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Nature of Suit Code: 620
Nature of Suit: Forfeiture and Penalty - Food and Drug Acts
Cause of Action: 

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PUBLISH 

Ji' 1 .L i.i; D 

Unltml fnlltQ.n CauM u! Ap~slEJ Tenth Clren.it ·· · 

IN THE UNITED STATES COURT OF APPEALS MAR 3 1 1994 

FOR THE TENTH CIRCUIT 

UNITED STATES OF AMERICA, 

Plaintiff-Appellant, 

v. 

UNDETERMINED QUANTITIES OF BOTTLES 

OF AN ARTICLE OF VETERINARY DRUG 

LABELED IN PART: "PETS SMELLFREE" 

OR "FRESH PET," AND THOSE CONTAINING 

CHLORTETRACYCLINE, 

Defendant-Appellee, 

PETS SMELLFREE, INC., 

Claimant-Appellee. 

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ROBERT L. HOECKER 

C!e:-k 

No. 91-4197 

APPEAL FROM THE UNITED STATES DISTRICT COURT 

FOR THE DISTRICT OF UTAH 

(D.C. No. 89-C-594 G) 

Deborah S. Smolover, United States Department of Justice, Civil 

Division, Appellate Staff, Washington, D.C. (Stuart M. Gerson, 

Assistant Attorney General, David J. Jordan, united States 

Attorney, Douglas N. Letter, Appellate Litigation Counsel, Leon F. 

Szeptycki, Attorney, Civil Division, United States Department of 

Justice, Washington, D.C.; and Margaret Jane Porter, Chief 

Counsel, Denise M. Zavagno, Associate Chief Counsel, Food and Drug 

Administration, Rockville, Maryland, were on the brief), for 

Plaintiff-Appellant. 

George K. Fadel, Bountiful, Utah, for Defendant-Claimant-Appellee. 

Before EBEL and HOLLOWAY, Circuit Judges, and COOK,* District 

Judge. 

HOLLOWAY, Circuit Judge. 

* The Honorable H. Dale Cook, United States District Judge for the 

Northern District of Oklahoma, sitting by designation. 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 1 
This case requires us to decide whether a compound sold as an 

internal pet "deodorant," whose only active ingredient is the 

antibiotic chlortetracycline, is a "drug" as defined by the 

Federal Food, Drug, and Cosmetic Act ("FDCA" or the Act), 21 

U.S.C. §§ 301, et seq. The United States brought this appeal from 

a grant of summary judgment to the defendant-claimant-appellee, 

Pets Smellfree, Inc. ("PSF"). 

I 

Pets Smellfree ("Smellfree") is a food additive for animals 

which purports to diminish pet odors. Its only active ingredient 

is chlortetracycline calcium complex ("CTC"), an antibiotic 

compound. Smellfree was advertised as being able to stop pet 

odors associated with feces, urine, gas, and bad breath. Such 

odors are typically caused by bacteria. In this in rem action, 

the government seeks the seizure, condemnation, and destruction of 

all existing Smellfree and an injunction against its further 

production pursuant to the FDCA on the ground that Smellfree is an 

adulterated and misbranded drug. 1 

A product is considered adulterated if.it is an unapproved 

new animal drug and misbranded if the company has not registered 

its facility and the drugs it produces with the Food and Drug 

Administration ("FDA") . The controlling issue before us is 

whether Smellfree is a drug because it is "intended for use in the 

diagnosis, cure, mitigation, treatment, or prevention of disease 

1 

The district court had jurisdiction under 21 U.S.C. § 334 and 

28 U.S.C. § 1345. Our appellate jurisdiction is granted by 28 

u.s.c. § 1291. 

2 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 2 
in man or other animals," or is an article "intended to affect the 

structure or any function of the body of man or other animals." 

