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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

U.S. Customs and Border Protection · CROSS Database

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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

Ruling Text

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 claims 27 and 32 of the ’123 patent that are manufactured abroad by, or on behalf of, or imported by or on behalf of, NJOY, or any of its affiliated companies, parents, subsidiaries, or other related business entities, or their successors or assigns. See 1368 LEO at 1-2. The FID describes the ‘722 and ‘981 patents together because they “have nearly identical specifications.” Certain Vaporizer Devices, Cartridges Used Therewith, and Components Thereof, Inv. No. 337-TA-1368, EDIS Doc. ID 832493, Initial Determination on Violation of Section 337 and Recommended Determination on Remedy and Bond (Aug. 23, 2024) at 14. According to the Commission, the ‘722 and ‘981 patents: relate to reusable electronic cigarettes or vaporizers containing a battery portion and a cartomizer. Vaporizers or reusable electronic cigarettes are typically separated into a battery and a cartomizer, to allow the disposal and replacement of a nicotine containing fluid cartomizer while preserving the more costly battery and associated circuitry (microcontroller, switch, indicating LED, etc.) for additional 3 use. The vaporizer may include a shell containing the battery segment and cartomizer receiving segment, with a chamber formed in the cartomizer receiving segment to receive the cartomizer. The cartomizer contains the vaporizable substance, heating element, electrical contacts, and mouthpiece. Id. at 4 (internal citations omitted) (internal quotations omitted). Similarly, the ’173 patent “relates to ‘apparatuses, including systems and devices, for vaporizing material to form inhalable aerosol’” which “may include, among other things, a cartridge, a mouthpiece, a heater/vaporizer, and a storage compartment to hold the vaporizable material.” Id. at 8 citing ’173 patent at 2:37-39; 2:51-55. Finally, the ’123 patent “relates generally to distinguishing between blowing (exhaling) and drawing (inhaling) in vaporizer devices.” FID at 7 citing ’123 patent at 2:15-19. a. Claims 1 and 15 of the ’722 Patent The ’722 patent is titled “Vaporizer.” Id. at 4 citing ’722 patent. Both claims 1 and 15 of the ’722 patent are independent. Id. at 14. Claims 1 and 15 of the ’722 patent are reproduced below: 1. [pre] A vaporizer comprising: [a] a battery portion comprising a battery housing segment and a cartomizer receiving segment, [b] the cartomizer receiving segment defining a chamber having an insertion end distal from the battery housing segment and a base end proximate to the battery housing segment, [c] the battery portion further comprising a plurality of charger electrical contacts to provide electrical charge to a battery housed in the battery housing segment, the charger electrical contacts disposed at a first end of the battery portion opposite the insertion end of the chamber of the cartomizer receiving segment, [d] wherein an outer shell is commonly shared by the battery housing segment and the cartomizer receiving segment; and [e] a cartomizer insertable into the chamber at the insertion end, the cartomizer comprising: [f] a body including a structure configured to hold a vaporizable liquid; [g] a wicking element provided within the body and at least partially in contact with the vaporizable liquid; and [h] a heating element provided within the body in contact with the wicking element and operable to heat the vaporizable liquid, wherein the wicking element is configured to deliver the vaporizable liquid to the heating element, and wherein the entire heating element is disposed between the insertion end of the chamber and the base end of the chamber when the cartomizer is inserted into the chamber such that the outer shell protects the heating element. 15. [pre] A vaporizer comprising: [a] a battery portion comprising: 4 [b] a plurality of charger electrical contacts disposed at a first end of the battery portion; [c] a battery housing segment for housing a battery between the first end of the battery portion and a second end of the battery portion; [d] a cartomizer receiving segment defining a chamber having an insertion end at the second end of the battery portion and distal from the battery housing segment, the chamber further having a base end proximate to the battery housing segment, wherein an outer shell is commonly shared by the battery housing segment and the cartomizer receiving segment; and [e] one or more battery electrical contacts in or proximate the chamber of the cartomizer receiving segment; and [f] a cartomizer insertable into the insertion end of the chamber, the cartomizer comprising: [g] a body including a structure configured to hold a vaporizable liquid; [h] a wicking element provided within the body and at least partially in contact with the vaporizable liquid; [i] a heating element provided within the body in contact with the wicking element and operable to heat the vaporizable liquid, wherein the wicking element is configured to deliver the vaporizable liquid to the heating element, and wherein the entire heating element is disposed between the insertion end of the chamber and the base end of the chamber when the cartomizer is inserted into the chamber such that the outer shell protects the heating element; and [j] one or more cartomizer electrical contacts for connecting with the one or more battery electrical contacts in or proximate the