Simon Gluck & Kane LLP

11/14/2024

Marking Matters - CBP Ruling on Origin Marking for Repackaged Pharmaceutical Medications Sold at Retail

In HQ Ruling H283420 (June 14, 2024), CBP issued an internal advice decision in response to an inquiry from an individual retail purchaser about the country of origin marking requirements for imported prescription medication repackaged by CVS Health.

CBP determined that the retail customer is the ultimate purchaser, as they receive the product in its imported form without substantial transformation. Therefore, the country of origin must be marked on the container that the customer receives at the point of sale.

The ruling concerns Omeprazole, manufactured in India, imported by Sandoz, and originally labeled with its country of origin. CVS repackaged the medication into unmarked containers before selling it to retail customers, raising the question of who qualifies as the "ultimate purchaser"—CVS or the retail customer—under U.S. marking regulations.

CBP clarified that although prescription drugs are exempt from individual marking as J-List articles, the outermost retail container must still display the country of origin. Under the regulations, Sandoz must provide certification to CBP and notice to CVS to ensure the repackaged product is marked in compliance with these requirements.

This decision underscores the obligation for pharmacies repackaging imported medication to clearly display the country of origin on retail containers.

09/13/2024

Window for the Mandatory Renewal of FDA Food Facility Registrations Opens October 1 and Closes December 31, 2024.

Foreign food facilities must appoint a U.S. domiciled agent in their registration.

03/20/2024

EAPA and Redacted Evidence: Better Than Nothing?

The Enforce and Protect Act ("EAPA") is part of the Trade Facilitation & Enforcement Act of 2015. It provides for "an interested party" to submit an allegation that an importer is evading its obligations to pay Antidumping and/or Countervailing Duties ("ADD/CVD").

As such, it can be a tool for CBP and U.S. producers of merchandise subject to ADD/CV to get some help from the government in making sure "cheating' is minimized. EAPA allegations are a step up from eAllegations, which are still an available means to complain of suspected misconduct by an importer. If as the late John Durant used to say, "Drawback is the black hole at Customs," eAllegations go to a place where no one dare enter. Too often they are the place where "something is made into nothing" and memory does not exist.

EAPA complaints are the opposite. They are often the place where CBP focuses attention and action. Until recently, the target of an EAPA allegation was at a tremendous disadvantage, as the details of the allegation were kept under wraps by CBP. Law enforcement methods and procedures are exempt from disclosure under the Freedom of Information Act, but the retention of information by CBP and refusal to share with the EAPA subject smacks of Kafkaesque bureaucracy. As the folklore of CBP interaction with the import community recalls, from the same perspective "If we told you what we wanted, to prove a GSP claim, you'd probably give it to us."

Enter the ROYAL BRUSH case (Royal Brush v. United States, Federal Circuit 2022-1226, July 27, 2023). The Court of Appeals vacated the Court of International Trade decision, and remanded the case with instructions to share business information, albeit redacted, which would allow the opportunity to rebut the EAPA allegations made against it.

In March 2024, CBP instituted an Administrative Protective Order ("APO") process which is intended to allow affected parties to see information of the kind which was routinely withheld by CBP in the past in EAPA investigations. However, the information will be redacted, which means that CBP can still decide what it will share. As with so many aspects of the law and life, it will be a balancing act. If CBP uses a paint roller to redact less than selectively, expect more litigation on this subject. But the Royal Brush decision and the APO mechanism are giant steps in the service of due process. Yet, as the advertisement copy advises: "Individual results may vary."

02/26/2024

Thousands of luxury VW cars have been seized by US customs officials over a part linked to allegations of forced labour in China's Xinjiang region.

