N354493

N354493 October 29, 2025 CLA-2-21:OT:RR:NC:N5:228 CATEGORY: Classification; Country of Origin; Marking; Trade Program TARIFF NO.: 2106.90.9998; 9903.01.25 Michael Califano Cognitec Labs Pty Ltd 3/6 Parsons Road, Eltham Eltham 3095 Australia RE: The tariff classification, country of origin, marking and status under the United States-Australia Free Trade Agreement (UAFTA) of a dietary supplement Dear Mr. Califano: In your letter dated October 2, 2025, you requested a tariff classification, country of origin, marking and status under the United States-Australia Free Trade Agreement (UAFTA) for two products. An ingredients breakdown, narrative description of the manufacturing process, and pictures of the product labels accompanied your inquiry. The subject merchandise, “Synergi Sleep – Advanced Sleep Complex,” and “Cognitec Synergi Cortex,” are described as powdered dietary supplements imported in consumer-ready PET jars containing approximately 30 servings each which are intended exclusively for retail sale to adult consumers in the United States. The products are marketed strictly as dietary supplement beverage mixes/general wellness supplements and are not pharmaceutical preparations; no claims are made that the products diagnose, treat, or cure any diseases. For Synergi Sleep, adults are instructed to mix 1 scoop (7.5 g) with 200–300 mL. of water, 30–60 minutes before bedtime and not exceed 2 servings per day. For Synergi Cortex, adults are instructed to mix 1 scoop (5 grams) with 200–300 mL. of water, preferably in the morning or prior to mental exertion and not to exceed 2 servings per day. Cognitec Synergi Sleep is said to contain glycine (China), L-tryptophan (China), chamomile extract (China), magnesium L-Threonate (China), magnesium glycinate (China), magnesium taurate (China), lemon balm extract (China), GABA (China), L-theanine (China), and magnolia bark extract (China). Cognitec Synergi Cortex is said to contain creatine monohydrate (China), ashwagandha extract (China), Acetyl-L-carnitine HCI (China), bacopa monnieri extract (China) CDP-choline (China), ginkgo biloba extract (China), L-tyrosine (China)< L-phenylalanine (China), L-theanine (China), vitamin C (China), zinc (China), copper (China), vitamin B-6 (China), and vitamin B12 (China). Synergi Sleep and Synergi Cortex are fully blended, processed, and packaged in Australia into finished retail-ready jars. Both products are produced in Australia by mechanical dry blending of purified nutrients and standardized botanical extracts. Ingredients are weighed, sieved, blended with natural flavours and flow agents, then filled into PET jars, induction-sealed, labelled, and tested for QC release. No chemical synthesis or solvent processing occurs. For Synergi Sleep, amino acids (glycine, tryptophan, theanine), minerals (magnesium forms), and botanicals (chamomile, lemon balm, magnolia) are included in quantities consistent with general dietary support for relaxation and healthy sleep quality. For Synergi Cortex, creatine, amino acids (ALCAR, tyrosine, phenylalanine, theanine), choline, vitamins, minerals, and botanicals (bacopa, ginkgo, ashwagandha) are combined to support mental energy, focus, and cognitive wellbeing. CLASSIFICATION: The applicable subheading for the products, “Synergi Sleep – Advanced Sleep Complex,” and “Cognitec Synergi Cortex,” will be 2106.90.9998, HTSUS, which provides for food preparations not elsewhere specified or included… Other… Other… Other… Preparations for the manufacture of beverages…other. The general rate of duty will be 6.4 percent ad valorem. Effective April 5, 2025, Executive Orders implemented “Reciprocal Tariffs.” All imported merchandise must be reported with either the Chapter 99 provision under which the reciprocal tariff applies or one of the Chapter 99 provisions covering exceptions to the reciprocal tariffs. At this time, products of Australia will be subject to an additional ad valorem rate of duty of 10 percent. At the time of entry, you must report the Chapter 99 heading applicable to your product classification, i.e. 9903.01.25 or exclusion subheading, in addition to subheading 2106.90.9998, HTSUS, listed above. The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/. COUNTRY OF ORIGIN AND MARKING: When determining the country of origin for purposes of applying current trade remedies under Section 301 and additional duties, the substantial transformation analysis is applicable. See, e.g., Headquarters Ruling Letter 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). Additionally, Section 304 of the 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 its 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.” See United States v. Friedlander & Co., 27 C.C.P.A. 297, 302 (1940). Part 134 of the U.S. Customs and Border Protection (“CBP”) Regulations (19 CFR 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.1(b), CBP 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 the marking laws and regulations. In this case, to manufacture Synergi Sleep – Advanced Sleep Complex, and Cognitec Synergi Cortex, various ingredients from China are mixed in the manufacturing facility in Australia based on a specific formula. This results in a finished product that differs from any of the individual ingredients. The vitamins, minerals and amino acids are put together for the purpose of creating a product that is designed to promote certain effects that are distinct from the effects if only the individual ingredients were taken. In other words, the combination of the various vitamins, minerals and amino acids results in a product that has an identity, character and use that is different and more convenient to use than taking the individual raw materials. Accordingly, we find that the products, “Synergi Sleep – Advanced Sleep Complex,” and “Cognitec Synergi Cortex,” have a new name, character and use different from the individual ingredients. Therefore, we find that the country of origin of Synergi Sleep – Advanced Sleep Complex, and Cognitec Synergi Cortex is Australia. At this stage, you have stated that you do not yet have a finished product or photographs available, to display how the products are intended to be marked as manufacturing and pa

is applicable. See, e.g., Headquarters Ruling Letter 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). Additionally, Section 304 of the 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 its 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.” See United States v. Friedlander & Co., 27 C.C.P.A. 297, 302 (1940). Part 134 of the U.S. Customs and Border Protection (“CBP”) Regulations (19 CFR 134) implements the country of origin marking requirements and exceptions of 19 U.S.C. 1304. Section 134.1(b), CBP 

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