21 U.S.C. § 321(g) (1) (B), (C). 

On cross-motions for summary 

granted summary judgment for 

motion and dismissed its action. 

judgment, the district judge 

PSF and denied the government's 

The judge found the labeling, 

advertising and promotional materials showed no objective intent 

to treat disease in animals; the product was not intended for 

such use. Even though PSF may assist the animal in prevention of 

disease in its mouth, that alone is insufficient to classify PSF 

as a drug under § 321(g) (1) (B). Memorandum Opinion and Order at 

7. 

The judge also found error in the FDA determination that PSF 

is an article intended to alter the structure or function of the 

animal; the agency action was not a permissible construction of 

the statute. There is no demonstrated intent literally to change 

the physical structure or function of the animal's body, and 

bacteria are not part of its body or structure. Thus, PSF was not 

intended to change the structure or function of animals within the 

meaning of § 321(g) (1) (C). Id. at 7-8. Finally, the judge held 

that the small amounts of chlortetracycline calcium complex (CTC) 

contained in PSF, a mere subtherapeu~ic dose, does not demonstrate 

an intent to treat disease under § 321(g) (1) (B). 

After the district judge entered judgment, the government 

filed a motion for reconsideration, which was denied. The 

government filed a timely notice of appeal which only purported to 

appeal the denial of its motion for reconsideration. Later the 

3 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 3 
government filed an amended notice of appeal challenging both the 

denial of its motion for reconsideration and the grant of PSF's 

motion for summary judgment. 

II 

We review a grant of summary judgment de novo. See Applied 

Genetics, Inc. v. First Affiliated Securities, Inc., 912 F.2d 

1238, 1241 (lOth Cir. 1990). In so doing, we examine the record 

to see whether there were any genuine issues of material fact and, 

if not, whether the district court correctly applied the 

substantive law. See id. 

look at the record in the 

When we review the summary judgment, we 

light most favorable to the party 

Adolph Coors Co. v. Brady, 944 F.2d 

Moreover, summary judgment must be 

opposing the motion. See 

1543, 1546 (lOth Cir. 1991). 

granted when the evidence before the district court demonstrates 

that the standard of Fed. R. Civ. P. 56 has been met. See Celotex 

Co~. v. Catrett, 477 U.S. 317, 322-23 (1986). 

A. 

The central question presented by this appeal is whether 

Smellfree is a drug under 21 U.S.C. § 32l(g) (1). For reasons that 

follow, we hold that it is. Accordingly, we must reverse the 

district court's grant of summary judgment to PSF and we remand 

the case for the entry of summary judgment in favor of the 

government. 

PSF produced Smellfree in batches of 70 pounds at a time. 

See Declaration of Lloyd W. Beaston ,r 8, R. at 73. To make one 70 

pound batch, PSF mixed one 50 pound package of CtC-50 

chlortetracycline premix with 20 pounds of "other" inactive 

4 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 4 
ingredients. See id. ,,,, 7-8, R. at 72-73. CtC-50 is an 

11 antibacterial feed premix for use in the manufacture of feeds 11 

which contains so grams of CTC per pound. See R. at 186-90 

(manufacturer's description and directions for use). Therefore, 

each pound of Smellfree made in this way contained approximately 

35.7 grams of CTC, so that Smellfree consists of approximately 

7.6% - 7.7% CTC, while the remainder of its ingredients are 

. t' 2 1nac 1ve. See Beaston Declaration Ex. 21, R. at 103, Beaston 

Declaration Ex. 17, R. at 96. 

It was uncontested below that the pet odors which Smellfree 

is claimed to alleviate are usually caused by bacterial 

contamination. See Declaration of Mukund R. Parkhie, D.V.M., 

M.S., Ph.D. ,, 7, R. at 55. It is also uncontested that the sole 

function of CTC is to kill susceptible bacteria. See Physicians' 

Desk Reference 1222 (47th ed. 1993); Affidavit of Stanley Marcus, 

Ph.D. ,, 12, R. at 162 (Smellfree 11 reduce[s] the number of bacteria 

in the digestive systems and oral cavities of pets"); Affidavit 

of Thomas H. Jukes, Ph.D. ,, 8, R. at 195 ( 11 Subtherapeutic doses of 

[CTC] can be effective in the modification of bacteria in the 

digestive tract of animals. This modification is accompanied by a 

lessening in the incidence of subacute intestinal infections. 11 ) 

