Notice of Issuance of Final Determination Concerning the Visionary Advanced 2 Dietary Supplement Tablets, 44894-44896 [2018-19162]

Download as PDF 44894 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Notice of Issuance of Final Determination Concerning the Visionary Advanced 2 Dietary Supplement Tablets U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of final determination. AGENCY: This document provides notice that U.S. Customs and Border Protection (‘‘CBP’’) has issued a final determination concerning the country of origin of three Visionary Advanced 2 vitamin and mineral dietary supplement tablets. Based upon the facts presented, for purposes of U.S. Government procurement, CBP has concluded that the United States is the country of origin of the Advanced 2 vitamin and mineral dietary supplement tablets. DATES: The final determination was issued on August 27, 2018. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within October 4, 2018. FOR FURTHER INFORMATION CONTACT: Robert Dinerstein, Valuation and Special Programs Branch, Regulations and Rulings, Office of Trade, at (202) 325–0132. SUPPLEMENTARY INFORMATION: Notice is hereby given that on August 27, 2018, pursuant to subpart B of part 177, U.S. Customs and Border Protection Regulations (19 CFR part 177, subpart B), CBP issued a final determination concerning the country of origin of three SUMMARY: versions of the Visionary Advanced 2 vitamin and mineral dietary supplement tablets which may be offered to the U.S. Government under an undesignated government procurement contract. This final determination, HQ H299717, copy attached, was issued under procedures set forth at 19 CFR part 177, subpart B, which implements Title Ill of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511–18). The three products are Visionary Advanced 2 coated tablets, Visionary Orange Advanced 2 chewable tablets, and Visionary Cherry Advanced 2 chewable tablets. Each of the dietary supplement tablets contains the same basic formula of vitamins and minerals, but with different flavorings. In the final determination, CBP concluded that the combining of the various vitamins and minerals in one tablet in the United States results in a product that has a name, character and use that is distinct from the individual ingredients that are used to make the dietary supplement. Therefore, for purposes of U.S. Government procurement, the United States is the country of origin. Section 177.29, CBP Regulations (19 CFR 177.29), provides that a notice of final determination shall be published in the Federal Register within 60 days of the date the final determination is issued. Section 177.30, CBP Regulations (19 CFR 177.30), provides that any party-atinterest, as defined in 19 CFR 177.22(d), may seek judicial review of a final determination within 30 days of publication of such determination in the Federal Register. Dated: August 27, 2018. Alice A. Kipel, Executive Director, Regulations and Rulings, Office of Trade. HQ H299717 August 27, 2018 OT:RR:CTF:VS H299717 RSD CATEGORY: Origin Mr. Marino Apollinari Visionary Vitamin Co. P.O. Box 1825 Dearborn, Michigan 48122 RE: U.S. Government Procurement; Country of Origin of Advanced 2 Multiple Vitamin and Mineral Dietary Supplement Tablets; Substantial Transformation Dear Mr. Apollinari: This is in response to the Visionary Vitamin Company’s (Visionary’s) request of June 4, 2018, for a final determination concerning the country of origin of products known as the Visionary Advanced 2 dietary supplements pursuant to subpart B of Part 177 of the U.S. Customs and Border protection (‘‘CBP’’) Regulations (19 C.F.R. Part 177). The National Commodity Specialist Division forwarded your request to the Headquarters office of Regulations and Rulings to issue this final determination. As an importer, Visionary is a party-atinterest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination. FACTS: Visionary is a manufacturer of dietary supplements. At issue are three different multiple vitamin and mineral dietary supplement tablets. The three dietary supplement tablets are the Advanced 2 Coated tablets, the Visionary Orange Advanced 2 chewable tablets, and the Visionary Cherry Advanced 2 chewable tablets. The vitamin and mineral tablets contain the following raw materials: sradovich on DSK3GMQ082PROD with NOTICES Country of origin Medicinal Ingredients: Vitamin C DC grade (Ascorbic Acid) (97%) .............................................................................................................................. Vitamin E (As DL-Alpha Tocopherol Acetate) 50%-Tab grad .................................................................................................. Zinc (as oxide) (80.34%) ........................................................................................................................................................... Copper (as cupric oxide) (78.3%) ............................................................................................................................................. Lutein (5%) beadlets ................................................................................................................................................................. Zeaxanthin (5%) beadlets from Omnixan ................................................................................................................................. Other ingredients: DI Calcium Phosphate ............................................................................................................................................................... Micro crystalline Cellulose ......................................................................................................................................................... Croscarmellose