UNITED STATES OF AMERICA v. 5 UNLABELED BOXES, more or less, of an article of food,… v. (continued) -- 1 of 16 -- The Honorable Louis H. Pollak, Senior District Judge of…

PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
_____________
No. 07-4352
_____________
UNITED STATES OF AMERICA
v.
5 UNLABELED BOXES, more or less, of an article of food,
each box containing various quantities of 100 tablet bottles,
labeled in part: "Lipodrene Dietary Supplement 100ct.
25 mg ephedrine group alkaloids Manufactured for:
Hi-Tech Pharmaceuticals, Inc. Norcoss, GA
05121004EXP09/08"
v.
HI-TECH PHARMACEUTICALS, INC.,
Third Party Plaintiff
v.
(continued)

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The Honorable Louis H. Pollak, Senior District Judge of the*
United States District Court for the Eastern District of
Pennsylvania, sitting by designation.
2
ANDREW C. VON ESCHENBACH, M.D.,
Commissioner of the U.S. Food and Drug Admimistration;
FOOD AND DRUG ADMINISTRATION;
MICHAEL O. LEAVITT, Secretary of the Department
of Health and Human Services;
DEPARTMENT OF HEALTH & HUMAN SERVICES,
Third Party Defendants
Hi-Tech Pharmaceuticals, Inc.,
Appellant
Appeal from the United States District Court
for the Western District of Pennsylvania
(D.C. Civil No. 06-cv-0027)
District Judge: The Honorable Nora Barry Fischer
Argued: October 23, 2008
Before: RENDELL, SMITH, Circuit Judges,
and POLLAK, District Judge*
(Filed: July 14, 2009)

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3
Kathryn L. Clark, Esq.
Eckert, Seamans, Cherin & Mellott
U.S. Steel Tower, 44th Floor
600 Grant Street
Pittsburgh, PA 15219
Joseph P. Schilleci, Jr., Esq. [ARGUED]
Timothy M. Fulmer, Esq.
Natter & Fulmer, P.C., Esq.
3800 Colonnade Parkway
Suite 450 Birmingham, AL 35243
Edmund J. Novotny [ARGUED]
Baker, Donelson, Bearman, Caldwell, & Berkowitz, P.C.
Six Concourse Parkway, Suite 3100
Atlanta, GA 30328
Counsel for Appellant
Hi-Tech Pharmaceuticals, Inc.
Christine N. Kohl, Esq. [ARGUED]
Douglas N. Letter, Esq.
United States Department of Justice
Civil Division
950 Pennsylvania Ave, N.W.
Washington, DC 20530-0001
Counsel for Appellees
United States of America;
(continued)

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This case was originally captioned with Andrew C.1
Von Eschenbach as Commissioner of the Food and Drug
Administration and Michael O. Leavitt as Secretary of Health
4
Andrew C. Von Eschenbach, M.D.,
Commissioner of the U.S. Food and Drug Administration;
Food and Drug Administration;
Michael O. Leavitt,
Secretary of the Department of
Health and Human Services;
Department of Health & Human Services.
OPINION OF THE COURT
POLLAK, District Judge.
This case concerns ephedrine alkaloids (“EDS”),
substances that were marketed beginning in the early 1990s as
dietary supplements to reduce weight and boost energy. In
2004, the Food and Drug Administration (“FDA”) banned all
supplements containing EDS after concluding that they present
an “unreasonable risk of illness or injury” at all dose levels.
Hi-Tech Pharmaceuticals, Inc., a maker of products containing
EDS, challenges that determination. As discussed below, we1