2 

The fact that the active ingredient of Smellfree comprises 

less than 10% of the product is irrelevant. In fact, 11 [t]he 

active ingredients in most prescription drugs constitute less than 

10% of the product. 11 United States v. Generix Drug Co:r:p., 460 

U.S. 453, 454 (1983). Under the Act, the term 11 drug 11 does not 

refer merely to the active ingredient in a drug product, but to 

the entire product. 

5 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 5 
21 U.S.C. § 321(g) (1) defines 11 drugsn as: 

(A) articles recognized in the official United States 

Pharmacopoeia, official Homoeopathic Pharmacopoeia of 

the United States, or official National Formulary, or 

any supplement to any of them; and (B) articles 

intended for use in the diagnosis, cure, mitigation, 

treatment, or prevention of disease in man or other 

animals; and (C) articles (other than food) intended to 

affect the structure or any function of the body of man 

or other animals. 

The government relies on§ 321{g) (1) (B) and (C) in arguing 

for reversal in the instant case. Its brief states that the 

issues presented here are whether the product Pets Smellfree is a 

drug under 21 U.S.C. § 321(g) (1) (B) or (C). Brief of Appellant 

United States of America at 2, 10-11. The complaint below alleged 

that Pets Smellfree was an adulterated and misbranded animal drug 

under the Act. Any new animal drug must be the subject of a new 

animal drug application, and reviewed and approved by the FDA, or 

be exempt from the filing requirement before it may be shipped in 

interstate commerce. Any unapproved new animal drug is deemed 

unsafe and adulterated. 21 U.S.C. § 360b{a) (1) and 

§ 351(a) (5). Moreover, a drug is misbranded, inter alia, if it is 

manufactured, etc., in any establishment not registered under 21 

U.S.C. § 360. See 21 U.S.C. § 352(o). 

In reviewing the FDA's determination that Smellfree is a 

drug, we must be guided by the directives regarding judicial 

review of administrative agency interpretations of their organic 

statutes laid down by the Supreme Court in Chevron U.S.A. Inc. v. 

Natural Resources Defense Council, Inc., 467 u.s. 837 (1984). 

Those directives require that we first determine whether Congress 

has directly spoken to the precise question at issue. If the 

6 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 6 
congressional intent is clear, we must give effect to that intent. 

If the statute is silent or ambiguous on that specific issue, we 

must determine whether the agency's answer is based on a 

permissible construction of the statute. See 467 U.S. at 842-43; 

N.L.R.B. v. Viola Industries- Elevator Div .. Inc., 979 F.2d 1384, 

1393 (lOth Cir. 1992) (en bane). Remedial legislation such as the 

Food, Drug, and Cosmetic Act is to be given a liberal construction 

consistent with the Act's overriding purpose to protect the public 

health. United States v. An Article of Drug Bacto-Unidisk, 394 

u.s. 784, 798 (1969). 

With this general framework about the facts, the issues and 

our review in mind, we turn to the specific contentions of the 

parties on the issues presented under § 321(g) (1) (B) and (C) .

3 

B. 

PSF argues that the district judge properly ruled that 

Smellfree was not intended to cure, mitigate or prevent disease. 

