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