Slip Op. 04 - 74
UNITED STATES COURT OF INTERNATIONAL TRADE
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _X
WARNER-LAMBERT COMPANY,
Plaintiff,
v. : Court No. 01-0O056
UNITED STATES,
Defendant.
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ x
Op`n`on
{Upon trial as to the classification of
HALLs »EFENSE"“ Vitamin C supplement Drops,
judgment for the defendant.]
Decided: June 21, 2004
Rode &`QualeV (Patrick D. Gill) for the plaintiff.
Peter D. Keisler, Assistant Attorney' General; Barbara S.
Williams, Attorney-in-Charge, International Trade Field Office,
Commercial Litigation Branch, Civil Division, U.S. Department of
Justice (Bruce N. Stratvert); and Office of Assistant Chief
Counsel, International Trade Litigation, U.S. Bureau of Customs and
Border Protection (Beth C. Brotman), of counsel, for the defendant.
AQUILINO, Judge: This action has been designated a test
case within the meaning of USCIT Rule 84(b). It contests revoca-
tion of U.S. Customs Service letter NY 832151 (Sept. 2l, 1988),
which ruled that "Halls vitamin C Drops" be classified under the
tariff schedules of the United States as medicamenti In HQ 958150
(April 7, l998), however, the Service, which is now known as Cus-
toms and Border Protection, U.S. Department of Homeland Security,
COUIt NO. 01-O0O56 Page 2
came to conclude that the British merchandise at bar as plaintiff's
trial exhibit 1, HALLsrmFENsnm vitamin C Supplement Drops, is sugar
confectionery, classifiable under heading 1704 of the Harmonized
Tariff Schedule of the United States ("HTSUS").
The subheading thereunder, 1704.90.35, pursuant to which
duties at rates of 6.l and 5.8 percent ad valorem Ihave been
collected, depending upon year of entry, appears in the HTSUS as
follows:
Sugar confectionery (including white choco-
late), not containing cocoa:
Chewing gum, whether or not sugar-
coated . . . . ... . . . . . . . . . . . . . . . . . . . . . . . ..
Other:
Confections or sweetmeats ready
for consumption:
Candied nuts . . . . . . . . . . . . . . ..
Other:
Cough drops . . . . . . . . . . ..
1'704.90.35 other . . . . . . . . . . . . . ..l.}
During the decade that letter NY 832151 ruled Customs,
the HTSUS had come to provide duty-free entry for Halls drops under
subheading 3004.50.50lO, to wit:
Medicaments . .. consisting of mixed or unmixed.products
for therapeutic or prophylactic uses, put up in measured
doses or in forms or packings for retail sale:
* * *k
Other medicaments containing vitamins or other
products of heading 2936:
Court No. 01-00056 Pag€ 3
Other:
Single vitamins:
Combined with minerals or
other nutrients . . . . . ..[.]
And the plaintiff prays for return to classification of its goods
thereunder.1
I
The court's jurisdiction is based upon 28 U.S.C. §§ 1581-
(a), 2631(a). Trial was conducted pursuant to a pretrial order
that set forth the following uncontested facts, among others:
2. . . . [T]he merchandise in issue . . . [is]
packaged in lozenge form [and] sold in . . . flavors
described as “ASSORTED CITRUS" and . . . as "STRAW-
BERRY". `
1 In doing so, the plaintiff abandons an alternative claim
that its drops are classifiable under HTSUS subheading 2936.27.00
("Vitamin C (Ascorbic acid) and its derivatives"). §eg Pretrial
Order, Schedule C, para. 17; Plaintiff's Proposed Findings of Fact
and Conclusions of Law {hereinafter referred to as "Plaintiff's
Brief"], p. 10.
The court notes in passing the absence of any claim herein
that the goods at issue are "Cough drops" within the meaning of
HTSUS subheading 1704.90.25, supra, because Additional U.S. Note 11
states that, for purposes of that subheading, such drops
must contain a minimum of 5 mg per dose of menthol, of
eucalyptol, or of a combination of menthol and euca-
lyptol[,]
which requirement is not met in this matter. See Pretrial Order,
Schedule C, paras. 3, 4, 12; and note 4, infra.
court No. 01-00056 § Page 4
3. The . . . ingredients in the assorted citrus
flavor [are] approximately as follows: Sugar 51.80%,
Glucose Syrup 44.20%, Sodiun1Ascorbate (vitamin C) 1.69%,
Citric Acid 1.83%, Natural flavors (orange, lemon, sweet
grapefruit & menthol) 0.26%, Asorbic [sic] Acid (vitamin
C) 0.22%, Colors (FD&C Red No. 40 and B-carotene) 0.01%.
4. The . . . ingredients in the strawberry flavor
[are] approximately as follows: Sugar 52.27%, Glucose
Syrup 44.57%, Sodium.Ascorbate (vitamin C) 1.69%, Citric
Acid 1.00%, Ascorbic Acid (vitamin C) 0.22%, Natural &
Artificial Flavors (strawberry & menthol) 0.21%, Colors
(Carmine) 0.04%.
5. Each . . . drop (lozenge) contains 60 milligrams
of vitamin C.