3 

Our decision is based on subsections (B) and (C) , and not on 

subsection (A) and the fact that CTC is listed in the United 

States Pharmacopoeia at 298-301 (XXII ed. 1990) . It has been said 

that because the Pharmacopoeia lists such a broad range of 

chemicals (many of which, like salt and water, are not drugs in 

all their forms) , the mere fact of such listing should not be 

dispositive that such chemicals are drugs under the Act. See. ~, National Nutritional Foods Ass'n. v. Mathews, 557 F.2d 325, 

337 & n.ll (2d Cir. 1977). But see United States v. Dianovin 

Pharmaceuticals. Inc., 342 F. Supp. 724, 728 (D.P.R. 1971), aff'd 

475 F.2d 100 (1st Cir.), cert. denied, 414 U.S. 830 (1973); 

United States v. Articles of Drug. etc., 263 F. Supp. 212, 215 

(D. Neb. 1967). Such listing in the Pharmacopoeia has been 

treated as some evidence that the substance is a drug under the 

Act. See AMP. Inc. v. Gardner, 275 F. Supp. 410, 414 (S.D.N.Y. 

1967), aff'd 389 F.2d 825 (2d Cir.), cert. denied, 393 U.S. 825 

(1968). 

7 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 7 
PSF cites the following statement from the judge's Memorandum 

Decision and Order at 9: 

3. Presence of small amounts of the antibiotic 

CTC in PSF 

Notwithstanding 

asserts that because 

compound containing 

classified as a drug 

Subsection (C) . 

the above, the United States 

CTC is a classified antibiotic, any 

CTC in any concentration must be 

under either Subsection (B) or 

Under Subsection (B) , the court agrees that the 

presence of CTC is [sic] PSF in some limited way may be 

used to treat or prevent disease. However, when a drug 

is only a small part of an article and constitutes a 

mere sub-therapeutic dose, the presence of the drug does 

not by itself demonstrate objective intent to treat 

disease. This court finds that the non-therapeutic uses 

outweigh the therapeutic uses of the article and that 

the presence of CTC under the totality of the 

circumstances does not demonstrate an intent to treat 

disease under §321(g) (1) (B). (emphasis in original). 

Essentially, PSF argues that the dosage of CTC contained in 

Smellfree is too small to have any therapeutic action, i.e. it is 

"subtherapeutic," and therefore Smellfree cannot be classified as 

a drug. We cannot agree. 

The fact that a drug is given in subtherapeutic doses does 

not prevent its being classed as a drug under the Act. It has 

been noted that "[s]ubtherapeutic, long-term application of 

antibiotics in animals is usually intended to promote faster 

growth, improve feeding efficiency, and limit disease outbreaks." 

See United States v. An Article of Drug Consisting of 4,680 Pails, 

725 F.2d 976, 988 n.27 (5th Cir. 1984) (emphasis added). Here it 

was stated by Dr. Parkhie that "[a] subtherapeutic dose of CTC can 

be used to prevent diseases in animals. Likewise, a 

subtherapeutic dose could cure, treat or mitigate a subclinical 

8 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 8 
disease, a mild disease which has not yet produced any signs or 

4 symptoms. 11 Affidavit of Dr. Parkhie at 5, R. at 219. 

On the other hand, we note that PSF's consultant, Dr. 

Marcus, 5 stated that because 11 each prescribed dosage of Pets 

Smellfree contains less than the minimum therapeutic dosage of 

chlortetracycline for dogs and cats, Pets Smellfree contains 

11 sub-therapeutic' dosages of chlortetracycline. A sub-therapeutic 

dosage is an amount that is insufficient to cure or treat a 

disease. 11 R. at 162. 

We doubt that the statements of Dr. Marcus or other matters 

relied on by PSF actually raised a genuine issue of material fact 

under § 321 (g) (1) (B). However, even if a factual issue is 

presented on that theory concerning Smellfree, the government 

argues that the labeling and marketing claims made by PSF make the 

substance a drug under § 321(g) (1) (B) in any event. We must 

agree. The courts have upheld similar arguments. See United 

States v. Article Consisting of 36 Boxes. etc., 415 F.2d 369 (3d 

Cir. 1969) ( 11 regardless of the actual physical effect of a 

product, it will be deemed a drug if the labeling, including 

separate promotional claims, attributes characteristics to the 

4 

Dr. Parkhie is a Doctor of Veterinary Medicine, holding a 

Master's of Science Degree in Reproductive Physiology and a Degree 

of Doctor of Philosophy in Animal Physiology. He specializes in 

Veterinary Clinical Pharmacology and is a Veterinary Medical 

Officer in the Center for Veterinary Medicine of the FDA. R. at 

216. 

