The tariff classification, country of origin, marking, and eligibility under the United States-Mexico-Canada Agreement (USMCA) of nasal spray training units

N351844 August 13, 2025 CLA-2-90:OT:RR:NC:N1:105 CATEGORY: Classification; Origin TARIFF NO.: 9023.00.0000; 9903.01.14; 9903.01.25; 9903.02.20; 9903.01.26 Ross Seeley Alden Dimensional Media Inc. 70 Denison Street Markham, ON L3R1B6 Canada RE: The tariff classification, country of origin, marking, and eligibility under the United States-Mexico-Canada Agreement (USMCA) of nasal spray training units Dear Mr. Seeley: In your letter dated July 30, 2025, you requested a tariff classification, country of origin, and USMCA applicability determination ruling. Descriptive literature was provided for our review. The items under consideration are described as reusable nasal spray training units, which are designed specifically to support patient and public education in two distinct therapeutic areas. The first is Opioid Overdose Response, which is for training in the recognition and reversal of opioid overdose using intranasal naloxone. The second is Anaphylaxis Preparedness, which is for training individuals at risk of severe allergic reactions in the use of intranasal epinephrine. The devices come in two different kits. The NS-T1 is a single trainer-in-sleeve item that includes a labeled demo trainer and is inserted into a printed educational sleeve. The NS-T2K is a two-trainer awareness kit that includes 2 labeled demo trainers, 2 educational sleeves, additional printed inserts and awareness stickers, and is all housed in a custom-printed folding carton. The printed sleeves and inserts contain clearly illustrated step-by-step instructions. The user reads the inserts and then uses the trainer to practice, which reinforces the technique described in the printed instructions. The nasal spray trainer devices are non-functional, demonstration-only units, intentionally designed to simulate the form and actuation of real therapeutic delivery devices. They contain no active pharmaceutical ingredient, do not deliver any spray, and are unsuitable for any clinical or therapeutic use. They are used to build confidence and competence in medication administration, particularly among first responders, educators, caregivers, and laypersons. In operation, when actuated, the device emits a tactile or audible “click,” simulating the deployment of a real intranasal spray without releasing any substance. It is designed to help users practice hand positioning, aiming, and pressure needed to administer a real dose. The nasal spray training units are shipped to public health units, emergency medical services (EMS), fire departments, police services, addiction services and community harm reduction programs, schools and universities, corporate wellness programs, and pharmacies and health clinics. In your letter, you state that the plastic demonstrational devices are produced entirely in either Canada, Germany, or China from a proprietary mold. This process would include molding the plastic article into shape to produce the finished item. Once the demonstrational devices are produced, they are moved to the assembly plant in Canada. In Canada, the Canadian-origin instructional adhesive labels are attached to the demonstrational devices. Different labels are used for the Epinephrine items and the Naloxone items. Then, the labeled demonstrational devices are paired with Canadian-origin printed educational materials (sleeves, inserts, etc.), and finally assembled into kits for distribution. The applicable subheading for the NS-T1 and NS-T2K reusable nasal spray training units will be 9023.00.0000, Harmonized Tariff Schedule of the United States (HTSUS), which provides for “Instruments, apparatus and models, designed for demonstrational purposes (for example, in education or exhibitions), unsuitable for other uses, and parts and accessories thereof.” The general rate of duty will be free. COUNTRY OF ORIGIN When determining the country of origin for purposes of applying current trade remedies under Section 301 and additional duties, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter H301619 (dated November 6, 2018). The test for determining whether a substantial transformation will occur is whether an article emerges from a process with a new name, character, or use different from that possessed by the article prior to processing. See Texas Instruments Inc. v. United States, 681 F.2d 778 (C.C.P.A. 1982). This determination is based on the totality of the evidence. See National Hand Tool Corp. v. United States, 16 C.I.T. 