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and Human Services; the current Commissioner and Secretary
are substituted for the former occupants of those positions
pursuant to Federal Rule of Civil Procedure 25(d).
5
conclude that Hi-Tech’s challenge is precluded.
I.
A. Rulemaking Background
The Food, Drug, and Cosmetic Act (“FDCA”) prohibits
the “introduction into interstate commerce of any food, drug,
device, or cosmetic that is adulterated or misbranded.”
21 U.S.C. § 331(a). In 1994, Congress amended the FDCA
through the Dietary Supplement Health and Education Act,
Pub. L. No. 103-417 (2000) (“DSHEA”), which sets guidelines
for how FDA may regulate dietary supplements. FDA may
declare that a dietary supplement is “adulterated” if it “presents
a significant or unreasonable risk of illness or injury under
conditions of use recommended or suggested in labeling, or if no
conditions of use are suggested or recommended in the labeling,
under ordinary conditions of use.” 21 U.S.C. § 342(f)(1)(a).
The DSHEA also makes clear that the FDA bears the burden of
proof in seeking to have a dietary supplement declared
adulterated, as the section provides: “In any proceeding under
this subparagraph, the United States shall bear the burden of
proof on each element to show that a dietary supplement is
adulterated. The court shall decide any issue under this

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This scheme is in contrast with the burdens under the FDCA2
for drugs and devices, for which the manufacturer bears the
burden of proving that the drug or device is safe before it may
be marketed.
6
paragraph on a de novo basis.” 21 U.S.C. § 342 (f).2
In 1995, FDA began examining EDS and in 1997 began
to consider regulating dietary supplements containing EDS.
62 Fed. Reg. 30,678 (June 4, 1997). FDA sought comment on
a proposed finding that a dietary supplement is adulterated if it
contains 8 mg or more of EDS per serving, or if its labeling
suggests usage resulting in a total daily intake of 24 mg or more
of EDS. FDA received negative feedback on this proposal and
in 2000 withdrew part of the proposed rule. 65 Fed. Reg.
17,474 (Apr. 3, 2000). Between 2000 and 2003, FDA released
information on EDS and solicited other comments through
notices to the public. In 2003, FDA published another notice,
informing the public that FDA intended to consider whether
EDS “present a ‘significant or unreasonable risk of illness or
injury under conditions of use recommended or suggested in
labeling, or if no conditions of use are suggested or
recommended in the labeling, under ordinary conditions of
use.’” 68 Fed. Reg. 10,417 (Mar. 5, 2003).
FDA issued a final rule in 2004, declaring all EDS to be
“adulterated” and therefore banned. FDA explained that it was
acting based on “the well-known pharmacology of ephedrine

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The Rule is codified at 21 C.F.R. § 119.1 and provides:3
“Dietary supplements containing ephedrine alkaloids present an
unreasonable risk of illness or injury under conditions of use
recommended or suggested in the labeling, or if no conditions
of use are recommended or suggested in the labeling, under
ordinary conditions of use. Therefore, dietary supplements
containing ephedrine alkaloids are adulterated under section
402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act.”
7
alkaloids, the peer-reviewed scientific literature on the effects of
ephedrine alkaloids, and the adverse events reported to have
occurred in individuals following consumption of dietary
supplements containing ephedrine alkaloids.” Final Rule
Declaring Dietary Supplements Containing Ephedrine Alkaloids
Adulterated Because They Present an Unreasonable Risk,
69 Fed. Reg. 6788-6854 (Feb. 11, 2004) (hereinafter “Final
Rule”). The Final Rule represented the first time FDA banned3
an entire class of dietary supplements under the DSHEA.
FDA determined in the Final Rule that its burden to show
unreasonable risk is met “when a product's risks outweigh its
benefits in light of the claims and directions for use in the
product's labeling, or if the labeling is silent, under ordinary
conditions of use.” FDA defined unreasonable risk to
“represent[ ] a relative weighing of the product’s known and
reasonably likely risks against its known and reasonably likely
benefits.” In conducting this weighing, FDA evaluated the
claimed benefits of EDS, including weight loss, enhanced