6. 60 milligrams is the current recommended daily
value of vitamin C as set by the United States Food and
Drug Administration
7. vitamin C prevents scurvy.
8. Scurvy is the disease caused by the lack of
vitamin C.
9. Human beings, unlike many other mammals, are
unable to make their own'vitamin C[] and therefore[] must
meet their vitamin C needs from external sources.
10. The vitamin CI in the imported Halls . .
drop[s], Sodium Ascorbate and Ascorbic Acid, is combined
with other nutrients; namely, sugar, glucose syrup and
citric acid.
11. vitamin C is an important part of daily
nutrition in that it maintains health and well being.
12. The average menthol content in the drops[] in
issue[] is 0.025 percent.
13. The merchandise[] in issue[] is a dietary sup-
plement, as defined by DSHEA [Dietary Supplement Health
and Education Act of 1994, Pub. L. No. 103-417] and FDA
regulations.
14. The molecular formula for ascorbic acid is
CJh05, and the molecular formula for sodium ascorbate is
csn,naoe .
Court No. 01-0O056 _ Pa9€ 5
15. The imported. product contains two forms of
vitamin C.
16. The imported merchandise is not marketed as
preventing or curing any disease.
Examination by the court of plaintifffs merchandise,
exhibit 1, shows it to be approximately three quarters of an inch
square by some three-and-one-half inches long, wrapped in such
manner as to display H'.ALLS DEFENSETM vitamin C supplement Drops on
contiguous side panels to the left of "100% Daily value of vitamin
C in each drop" and "9 DROPS", to the right of which references are
the words "ASSORTED CITRUS" and "ALL NATURAL FLAvORS" imprinted on
a green.banner superimposed upon what apparently are intended to be
likenesses of~a grapefruit, lemon and orange. A third side panel
specifies the ingredients of each, the name and address of its
corporate distributor, the country' of origin, and. a chart of
"Supplement Facts", including percentages of certain "Daily values"
in addition to vitamin C, The fourth wrapper panel is stamped with
a code number and a bar code plus the following prose:
Halls Defense vitamin C Supplement Drops help keep you
going, because each drop delivers 100% of the Daily value
of vitamin C. So now, your family can soothe their
throats with delicious, fruit flavored drops while
getting the vitamin C they need. Assorted Citrus Halls
Defense vitamin C Supplement Drops are available in the
following all natural flavors: Lemon, Sweet Grapefruit,
and Orange. `Assortment in each package may vary. 100%
Daily value of vitamin C in each drop.
In sum, the thrust of plaintiff's product, on its face, is that
Court No. 01-O0056 Page 6
vitamin2, which this court notices has been the subject of much
scientific ergo commercial discourse.
Based upon the record adduced herein, the court can find
that the availability of vitamin C in various forms and substances
has relegated one of the oldest nutritional disorders of mankind,
scurvy, to a low rung of medical concern. The same cannot be said
for many other, such concerns vis-a-vis vitamin C. Nonetheless,
studies have concluded that that vitamin may help forestall mala-
dies such as cancer, cardiovascular deterioration, cataracts, pul-
monary disease, although at least some of those studies have been
carried out in conjunction with vitamin E, making it difficult to
define the precise therapeutic or prophylactic properties of the C
vitamin itself. What is known, and was confirmed at the trial, is
that some oxygen is metabolized within the human body into "free
radicals" that are
highly reactive, toxic molecules, and the body has
evolved some endogenous, defensive mechanisms, enzymes,
to combat these toxic products but also relies very much
on dietary factors such as essential vitamins like . . .
C and . . . E . . . to combat the toxic effects of these
metabolites.
Tr., p. 15. In other words, vitamin C "functions physiologically
as a water-soluble antioxidant by virtue of its high reducing
power.“ Defendant's Exhibit A (Institute of Medicine, Dietary Ref-
2 At the trial, plaintiff's product manager characterized the
fact of 100 percent of the daily value of vitamin C as "a very
compelling claim from a consumer standpoint". Transcript ("Tr."),
p. 129. _s_ee_ generally _i_c_l. at 129-33. ‘
Court No. 01-00056 Page 7
erence Intakes (DRI) for ‘vitamin C, vitamin. E, Seleniunh and
Carotenoids), p. 95 (2000). This antioxidant property is the basis
of vitamin C's recommended dietary allowance ("RDA")3, which is the
dietary intake level that is sufficient to meet the
nutrient requirement of nearly all (97 to 98 percent)
healthy individuals in.a particular life stage and gender
group.
;Q. at 3. This allowance has not been set as a result of any
therapeutic or prophylactic properties. Compare Tr., pp. 78-79,
with iQ. at 119-21. In fact, the studies with regard thereto often
entail doses of vitamin C in excess of the RDA. See, g.g., ig. at_
84.
II
The Customs letter HQ 95815O that overruled the Service's
earlier ruling as to plaintiff's merchandise states in part:
In NY 832151, Customs classified.HvCDs in subheading
3004.50.5010, HTSUS, based upon the belief that vitamin
C imparted therapeutic or prophylactic character to the
merchandise. Additional research indicates that vitamin
C has not been shown in the U.S. to have substances which
imbue it with therapeutic or prophylactic properties or
uses. Therefore, HvCDs are not classifiable as medica-
ments of chapter 30, HTSUS, and NY 832151 must be re-
voked.