Sodium ............................................................................................................................................................ Silicon Dioxide ........................................................................................................................................................................... Magnesium Stearate (vegetable source) .................................................................................................................................. Stearic Acid Vegetable grade .................................................................................................................................................... Pharmaceutical Glaze (only used for coated tablets) ............................................................................................................... Instead of pharmaceutical glaze, the chewable orange and cherry tablets contain a natural masking flavor from the United States, either in a natural orange flavor or VerDate Sep<11>2014 17:54 Aug 31, 2018 Jkt 244001 natural cherry flavor. In addition, the chewable cherry and orange tablets also incorporate sucralose from China. You have indicated that the most expensive single PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 China. China. India. USA. China. USA. China. India. Brazil. USA. Spain. Malaysia. USA. ingredient used in making the Advanced 2 dietary supplement tablets is the Zeaxanthin Omnixan from the United States. E:\FR\FM\04SEN1.SGM 04SEN1 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices The manufacturing processes of the three products occurs at Visionary’s facility in Michigan, United States. The same basic procedures are used to manufacture the three different dietary supplement tablets. A flow chart of the processes was submitted. The active and inactive ingredients in powder form are weighed and all vital information is logged in. Next, the ingredients are dispensed, and the dry mix is blended. A vibro sifter is used to pass the raw powder materials through a 40-mesh screen, while being added to a drum for mixing. Weight and yield are recorded. Mixing and lubrication is performed by a blender. The approved blend is then transferred to the compression area. The blend is loaded into the hopper of a tablet press. The tablet press is set for the specified parameters and the details are noted in a start-up test during the tablet compression. The weight of the first few tablets is taken and checked against the actual weight of the product. Adjustments in the weight of the tablets are made until the right weight is obtained. The hardness of the tablets is also adjusted by carefully turning the pressure rollers by hand until the correct hardness is obtained. The tablets are then compared to previous samples. A series of in-process quality checks are performed in various intervals while the tablets are produced. These include: 1) appearance; 2) average weight per 10 tablets; 3) tablet thickness); 4) disintegration of tablet; 5) friability; 6) hardness; and 7) temperature and humidity. The coating solution is prepared by loading the tablets in a pan and recording the actual weight. The tablets are pre-heated until the temperature reaches 100 degrees Fahrenheit. The coating solution is sprayed on the tablets until all surfaces of the tablets are covered. The tablets are unloaded into trays and placed in an oven room for drying. The tablets are then sorted and damaged tablets (such as broken, color or thickness variance, capping issues, or black/foreign material) are rejected. Next, the product moves to the packaging line using the following equipment: an unscrambler, a conveyor, a tablet counter, a cottoner, a capper labeler, induction sealer, heat tunnel, printer coder, accumulation table and weighing balance. A system of quality controls occurs to ensure that the tablets are properly packaged, coded, and labeled. sradovich on DSK3GMQ082PROD with NOTICES ISSUE: What is the country of origin of the Visionary Advanced 2 Coated tablets, Visionary Orange Advanced 2 Chewable tablets, and Visionary Cherry Advanced 2 Chewable tablets for purposes of U.S. Government procurement? LAW AND ANALYSIS: CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain ‘‘Buy American’’ restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of VerDate Sep<11>2014 17:54 Aug 31, 2018 Jkt 244001 Part 177, 19 C.F.R. § 177.21 et seq., which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. § 2511 et seq.) (‘‘TAA’’). Under the rule of origin set forth under 19 U.S.C. § 2518(4)(8): An article is a product of a country or instrumentality only if (i) it is wholly the growth, product, or manufacture of that country or instrumentality, or (ii) in the case of an article which consists in whole or in part of materials from another country or instrumentality, it has been substantially transformed into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was so transformed. See also 19 C.F.R. § 177.22(a). In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations. See 19 C.F.R. § 177.21. In this regard, CBP recognizes that the Federal Acquisition Regulations restrict the U.S. Government’s purchase of products to U.S.-made or designated country end products for acquisitions subject to the TAA. See 48 C.F.R. § 25.403(c)(1). The Federal Acquisition Regulations define ‘‘U.S.-made end product’’ as: . . . an article that is mined, produced, or manufactured in the United States or that is substantially transformed in the United States into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. 48 C.F.R. § 25.003. 