02/23/2024

More Russia Sanctions as BIS Adds to Entity List

https://www.bis.doc.gov/index.php/documents/about-bis/newsroom/press-releases/3452-2024-02-23-bis-press-release-russia-two-year-actions/file

02/22/2024

Trijicon, Inc. v. U.S. (Feb. 16, 2024)
(Issue: Classification under HTSUS)

The U.S. Court of International Trade (CIT) held that certain items called "Tritium Sight Inserts," "Tritium Lamps," and "Trigalights" are more appropriately classified as "lamps" of Heading 9405 rather than under Heading 9022 as apparatus based on the use of alpha, beta or gamma radiations when imported into the U.S.

The CIT noted its duty under Jarvis Clark to find the correct result - whether it be the classification proposed by the importer, the government or even another classification. After reviewing the provisions that might apply, the CIT reasoned that GRI 3(a) (relative specificity) was inapplicable in the analysis since the HTSUS Chapters at issue are mutually exclusive. Proceeding under GRI 1, the CIT concluded that the merchandise neither met any of the definitions of "apparatus" put forth by the parties nor did it meet the description in the Explanatory Notes (ENs) to Chapter 90. Additionally, the CIT noted that the CBP Rulings cited by the importer were unpersuasive.

Ultimately, the CIT ruled that the subject goods are more appropriately classified as "lamps" because they are designed to produce illumination. The CIT also noted that the ENs state that "lamps" of Heading 9405 can be made of any material (even those using beta radiation) and that the list of items found there are exemplary and not exhaustive. Furthermore, the CIT held that the tariff term "lamps" is not limited to those items that light up a room as argued by the importer. The term also includes searchlights, spotlights, exterior lamps and headlamps for trains - all items that guide or warn - similar to the subject merchandise. The CIT added that the goods indeed do "light up a space" as they illuminate the aiming points in firearm sights.

https://www.cit.uscourts.gov/sites/cit/files/24-18.pdf

06/23/2023

https://public-inspection.federalregister.gov/2023-12921.pdf

Continuing Education for Licensed Customs Brokers Final Rule - 36 hours every three years beginning Feb. 1, 2024

06/09/2023

DHS to add two companies and eight subsidiaries to UFLPA Entity List

06/06/2023

Suspension of Section 232 duties on Ukrainian steel extended another year through June 1, 2024. EU steel articles using steel melted and poured in Ukraine are also exempt. Read the CBP guidance here: https://content.govdelivery.com/bulletins/gd/USDHSCBP-35e62fb?wgt_ref=USDHSCBP_WIDGET_2



https://content.govdelivery.com/bulletins/gd/USDHSCBP-35e62fb?wgt_ref=USDHSCBP_WIDGET_2

CSMS # 56517371 - GUIDANCE: Suspension of Section 232 Duties on Steel Articles from Ukraine U.S. Customs and Border Protection sent this bulletin at 06/05/2023 02:29 PM EDT CSMS # 56517371 - GUIDANCE: Suspension of Section 232 Duties on Steel Articles from Ukraine The purpose of this message is to p...

06/01/2023

5/31/23: Coalition for Fair Trade in Shopping Bags filed ADD/CVD petition at USITC requesting investigation of paper shopping bags from Cambodia, China, Colombia, India, Malaysia, Portugal, Taiwan, Turkey and Vietnam.

05/31/2023

Nature’s Touch Frozen Foods (West), Inc. v. U.S. (May 26, 2023)

U.S. Court of International Trade (CIT) holds that certain mixtures of frozen fruit should be classified under Heading 0811, HTSUS, per General Rules of Interpretation (GRI) 1 as the term “fruit” in the heading “embraces mixed fruit.” The CIT also held that certain mixtures of frozen fruit and vegetables are properly classified under Heading 0811, but per GRI 3(b). At the eight-digit level, the CIT reasoned that all of the mixtures in issue should be classified under 0811.90.80, the basket provision, as none of the other subheadings cover the products and the basket provision does not exclude mixtures. Finally, the CIT found that since no tariff shift occurs at plaintiff’s Canadian facility, the merchandise does not qualify for NAFTA preferential treatment.