The country of origin of Nitroglycerin Ointment, USP 2%

N348080 May 15, 2025 OT:RR:NC:N3:138 CATEGORY: Origin Kamesh Venugopal Encube Ethicals, Inc. 200 Meredith Drive Durham, NC 27713 RE: The country of origin of Nitroglycerin Ointment, USP 2% Dear Mr. Venugopal: In your letter dated April 22, 2025, you requested a country of origin ruling on Nitroglycerin Ointment. Nitroglycerin Ointment is a medicinal preparation containing Nitroglycerin, a vasodilator, as the active ingredient. It is indicated for the prevention of angina pectoris due to coronary artery disease. Nitroglycerin Ointment for topical use only contains Nitroglycerin (glyceryl trinitrate) 2% and lactose in a lanolin, white petrolatum and purified water base. You stated that the active pharmaceutical ingredient (API), Nitroglycerin, is manufactured in the United States and that the finished ointment in dosage form is made in India. In India, the Nitroglycerin will be mixed with various inactive ingredients to produce the final ointment in dosage form. When determining the country of origin, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter (“HQ”) 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). In this case, we find the mixing of the active ingredient Nitroglycerin (made in the United States) with the inactive ingredients into the final ointment in India does not result in a substantial transformation and the country of origin will be the United States. You provided pictures of labels for our review. The labels indicate the product is manufactured in India, which appears to be incorrect since the country of origin is the United States. Goods determined to be an article of U.S. origin are not subject to the country of origin marking requirements of 19 U.S.C. §1304. Whether an article may be marked with the phrase “Made in the USA” or similar words denoting U.S. origin, is an issue under the authority of the Federal Trade Commission (FTC). Consequently, any inquiries regarding the use of such phrases reflecting U.S. origin should be directed to the FTC, at the following address: Federal Trade Commission, 600 Pennsylvania Avenue, NW, Washington, D.C. 20580. This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.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 Judy Lee at judy.h.lee@cbp.dhs.gov. Sincerely, Steven A. Mack Director National Commodity Specialist Division