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. lnt’I Trade 1986). With respect to whether combining and mixing different materials results in a substantial transformation, CBP held in Headquarters Ruling Letter (‘‘HQ’’) 731685, dated March 15, 1990, that converting fruit concentrates and other ingredients into fruit drinks in Mexico constituted a substantial transformation. The manufacturing process involved mixing the juice concentrates with other ingredients including water, artificial flavor, sodium benzoate, and food coloring. CBP held that, considering the totality of the circumstances, a substantial transformation had occurred because ‘‘[t]he juice concentrates are subsumed into a product that is no longer considered a juice.’’ This situation is distinguished from a situation considered in National Juice Products Ass’n v. United States, 628 F. Supp. 978 (Ct. lnt’I Trade 1986), in which the United States Court of International Trade (‘‘CIT’’) upheld CBP’s decision in HQ 728557, dated September 4, 1985, that imported orange juice concentrate was not substantially transformed when it was mixed with water, PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 44895 essential oils, flavoring ingredients and domestic fresh juice in order to produce frozen concentrated orange juice and reconstituted orange juice. CBP found that the manufacturing process did not create an article with a new name, character or use. The CIT agreed that the manufacturing process did not change the ‘‘fundamental character of the product’’ as ‘‘it was still essentially the juice of oranges‘‘. See HQ H237605 dated June 25, 2014. In HQ 731685, a substantial transformation was found because the raw ingredients had been converted into a different article of commerce through a process beyond simple combining, packaging or mere diluting. In the context of the manufacture of chemical products such as pharmaceuticals, CBP has consistently examined the complexity of the processing and whether the final article retains the essential identity and character of the raw material. CBP has generally held that the processing of pharmaceutical products from bulk form into measured doses does not result in a substantial transformation. See, e.g., HQ 561975, dated April 3, 2002; HQ 561544, dated May 1, 2000; HQ 735146, dated November 15, 1993; HQ H267177, dated November 5, 2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated April 3, 2002. However, where the processing from bulk form into measured doses involves the combination of two or more active ingredients and the resulting combination offers additional medicinal benefits compared to taking each alone, CBP has held that a substantial transformation occurs. See, e.g., HQ 563207, dated June 1, 2005. For example, in HQ 563207, CBP held that the combination of two APls to form Actoplus Met, an alternative treatment for type 2 diabetes, constituted a substantial transformation. The first API, Pioglitazone HCI sourced from Japan or other countries, functioned as an insulin sensitizer that targets insulin resistance in the body. The second API, biguanide sourced from Japan, Spain, and other countries, functioned to decrease the amount of glucose produced by the liver and to make muscle tissue more sensitive to insulin so glucose can be absorbed. In Japan, the two APls were mixed together to form the Ectoplasm Met. In holding that a substantial transformation occurred when the two APl’s were combined, CBP emphasized that ‘‘[w]hile we note that pioglitazone and metformin may be prescribed separately, the final product, Actoplus Met, increases the individual effectiveness of piofliazone and metformin in treating type 2 diabetes patients.’’ Similarly, in HQ H253443, dated March 13, 2015, CSP held that the combination of two APls in China to produce Prepopik, ‘‘a dualacting osmotic and stimulant laxative bowel preparation for a colonoscopy in adults,’’ constituted a substantial transformation. CBP found that taking Prepopik had ‘‘a more stimulative laxative effect’’ than taking each of the APls individually. Further, in HQ H290684, dated July 2, 2018, CSP considered the country of origin of Malarone, a drug indicated for the prevention and treatment of acute, uncomplicated Plasmodium falciparum malaria. Two separate APls were E:\FR\FM\04SEN1.SGM 04SEN1 44896 Federal Register / Vol. 83, No. 171 / Tuesday, September 4, 2018 / Notices sradovich on DSK3GMQ082PROD with NOTICES mixed to create a fixed combination drug that offered additional medicinal benefits compared to taking each API alone. The first API, atovaquone, was not indicated for the prevention or treatment of malaria, the second API, proguanil hydrochloride, was used to treat malaria, but was less effective than Malarone. Because of the ‘‘synergies in [the APls’] method of action,’’ which resulted in a product that ‘‘interfere[s] with 2 different pathways’’ to prevent and treat malaria, CBP held that the combination of atovaquone, proguanil hydrochloride, and inactive ingredients to form the Malarone tablets in Canada resulted in a substantial transformation. In this case, to make the dietary supplement tablets, various ingredients from different countries of origin are mixed together based on a specific formula. This results in a finished product that differs from any of the individual ingredients. The vitamins and minerals are put together in one tablet for the purposes of creating a product that is designed to promote certain effects that are distinct from the effects if only the individual ingredients were taken. Similar to HQ H253443, the combination of the vitamins and minerals in a single tablet creates a product with a synergistic effect that promotes benefits that otherwise would only be possible by taking the individual ingredients separately. In other words, the