At its Eleventh Session on September 16, 1993, the
Harmonized System Committee . . . greatly limited the
list of ingredients which are considered to possess
"therapeutic or prophylactic" value. This change was
adopted in the form of two amendments to the ENs
3
ee, g.g., iQ. at 78-79; Defendant's Exhibit A, pp. 12, 95.
Court No. 01-00056 Page 8
[T]he vitamin C contained in HvCDs is akin to other
'common lozenge additives which seem to possess curative
properties, but do not satisfy the new, higher standard
for "therapeutic or prophylactic" goods.
Additionally, EN 30.04[] states . . . that:1
This heading includes pastilles, tablets,
drops, etc., of a kind suitable only for medi-
cinal purposes; such as those based on
sulphur, charcoal, sodium tetraborate, sodium
benzoate, potassium chlorate org magnesia.
However, preparations put up as throat pastil-
les or cough drops, consisting essentially of
sugars (whether or not with other foodstuffs
such as gelatin, starch or flour) and fla-
vouring agents (including substances having
medicinal properties, such as benzyl alcohol,
menthol, eucalyptol, and tolu balsam)
fall in heading 17.04.
Pastilles, tablets, or drops, suitable only for medicinal
purposes, are normally dispensed with a doctor's pre-
scription, or are only purchased with the intention of
curing an ailment. HvCDs are sold in a variety of stores
together with other sugar-confectionary products "over
the counter" without a prescription. Therefore, Customs
remains of the opinion that the merchandise is
classifiable in heading 1704, HTSUS.‘
4 Defendant's Exhibit T, p. 4 (boldface in original). "HvCDs"
and "EN" refer respectively to plaintiff's product and to Explana-
tory Note(s) to the HTSUS. This ruling letter further states:
The decision in NY 832151 was based on Customs
belief that HvCDs had therapeutic or prophylactic pro-
perties. Since this is not the case, the merchandise
cannot be classified in chapter 30, HTSUS. Likewise, the
presence of sugars, flavorings and.colorings renders them
ineligible for classification in chapter 29, HTSUS.
Therefore, HvCDs are classifiable as sugar confections of
chapter 17, HTSUS. The lack of menthol, eucalyptol, or
a combination thereof in the merchandise prevents its
classification in subheading 1704.90.25, HTSUS. Sugar-
based drops containing vitamin C, but no menthol or euca-
lyptol, are therefore classifiable in the basket pro-
vision, subheading 1704.90.35, HTSUS
Court No. 01-0O056 Page 9
A
A Customs ruling like the foregoing "is eligible to claim
respect according to its persuasiveness", United States v. Mead
Corp., 533 U.S. 218, 221 (2001), citing Skidmore v. Swift & Co.,
`323 U.S. 134 (1944), based on "the thoroughness evident in its
consideration, the validity of its reasoning, its consistency with
earlier and later pronouncements, and all those factors which give
it power to persuade, if lacking power to control." 323 U.S. at
140. Moreover, factual findings underlying a Customs classifica-
tion are presumed by 28 U.S.C. §2639(a)(1) to be correct5y thereby
placing the burden of proof upon the party protesting it. §§e,
§.g., Rollerblade, Inc. v. United States, 282 F.3d 1349, 1352 (Fed.
cir. 2o02).
Judicial review of a classification is a two-step process
in which the court determines the meaning of the relevant tariff
terms and whether the merchandise in question satisfies that
meaning. §.g., ig. at 1352, citing Sports GraphicsJ Inc. v. United
States, 24 F.3d 1352, 1391 (Fed.Cir. 1994). The General Rules of
Interpretation ("GRI") and the Additional U.S. Rules of Interpreta-
tion ("ARI") of the HTSUS are an element of this review process.
§ee, §.g., Carl Zeiss, Inc. v. United States, 195 F.3d 1375, 1379
(Fed.Cir. 1999). §§§ al§g Rollerblade, Inc. v. United States, 282
F.3d at 1351-52. Specifically, GRI 1 provides that "classification
5 See, g.g., Universal Electronics Inc. v. United States, 112
F.3d 488, 491-92 (Fed.Cir. l997).
Court No. 01-0O056 ` Page 10
shall be determined according to the terms of the headings and any
relative section or chapter notes". See, §.g., Orlando Food Corp.
v. United States, 140 F.3d 1437, 1440 (Fed.Cir. 1998). Further-'
more, a "use" provision, which "describ[es] articles by the manner
in which they are used as opposed to by name"‘, is guided by ARI 1-
(e) to the effect that
a tariff classification controlled by use (other than
actual use) is to be determined in accordance with the
use in the United States at, or immediately prior to, the
date of importation, of goods of that class or kind to
which the imported goods belong, and the controlling use
is the principal use[.]
§§g, §.g., Primal Lite, Inc. v. United States, 182 F.3d 1362, 1363
(Fed.Cir. 1999).
On its face, HTSUS heading 3004, `supra, is such a
provision. Q§. HQ 964673 (Feb. 4, 2002).
(1)
The use contemplated by that heading is "therapeutic or
prophylactic", the meaning of which this court must now determine.
