CLA-2-21:OT:RR:NC:N5:229

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 March 17, 2026, you requested a tariff classification, country of origin, marking and status under the United States-Australia Free Trade Agreement (UAFTA) for two products. We previously classified this merchandise in N354493 dated October 29, 2025.

An ingredients breakdown, narrative description of the manufacturing process, and pictures of the product labels accompanied your inquiry.

The subject merchandise, “Cognitec 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 1-2 scoops (5-10 grams) with 250–300 mL. of water, 20–40 minutes before bedtime and not exceed 2 servings per day. For Synergi Cortex, adults are instructed to mix 1-2 scoops (5-10 grams) with 250–300 mL. of water or juice, preferably in the morning or prior to mental exertion and not to exceed 2 servings per day.

Cognitec Synergi Sleep is said to contain L-glycine (China), L-tryptophan (China), lemon balm extract (China), ashwagandha extract (China), magnesium L-threonate (China), magnesium glycinate (China), magnesium taurate (China), GABA (China), L-theanine (China), chocolate flavour (Australia), monk fruit extract (China), and cocoa powder (Indonesia). Cognitec Synergi Cortex is said to contain creatine monohydrate (China), taurine (China), ashwagandha extract (China), bacopa monnieri extract (China), CDP choline (China), L-theanine (China), L-tyrosine (China), L-phenylalanine (China), zinc (China), vitamin B-6 (China), vitamin B12 (China), copper (China), natural intense orange flavour (Australia), monk fruit extract (China), and citric acid anhydrous (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 (lemon balm, monk fruit extract) are included in quantities consistent with general dietary support for relaxation and healthy sleep quality. For Synergi Cortex, creatine, amino acids (tyrosine, taurine, phenylalanine, theanine), choline, vitamins, minerals, and botanicals (bacopa, monk fruit extract, 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, Harmonized Tariff Schedule of the United States (HTSUS), which provides for food preparations not elsewhere specified or included… other… other… other. The general rate of duty will be 6.4 percent ad valorem.

The 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:

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. Friedlaender & 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.

A substantial transformation occurs when, as a result of manufacturing process, a new and different article emerges, having a distinct name, character or use, which is different from that originally possessed by the article or material before being subjected to the manufacturing process. See United States v. Gibson-Thomsen Co., Inc., 27 C.C.P.A. 267 (C.A.D. 98) (1940).

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.

The proposed marking of the products as depicted from the pictures provided states, “Australian Made” in large, bold white font on the product label. The placement of the marking is in the same location as the ingredient list and directions for use. Since the country of origin of the “Cognitec Synergi Sleep – Advanced Sleep Complex,” and “Cognitec Synergi Cortex,” is Australia, the proposed marking will satisfy the marking requirements of 19 CFR 134 and 19 U.S.C. 1304.

UNITED STATES-AUSTRALIA FREE TRADE AGREEMENT:

Regarding the United States-Australia Free Trade Agreement (UAFTA) eligibility:

General Note 28(b), HTSUS, sets forth the criteria for determining whether a good is originating under the UAFTA. General Note 28(b), HTSUS, (19 U.S.C. § 1202) states, in pertinent part, that

For the purposes of this note, subject to the provisions of subdivisions (c), (d), (m) and (n) thereof, a good imported into the customs territory of the United States is eligible for treatment as an originating good of a UAFTA country under the terms of this note only if -

(i) the good is a good wholly obtained or produced entirely in the territory of Australia or of the United States, or both;

(ii) the good was produced entirely in the territory of Australia or of the United States, or both, and-

(A) each of the non-originating materials used in the production of the good undergoes an applicable change in tariff classification specified in subdivision (n) of this note;

(B) the good otherwise satisfies any applicable regional value content requirement referred to in subdivision (n) of this note; or

(C) the good meets any other requirements specified in subdivision (n) of this note; and such good satisfies all other applicable requirements of this note;

(iii) the good was produced entirely in the territory of Australia or of the United States, or both, exclusively from materials described in subdivision (b)(i) or (b)(ii) of this note; or

(iv) the good otherwise qualifies as an originating good under this note, and is imported directly into the customs territory of the United States from the territory of Australia.

As both products incorporate non-originating goods/materials, they would have to undergo an applicable change in tariff classification in order to meet the requirements of GN 28(b)(ii). We must refer to GN 28 (n)(F) for the specific classification change required. Goods classified in subheading 2106.90.9998, HTSUS, require: “A change to other goods of heading 2106 from any other chapter.”

Based on the facts provided, the goods described above qualify for UAFTA preferential treatment, because they will meet the requirements of HTSUS General Note 28(b)(ii)(A). All non-originating goods/materials, as set forth above, undergo the required tariff shift. The products, “Synergi Sleep – Advanced Sleep Complex,” and “Cognitec Synergi Cortex,” are therefore eligible for preferential treatment under the UAFTA, upon compliance with all applicable laws, regulations, and agreements.

This ruling does not address the applicability of any additional duties, taxes, fees, exactions and/or other charges, which may apply to the goods discussed herein. This includes, but is not limited to, tariffs and other duties as provided for in Subchapter III to Chapter 99, HTSUS. Thus, for example, in addition to the classification stated above, the merchandise covered by this ruling may also need to be reported with either the Chapter 99 provision under which an additional tariff applies or one of the Chapter 99 provisions covering exceptions to such tariffs.

For further information to assist with the importation process, please refer to the frequently updated Cargo Systems Messaging Service (CSMS) messages at https://www.cbp.gov/trade/automated/cargo-systems-messaging-service and the Trade Remedies page at https://www.cbp.gov/trade/programs-administration/trade-remedies.

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 merchandise is subject to The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which is regulated by the Food and Drug Administration (FDA). Information on the Bioterrorism Act can be obtained by calling FDA at 301-575-0156, or at the Web site www.fda.gov/oc/bioterrorism/bioact.html.

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 Christopher Gangaprashad at [email protected].
Sincerely,

(for)
James P. Forkan
Director
National Commodity Specialist Division