combination of the various vitamins and minerals in one tablet results in a product that has an identity, character and use that is different from and more convenient to use than taking the individual raw materials. Accordingly, we find that the three Visionary dietary supplement tablets have a new name, character and use different from the individual vitamins, minerals, and the inert ingredients used in the production of the finished tablets. Therefore, we find that the country of origin of the Visionary Advanced 2 multiple vitamin and mineral dietary supplement tablets is the United States, where the manufacturing process take place. HOLDING: The country of origin of the Visionary Advanced 2 Coated Tablets, Visionary Orange Advanced 2 Chewable Tablets, and Visionary Cherry Advanced 2 Chewable Tablets for purpose of U.S. Government procurement is the United States. Notice of this final determination will be given in the Federal Register, as required by 19 C.F.R. § 177.29. Any party-at-interest other than the party which requested this final determination may request, pursuant to 19 C.F.R. § 177.31, that CBP reexamine the matter anew and issue a new final determination. Pursuant to 19 C.F.R. § 177.30, any party-at-interest may, within 30 days of publication of the Federal Register Notice referenced above, seek judicial review of this final determination before the Court of International Trade. Sincerely, Alice A. Kipel, Executive Director Regulations & Rulings Office of Trade [FR Doc. 2018–19162 Filed 8–31–18; 8:45 am] BILLING CODE P VerDate Sep<11>2014 17:54 Aug 31, 2018 Jkt 244001 INTER-AMERICAN FOUNDATION Sunshine Act Meetings September 6, 2018, 11:00 a.m.–12:00 p.m. PLACE: Via tele-conference hosted at Inter-American Foundation, 1331 Pennsylvania Ave. NW, Suite 1200, Washington, DC 20004. STATUS: Meeting of the Board of Directors, Open to the public. MATTERS TO BE CONSIDERED: • Commemorating the IAF’s 50th Anniversary FOR DIAL-IN INFORMATION CONTACT: Karen Vargas, Executive Assistant, (202) 524– 8869. CONTACT PERSON FOR MORE INFORMATION: Paul Zimmerman, General Counsel, (202) 683–7118. TIME AND DATE: Paul Zimmerman, General Counsel. [FR Doc. 2018–19190 Filed 8–30–18; 11:15 am] BILLING CODE 7025–01–P DEPARTMENT OF THE INTERIOR Bureau of Land Management [LLES930000.LLES1320000.EL0000] Notice of Competitive Coal Lease Sale ALES–55199, Alabama Bureau of Land Management, Interior. ACTION: Notice. AGENCY: Notice is hereby given that the coal resources in the lands described below in Jefferson County, Alabama, will be re-offered for competitive lease by sealed bid in accordance with the provisions of the Mineral Leasing Act of 1920, as amended. DATES: The coal lease sale will be held at 1 p.m. Central Daylight Time (CDT) on a date to be determined by the BLM Eastern States Deputy State Director, no sooner than October 4, 2018. Sealed bids must be received on or before 10 a.m. CDT on the date of sale. ADDRESSES: The date of the sale will be posted at https://www.blm.gov/easternstates. The lease sale will be held at the Bureau of Land Management (BLM) Southeastern States District Office located at 273 Market Street, Flowood, MS 39232. The Detailed Statement of Lease Sale, the proposed coal lease, and Casefile ALES–55199 are available at this address. Sealed bids must be submitted to the Cashier, BLM Southeastern States District Office, at this same address. FOR FURTHER INFORMATION CONTACT: Contact Randall Mills, BLM Mining SUMMARY: PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 Engineer, by telephone at 601–919– 4668, by email to ramills@blm.gov, or at the address indicated above. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1–800–877–8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours. SUPPLEMENTARY INFORMATION: This coal lease sale is being held in response to a lease by application (LBA) filed by Best Coal Company. The Federal coal reserves to be re-offered consist of all reserves recoverable by surface mining methods in the following described lands located approximately 5 miles north of Mt. Olive, Alabama, in Jefferson County, Alabama: Huntsville Meridian, Alabama T. 15 S, R. 4 W, Sec. 24, SW1⁄4NW1⁄4, N1⁄2SW1⁄4, and SE1⁄4SW1⁄4. The areas described aggregate 160.82 acres. The Narley Mine Coal Tract contains three minable coal beds known as the New Castle, Mary Lee, and Blue Creek seams of the Mary Lee coal group. The seams are under private surface lands. The minable thickness of these coal beds for this tract are approximately 4 to 5 feet. The tract contains approximately 469,000 tons of recoverable high-volatile bituminous coal. The estimated average coal quality on an ‘‘as received basis’’ is as follows: 12,500 ......... British Thermal Unit (Btu/lb). 3.50 ............. Percent moisture.* 12.00 ........... Percent ash. 34 ................ Percent volatile matter. 50.50 ........... Percent fixed carbon. 1.50 ............. Percent sulfur. * Estimated as received moisture; also used for calculating as received from dry basis. The tract will be leased to the qualified bidder of the highest cash amount, provided that the bid meets or exceeds the BLM’s estimate of the fair market value of the tract. The minimum bid established by regulation is $100 per acre or fraction thereof. The minimum bid is not intended to represent fair market value. The fair-market value will be determined by the authorized officer after the sale. The sealed bids should be sent by certified mail, return-receipt requested, or be hand delivered to the cashier, BLM Southeastern States District Office, at the address given above and clearly marked ‘‘Sealed Bid for ALES–55199 Coal Sale—Not to be opened before 1 p.m. CDT on (date of Sale), 2018.’’ The E:\FR\FM\04SEN1.SGM 04SEN1