5 

Professor Marcus is a Professor Emeritus of Microbiology and 

Immunology at the University of Utah School of Medicine, holding a 

Doctor of Philosophy Degree in Microbiology and Immunology. 

9 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 9 
product that would bring it within the Act's definition.") (citing 

Kordel v. United States, 335 U.S. 345 (1948)); United States v. 

""'An...,._ ..... A..,r'-=t"""i'""c'""'l'""e::........o . ..___, . ..___,.,__,S=u=d=d=e=n~C,..h~a""'n=g"""e , 4 0 9 F . 2 d 7 3 4 , 7 3 9 ( 2 d Cir. 1969) 

(same). PSF's labeling and promotional materials claim it will 

eliminate odor from bad breath and the animal's waste. 

Declaration of Lloyd W. Beaston, Compliance Officer for the United 

States, R. 70, 98. Mr. Beaston attached one advertisement 

stating: "We know it works because it cured our 'smelly beast.'" 

Dr. Parkhie's Affidavit stated that pet odors are usually 

associated with dermatological disorders, otic and perineal 

infections, metabolic diseases, and oral/dental diseases, such as 

decay, plaque and gingivitis. "These pet odors therefore are due 

to bacterial contamination. Removal of these bacteria to stop pet 

odors constitutes prevention or treatment of a disease." 

Affidavit of Dr. Parkhie, R. at 55. 

In sum, we are convinced that Smellfree was intended for use 

in the cure, mitigation, treatment or prevention of disease in 

animals. There being no issue of material fact on this question, 

we hold that the summary judgment in favor of PSF under 

§ 321(g) (1) (B) was error and that instead summary judgment on this 

issue should have been entered for the government. 

PSF also maintains 

show that Smellfree was 

function of animals. 

c. 

that the government's evidence does not 

intended to affect the structure or 

It says again that the evidence was that 

Smellfree contained nontherapeutic amounts of Tetracycline. Brief 

of Appellee at 16. The government points to the affidavits 

10 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 10 
demonstrating that the use of CTC will reduce the normal levels of 

bacteria in the animal's intestine and that this can affect the 

way the animal's body functions. 

We must agree with the government on this issue also. As 

noted, Dr. Parkhie's Affidavit stated that the therapeutic or 

subtherapeutic doses of Smellfree are likely to reduce the number 

of bacteria in the digestive system and oral cavities of the 

animal. 11 Elimination of the 'normal' bacterial flora will affect 

the function of the animal's body. 11 R. at 218. The Affidavit of 

Dr. Stanley Marcus stated that the subtherapeutic dosage 

prescribed for Smellfree is an amount insufficient to cure or 

treat a disease; he stated, however, that the Smellfree dosages 

11 reduce the number of bacteria in the digestive systems and oral 

cavities of pets. The reduction of bacteria reduces the 

production of malodorous substances by the pet, while not wholly 

eliminating the presence of bacteria in the digestive tract and 

oral cavity. 11 Marcus Affidavit, R. at 162. We are persuaded that 

the record clearly establishes that Smellfree is intended to 

affect a bodily function of animals, their digestion and 

elimination function. Again, we note the labeling claims, such as 

that PSF stops 11 odors at the source, 11 and that it is 11 an absolute 

revolution in pet odor control. 11 Beaston Declaration, R. at 96, 

98. See Nutrilab v. Schweiker, 713 F.2d 335, 339 (7th Cir. 1983) 

(Starch blockers indisputably satisfy [§ 321(g) (1) (C)'s] 

requirement for they are intended to affect digestion in the 

people who take them. 11 ) 

11 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 11 
PSF relies upon E. R. Squibb and Sons. Inc. v. Bowen, 870 

F.2d 678 (D.C. Cir. 1989). PSF argues that Squibb held that 

Mysteclin was not a "structure or . function" drug, and that 

"structure or . . . function" drugs were those having only 

physiologic effects, such as antifat remedies. PSF relies on the 

portion of Squibb stating that the suppression of growth of 

nonhuman organisms in the body does not affect the structure or 

function of the body. Id. at 682. Brief of Appellee at 14-16. 