§ge, e.g., Universal Electronics Inc. v. United States, 112 F.3d
488 (Fed.Cir. 1997):
. . Questions of law such as [the proper interpretation
of a particular tariff provision or term] lie within the
domain of the courts, for "[i]t is emphatically the
province and duty of the judicial department to say what
the law is."
6 Len-non Mfq. co. v. united States, 334 F.3d 13o4, 1308 (Fed.
cir. 2oo3).
court No. 01~00056 ` Page 11
112 F.ad et 492, quoting marbury v. Medison, 5 U.s. 137, 177
(1803). Absent a definition in the HTSUS, those terms are to be
defined according to their common meaning, provided that such
meaning is consistent with legislative intent. §g§, g.g., Lonza,
Inc. v. United States, 46 F.3d 1098, 1106 (Fed.Cir. 1995), citing
Nippon Kogaku §USA), Inc. v. United States , 69 CCPA 89, 92, 673
F.2d 380, 382 (1982). See also Schott optical Glass, Inc. v.
United States, 67 CCPA 32, 34, 612 `F.Zd 1283, l285 (19'79); §_§._L_:L
Zeiss, Inc. v. United States, 195 F.3d at 1379. To determine com-
mon meaning, the court "may consult dictionaries, lexicons,
scientific authorities, and other such reliable sources". Lonza,
Inc. v. United States, 46 F.3d at 1106, citing C.J. Tower & Sons of
Buffalo, Inc. v. United States, 69 CCPA 128, 133-34, 673 F.2d
1268, 1271 (1982).
The term "therapeutic" is defined in Stedman's Medical
Dictionary, page 1587 (25th ed. 1990), as "[r]elating to therapeu-
tics or to the treatment of disease". Webster's Third New lnter-
.national Dictionary Unabridged, page 2372 (1981), defines the term
as "of or relating to the treatment of disease or disorders by
remedial agents or methods: CURATIvE, MEDICINAL". Consistent with
these definitions, the court in Richards Medical Co. v. United
States, 13 cIT 519, 521, 720 F.supp. 998, 1000 (1989), _a_ii_§__'_<;, 910
F.2d 828 (Fed.Cir. 1990), for example, accepted therapeutic as
"having healing or curative powers".
Court No. 01-0O056 § Page 12
Stedman's Medical Dictionary, page 1268, defines "pro-
phylactic" as "1. Preventive; preventing disease; relating to
prophylaxis. 2. An agent that acts to prevent a disease." That
term is defined by Webster's Third New International Dictionary'Un~
abridged on page 1818 as "guarding from disease; preventing or
contributing to the prevention of disease".
The plaintiff contends that its drops have
prophylactic or therapeutic uses in the prevention or
cure of, inter alia, the following diseases: scurvy,
cancer, pulmonary and cardiovascular disease, cataracts,
diabetes, osteoporosis, periodontal disease, hyperten-
sion, reduction of mortality, and diseases and illnesses
associated with the reproductive function as well as the
cognitive and immune functions.
Pretrial Order, Schedule C-1, para. 2. In support, it relies
primarily on the opinion of its expert, the Associate Director of
the ;U.S. Department of Agriculture's Human. Nutrition Research
Center on Aging at Tufts University, Professor Jeffrey Blumberg,
Ph.D., F.A.C.N., C.N.S. lt produced at the trial both him and his
report(s) entitled Scientific Substantiation of the Benefits of
vitamin C on vitality and well-Being (Sept. 1998) and Scientific
Substantiation of the Benefits of vitamin C on vitality and Well-
Bein9[,] An'Update of the Scientific Literature (July 1998-December
2001) (Jan. 2002), received in evidence together as plaintiff's
exhibit 2.
The defendant challenges the epidemiological nature of
this analysis, its expert taking the position at trial that such
court No. 01-oo056 ` Page 13
an approach seeks "associations" and "cannot lead to a definition
of cause and effect".7 The defendant cites no law that stands for
7 Tr., p. 253. §§§ Defendant's Exhibit B [Report of Robert E.
Olson, M.D., Ph.D.], p. 17 ("I am not impressed with the results of
the epidemiologic data which Dr. Blumberg quotes since they
represent associations but not proof of cause and effect").
The plaintiff objected to admission into evidence of this
exhibit B. First, it argued that this report fails to comply with
USCIT Rule 26(a)(2)(B) in that the defendant was "required to
indicate the compensation paid to the Witness." Tr., p. 237.
Counsel also claimed that portions of the report are legal argument
and views that have little bearing on the scientific expertise of
Dr. Olson and thus violate the standards set forth in Daubert v.
Merrell Dow Pharmaceuticals, lnc., 509 U.S. 579 (1993). See id.;
Plaintiff's Brief, p. 8.
The court reserved decision. lt now concludes that plain-
tiff's second claim has merit; the first does not. USCIT Rule 37-
(c)(1) states:
A party that without substantial justification fails to
disclose information required by Rule 26(a) . . . is not,
unless such failure is harmless, permitted to use as
evidence y. . . any witness or information not so
disclosed.
while true that Dr. Olson's compensation is not disclosed in his
report, the plaintiff was notified thereof prior to its production.