Agencies

[Federal Register Volume 83, Number 171 (Tuesday, September 4, 2018)]
[Notices]
[Pages 44894-44896]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-19162]



[[Page 44894]]

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DEPARTMENT OF HOMELAND SECURITY

U.S. Customs and Border Protection


Notice of Issuance of Final Determination Concerning the 
Visionary Advanced 2 Dietary Supplement Tablets

AGENCY: U.S. Customs and Border Protection, Department of Homeland 
Security.

ACTION: Notice of final determination.

-----------------------------------------------------------------------

SUMMARY: This document provides notice that U.S. Customs and Border 
Protection (``CBP'') has issued a final determination concerning the 
country of origin of three Visionary Advanced 2 vitamin and mineral 
dietary supplement tablets. Based upon the facts presented, for 
purposes of U.S. Government procurement, CBP has concluded that the 
United States is the country of origin of the Advanced 2 vitamin and 
mineral dietary supplement tablets.

DATES: The final determination was issued on August 27, 2018. A copy of 
the final determination is attached. Any party-at-interest, as defined 
in 19 CFR 177.22(d), may seek judicial review of this final 
determination within October 4, 2018.

FOR FURTHER INFORMATION CONTACT: Robert Dinerstein, Valuation and 
Special Programs Branch, Regulations and Rulings, Office of Trade, at 
(202) 325-0132.

SUPPLEMENTARY INFORMATION: Notice is hereby given that on August 27, 
2018, pursuant to subpart B of part 177, U.S. Customs and Border 
Protection Regulations (19 CFR part 177, subpart B), CBP issued a final 
determination concerning the country of origin of three versions of the 
Visionary Advanced 2 vitamin and mineral dietary supplement tablets 
which may be offered to the U.S. Government under an undesignated 
government procurement contract. This final determination, HQ H299717, 
copy attached, was issued under procedures set forth at 19 CFR part 
177, subpart B, which implements Title Ill of the Trade Agreements Act 
of 1979, as amended (19 U.S.C. 2511-18). The three products are 
Visionary Advanced 2 coated tablets, Visionary Orange Advanced 2 
chewable tablets, and Visionary Cherry Advanced 2 chewable tablets. 
Each of the dietary supplement tablets contains the same basic formula 
of vitamins and minerals, but with different flavorings. In the final 
determination, CBP concluded that the combining of the various vitamins 
and minerals in one tablet in the United States results in a product 
that has a name, character and use that is distinct from the individual 
ingredients that are used to make the dietary supplement.
    Therefore, for purposes of U.S. Government procurement, the United 
States is the country of origin. Section 177.29, CBP Regulations (19 
CFR 177.29), provides that a notice of final determination shall be 
published in the Federal Register within 60 days of the date the final 
determination is issued. Section 177.30, CBP Regulations (19 CFR 
177.30), provides that any party-at-interest, as defined in 19 CFR 
177.22(d), may seek judicial review of a final determination within 30 
days of publication of such determination in the Federal Register.

    Dated: August 27, 2018.
Alice A. Kipel,
Executive Director, Regulations and Rulings, Office of Trade.