chamber. Id. at 4-6; ’722 patent at 18:33-61; 20:8-42. b. Claims 1 and 8 of the ’981 Patent The ’981 patent is titled “Vaporizer.” FID at 4n.2 citing ’981 patent. Claim 1 of the ’981 patent is an independent claim and claim 8 is dependent from claim 1. Id. at 14. Claims 1 and 8 of the ’981 patent are reproduced below: 1. [pre] A vaporizer comprising: [a] a battery portion having an outer shell and a chamber defined by the outer shell; and [b] a cartomizer having a mouthpiece end and an insertion end disposed opposite the mouthpiece end, the cartomizer comprising: [c] a cartomizer body having a volume defined therein, the volume configured to hold a fluid vaporizable substance, [d] wherein at least a portion of the cartomizer body comprises a translucent material configured to allow viewing of the fluid vaporizable substance, [e] wherein the cartomizer body is configured for insertion into the chamber such that at least part of the volume is positioned in the chamber when the cartomizer body is inserted into the chamber; [f] a heating element and a wicking element within the cartomizer body; 5 [g] an inhalation tube in fluid communication with the heating element and the wicking element; [h] a mouthpiece at or proximate to the mouthpiece end, the mouthpiece in fluid communication with the inhalation tube; and [i] a plurality of cartomizer electrical contacts on an exterior of the insertion end, wherein the plurality of cartomizer electrical contacts is positioned to contact a plurality of battery electrical contacts at a base end of the chamber when the cartomizer body is inserted into the chamber. 8. The cartomizer of claim 1, wherein the plurality of cartomizer electrical contacts is further configured to at least partially compress the plurality of battery electrical contacts when the cartomizer body is inserted into the chamber. Id. at 6-7; ’981 patent at 18:10-37; 18:62-65. c. Claims 1 and 4 of the ’173 Patent The ’173 patent is titled “Vaporizer Apparatus.” Id. at 8 (citing ’173 patent). Claim 1 is independent, and claim 4 is dependent from claim 1 and claim 3. See id. at 190. Claims 1 and 3- 4 of the ’173 patent are reproduced below: 1. [pre] An apparatus comprising: [a] a cartridge comprising [b] a mouthpiece, [c] a storage compartment configured to hold a vaporizable material, and [d] a heater chamber comprising a resistive heating element configured to heat the vaporizable material, wherein the heating of the vaporizable material generates an aerosol comprising the vaporizable material and air passing along an airflow path; and [e] a body comprising [f] a receptacle configured to insertably receive and couple to the cartridge, [g] wherein the heater chamber is disposed within the receptacle when the receptacle insertably receives and couples to the cartridge, [h] wherein the airflow path comprises: [i] an air inlet passage having a first side formed by an exterior surface of the cartridge and a second side formed by an internal surface of the receptacle when the receptacle insertably receives and couples to the cartridge, [j] wherein the air inlet passage is configured to deliver the air to the heater chamber; and [k] a fluid connection in the cartridge, the fluid connection connecting the heater chamber and the mouthpiece. 3. The apparatus of claim 1, wherein the cartridge has a proximal end and a distal end opposite the proximal end, wherein the mouthpiece is disposed at the proximal end, and wherein the heater chamber is disposed proximate to the distal end. 6 4. The apparatus of claim 3 wherein the receptacle terminates in a proximal edge, wherein the air inlet passage extends from the proximal edge of the receptacle towards the distal end of the cartridge when the receptacle insertably receives and couples to the cartridge. Id. at 8-9; ’173 patent at 55:28-49; 55:55-64. d. Claims 27 and 32 of the ’123 Patent The ’123 patent is titled “Vaporizer Devices With Blow Discrimination.” Id. at 7 citing ’123 patent. Claim 27 is independent, and claim 32 is dependent from claim 27. See id. at 146. Claims 27 and 32 of the ’123 patent are reproduced below: 27. [pre] A vaporizer device comprising: [a] a cartridge comprising a reservoir configured to hold a vaporizable material, a heater configured to heat the vaporizable material, and a mouthpiece in fluid communication with the heater; and [b] a device body comprising: [c] a cartridge receptacle configured to insertably receive the cartridge; [d] a pressure sensor configured to output sensor readings, [e] wherein a first side of the pressure sensor is exposed to a sealed air flow path and a second side of the pressure sensor is exposed to a device air path open to ambient pressure, [f] the sealed air flow path comprising a channel formed between an interior surface of the cartridge receptacle and an exterior surface of the cartridge, [g] the sealed air flow path passing from an air inlet, through the channel and to the heater and an outlet in the mouthpiece of the cartridge; and [h] a gasket around the pressure sensor, the gasket configured to seal the device air path from the sealed air flow path. 32. The vaporizer device of claim 27, wherein the cartridge comprises the vaporizable material, and wherein the vaporizable material comprises a nicotine formulation. Id. at 7-8; ’123 patent at 49:50-50:3; 50:14-16. B. 19 C.F.R. Part 177 Ruling Request 1. Procedural History On December 3, 2025, NJOY submitted a letter to CBP requesting an administrative ruling pursuant to 19 C.F.R. Part 177, which included three sets of expert declarations and fourteen exhibits. NJOY Email to EOE Branch, dated December 3, 2025. In