The Country of Origin of Menthol Cough Drops

N353822 September 26, 2025 OT:RR:NC:N5:232 CATEGORY: Origin Ms. Kristina Barry Grunfeld Desiderio Lebowitz Silverman & Klestadt LLP 599 Lexington Avenue New York, NY 10022 RE: The Country of Origin of Menthol Cough Drops Dear Ms. Barry: In your letter, dated September 16, 2025, you requested a country of origin determination on behalf of your client, Altray Company Inc. (Stamford, CT). The subject merchandise is described as Menthol Cough Drops. The cough drops are said to contain pharmaceutical grade menthol pellets that are manufactured in the United States. The cough drops’ ingredients include sucrose (53.2 percent), corn syrup (43.7 percent), water (2.5 percent), the aforementioned menthol (0.22 percent), soy lecithin (0.05 percent), maltodextrin (0.05 percent), gum arabic (0.03 percent), artificial color red 40 (0.02 percent), and artificial color blue 1 (0.01 percent). The cough drops will be produced in Brazil by Riclan S.A. The U.S.-origin pharmaceutical-grade menthol pellets will initially be weighed and then processed into a syrup via heating, dissolving, and then adding water. The inactive ingredients in the cough drops will also be heated and dissolved to create a concentrated sugar base. Next, the menthol syrup will be mixed into the sugar base, placed into lozenge molds, and cooled to solidify the mixture into cough drops. The drops will then be wrapped, stored in bulk for batch testing, bagged in individual packs, and boxed in shipping cartons for export to the United States. The cough drops will be sold in drug stores, national chains, and supermarkets. You seek a determination as to the country of origin of the above-described product. The “country of origin” is defined in 19 CFR 134.1(b) 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 in order to render such other country the ‘country of origin’ within the meaning of this part.” 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, 69 C.C.P.A. 151 (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), and National Juice Products Association v. United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986). In the present case, we find that according to the presented facts, the country of origin of the menthol cough drops is the United States, where the menthol is produced. Processing operations in Brazil will not rise to the level of a substantial transformation. The menthol cough drops created by the manufacturing operation in Brazil will therefore be considered a product of the United States for duty purposes. The question of whether the applicable merchandise at issue may be marked with a phrase such as “Product of U.S.A.” is under the jurisdiction of the U.S. Federal Trade Commission, Bureau of Consumer Protection, Division of Enforcement, which may be contacted for advice at 600 Pennsylvania Avenue N.W., Washington, D.C. 20580, or through the FTC’s website at http://www.ftc.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 merchandise is subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is regulated by the Food and Drug Administration (FDA). Information on the Bioterrorism Act can be obtained by calling FDA at 301-575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html. 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 questions regarding the ruling, contact National Import Specialist Frank Troise at frank.l.troise@cbp.dhs.gov. Sincerely, (for) Denise Faingar Designated Official Performing the Duties of the Division Director National Commodity Specialist Division