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). Regarding the origin of the NS-T1 and NS-T2K reusable nasal spray training units, the assembly process predominantly involves placing the stickers onto the plastic units and combining with the educational materials and packaging. The combining of these articles in Canada does not create a new and different article of commerce with a name, character, and use distinct from the individual components. Therefore, to determine the country of origin of the NS-T1 and NS-T2K reusable nasal spray training units, we rely on the origin of the plastic demonstrational trainer. It is the plastic demonstrational trainer that provides the practice required to administer real nasal sprays in the field. It is the plastic demonstrational trainer produced in China, Canada or Germany which provides the essence of the entire kit without which the user would not be able to physically practice as intended. Accordingly, the country of origin for trade remedy purposes of the NS-T1 and NS-T2K reusable nasal spray training units will be China, Canada or Germany, depending on where the plastic demo trainer is produced. Section 304 of the Tariff Act of 1930, as amended (19 U.S.C. 1304), provides that unless excepted, every article of foreign origin imported into the United States shall be marked in a conspicuous place as legibly, indelibly, and permanently as the nature of the article (or its container) will permit, in such a manner as to indicate to the ultimate purchaser in the United States, the English name of the country of origin of the article. Congressional intent in enacting 19 U.S.C. 1304 was “that the ultimate purchaser should be able to know by an inspection of the marking on the imported goods the country of which the goods is the product. The evident purpose is to mark the goods so that at the time of purchase the ultimate purchaser may, by knowing where the goods were produced, be able to buy or refuse to buy them, if such marking should influence his will.” See United States v. Friedlander & Co., 27 C.C.P.A. 297, 302 (1940). Section 134.1(b), CBP Regulations (19 CFR 134.1(b)), defines “country of origin” as the country of manufacture, production, or growth of any article of foreign origin entering the United States. Further work or material added to an article in another country must effect a substantial transformation to render such other country the “country of origin” within the meaning of the marking laws and regulations. Pursuant to section 102.0, interim regulations, related to the marking rules, tariff-rate quotas, and other United States-Mexico-Canada Agreement (USMCA) provisions, published in the Federal Register on July 6, 2021 (86 FR 35566), the rules set forth in sections 102.1 through 102.18 and 102.20 determine the country of origin for marking purposes with respect to goods imported from Canada and Mexico. Section 102.11 provides a required hierarchy for determining the country of origin of a good for marking purposes, apart from textile and apparel goods which are subject to the provisions of 19 CFR 102.21. See 19 CFR 102.11. Applied in sequential order, 19 CFR 102.11(a) provides that the country of origin of a good is the country in which: (1) The good is wholly obtained or produced; (2) The good is produced exclusively from domestic materials; or (3) Each foreign material incorporated in that good undergoes an applicable change in tariff classification set out in Part 102.20 and satisfies any other applicable requirements of that section, and all other applicable requirements of these rules are satisfied. Since the subject merchandise is neither “wholly obtained or produced” nor “produced exclusively from domestic materials,” paragraphs (a)(1) and (a)(2) cannot be used to determine the country of origin of the NS-T1 and NS-T2K reusable nasal spray training units, and paragraph (a)(3) must be applied to determine the origin of the finished article. As the NS-T1 and NS-T2K reusable nasal spray training units are classified under heading 9023, HTSUS, the applicable tariff shift requirement in Part 102.20 for the items under consideration states, in pertinent part: A change to heading 9023 from any other heading. The NS-T1 and NS-T2K reusable nasal spray training units under consideration herein are made of Chinese, German or Canadian components. Of significance here is the Chinese or German plastic demo trainer that is classifiable under heading 9023, HTSUS. As a result of the foreign status of the plastic demo trainer, the Part 102.20 tariff shift requirement is not met and the origin of the NS-T1 and NS-T2K reusable nasal spray training units will be determined under Part 102.11(b), which states, in pertinent part: The country of origin of the good is the country or countries of origin of the single material that imparts the essential character to the good. It is the decision of this office that the plastic demo trainer is the principal component of the subject NS-T1 and NS-T2K reusable nasal spray training units. Furthermore, adding the stickers and descriptive inserts is a minor assembly production where the plastic demo trainer is not substantially transformed as a result of the work performed in Canada. See Texas Instruments and National Hand Tool. As a result, at the time of importation into the United States, the country of origin of the NS-T1 and NS-T2K reusable nasal spray training units will be China or Germany for origin and marking purposes when the plastic demo trainer is produced in China or Germany. Consequently, when the plastic demo trainer