HQ H299717

August 27, 2018

OT:RR:CTF:VS H299717 RSD

CATEGORY: Origin

Mr. Marino Apollinari Visionary Vitamin Co. P.O. Box 1825 Dearborn, 
Michigan 48122

RE: U.S. Government Procurement; Country of Origin of Advanced 2 
Multiple Vitamin and Mineral Dietary Supplement Tablets; Substantial 
Transformation

Dear Mr. Apollinari:

    This is in response to the Visionary Vitamin Company's 
(Visionary's) request of June 4, 2018, for a final determination 
concerning the country of origin of products known as the Visionary 
Advanced 2 dietary supplements pursuant to subpart B of Part 177 of 
the U.S. Customs and Border protection (``CBP'') Regulations (19 
C.F.R. Part 177). The National Commodity Specialist Division 
forwarded your request to the Headquarters office of Regulations and 
Rulings to issue this final determination.
    As an importer, Visionary is a party-at-interest within the 
meaning of 19 C.F.R. Sec.  177.22(d)(1) and is entitled to request 
this final determination.

FACTS:

    Visionary is a manufacturer of dietary supplements. At issue are 
three different multiple vitamin and mineral dietary supplement 
tablets. The three dietary supplement tablets are the Advanced 2 
Coated tablets, the Visionary Orange Advanced 2 chewable tablets, 
and the Visionary Cherry Advanced 2 chewable tablets.
    The vitamin and mineral tablets contain the following raw 
materials:

------------------------------------------------------------------------
                                                   Country of origin
------------------------------------------------------------------------
Medicinal Ingredients:
    Vitamin C DC grade (Ascorbic Acid) (97%).  China.
    Vitamin E (As DL-Alpha Tocopherol          China.
     Acetate) 50%-Tab grad.
    Zinc (as oxide) (80.34%).................  India.
    Copper (as cupric oxide) (78.3%).........  USA.
    Lutein (5%) beadlets.....................  China.
    Zeaxanthin (5%) beadlets from Omnixan....  USA.
Other ingredients:
    DI Calcium Phosphate.....................  China.
    Micro crystalline Cellulose..............  India.
    Croscarmellose Sodium....................  Brazil.
    Silicon Dioxide..........................  USA.
    Magnesium Stearate (vegetable source)....  Spain.
    Stearic Acid Vegetable grade.............  Malaysia.
    Pharmaceutical Glaze (only used for        USA.
     coated tablets).
------------------------------------------------------------------------

    Instead of pharmaceutical glaze, the chewable orange and cherry 
tablets contain a natural masking flavor from the United States, 
either in a natural orange flavor or natural cherry flavor. In 
addition, the chewable cherry and orange tablets also incorporate 
sucralose from China. You have indicated that the most expensive 
single ingredient used in making the Advanced 2 dietary supplement 
tablets is the Zeaxanthin Omnixan from the United States.

[[Page 44895]]

    The manufacturing processes of the three products occurs at 
Visionary's facility in Michigan, United States. The same basic 
procedures are used to manufacture the three different dietary 
supplement tablets. A flow chart of the processes was submitted. The 
active and inactive ingredients in powder form are weighed and all 
vital information is logged in.
    Next, the ingredients are dispensed, and the dry mix is blended. 
A vibro sifter is used to pass the raw powder materials through a 
40-mesh screen, while being added to a drum for mixing. Weight and 
yield are recorded. Mixing and lubrication is performed by a 
blender.
    The approved blend is then transferred to the compression area. 
The blend is loaded into the hopper of a tablet press. The tablet 
press is set for the specified parameters and the details are noted 
in a start-up test during the tablet compression. The weight of the 
first few tablets is taken and checked against the actual weight of 
the product. Adjustments in the weight of the tablets are made until 
the right weight is obtained. The hardness of the tablets is also 
adjusted by carefully turning the pressure rollers by hand until the 
correct hardness is obtained. The tablets are then compared to 
previous samples. A series of in-process quality checks are 
performed in various intervals while the tablets are produced. These 
include: 1) appearance; 2) average weight per 10 tablets; 3) tablet 
thickness); 4) disintegration of tablet; 5) friability; 6) hardness; 
and 7) temperature and humidity.
    The coating solution is prepared by loading the tablets in a pan 
and recording the actual weight. The tablets are pre-heated until 
the temperature reaches 100 degrees Fahrenheit. The coating solution 
is sprayed on the tablets until all surfaces of the tablets are 
covered. The tablets are unloaded into trays and placed in an oven 
room for drying. The tablets are then sorted and damaged tablets 
(such as broken, color or thickness variance, capping issues, or 
black/foreign material) are rejected.
    Next, the product moves to the packaging line using the 
following equipment: an unscrambler, a conveyor, a tablet counter, a 
cottoner, a capper labeler, induction sealer, heat tunnel, printer 
coder, accumulation table and weighing balance. A system of quality 
controls occurs to ensure that the tablets are properly packaged, 
coded, and labeled.

