "Epsilon Electronics v. US Department of Treasury" on Justia Law

Following a request from ICP, Customs issued a Ruling Letter, classifying ICP’s white sauce as “sauces and preparations therefor” under the Harmonized Tariff Schedule of the United States (HTSUS) 2103.90.9060. Years later, Customs issued a Notice of Action reclassifying pending and future entries of white sauce as “[b]utter and . . . dairy spreads” under HTSUS 0405.20.3000, which increased the tariff by approximately 2400%. After protesting and paying duties on a single entry, ICP filed a claim in the Court of International Trade, alleging the Notice of Action improperly revoked the Ruling Letter without following the procedures required by 19 U.S.C. 1625(c). Since ICP filed its first action in 2005, the CIT has issued five separate opinions on the matter, two of which were appealed to the Federal Circuit. In awarding ICP attorney fees, the Trade Court found that “The record ... establishe[d] that the goverment position was rooted in a desire to avoid the timely revocation process” by using the Notice of Action, rather than following the procedures of 1625(c)(1). The Federal Circuit affirmed the award under the Equal Access to Justice Act, 28 U.S.C. 2412(d)(1)(A), upholding the Trade Court’s analysis of whether the government’s conduct was “substantially justified.” View "International Custom Products, Inc. v. United States" on Justia Law

Ford imported automotive goods and paid duties. Ford later claimed North American Free Trade Agreement (NAFTA) preference on those imports and sought a refund of duties under 19 U.S.C. 1520(d). The parties relied on a June 1997 entry as a test case. Ford was required to file certificates of origin within one year of importation, but did not file the certificate until November 1998 and was unable to secure a written waiver. Customs denied Ford’s claim, then denied Ford’s protest. The Federal Circuit rejected Ford’s argument that Customs had an affirmative obligation under its regulations to accept Ford’s untimely filing, but remanded for determination of whether traditional refund claims, not processed through the electronic “reconciliation” program, should enjoy the same waiver benefit available through that program. On remand, Customs explained that the reconciliation program (19 U.S.C. 1484(b)) is a procedural means for processing import entries, including an ability to claim the substantive duty refund benefit under section 1520(d), and has statutory safeguards that permit Customs to remedy mistakes and misconduct in awarding NAFTA duty free treatment. Many reconciliation program safeguards are not available in the traditional post-entry duty refund process. The reconciliation program provides added confidence in the legitimacy of the importer’s claims. The Federal Circuit affirmed that Customs’ interpretation of the statutory scheme was reasonable. View "Ford Motor Co. v. United States" on Justia Law

In 2006, the Department of Commerce announced that it was changing a method it used to calculate whether imported goods are being sold in the United States at less than fair value, i.e., being dumped. Previously, Commerce employed “zeroing” in that calculation: for goods sold above fair value, Commerce treated the sale price as being at (rather than above) fair value—it zeroed out margins above fair value and permitted no offset against below-fair-value sales in calculation of the average, resulting in larger average dumping margins than if offsetting had been allowed. The new policy generally made it more difficult to find dumping. Commerce stated that the change would apply “in all current and future antidumping investigations as of the effective date” and that it would apply the final modification to all investigations pending as of the effective date. There were seven such investigations, all initiated by petitions filed after March 6, 2006, when the new no-zeroing policy was proposed. Two companies found to have engaged in dumping argued that their cases were governed by the new policy. The Federal Circuit upheld Commerce’s determination that they were not. Commerce spoke ambiguously on timing in adopting its new policy and reasonably resolved the ambiguity to exclude the cases. View "Diamond Sawblades Mfr. Coal. v. United States" on Justia Law

