H358516

H358516 April 22, 2026 OT:RR:BSTC:EOE H358516 RLP CATEGORY: 19 U.S.C. § 1337; Unfair Competition Paul M. Schoenhard McGuireWoods LLP 888 16th Street NW Washington, DC 20006 VIA EMAIL: pschoenhard@mcguirewoods.com RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1368; Certain Vaporizer Devices, Cartridges Used with Therewith, and Components Thereof Dear Mr. Schoenhard: Pursuant to 19 C.F.R. Part 177, the Exclusion Order Enforcement Branch (“EOE Branch”), Regulations and Rulings, U.S. Customs and Border Protection (“CBP”), issues this administrative ruling in response to the request from NJOY LLC, NJOY Holdings, Inc., Altria Group, Inc., Altria Group Distribution Company, and Altria Client Services LLC (collectively “NJOY”), dated December 3, 2025, which includes Exhibits 1 to 14 (collectively, the “Ruling Request”). We find that NJOY has established, through this inter partes proceeding, that its modified vaporizer devices and cartridges used with those devices (the “New NJOY ACE”) is not subject to exclusion from entry based on the limited exclusion order (“1368 LEO”) that the U.S. International Trade Commission (“Commission” or “ITC”) issued in Investigation No. 337-TA-1368 (“the underlying investigation” or “the 1368 investigation”), pursuant to section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337 (“section 337”) unless and until this ruling letter is revoked or modified pursuant to 19 C.F.R. § 177.12. We further note that determinations of the Commission resulting from the underlying investigation or a related proceeding under 19 C.F.R. Part 210 are binding authority on CBP and, in the case of conflict, will by operation of law modify or revoke any contrary CBP ruling or decision pertaining to section 337 exclusion orders. As noted above, this ruling letter is the result of a request for an administrative ruling from CBP under 19 C.F.R. Part 177, which was conducted on an inter partes basis. The process involves the parties with a direct and demonstrable interest in the question presented by the ruling request: (1) your client, NJOY, the ruling requester and respondent in the 1368 investigation; and (2) JUUL Labs, Inc. (“JLI”), complainant in the 1368 investigation. See, e.g., 19 C.F.R. § 177.1(c). The EOE branch asked the parties to clearly identify confidential information, including information subject to the administrative protective order in the underlying investigation, with [[red brackets]] in all of their submissions to CBP. See 19 C.F.R. §§ 177.2; 177.8. If this ruling letter includes additional information not currently bracketed in red [[ ]] that either party believes constitutes confidential information and that should be redacted from the published ruling, then the parties should contact CBP within ten (10) working days of the date of this ruling letter. See, e.g., 19 C.F.R. § 177.8(a)(3). Please note that disclosure of information related to administrative rulings under 19 C.F.R. Part 177 is governed by, for example, 6 C.F.R. Part 5, 31 C.F.R. Part 1, 19 C.F.R. Part 103, and 19 C.F.R. § 177.8(a)(3). See, e.g., 19 C.F.R. § 177.10(a). In addition, CBP is guided by the laws relating to confidentiality and disclosure, such as the Freedom of Information Act (“FOIA”), as amended (5 U.S.C. § 552), the Trade Secrets Act (18 U.S.C. § 1905), and the Privacy Act of 1974, as amended (5 U.S.C. § 552a). A request for confidential treatment of information submitted in connection with a ruling requested under 19 C.F.R. Part 177 faces a strong presumption in favor of disclosure. See, e.g., 19 C.F.R. § 177.8(a)(3). The person seeking this treatment must overcome that presumption with a request that is appropriately tailored and supported by evidence establishing that: the information in question is customarily kept private or closely-held and either that the government provided an express or implied assurance of confidentiality when the information was shared with the government or there were no express or implied indications at the time the information was submitted that the government would publicly disclose the information. See Food Marketing Institute v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (concluding that “[a]t least where commercial or financial information is both customarily and actually treated as private by its owner and provided to the government under an assurance of privacy, the information is ‘confidential’ within the meaning of exemption 4.”); see also U.S. Department of Justice, Office of Information Policy: Step-by-Step Guide for Determining if Commercial or Financial Information Obtained from a Person is Confidential Under Exemption 4 of the FOIA (updated 10/7/2019). I. BACKGROUND A. ITC Investigation No. 337-TA-1368 1. Procedural History at the ITC The Commission instituted Investigation No. 337-TA-1368 on August 7, 2023, based on a complaint filed by JLI. Certain Vaporizer Devices, Cartridges Used Therewith, and Components