ISSUE:

    What is the country of origin of the Visionary Advanced 2 Coated 
tablets, Visionary Orange Advanced 2 Chewable tablets, and Visionary 
Cherry Advanced 2 Chewable tablets for purposes of U.S. Government 
procurement?

LAW AND ANALYSIS:

    CBP issues country of origin advisory rulings and final 
determinations as to whether an article is or would be a product of 
a designated country or instrumentality for the purposes of granting 
waivers of certain ``Buy American'' restrictions in U.S. law or 
practice for products offered for sale to the U.S. Government, 
pursuant to subpart B of Part 177, 19 C.F.R. Sec.  177.21 et seq., 
which implements Title III of the Trade Agreements Act of 1979, as 
amended (19 U.S.C. Sec.  2511 et seq.) (``TAA'').
    Under the rule of origin set forth under 19 U.S.C. Sec.  
2518(4)(8):

An article is a product of a country or instrumentality only if (i) 
it is wholly the growth, product, or manufacture of that country or 
instrumentality, or (ii) in the case of an article which consists in 
whole or in part of materials from another country or 
instrumentality, it has been substantially transformed into a new 
and different article of commerce with a name, character, or use 
distinct from that of the article or articles from which it was so 
transformed.

See also 19 C.F.R. Sec.  177.22(a).
    In rendering advisory rulings and final determinations for 
purposes of U.S. Government procurement, CBP applies the provisions 
of subpart B of Part 177 consistent with Federal Acquisition 
Regulations. See 19 C.F.R. Sec.  177.21. In this regard, CBP 
recognizes that the Federal Acquisition Regulations restrict the 
U.S. Government's purchase of products to U.S.-made or designated 
country end products for acquisitions subject to the TAA. See 48 
C.F.R. Sec.  25.403(c)(1). The Federal Acquisition Regulations 
define ``U.S.-made end product'' as:
. . . an article that is mined, produced, or manufactured in the 
United States or that is substantially transformed in the United 
States into a new and different article of commerce with a name, 
character, or use distinct from that of the article or articles from 
which it was transformed.

48 C.F.R. Sec.  25.003.
    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. lnt'I Trade 1986).
    With respect to whether combining and mixing different materials 
results in a substantial transformation, CBP held in Headquarters 
Ruling Letter (``HQ'') 731685, dated March 15, 1990, that converting 
fruit concentrates and other ingredients into fruit drinks in Mexico 
constituted a substantial transformation. The manufacturing process 
involved mixing the juice concentrates with other ingredients 
including water, artificial flavor, sodium benzoate, and food 
coloring. CBP held that, considering the totality of the 
circumstances, a substantial transformation had occurred because 
``[t]he juice concentrates are subsumed into a product that is no 
longer considered a juice.'' This situation is distinguished from a 
situation considered in National Juice Products Ass'n v. United 
States, 628 F. Supp. 978 (Ct. lnt'I Trade 1986), in which the United 
States Court of International Trade (``CIT'') upheld CBP's decision 
in HQ 728557, dated September 4, 1985, that imported orange juice 
concentrate was not substantially transformed when it was mixed with 
water, essential oils, flavoring ingredients and domestic fresh 
juice in order to produce frozen concentrated orange juice and 
reconstituted orange juice. CBP found that the manufacturing process 
did not create an article with a new name, character or use. The CIT 
agreed that the manufacturing process did not change the 
``fundamental character of the product'' as ``it was still 
essentially the juice of oranges``. See HQ H237605 dated June 25, 
2014. In HQ 731685, a substantial transformation was found because 
the raw ingredients had been converted into a different article of 
commerce through a process beyond simple combining, packaging or 
mere diluting.
    In the context of the manufacture of chemical products such as 
pharmaceuticals, CBP has consistently examined the complexity of the 
processing and whether the final article retains the essential 
identity and character of the raw material. CBP has generally held 
that the processing of pharmaceutical products from bulk form into 
measured doses does not result in a substantial transformation. See, 
e.g., HQ 561975, dated April 3, 2002; HQ 561544, dated May 1, 2000; 
HQ 735146, dated November 15, 1993; HQ H267177, dated November 5, 
2016; HQ H233356, dated December 26, 2012; and, HQ 561975, dated 
April 3, 2002. However, where the processing from bulk form into 
measured doses involves the combination of two or more active 
ingredients and the resulting combination offers additional 
medicinal benefits compared to taking each alone, CBP has held that 
a substantial transformation occurs. See, e.g., HQ 563207, dated 
June 1, 2005.
    For example, in HQ 563207, CBP held that the combination of two 
APls to form Actoplus Met, an alternative treatment for type 2 
diabetes, constituted a substantial transformation. The first API, 
Pioglitazone HCI sourced from Japan or other countries, functioned 
as an insulin sensitizer that targets insulin resistance in the 
body. The second API, biguanide sourced from Japan, Spain, and other 
countries, functioned to decrease the amount of glucose produced by 
the liver and to make muscle tissue more sensitive to insulin so 
glucose can be absorbed. In Japan, the two APls were mixed together 
to form the Ectoplasm Met. In holding that a substantial 
transformation occurred when the two APl's were combined, CBP 
emphasized that ``[w]hile we note that pioglitazone and metformin 
may be prescribed separately, the final product, Actoplus Met, 
increases the individual effectiveness of piofliazone and metformin 
in treating type 2 diabetes patients.''
    Similarly, in HQ H253443, dated March 13, 2015, CSP held that 
the combination of two APls in China to produce Prepopik, ``a dual-
acting osmotic and stimulant laxative bowel preparation for a 
colonoscopy in adults,'' constituted a substantial transformation. 
CBP found that taking Prepopik had ``a more stimulative laxative 
effect'' than taking each of the APls individually. Further, in HQ 
H290684, dated July 2, 2018, CSP considered the country of origin of 
Malarone, a drug indicated for the prevention and treatment of 
acute, uncomplicated Plasmodium falciparum malaria. Two separate 
APls were