§e§ Tr., p. 238. Thus, defendant‘s approach did not prejudice the
plaintiff and does not require exclusion of the report under the
foregoing rule. §gg, §.g., Norbrook Labs. Ltd. v. G.C. Hanford
Mfg. CO., 297 F.Supp.2d 463, 481 (N.D.N.Y. 2003) ("Fai1ure to
comply with the mandate of [Rule 371 is harmless when there is no
prejudice to the party entitled to the disclosure"), quoting Nguyen
V. IBP, InC., 162 F.R.D. 675, 680 (D.Kan. l995).
To accept testimony as expert, the court must find that it is
based on "scientific knowledge" and "will assist the trier - . . to
understand a fact in issue". Daubert v. Merrell Dow Pharma-
ceuticals, Inc., 509 U.S. at 589-90, 592. §g§ also Meister v. Med.
Eng'g COIQ., 267 F.3d 1123, 1126 (D,C.CiI. 2001); FedeIa1 RUle Of
Evidence 702 (2000): .
(footnote continued)
court No. 01-00056 Page 14
the proposition that evidence of cause and effect must be presented
in order to draw scientific conclusions, nor has the court found
If scientific, technical, or other specialized
knowledge will assist the trier of fact to understand the
evidence or to determine a fact in issue, a witness
qualified as an expert by knowledge, skill, experience,
training, or education, may testify thereto in the form
of an opinion or otherwise
The Court in Daubert stressed that "the adjective 'scientific' im-
plies a grounding in the methods and procedures of science". 509
U.S. at 589-90. Paragraphs 9-12 of defendant‘s exhibit B, which
characterize the history of this action and also the law, are
inadmissable as not within the scope of the scientific expertise of
Dr. Olson. §§g, g.g., wheeling Pittsburqh Steel Corp. v. Beelman
River Terminals, Inc., 254 F.3d 706, 715-16 (8th Cir. 2001):
Once initial expert qualifications and usefulness
. are established, . . . a [trial] court must
continue to perform its gatekeeping role by ensuring that
the actual testimony does not exceed the scope of the
expert's expertise, which if not done can render [the]
testimony unreliable under Rule 702, Kumho Tire, and re-
lated precedents.
In this action, an expert is to provide opinion that may be helpful
in determining the nature of the merchandise and any therapeutic or
prophylactic properties or uses. Attempted recital of the case
history, including an incorrect summary of the parties’ arguments
and an interpretation of the law, does not advance that objective.
While the plaintiff broadly invokes the "standards“ of
Daubert, the court need not delve into the reliability factors for
which that case stands. The inquiry here pertains to the scope of
expert testimony under Rule 702, supra, which "clear1y' con-
templates some degree of regulation of the subjects and theories
about which an expert may testify". 509 U.S. at 589. Finding that
paragraphs 9-12 of Dr. Olson's report must be disregarded, resort
to those factors is unnecessary. §§§, g.g., Libas Ltd. v. United
States, 193 F.3d 1361, 1367 (Fed.Cir. 1999):
There is no iron law that the Daubert factors be
applied in Customs classification cases. The Court of
International Trade obviously need not use them in every
case, or even in most such cases. These factors are
primarily applicable when the question involves a
technical process where the reliability of a scientific
or technical methodology has been raised as an issue.
Court No. 01-00056 . _ Page 15
any. 'While proof of cause and effect is an element of toxic tort
actions&, for example, it is not required in a matter like this.
Rather, the plaintiff at bar can overcome the presumption of
correctness with a preponderance of the evidence, "the greater
weight of evidence, evidence which is more convincing than the
evidence which is offered in opposition to it". St. Paul Fire &
Marine Ins. Co. v. United States, 6 F.3d 763, 769 (Fed.Cir. l993),
quoting Hale v. Dep't of Transportation, 772 F.2d 882, 885 (Fed.
Cir. 1985).
Scientific evidence need not be compelling, definitive,
conclusive, or cause-and-effect certain. In upholding an adminis-
trative decision to promulgate regulations reducing the lead
content in gasoline, for example, the court in Ethvl CorD~ v. EPA,
541 F.2d 1, 37-38 (D.C.Cir. 1976), Stated:
. [W]e need not seek a single dispositive study that
fully supports the Administrator's determination.
Science does not work that way . . .. [T]he Administra-
tor's decision may be fully supportable if it is based,
as it is, on the inconclusive but suggestive results of
numerous studies. By its nature, scientific evidence is
cumulative: the more supporting, albeit inconclusive,
evidence available, the more likely the accuracy of the
conclusion.
See also Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. at
590 ("it would be unreasonable to conclude that the subject of
scientific testimony must be 'known' to a certainty; arguably,
there are no certainties in science" (citations omitted)); Hodges
See, g.g., Raynor v. Merrell Pharmaceuticals Inc., 104 F.3d
1371 (D.C.Cir. l997).
Court No. 01-00056 1 Page 16
v. Sec'V Qf Dep‘t of Health & Human Services, 9 F.3d 958, 966-67
(Fed.Cir. 1993)("The statutory standard of a simple preponderance
of evidence precludes the imposition of the standard of scientific
certainty" (citation omitted)); LeFevre v. Sec'v, Dep't of vet-
erans Affairs, 66 F.3d 1191, 1199 (Fed.Cir. 1995)("The standard for
determining whether a positive association exists is whether the
'credible evidence' for the association equals or outweighs the
credible evidence against it"). Hence, to the extent that de-
fendant's expert is opining about the value of epidemiological
research to prove or disprove scientific theory, his criticism
misses the mark.
