OT:RR:NC:N3:138
Kamesh Venugopal
Encube Ethicals, Inc.
200, Meredith Drive
Durham, NC 27713
RE: The country of origin of Mesalamine Rectal Suspension USP Enema 4 g/60 mL
Dear Mr. Venugopal:
In your letter dated October 26, 2023, filed on behalf of Encube Ethicals Private Limited, you requested a country of origin ruling on Mesalamine Rectal Suspension USP Enema 4 g/60 mL.
Mesalamine Rectal Suspension USP Enema, imported in 7 × 60 mL unit dose bottles, is a medicinal preparation containing 4 grams of Mesalamine, also known as 5-aminosalicylic acid (5-ASA), as the active ingredient. It is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.
You stated that the active pharmaceutical ingredient (API), Mesalamine, is manufactured in Sweden and that the finished Mesalamine Rectal Suspension USP Enema 4 g/60 mL is made in India. In India, the Mesalamine will be mixed with various inactive ingredients to produce the final Mesalamine Rectal Suspension USP Enema.
Section 134.1(b), Customs 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 in order to render such other country the "country of origin" within the meaning of this part; ….
A substantial transformation occurs when an article emerges from a process with a new name, character or use different from that possessed by the article prior to processing. A substantial transformation will not result from a minor manufacturing or combining process that leaves the identity of the article intact. See United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (1940); and National Juice Products Association v. United States, 628 F. Supp. 978 (Ct. Int’l Trade 1986).
In this case, we find the mixing of the active ingredient Mesalamine (made in Sweden) with the inactive ingredients into the final Mesalamine Rectal Suspension USP Enema in India does not result in a substantial transformation and the country of origin will be Sweden.
You also submitted pictures of labels marked with the country of origin for our review. Based upon the labels provided, the subject product does not appear to be legally marked with the proper country of origin. The labels state the product is manufactured in India and distributed in the United States. However, the country of origin is Sweden where the API is made and should be marked “Made in”,” Product of,” or other words of similar meaning with “Sweden” as the country of origin. It is also acceptable to mark the product with Mesalamine Rectal Suspension USP Enema as “Made in Sweden, formulated in India.”
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 [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division