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Hi-Tech stopped making EDS products once the Final Rule4
took effect. However, Hi-Tech resumed production after a
district court in the District of Utah found problems with the
rule and remanded it to FDA for further proceedings.
Neutraceutical Corp. v. Crawford, 364 F. Supp. 2d 1310, 1321
(D. Utah 2005). That decision was later reversed by the Tenth
Circuit, which upheld the Final Rule. Neutraceutical v. Von
Eschenbach, 459 F. 3d 1033 (10th Cir. 2006), cert. denied, 127
S. Ct. 2295 (2007).
8
athletic performance, and increased energy, against the known
risks, including increased blood pressure and heart rate, and
their consequences, such as increased risk of stroke and heart
attack. FDA found that the “best clinical evidence for a benefit
is for weight loss, but even there the evidence supports only a
modest short-term weight loss, insufficient to positively affect
cardiovascular risk factors associated with being overweight or
obese.” FDA concluded that the potential benefits of EDS did
not outweigh the risks and therefore determined that EDS
products were adulterated and must be banned.
B. The Two Litigation Proceedings
Hi-Tech filed a complaint challenging the Final Rule in
the Northern District of Georgia on August 15, 2005. Hi-Tech4
claimed that the Final Rule was issued in violation of the
Administrative Procedures Act and that FDA failed to meet its
burden to prove that supplements containing EDS present an

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9
unreasonable risk. Hi-Tech’s main claim was that FDA could
not meet its burden of proving adulteration with a generally
applicable rule for an entire class of substances, but was,
instead, required to proceed on a product-by-product basis. On
February 22, 2006, FDA sought forfeiture of EDS products,
made by Hi-Tech, in the Northern District of Georgia. Hi-Tech,
asserting an interest in the seized products, initiated its own
action in the same court, and the two cases were consolidated.
In the meantime, FDA on January 9, 2006 initiated
forfeiture proceedings in the District Court for the Western
District of Pennsylvania against certain EDS products
manufactured by Hi-Tech and located in that district. Hi-Tech
filed a third-party complaint against FDA and challenged the
Final Rule based on the same grounds it had asserted in its
complaint in the Northern District of Georgia.
In both the Georgia and the Pennsylvania cases, Hi-Tech
and the FDA filed cross-motions for summary judgment. The
Georgia District Court granted summary judgment to the
government on August 15, 2007. Hi-Tech Pharms., Inc. v.
Crawford, 505 F. Supp. 2d 1341 (N.D. Ga. 2007). Hi-Tech filed
a notice of appeal to the Eleventh Circuit on September 13,
2007. On October 15, 2007, the Pennsylvania District Court
subsequently (and in part in relying on the Georgia decision)
granted summary judgment to the government, upholding the
Final Rule. That decision was appealed in the case at bar, in
which Hi-Tech asks this court to invalidate the Final Rule.

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10
However, before this court heard the appeal from the
Western District of Pennsylvania, the Eleventh Circuit, on
October 7, 2008, affirmed the decision of the Georgia District
Court and upheld the Final Rule. Hi-Tech Pharms., Inc. v.
Crawford, 544 F.3d 1187 (October 7, 2008). Argument was
held in this case on October 23, 2008. Subsequent to argument
in this case, Hi-Tech sought rehearing in the Eleventh Circuit,
a request which was denied on January 5, 2009. Hi-Tech has
not sought further review of the Eleventh Circuit’s decision.
About a week after the Eleventh Circuit’s decision and
about a week before oral argument in this case, the government
raised the possibility that review in this court was precluded by
the Eleventh Circuit’s decision. The parties presented argument
on preclusion and, at the request of the panel, submitted
supplemental briefing on the issue.
II.
FDA argues that, in view of the Eleventh Circuit’s
decision, res judicata or collateral estoppel should operate to bar
Hi-Tech’s arguments on this appeal.
Res judicata “requires a showing that there has been (1) a
final judgment on the merits in a prior suit involving (2) the
same claim and (3) the same parties or their privies.” EEOC v.
United States Steel Corp., 921 F.2d 489, 493 (3d Cir. 1990).
Collateral estoppel, on the other hand, requires of a previous