If, however, defendant‘s critical stance is not just
general disagreement, but derives from the standard. governing
heading 3004, it comes closer to the point. Though not exactly
cause and effect, this court understands that heading as requiring
that a substance have some recognizable "medicinal" impact. The
Explanatory Notes to heading 3004 state that
[t]hroat pastilles or cough drops containing substances
having medicinal properties . . . remain classified in
this heading . . . provided that the proportion of those
substances in each pastille or drop is such that they are
thereby given therapeutic or prophylactic uses.’
Though not binding, such notes are instructive with regard to
tariff provisions. §.g., Mita CoDVstar America v. United States,
21 F.3d 1079, 1082 (Fed.Cir. 1994), citing Lynteq, Inc. v. United
9 Emphasis in original. _The Explanatory Notes to heading
1704 complement those to 3004 with similar reasoning.
Court No. 01-00056 Page 17
States, 976 F.2d 693, 699 (Fed.Cir. 1992). The significance of a
connection between a dose and therapeutic or prophylactic proper-
ties also finds support in the body of the HTSUS itself. To be
classified in heading 3004, qualifying medicaments must be "put up
in measured doses or in forms or packings for retail sale". Again,
resort to the explanatory notes provides guidance and affirms the
importance of nmintaining the substances "ready for taking as
single doses for therapeutic or prophylactic use“ or, alterna-
tively, in a packing where because of the "presence of appropriate
indications (. . . statement of dose, etc. . . .) [the products]
are clearly intended . '. . for [therapeutic cmc prophylactic]
purposes."
In short, dosage cannot be separated from therapeutic or
prophylactic properties. A measured dose is not merely a certain
amount; it should contemplate an effect therefrom. Hence, the dose
must be viewed as a way to link the properties of a substance with
that effect. Here, the plaintiff must show that a specific
quantity of vitamin C, g.g., 60 ndlligrams per day, can help
prevent disease. lt would make little sense to classify a product
as a medicament merely because of a vitamin content without first
finding that that particular content could or does precipitate the
therapeutic or prophylactic properties contemplated 1qr heading
3004. Indeed, the use provision guards against that.
Court No. 01-0O056 Page 18
In this action, the role of vitamin C in treating and
preventing scurvy is uncontested. That that malady is of little
moment now in this land of fruits and imports does not diminish
that therapeutic and prophylactic phenomenon. As for the numerous
other diseases that are not yet under such control, at the trial
plaintiff's expert seemingly chose his words carefully, for ex-
ample: "there's a number of epidemiological studies showing . . ."
[cancer] Tr., p. 18; "there has been a remarkably consistent body
of evidence showing . . ." [cataracts] iQ. at 19; "there are a
number of studies. . ." [pulmonary disease and function] id. at 23;
"there actually have been a number of clinical trials showing"
[hypertensionJ id. at 21. This stands in contrast to other
qualified language to describe the strength of studies examining
other diseases, §.g., the evidence is "not so direct" [diabetes]
id. at 20; there were "really just a few studies" [mortality] id.;
"a very limited number of studies" [bone health] id. at 22.
On his part, defendant‘s expert generally sought to
disagree that vitamin C has therapeutic or prophylactic prop-
erties“, but without conclusive success. In fact, defendant‘s own
exhibit A, the Institute of Medicine's Dietary Reference Intakes
q m Dr. Olson testified, for example, that the evidence con-
cerning vitamin C's therapeutic or prophylactic properties is
"unproven", that he was "not impressed with the results of the
epidemiologic data which Dr. Blumberg quotes", and that he “disa-
gree[s] that the data available permit[Dr. Blumberg']s con-
clusion". Tr., p. 211; Defendant's Exhibit B, pp. 17-18.
Court No. 01-00056 Page 19
(DRI) for vitamin C etc., supports the view that studies examining
cardiovascular disease, cancer, cataracts, and asthma and
obstructive pulmonary disease "suggest a protective effect of vita-
min C"F‘ Affirming this view, Dr. Olson himself conceded that
plaintiff's studies were "suggestive"” and thus compatible with the
standard enunciated hereinabove.
Whatever the evidence as to vitamin C per se, the issue
herein is whether goods containing that vitamin, but mostly sugar
and glucose syrup, have therapeutic or prophylactic properties.
The defendant argues that, of
the 107 publications cited by Dr. Blumberg, only 49
employ only vitamin C2 as the agent for study. The
majority of the papers 58 (54%) involve other antioxi-
dants in addition to vitamin C (vitamin E, carotinoids
and selenium).
Defendant's Exhibit B, p. 16. See also Tr., p. 60. In addition,
the defendant points out that many of the studies focus on quanti-
ties of vitamin C that far exceeded the amount found in the Halls
drops, See id. 84.
“ Defendant's Exhibit A, pp. 122, 125-26. The Institute of
Medicine was unable to reach that point for any of the cmher
chronic diseases under study.