Thereof, Inv. No. 337-TA-1368, EDIS Doc. ID 843889, Public Commission Opinion (Feb. 19, 2025) at 5 citing 88 Fed. Reg. 52207 (Aug. 7, 2023) (“Commission Opinion”). The complaint alleged a violation of section 337 by reason of infringement of certain claims of the 11,134,722 patent (the ’722 patent), the 11,606,981 patent (the ’981 patent), the 10,709,173 patent (the ’173 patent), the 10,130,123 (the ’123 patent), and the RE49,114 patent (“the ’114 patent”). Id. The notice of investigation named NJOY as the respondent. Id. at 2. The Commission’s Office of Unfair Import Investigations (“OUII”) was also named as a party in the investigation. Id. 2 On August 23, 2024, the Administrative Law Judge (“ALJ”) issued the final initial determination (“FID”) finding a violation of section 337. Id. at 7. Specifically, the ALJ determined that a violation of section 337 occurred in the importation into the United States, the sale for importation, or the sale within the United States after importation, of the accused products that infringed claims 1 and 15 of the ’722 patent, claims 1 and 8 of the ’981 patent, claims 1 and 4 of the ’173 patent, and claims 27 and 32 of the ’123 patent, but these products were found not to infringe the ’144 patent. Id. at 6-8. On October 24, 2024, the Commission issued a notice in which it determined to review the FID in part and requested submissions responding to the selected issues under review and on remedy, the public interest, and bonding. Id. at 10 citing 89 Fed. Reg. 89042. The Commission, in its review of the FID, found a violation of section 337 as to claims 1 and 15 of the ’722 patent, claims 1 and 8 of the ’981 patent, claims 1 and 4 of the ’173 patent, and claims 27 and 32 of the ’123 patent. Id. at 136. The Commission determined that the appropriate remedy was a limited exclusion order directed at NJOY. Id. In the limited exclusion order, the Commission ordered that “[c]ertain vaporizer devices, cartridges used therewith, and components thereof that infringe one or more of claims 1 and 15 of the ’722 patent, claims 1 and 8 of the ’981 patent, claims 27 and 32 of the ’123 patent, and claims 1 and 4 of the ’173 patent…a re excluded from entry for consumption into the United States, entry for consumption from a foreign-trade zone, or withdrawal from a warehouse for consumption, for the remaining terms of the Asserted Patents, except under license from, or with the permission of, the patent owner or as provided by law.” Certain Vaporizer Devices, Cartridges Used Therewith, and Components Thereof, Inv. No. 337-TA-1368, EDIS Doc. ID 841098, Limited Exclusion Order (Jan. 29, 2025) at 2, ¶ 1. 2. The Patent Claims in the 1368 LEO The 1368 LEO prohibits the unlicensed entry for consumption of certain vaporizer devices, cartridges used therewith, and components thereof that infringe one or more of claims 1 and 15 of the ’722 patent, claims 1 and 8 of the ’981 patent, claims 1 and 4 of the ’173 patent, and cl

below. IV. ANALYSIS The parties do not dispute any factual questions related to the operation of the articles at issue, and JLI did not contest NJOY’s description of how the articles function throughout the inter partes proceeding. See JLI Response; JLI Sur-Reply; Oral Discussion Transcript. JLI only disputes whether CBP may issue a prospective ruling in this instance under 19 C.F.R. Part 177 and does not present any arguments on whether the articles infringe the claims at issue in the ’722 patent, the ’981 patent, the ’173 patent, and the ’123 patent (collectively, the “Asserted Patents”). See JLI Response; JLI Sur-Reply; Oral Discussion Transcript. A. Whether CBP Can Issue a Ruling Regarding this Matter JLI contends that CBP cannot issue a ruling regarding the New NJOY ACE under 19 C.F.R. Part 177. See e.g., JLI Response. First, JLI argues that without approval from the Food & Drug Administration (“FDA”) the New NJOY ACE is hypothetical and that issuing a ruling is against the sound administration of customs law. Id. at 2-3 citing 19 C.F.R. § 177.7(a). If that argument fails, JLI next contends that CBP cannot issue a ruling for the New NJOY ACE until the Federal Circuit has ruled on NJOY’s appeal of the ITC’s decision. JLI Response at 2. Our analysis of JLI’s arguments are laid out below. a. The New NJOY ACE is not Hypothetical and Issuing a Ruling is Against the Sound Administration of Customs Law JLI argues that the design for the New NJOY ACE is “hypothetical” until NJOY receives FDA approval. JLI Response at 2-3. According to JLI, the FDA has a lengthy approval process, has previously required NJOY to modify the product, still has two other NJOY products pending review, and has only ever approved twenty-three tobacco-flavored e-cigarette products out of all applications. Id. at 8. JLI also argues that issuing a ruling here is against the sound administration of customs law because NJOY cannot legally import the articles without FDA approval. JLI Response at 5-