The government responds that Squibb 

Smellfree is a drug because the 

supports its 

claim that 

position that 

Mysteclin would 

suppress the growth of resident organisms in the gastrointestinal 

tract demonstrated intended use in the cure, mitigation, treatment 

or prevention of disease. Brief of Appellant at 28. We must 

agree that this reasoning in Squibb supports the position of the 

government that PSF is a drug within § 321(g) (1) (B). We also are 

in agreement with the government that PSF's claims that Smellfree 

will eliminate odors resulting from the digestive and elimination 

function of the animal's body bring Smellfree within the scope of 

§ 321(g) (1) (C). See Squibb, 870 F.2d at 683 (noting that sleep 

and digestion are functions of the body) . Squibb did construe the 

"structure or . function" definition rather narrowly, unlike 

the "disease in man" definition. Id. at 682. Nevertheless, the 

claims advanced in the PSF's promotional materials firmly support 

a holding that Smellfree was intended to alter a function of the 

animal's body. See Article Consisting of 36 Boxes. etc., 415 F.2d 

at 371. 

12 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 12 
In sum, we feel the showing of intent to alter a function of 

the animal's body by the use of Smellfree is clearly demonstrated 

by the record. Hence, Smellfree is also a drug within the meaning 

of § 321 (g) (1) (C). 

III 

We hold that PSF comes within the drug definition of 21 

U.S.C. § 321(g) (1) (B) since it is intended to cure, mitigate, 

treat or prevent disease in animals. Further, we hold PSF is 

within the drug definition of § 321(g) (1) (C) because it is 

intended to affect a function of the body of animals -- digestion 

and elimination. Since there is no issue of material raised 

regarding the question of Smellfree's status as a drug, the 

government was entitled to summary judgments a matter of law. 

Hence PSF's motion for summary judgment should have been denied 

and that of the government should have been granted. 6 

Accordingly, the summary judgment in favor of PSF is 

REVERSED. The case is REMANDED with directions to enter summary 

judgment in favor of the United States, determining that Pets 

Smellfree is a drug under the Act, and to conduct further 

proceedings consistent with this opinion to consider whether the 

6 

Since there is no material dispute as to the facts, and the 

government is entitled to judgment on those facts, it is proper to 

order entry of summary judgment in favor of the government. See 

Schmidt v. Farm Credit Services, 977 F.2d 511, 513 n.3 (lOth Cir. 

1992) . 

13 

Appellate Case: 91-4197 Document: 01019282879 Date Filed: 03/31/1994 Page: 13 
product is an adulterated or misbranded drug. 7 

7 

The government's Memorandum in support of its motion for 

summary judgment below argued that Pets Smellfree is both an 

adulterated new animal drug and a misbranded new animal drug. 

Memorandum in Support of Plaintiff's Motion for Summary Judgment 

at 25; Record Appendix of Appellant United States of America at 

47. However, in its opening brief on this appeal, the government 

does not request that summary judgment be directed in its favor on 

these adulteration and misbranding issues. The government asks 

only that this court "hold that the product is a drug, reverse the 

district court's grant of summary judgment, and remand the case 

for consideration of whether Pets Smellfree is an adulterated and 

misbranded drug." Brief of Appellant United States of America at 

29. At oral argument, government counsel took that same position 

that the case should be remanded for a determination on 

misbranding or alteration. Hence the judgment which we direct to 

be entered below for the government should only determine that 

Pets Smellfree is a drug within the meaning of the Act. As 

stated, further proceedings should then be conducted to determine 

the adulteration and misbranding issues and to make final 

disposition of the case. 

14 

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