Warner-Lambert Co. v. United States

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