CLA-2-21:OT:RR:NC:N5:228
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 packaging are still in progress. However,
you have included a product label showing how the Australian formulation and TGA label is currently
marked, as the U.S. FDA label version has not been finalized. However, the placement of the country of
origin on the label for U.S. markets, specifically, “Made in Australia,” logo will be in the same location as in
the images provided. These images depict that the placement of the country of origin are in large, bold white
font is prominent at the bottom right corner of the label in comparison to other information (ingredients,
directions for use, etc.) that appears on the label. The product label must be marked in a conspicuous place as
legible, indelible and permanent, as the nature of the containers will permit to indicate that the product is
"Made in," "Product of," or other words of similar meaning, Australia, in order satisfy the requirements of 19
CFR 134 and 19 U.S.C. 1304. The proposed marking and placement of “Made in Australia,” in large bold
white font on the product label as set forth in the proposed label provided will satisfy the marking
requirements of 19 U.S.C. §1304 and 19 CFR Part 134.
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( 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 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.
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 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 Timothy Petrulonis at [email protected].
Sincerely,
(for)
Evan Conceicao
Designated Official Performing the Duties of the Division Director
National Commodity Specialist Division