Country of Origin; Marking; Infant Formula Products

H351350 April 6, 2026 OT:RR:CTF:FTM H351350 MJD CATEGORY: Origin Mr. Victor Burtea Chief Executive Officer 15414 Lemon Dr. La Mirada, CA 90638 RE: Country of Origin; Marking; Infant Formula Products Dear Mr. Burtea: This is in response to your request for a binding ruling, dated May 27, 2025, regarding the country of origin and country of origin marking for two infant formula products: (1) The ALUBaby Ready-to-Feed Pouches and (2) the ALUBaby Powder Formula Cans. Our ruling is set forth below. FACTS: The products under consideration are the ALUBaby Ready-to-Feed Pouches and the ALUBaby Powder Formula Cans. The ALUBaby Ready-to-Feed Pouches are a specialized dual-compartment feeding system designed to deliver infant formula and purified water in a single, ready-to-use format that maintains separation of the components until activation by the ultimate consumer. The pouch itself, including its integrated nipple, spout, frangible seal, and cap, is imported empty from China. The formula is manufactured in the Netherlands. In the United States, the pouches are loaded into proprietary assembly machines, where they are filled with two components. The lower chamber is filled with purified water, and the upper chamber is filled with the infant formula. The internal frangible seal remains intact throughout the process to preserve separation between the water and formula. Each pouch is then nitrogen flushed, hermetically sealed, labeled, and boxed for retail distribution. The ALUBaby Ready-to-Feed Pouches are marked “Premium Infant Formula from the Netherlands – Proudly Assembled & Packaged in the U.S.A.” The ALUBaby Powder Formula Cans are a finished retail product consisting of powdered infant formula manufactured in the Netherlands and packaging components sourced from China, including empty steel cans, aluminum bottom lids, and plastic over-caps. These imported components arrive in an unfinished, empty condition and serve only as a delivery system for the formula. In the United States, each can is filled with infant formula, which is manufactured in the Netherlands using the automated production line owned by the company. The cans are nitrogen flushed, hermetically sealed with aluminum bottoms, inverted, and fitted with a plastic over-cap. The ALUBaby Powder Formula Cans are marked “Premium Formula from the Netherlands – Assembled in the U.S.A. using imported packaging.” ISSUE: 1) What is the country of origin of the ALUBaby Ready-to-Feed Pouches and the ALUBaby Powder Formula Cans? 2) Does the proposed country of origin marking for the ALUBaby Ready-to-Feed Pouches and the ALUBaby Powder Formula Cans satisfy the marking requirements of 19 U.S.C. § 1304 and 19 C.F.R. § 134? LAW AND ANALYSIS: Country of Origin The marking statute, section 304, 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 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.” United States v. Friedlaender & Co. Inc., 27 C.C.P.A. 297, 302, C.A.D. 104 (1940). The country of origin marking requirements and the exceptions of 19 U.S.C. § 1304 are set forth in Part 134, Customs Regulations (19 C.F.R. Part 134). Section 134.1(b), Customs Regulations (19 C.F.R. § 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 the marking laws and regulations. A substantial transformation is said to have occurred when an article emerges from a manufacturing process with a name, character, and use which differs from the original material subjected to the process. United States v. Gibson-Thomsen Co., 27 C.C.P.A. 267 (C.A.D. 98) (1940); Texas Instruments, Inc. v. United States, 681 F.2d 778, 782 (1982). U.S. Customs and Border Protection (“CBP”) has consistently held that repackaging products does not constitute a substantial transformation for country of origin purposes. For example, in Headquarters Ruling Letter (“HQ”) H283420, dated June 14, 2024, CBP held that 2 the medication, Omeprazole, that was imported into the United States and then repackaged into an orange translucent plastic container in the United States was not substantially transformed. (See also HQ H346255, dated July 3, 2025, which affirmed HQ H283420). Likewise, in NY N065436, dated June 30, 2009, CBP found that the country of origin of R134a (1,1,1,2- tetrafluorethane), refrigerant gas from the United Sates that was repackaged in the United Kingdom into 12 oz cans manufactured in the Unites States, was the United States. CBP provided that foreign repackaging process does not constitute a substantial transformation and that the gas remained a product of the United States. In the instant case, the ALUBaby Ready-to-Feed Pouches consist of empty pouches made in China and powdered infant formula manufactured in the Netherlands. Both articles are then imported to the United States where the pouches are filled with water and formula, in separate chambers of the pouches, and hermetically sealed and labeled for retail distribution. Likewise, the ALUBaby Powder Formula Cans are produced by importing to the United States empty steel cans, aluminum bottom lids, and plastic over-caps from China and powdered infant formula manufactured in the Netherlands. In the United States, the cans are filled with the infant formula manufactured in the Netherlands, then nitrogen flushed, hermetically sealed with aluminum bottoms, inverted, and fitted with a plastic over-cap. Based on the facts provided, we find that the operations in the United States for both the ALUBaby Ready-to-Feed Pouches and the ALUBaby Powder Formula