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11
determination that “(1) the identical issue was previously
adjudicated; (2) the issue was actually litigated; (3) the previous
determination was necessary to the decision; and (4) the party
being precluded from relitigating the issue was fully represented
in the prior action.” Jean Alexander Cosmetics, Inc. v. L’Oreal
USA, Inc., 458 F.3d 244, 249 (3d Cir. 2006) (citing Henglein v.
Colt Indus. Operating Corp., 260 F.3d 201, 209 (3d Cir. 2001)).
The parties use the terms “res judicata” and “collateral
estoppel” nearly interchangeably, and neither side argues that
using one or the other would meaningfully affect the analysis.
Collateral estoppel customarily refers to issue preclusion, while
res judicata, when used narrowly, refers to claim preclusion.
This court has previously noted that “the preferred usage” of the
term res judicata “encompasses both claim and issue
preclusion.” Venuto v. Witco Corp., 117 F.3d 754, 758 n.5
(3d Cir. 1997).
A comparison of the parties and the issues makes the
appropriateness of res judicata immediately apparent. The
parties in the Eleventh Circuit are identical to the parties before
this court. The claims are also identical. Hi-Tech contends that
the claims are not the same because different EDS products
were seized in Georgia than in Pennsylvania; therefore, Hi-Tech
argues that because FDA must prove that each individual
product is adulterated, the products seized in the Georgia action
cannot be classified as the same as those seized in the
Pennsylvania action. However, this argument is, in effect,

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These identical questions are:5
I. Whether the District Court erred in an enforcement
proceeding brought by the Food and Drug Administration
(“FDA”) by deferring to the FDA’s judgment rather than
conducting a de novo review of the alleged adulteration of
dietary supplement products manufactured by Hi-Tech
Pharmaceuticals, Inc. (“Hi-Tech”) as required by the Dietary
Supplement Health and Education Act of 1994 (“DSHEA”),
21 U.S.C. § 342(f)?
II. Whether the District Court erred in holding that the FDA met
its burden of proof under 21 U.S.C. § 342(f) to establish that
dietary supplement products manufactured by Hi-Tech were
adulterated under the conditions of use recommended by
Hi-Tech where the FDA relied solely upon its own
determination that all dietary supplements containing ephedrine
alkaloids (“EDS”) were adulterated regardless of dosage as set
forth in the FDA’s final rule declaring dietary supplements
containing ephedrine alkaloids adulterated?
III. Whether the District Court erred in holding that the FDA
final rule was such a logical outgrowth of the previous attempts
to regulate EDS through various warning labels and dosage
restrictions to provide the dietary supplement industry with
sufficient notice under the Administrative Procedures Act that
the FDA intended to ban an entire class of dietary supplements?
IV. Whether the District Court erred in holding that the FDA’s
final rule complied with the unambiguous congressional
12
simply a reiteration of Hi-Tech’s claims on the merits of this
appeal. The argument, undertaking to counter the FDA’s
determination that the FDA could, via rulemaking, declare
adulterated and ban an entire class of substances, is the exact
argument the Eleventh Circuit rejected. Hi-Tech’s brief to the
Eleventh Circuit posed questions identical to those presented in
Hi-Tech’s brief to this court. The Eleventh Circuit reached a5

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mandate in DSHEA to treat dietary supplements as
presumptively safe when the FDA employed a previously
undisclosed and unauthorized analysis expressly reserved for
drugs and medical devices but not dietary supplements which
weighed any risks of EDS versus the known benefits of such
supplements in order to declare EDS presented an unreasonable
risk of illness or injury pursuant to 21 U.S.C. § 342(f)?
The Eleventh Circuit also rejected as meritless for the6
reasons expressed by the District Court for the Northern District
of Georgia Hi-Tech’s remaining challenges to the Final Rule.
13
judgment on the merits of these issues, concluding that the FDA
is empowered to declare, through rulemaking, a class of
substances adulterated and the “de novo review” requirement of
the statute does not require the government to present additional
proof of adulteration where there exists a validly-promulgated
rule applicable to the product that is the subject of the
enforcement action in question This judgment on the merits in6
a case involving issues and parties identical to those in the case
before this court meets the requirements for res judicata.
Hi-Tech argues, however, that the government has
waived the res judicata defense by not asserting it until this “late
hour.” Hi-Tech correctly observes that FDA did not raise this
issue as an affirmative defense in its answers in either the
Pennsylvania or the Georgia litigation. But this is beside the
point. Res judicata could not have been pleaded at those times,
because, at the time the answers were filed, no final judgment
had been rendered in either case. FDA did not argue that the
Georgia action should have a preclusive effect on the
Pennsylvania action until the Eleventh Circuit had affirmed the
Georgia District Court’s decision. But it should be noted that,