12 Tr., p. 260=
. I will say the whole field . . . put forth by the
Plaintiff is suggestive data not compelling data. It is
suggestive, but it has not stood the test of scientific
rigor that requires that it be tested experimentally and
in clinical studies, and it yields such positive results
that it is compelling.
Court No. 01-00056 . Page 20
This court's understanding of HTSUS heading 3004 is that
there must be a connection between a dosage and any therapeutic or
prophylactic effect therefrom. ATo this end, and thus to link the
properties of vitamin C in the abstract with those of the drops at
issue, the plaintiff relies on the fact that each contains 100
percent of the daily value. But that value is not shown on the
record developed to cure or prevent disease other than scurvy. The
facts, as presented on both sides, simply do not support a grander
finding. The Food and Nutrition Board, which helps set the RDA“,
found that even the studies suggestive of an association between
vitamin. C and 1therapeutic or' prophylactic properties were `of
limited utility in the derivation of an appropriate vitamin C
intake level because,
[a]lthough many of the [] studies suggest a protective
effect of vitamin C . . ., the data are not consistent or
specific enough to estimate a vitamin C requirement
Defendant's Exhibit A, pp. 122, 125-126. Plaintiff's expert
confirmed this inability to link a particular dose with a thera-
peutic or prophylactic effect:
” Though not interchangeable, the terms daily value and rec-
ommended dietary allowance are both relevant to the facts of this
action, while that allowance sets an intake level for a particular
life stage and gender group, the daily value averages levels. In
addition, reference is made to the DRI, which are the focus of
defendant‘s exhibit A. This approach provides a new method for
quantitative estimates of nutrient intakes, which include the
Recommended Dietary Allowance, in addition to the Adequate Intake,
the Tolerable Upper Intake Level, and the Estimated .Average
Requirement. §§§ Defendant's Exhibit A.
court No. 01-00056 ' page 21
what I'm merely saying is that the scientific
studies show that there is an association of benefit from
increasing vitamin C intakes.
[T]here's a benefit for vitamin C, but I am unable,
as was the Food and Nutrition Board, . . . to make a
quantitative decision on what the dose would be. Part of
that is the challenge that there are a lot of different
diseases, and it's very likely that the doses needed in
each case might be different.
Tr., p. 119.
(2) _
he this inability as it is, were this court to find
plaintiff's product to be a medicament (at least because of
scurvy), the issue remains whether or not that is its principal
`llS€ 2
The purpose of "principal use“ provisions in the
'HTSUS is to classify particular merchandise according to
the ordinary use of such merchandise
Primal Lite, Inc. v. United States, 182 F.3d 1362, 1364 (Fed.Cir.
1999). That has been defined as the “predominant use, rather than
simply one possible use"“ and the "use which exceeds any other
single use". Lenox Collections v. United States, 20 CIT 194, 196
(1996) (italics in original). The Explanatory Notes to heading 3004
suggest an even more stringent standard. They state that "heading
[3004] includes pastilles, tablets, drops, etc., of a kind suitable
only for medicinal purposes" (emphasis in original).
14
Len-Ron Mfq. Co. v. United States, 334 F.3d 1304, 1311
(Fed.Cir. 2003).
Court No. 01-0O056 Page 22
whatever the definition, the plaintiff has failed to bear
its burden. The following factors have been considered to
ascertain the nature of goods:
(1) the general physical characteristics of the merchan-
dise; (2) the expectation of the ultimate purchasers; (3)
the channels, class or kind of trade in which the
merchandise moves; (4) the environment of the sale (i.e.,
accompanying accessories and the manner in which the
merchandise is advertised and displayed); (5) usage, if
any, in the same manner as merchandise which defines the
class; (6) the economic practicality of so using the
import; and (7) the recognition in the trade of the use,
Minnetonka Brands, Inc. v. United States, 24 CIT 645, 651-52, 110
F. Supp. 2d 1020, 1027 (2000), citing United States v. Carborundum
Qg., 63 CCPA 98, 102, 536 F.2d 373, 377 (1976). The plaintiff did
not offer evidence as to five of them, namely, those numbered (2),
(3), (5), (6) and (7).“ Rather, it relied almost exclusively on
the labelling and marketing of the drops within the ambit of factor
number four.“
§ In fact, the only evidence as to this last factor was of-
fered by the defendant, namely, a manufacturer‘s invoice for an
entry at issue in this action referring to the goods as “vIT C
confectionary". Tr., p. 150. §ee id. at 150-54.
Although invoice descriptions are not controlling for classi-
fication purposes, they are "evidence which can aid the Court in
reaching the proper classification." North.American Processing Co.
v. United States, 22 CIT 55, 58 (1998), citing Peterson Electro
Musical Products v. United States, 7 CIT 293, 295 (1984)(they "are
evidence of what the parties, and presumably, the commercial world,
consider the merchandise to be").
16 Although the general physical characteristic of the mer-
chandise, its lozenge form, is consistent with classification as a
medicament, that configuration does not foreclose other intake.
Court No. 01-00056 Page 23
As described in part I above, in addition to vitamin C,
the packaging of plaintiff's product, exhibit 1, refers to "help
keep you going", to the ability to soothe throats, and to all
natural fruit flavors. Given these messages, plaintiff's product
manager testified that the product is not marketed with any use in
mind, leaving that decision to the consumer:
Q when you market this product to the consumer, do
you leave it to the consumer to decide what benefits he
or she wants from the product? »
A Absolute1y.