Best, a Hong Kong manufacturer, produces Metalized Yarn from polyester chips melted with metal nanopowders to form monofilament yarns. Best sought a pre-importation ruling concerning proper tariff classification in the Harmonized Tariff Schedule (HTSUS), attaching a laboratory report describing the yarn as having a fiber content of 100% polyester, with 0.7%- 0.74% metal by weight. Customs classified the yarn as metalized yarn, HTSUS 5605.00.90, dutiable at 13.2%, stating “yarn combined with metal in the form of powder is considered a metalized yarn.” Best then sought a ruing regarding a “Johnny Collar” garment made of its yarn, asserting the garment was classifiable under HTSUS 6105.90.8030 as a shirt of other textile materials (duty rate 5.6%), not HTSUS 6110.30.3053 for polyester shirts (duty rate 32%). Based on trace amounts of metal and a label that stated “100% polyester,” Customs classified the sample as man-made non-metalized fibers under HTSUS 6110.30.3053. Customs subsequently revoked the Yarn Ruling, reclassifying the yarn as a polyester yarn under HTSUS 5402.47.90 (duty rate 8%). Customs also revoked the Johnny Collar Ruling as conflicting with the Yarn Ruling, but continued to classify the garment under 6110.30.30. Best challenged the Yarn Ruling Revocation, but not the Johnny Collar revocation. The Trade Court sustained the Revocation. The Federal Circuit vacated with instructions to dismiss for lack of jurisdiction. Best sought reversal of a Revocation, the effect of which would be to increase Best ’s own duty rate while benefiting manufacturers of products made from its yarn. The statute does not provide jurisdiction over such requests View "Best Key Textiles Co., Ltd. v. United States" on Justia Law

In 1997, the U.S. Department of Commerce determined, under 19 U.S.C. 1673b, that freshwater crawfish tail meat from China was being sold in the U.S. at less than fair value and directed Customs to suspend final computation of duties on such entries and to require a deposit or bond to cover estimated duties. In 2000-2001, New Phoenix made entries of the product. The exporters were subject to “new shipper” review to determine whether they were entitled to antidumping-duty rates distinct from the default rate. Each of five bonds issued by Great American to cover anticipated duties was for $1,219,458 and was signed by Davis and accepted by the government, although the power-of-attorney filed with Customs indicated a limit of $1 million on his authority. Great American later revoked his authority. In 2003, Commerce published final results, finding that the exporter was not entitled to a different rate and sought payment from New Phoenix and Great American. The amount owed is greater than the amounts of the bonds. The trial court granted the government summary judgment, without pre- and post-judgment interest, finding that the government did not timely address those issues. The Federal Circuit affirmed that the bonds were not enforceable beyond Davis’s stated authority and the denial of pre-judgment interest View "United States v. Great Am. Ins. Co" on Justia Law

Itochu asked the U.S. Department of Commerce to act under 19 U.S.C. 1675(b) to revoke part of an antidumping-duty order applicable to imported steel nails. Before Commerce issued its preliminary determination, Itochu submitted comments and provided legal authority to urge that the requested partial revocation take effect at an early specified date. Commerce rejected that position in its preliminary ruling and generally invited interested parties to comment. Itochu did not avail itself of that opportunity. In its final ruling, Commerce adopted the partial revocation, which the domestic industry did not oppose, but with the later effective date. When Itochu challenged the effective-date determination, the U.S.s Court of International Trade declined to address the merits, citing failure to exhaust administrative remedies, 28 U.S.C. 2637(d), because Itochu had failed to resubmit, after the preliminary ruling, the comments it had submitted earlier. The Federal Circuit reversed, stating that in these circumstances, requiring exhaustion served no discernible practical purpose and resulting delay would have risked harm to Itochu. View "Itochu Bldg. Prods. v. United States" on Justia Law

The government appealed the district court's order which altered the terms of a bond the Coast Guard had fixed for the release of a detained ship that was under investigation and restricted the types of penalties the government could seek for the ship's potential violations of certain ocean pollution prevention statutes. The ship at issue, the Pappadakis, an ocean-going bulk cargo carrier carrying a shipment of coal to Brazil, was detained by the Coast Guard because the vessel had likely been discharging bilge water overboard. The court reversed and remanded for dismissal under Federal Rule of Civil Procedure 12(b)(1) where the matter was not subject to review in the district court because the Coast Guard's actions were committed to agency discretion by law. Consequently, the district court lacked jurisdiction to consider the petition. View "Angelex Ltd. v. United States" on Justia Law