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14
while the Georgia case was making its way to the Eleventh
Circuit, FDA apprised both the Pennsylvania District Court and
this court of the Georgia case’s status.
FDA could probably have asked this court to give
preclusive effect to the decision in the Northern District of
Georgia without waiting for the Eleventh Circuit’s decision, as
the pendency of an appeal does not affect the potential for res
judicata flowing from an otherwise-valid judgment. However,
where, as in the situation here, “two or more cases wend toward
judgment at differing speeds,” early application of res judicata,
though technically permissible, can create later problems if a
first judgment, relied on in a second proceeding, is reversed on
appeal. 18A Charles Alan Wright, et al., Federal Practice and
Procedure 2d § 4433 at 71 (2002). The Restatement (Second)
of Judgments, noting that a final judgment will customarily be
given preclusive effect even though an appeal is pending,
suggests, if possible, postponing decision on the question of
preclusion in a second action until the appeal of the first
judgment has been concluded. Restatement (Second) of
Judgments, § 13, cmt. f. Any concerns about whether the
Eleventh Circuit’s decision is “sufficiently firm,” id., have now
been allayed: Hi-Tech’s appeals as of right have been
exhausted, its petition for rehearing has been denied, and the
time for it to seek Supreme Court review via certiorari has now
elapsed.
Putting aside the question of waiver, this court also has
an interest in the consistent application, where appropriate, of
preclusion doctrines. Out of concern for judicial economy and
respect for the conclusions reached by other courts considering
the same issues, courts “have traditionally attached additional

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The Eleventh Circuit was in fact not the first circuit to7
address the validity of the Final Rule; the Tenth Circuit upheld
the rule in Neutraceutical v. Von Eschenbach, 459 F. 3d 1033
15
importance to the application of res judicata principles.”
Bechtold v. City of Rosemount, 104 F.3d 1062, 1068 (8th Cir.
1997). “[I]n special circumstances,” a court may even raise the
issue of preclusion sua sponte. Arizona v. California, 530 U.S.
392, 412 (2000); see 18A Charles Alan Wright, et al., Federal
Practice and Procedure 2d § 4405 n.10. That is not necessary
here, where FDA raised the issue in advance of oral argument
and the parties have addressed preclusion both at argument and
in supplemental submissions.
Hi-Tech argues that, even if res judicata technically
applies, its use in this case would be inconsistent with the
congressional directives embodied in the DSHEA to “prove
adulteration of a dietary supplement on a product-by-product
basis.” This argument is without merit, as it is merely another
redundant invocation of Hi-Tech’s main challenge to the validity
of the Final Rule. Hi-Tech also argues that application of res
judicata on issues of statutory interpretation would improperly
“squelch[] the circuit disagreements that can lead to Supreme
Court review.” However, this concern–if assumed to have
some weight–would be relevant only where the “differing
[statutory] interpretations are developed in different cases, not
in the same dispute” and where there is not mutuality of parties.
Holland v. Nat’l Mining Ass’n, 309 F.3d 808, 815 (D.C. Cir.
2002); United States v. Mendoza, 464 U.S. 154, 160 (1984). In
this case, the same dispute, between the same parties, that was
before the Eleventh Circuit is now before this court, and there
is no reason to permit re-litigation of issues already resolved.7

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(10th Cir. 2006), cert. denied, 127 S. Ct. 2295 (2007). Hi-Tech
was not a party to that case, as it was brought by a different EDS
manufacturer.
16
III.
Hi-Tech has had two full opportunities to litigate its
challenge to the Final Rule banning EDS, first in the Northern
District of Georgia and then in the Western District of
Pennsylvania. The Eleventh Circuit has evaluated Hi-Tech’s
claims and determined them to be without merit, and we will
give that decision preclusive effect. Hi-Tech’s appeal founders
on the shoals of res judicata. Therefore, we will AFFIRM the
Order of the District Court.

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