Q Do you let the consumer decide rather than push-
ing a specific remedy yourself?
A Yes, we do, and the reason we do is to create the
most ubiquitous appeal. By pigeon-holing ourselves into
different areas, it just doesn't make sense. It makes
more sense in terms of trying to sell the most product to
allow consumers to decide for themselves why they want
vitamin C. we just kind of really market this as vitamin
C and allow them to decide why they want it.
Tr., p. 133.
The court must decide whether this approach, combined_
with the words and symbols on the drops package, circumscribe a
medicament for use to treat or prevent at least scurvy. It cannot
do so, Even if the court were to find that the Halls lozenges are
marketed as vitamin C, it could not, without more, interpret that
to mean that they are principally for therapeutic and prophylactic
use -- to treat or prevent disease. To so decide on this record
,court No. 01-00056 ` Page 24
would be to find that vitamin C has become synonymous with such
use. Neither the record nor the reference to 100 percent of the
daily value of vitamin C establishes such synonymity. Moreover,
_while the better-educated consumer might understand the signifi-
cance of that value, such individual understanding itself could not
constitute principal use.
The other package references provide different indica-
tions of use. First, the soothing of throats is not derived from
the vitamin C. See, e.g., Tr., pp. 89-90 ("Most likely vitamin C_
contributes little to nothing to the throat-soothing properties of
the lozenge"). Rather, that phenomenon is due to the sugar
content. §§e i_. at 89, Hence, the packaging of the drops clearly
encourages a use of the merchandise not founded on their vitamin C
and that has no connection to any therapeutic or prophylactic
properties associated therewith.
Second, to "help keep you going" is too vague to project
any particular, principal use. while that kind of assistance might
derive from the intake of vitamin C in some way, such sensation
would understandably be outside the parameters of "therapeutic or
prophylactic" as defined by the Explanatory Notes to heading 3004:
[T]his heading excludes food supplements containing
vitamins or mineral salts which. are put up for the
purpose of maintaining health or well-being but have no
indication as to use for the prevention or treatment of
any disease or ailment.
Court No. 01-0O056 Page 25
Emphasis in original. On this point, the court concurs with the
position articulated by Customs in HQ 964188 (April 3, 2002):
Although no clear criteria is [sic] provided in
either the tariff text or the ENs to differentiate
products which are medicinal preparations from those
which are designed to maintain general health and well-
being, there is a definite distinction.made between them.
This is supported by H. Reisman Corp. v. United States, 17 CIT
1260 (1993), appeal dismissedq 39 F.3d 1195 (Fed.Cir. 1994),
wherein the court concluded that a substance for mixing vitamin B-
12 into animal feed is not a medicament for purposes of heading
3003.90.00, finding that
the merchandise is not used in a therapeutic or prophy-
lactic manner beyond the purposes provided by any
nutrient, including ordinary grain food or food of any
kind. `
Another explanatory note with regard to HTSUS heading 3004 states:
On the other hand, the heading covers preparations
in which the foodstuff or the beverage merely serves as
a support, vehicle or sweetening agent for the medicinal
substances
_f. Tr., pp. 39-40. Before concluding that the Halls drop is a
vehicle for vitamin C's therapeutic or prophylactic properties,
however, it must have been proven that the product's principal use
is for its vitamin C content and for the properties associated
therewith. This, the plaintiff has failed to do.
Court No. 01-0O056 ‘ ` Page 26
Third, drawing attention to taste and flavor also tends
to expand the use of the drops more than the reference to vitamin
C content might tend to limit it. Of course, the goods can be
"delicious" or "fruit flavored", but, absent record evidence of
principal use for therapeutic or' prophylactic purposes, those
references distend plaintiff's preferred finding. That is, if the
packaging were permitted to, and did in fact, refer to scurvy, with
indication of treatment or prevention thereof, then references to
gustatory sense could more easily be considered as ancillary.
Here, however, Halls consumers have packaged, printed
inducements that do not pinpoint classification under HTSUS heading
3004, g.g., ingest the lozenges for the vitamin C, but not as that
substance relates to therapeutic or prophylactic properties; soothe
thy self for reasons not associated with that vitamin; or swallow
the drops for reasons not yet substantiated by science or proven in
this test case.
III
In conclusion, many substances have medicinal properties .
Not all of them, however, are medicaments within the meaning of
heading 3004. Here, the plaintiff has failed to satisfy its burden
of proving that the principal use of its Halls drops corresponds to
their therapeutic or prophylactic properties vis-a-vis scurvy or
any other disease. Absent a record that classification under HTSUS
heading 3004 is compelled by a preponderance of evidence adduced
Court No. 01-0O056 _ 3 Page 27
thereon, this court concurs that the HTSUS "basket provision",
subheading 1704 . 90 . 35 , is where the nALLs :JEFENSE'”" vitamin C Supple-
ment Drops must and do land. Judgment will enter accordingly.
Decided: New York, New York
June 21, 2004
/S/ Thomas J. Aqui1in0, Jr
judge