OT:RR:NC:N3:138
Mr. Vamsi Nama
Granules Pharmaceuticals Inc.
3701 & 3725 Concorde Parkway
Chantilly, VA 20151
RE: The country of origin of Ibuprofen Tablets in dosage form
Dear Mr. Nama:
In your letter dated December 28, 2021, you requested a country of origin ruling determination on Ibuprofen Tablets. Ibuprofen, imported in 400 mg, 600 mg, and 800 mg tablets, is a medicinal preparation containing Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), as the active ingredient. It is used to relieve pain from various conditions such as headache, dental pain, menstrual cramps, muscle aches and arthritis.
You stated that the active pharmaceutical ingredient (API), Ibuprofen, is manufactured in the United States and that the finished tablets in dosage form are made in India. In India, the Ibuprofen will be mixed with various inactive ingredients to produce the final tablets in dosage form.
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 Ibuprofen (made in the United States) with the inactive ingredients into the final dosage tablets in India does not result in a substantial transformation and the country of origin will be the United States.
You have included pictures of labels marked “Made in India” which appears to be incorrect since the country of origin for Customs and Border Protection purposes 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.
This ruling is being issued under the provisions of Part 177 of the Customs 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, contact National Import Specialist Judy Lee at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division