[[Page 44896]]

mixed to create a fixed combination drug that offered additional 
medicinal benefits compared to taking each API alone. The first API, 
atovaquone, was not indicated for the prevention or treatment of 
malaria, the second API, proguanil hydrochloride, was used to treat 
malaria, but was less effective than Malarone. Because of the 
``synergies in [the APls'] method of action,'' which resulted in a 
product that ``interfere[s] with 2 different pathways'' to prevent 
and treat malaria, CBP held that the combination of atovaquone, 
proguanil hydrochloride, and inactive ingredients to form the 
Malarone tablets in Canada resulted in a substantial transformation.
    In this case, to make the dietary supplement tablets, various 
ingredients from different countries of origin are mixed together 
based on a specific formula. This results in a finished product that 
differs from any of the individual ingredients. The vitamins and 
minerals are put together in one tablet for the purposes of creating 
a product that is designed to promote certain effects that are 
distinct from the effects if only the individual ingredients were 
taken. Similar to HQ H253443, the combination of the vitamins and 
minerals in a single tablet creates a product with a synergistic 
effect that promotes benefits that otherwise would only be possible 
by taking the individual ingredients separately. In other words, the 
combination of the various vitamins and minerals in one tablet 
results in a product that has an identity, character and use that is 
different from and more convenient to use than taking the individual 
raw materials. Accordingly, we find that the three Visionary dietary 
supplement tablets have a new name, character and use different from 
the individual vitamins, minerals, and the inert ingredients used in 
the production of the finished tablets. Therefore, we find that the 
country of origin of the Visionary Advanced 2 multiple vitamin and 
mineral dietary supplement tablets is the United States, where the 
manufacturing process take place.

HOLDING:

    The country of origin of the Visionary Advanced 2 Coated 
Tablets, Visionary Orange Advanced 2 Chewable Tablets, and Visionary 
Cherry Advanced 2 Chewable Tablets for purpose of U.S. Government 
procurement is the United States.
    Notice of this final determination will be given in the Federal 
Register, as required by 19 C.F.R. Sec.  177.29. Any party-at-
interest other than the party which requested this final 
determination may request, pursuant to 19 C.F.R. Sec.  177.31, that 
CBP reexamine the matter anew and issue a new final determination. 
Pursuant to 19 C.F.R. Sec.  177.30, any party-at-interest may, 
within 30 days of publication of the Federal Register Notice 
referenced above, seek judicial review of this final determination 
before the Court of International Trade.

Sincerely,

Alice A. Kipel, Executive Director Regulations & Rulings Office of 
Trade

[FR Doc. 2018-19162 Filed 8-31-18; 8:45 am]
 BILLING CODE P