Cans, is merely repackaging which does not amount to a substantial transformation. Specifically, we find that the process of filling the cans or pouches in the United States with formula manufactured in the Netherlands does not affect any change in the name, character, and use of the formula from the Netherlands. Accordingly, the country of origin of the ALUBaby Ready-to-Feed Pouches and the ALUBaby Powder Formula Cans is the Netherlands. Country of Origin Marking In addition, you asked CBP to opine on the country of origin marking of the infant formula products. Section 134.43(e), Customs Regulations (19 C.F.R. § 134.43(e)), is relevant, and states in pertinent part that: Where an article is produced as a result of an assembly operation and the country of origin of such article is determined under this chapter to be the country in which the article was finally assembled, such article shall be marked, as appropriate, in a manner such as the following: (1) Assembled in (country of final assembly); (2) Assembled in (country of final assembly) from components of (name of country or countries of origin of all components); or (3) Made in, or product of, (country of final assembly). 3 As a result of 19 C.F.R. § 134.43(e), CBP has determined that the terms “Made in,” “Product of,” and “Assembled in” are words of similar meaning and that it is not acceptable to use “Made in,” “Product of,” or words of similar meaning, along with the words “Assembled in” in a single country of origin statement on articles of foreign origin imported into the United States. Therefore, the marking for the ALUBaby Ready-to-Feed Pouches, “Premium Infant Formula from the Netherlands – Proudly Assembled & Packaged in the U.S.A,” and the marking the ALUBaby Powder Formula Cans, “Premium Formula from the Netherlands – Assembled in the U.S.A using imported packaging” is not acceptable. Instead, both infant formula products should be marked, “Made in the Netherlands,” or “Product of the Netherlands.” Additionally, we reviewed the product images on the ALUBaby website1, and note that the ALUBaby Ready-to-Feed Pouches also have the text “Manufactured by ALUBaby, Inc. 15414 Lemon Dr, La Mirada, CA 90638” in large black ink on the same side as the country of origin statement. Since the U.S. address is a non-origin reference, 19 C.F.R. § 134.46 applies and this regulation provides the following: In any case in which the words “United States,” or “American,” the letters “U.S.A.,” any variation of such words or letters, or the name of any city or location in the United States, or the name of any foreign country or locality other than the country or locality in which the article was manufactured or produced appear on an imported article or its container, and those words, letters or names may mislead or deceive the ultimate purchaser as to the actual country of origin of the article, there shall appear legibly and permanently in close proximity to such words, letters or name, and in at least a comparable size, the name of the country of origin preceded by “Made in,” “Product of,” or other words of similar meaning. While the country of origin marking and the U.S. non-origin address are on the same side, they are not in comparable texts and fonts. The U.S. non-origin address is in larger black text compared to the country of origin marking. Additionally, the U.S. non-origin address appears more prominently than the country of origin text, which is smaller, in difficult to view white text, and located at the lowest part of the pouch. Therefore, in order to satisfy the marking requirements, the country of origin marking needs to be in similar black text and at least the same size or larger as the U.S. non-origin address. Accordingly, the country of origin marking for the ALUBaby Ready-to-Feed Pouches and the ALUBaby Powder Formula Cans do not satisfy the marking requirements of 19 U.S.C. § 1304 and 19 C.F.R. § 134. 1 ALUBaby Baby Formula, https://www.alubabypouches.com/products/infant-formula-pouches-fast-flow-10-count- 3oz (last visited April 1, 2026). 4 HOLDING: Based on the information provided, the country of origin of the ALUBaby Ready-to-Feed Pouches and the ALUBaby Powder Formula Cans is the Netherlands. The country of origin markings, “Premium Infant Formula from the Netherlands – Proudly Assembled & Packaged in the U.S.A,” and “Premium Formula from the Netherlands – Assembled in the U.S.A. using imported packaging” is not acceptable. Instead, the products should be marked, “Made in the Netherlands,” or “Product of the Netherlands.” Please note that 19 C.F.R. § 177.9(b)(1) provides that “[e]ach ruling letter is issued on the assumption that all of the information furnished in connection with the ruling request and incorporated in the ruling letter, either directly, by reference, or by implication, is accurate and complete in every material respect. The application of a ruling letter by a Customs Service field office to the transaction to which it is purported to relate is subject to the verification of the facts incorporated in the ruling letter, a comparison of the transaction described therein to the actual transaction, and the satisfaction of any conditions on which the ruling was based.” A copy of this ruling letter should be attached to the entry documents filed at the time this merchandise is entered. If the documents have been filed without a copy, this ruling should be brought to the attention of the CBP officer handling the transaction. Sincerely, Sarah Kafka, Chief Food, Textiles, and Marking Branch 5