is produced in Canada and combined with the remaining Canadian materials, 19 CFR 102.11(a)(2) is applied and the country of origin for marking purposes will be Canada. USMCA The USMCA was signed by the Governments of the United States, Mexico, and Canada on November 30, 2018. The USMCA was approved by the U.S. Congress with the enactment on January 29, 2020, of the USMCA Implementation Act, Pub. L. 116-113, 134 Stat. 11, 14 (19 U.S.C. § 4511(a)). General Note (GN) 11 of the HTSUS implements the USMCA. GN 11(b) sets forth the criteria for determining whether a good is an originating good for purposes of the USMCA. GN 11(b) states: For the purposes of this note, a good imported into the customs territory of the United States from the territory of a USMCA country, as defined in subdivision (l) of this note, is eligible for the preferential tariff treatment provided for in the applicable subheading and quantitative limitations set forth in the tariff schedule as a “good originating in the territory of a USMCA country” only if— (i) the good is a good wholly obtained or produced entirely in the territory of one or more USMCA countries; (ii) the good is a good produced entirely in the territory of one or more USMCA countries, exclusively from originating materials; (iii) the good is a good produced entirely in the territory of one or more USMCA countries using non-originating materials, if the good satisfies all applicable requirements set forth in this note (including the provisions of subdivision (o)); . . . . In reviewing the NS-T1 and NS-T2K reusable nasal spray training units, when the plastic demo trainer is produced in Canada GN 11(b)(ii) will apply, as they are “produced entirely in [Canada], exclusively from originating materials.” Therefore, when the demo trainer is produced in Canada, the NS-T1 and NS-T2K reusable nasal spray training units are eligible for preferential tariff treatment under the USMCA. In reviewing the NS-T1 and NS-T2K reusable nasal spray training units when the origin of the plastic demo trainer is China or Germany, neither GN 11(b)(i) or (b)(ii) apply, as neither are “wholly obtained or produced entirely” in Canada, nor are they “produced entirely in [Canada], exclusively from originating materials.” CBP turns to GN 11(b)(iii) to determine whether the NS-T1 and NS-T2K reusable nasal spray training units are eligible for preferential tariff treatment under the USMCA. GN 11(b)(iii) provides that a good is eligible for preferential tariff treatment under the USMCA if it is a “good produced in [Canada] using non-originating materials, if the good satisfies all applicable requirements set forth in this note (including in the provisions of subdivision (o)).” GN 11(o) provides for the applicable tariff shift requirements. For products of Chapter 90, GN 11(o) states that the applicable tariff shift is “[a] change to heading 9023 from any other heading.” As the plastic demo trainer is classified in heading 9023, HTSUS, the tariff shift is not met. Accordingly, when the NS-T1 and NS-T2K reusable nasal spray training units are imported with a Chinese or German plastic demo trainer they are not eligible for preferential tariff treatment under the USMCA. Products of Canada as provided by heading 9903.01.10 in Section XXII, Chapter 99, Subchapter III, U.S. Note 2(j), HTSUS, other than products classifiable under headings 9903.01.11, 9903.01.12, 9903.01.13, 9903.01.14, and 9903.01.15, HTSUS, will be subject to an additional 25 percent ad valorem rate of duty. At the time of entry, you must report the applicable Chapter 99 heading, i.e. 9903.01.10, in addition to subheading 9023.00.0000, HTSUS, listed above. Articles that are entered free of duty under the terms of general note 11 to the HTSUS (U.S.-Mexico-Canada Agreement (USMCA)), including any treatment set forth in subchapter XXIII of Chapter 98 and subchapter XXII of chapter 99 of the HTSUS, will not be subject to the additional ad valorem duties provided for in heading 9903.01.10. If your product is entered duty free as originating under the USMCA, you must report heading 9903.01.14, HTSUS, in addition to subheading 9023.00.0000, HTSUS. Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time, products of China will be subject to an additional 10 percent ad valorem rate of duty. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.25, in addition to subheading 9023.00.0000, HTSUS, listed above. Products of the European Union with an ad valorem (or ad valorem equivalent) rate of duty under column 1-General less than 15 percent will be subject to an additional ad valorem rate of duty of 15 percent minus the column 1-General duty rate. At the time of entry, you must report 9903.02.20, in addition to subheading 9023.00.0000, HTSUS. Products of Canada are not subject to reciprocal tariffs. At the time of entry, you must report 9903.01.26 in addition to subheading 9023.00.0000, HTSUS. The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Jason Christie at jason.m.christie@cbp.dhs.gov. Sincerely, (for) James Forkan Acting Director National Commodity Specialist Division