[PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
________________________ FILED
U.S. COURT OF APPEALS
No. 07-14309 ELEVENTH CIRCUIT
OCT 7, 2008
________________________
THOMAS K. KAHN
CLERK
D.C. Docket Nos. 05-02083 CV-GET-1
06-00406-CV-GET
HI-TECH PHARMACEUTICALS, INC.,
Plaintiff-Appellant,
versus
LESTER M. CRAWFORD, D.V.M., Ph.D.,
as Commissioner of the United States Food and Drug Administration,
UNITED STATES FOOD AND DRUG ADMINISTRATION,
MICHAEL O. LEAVITT, as Secretary of the
Department of Health and Human Services,
UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES,
ACTING COMMISSIONER ANDREW C. VON ESCHENBACH, M.D.,
Defendants-Appellees.
________________________
No. 07-14312
________________________
D.C. Docket Nos. 06-00406 CV-GET-1
05-02083-CV-GET
UNITED STATES OF AMERICA,
Plaintiff-Third Party Defendant-Appellee,
versus
18 CASES, MORE OR LESS, OF AN ARTICLE OF
FOOD, EACH CASE CONTAINING 120/100
TABLET BOTTLES LABELED IN PART
Lipodrene Dietary Supplement 100 ct.
Sida Cordifolia (leaves) (25 mg ephedrine group
alkaloids) Lot 05121004 Manufactured for
Hi-Tech Pharmaceuticals, Inc., Norcross, GA, et al.,
Defendants,
HI-TECH PHARMACEUTICALS, INC.,
Claimant-Third Party Plaintiff-Appellant.
________________________
Appeals from the United States District Court
for the Northern District of Georgia
________________________
(October 7, 2008)
Before WILSON, PRYOR and COX, Circuit Judges.
PER CURIAM:
We consider in this appeal whether 21 U.S.C. § 342(f)(1)’s de novo provision
impacts the evidentiary weight to be given to Food and Drug Administration (FDA)
regulations. Section 342(f)(1)’s de novo provision provides that a reviewing court
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shall decide any issue in an adulterated dietary supplement proceeding de novo. The
issue is whether a FDA regulation which declares that dietary supplements containing
ephedrine alkaloids are adulterated is sufficient proof of adulteration, or is more
evidence needed under § 342(f)(1)’s de novo provision? Because FDA regulations
have the force and effect of law, we conclude that the no other evidence is needed.
We affirm.
I. BACKGROUND
Hi-Tech Pharmaceuticals, Inc. manufactured, marketed, distributed, and sold
dietary supplements containing ephedrine alkaloids. In June 1997, the United States
FDA proposed a rule regarding products containing certain levels of ephedrine
alkaloids. The FDA received thousands of comments and considered voluminous
evidence about the risks of ephedrine alkaloids. Then, six and a half years later, in
February 2004, the FDA issued the “Final Rule Declaring Dietary Supplements
Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable
Risk” (the “Final Rule”). The Final Rule states:
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
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adulterated under section 402(f)(1)(A) of the Federal Food, Drug, and
Cosmetic Act.
21 C.F.R. 119.1.
The Final Rule was enacted under the Dietary Supplement Health Education
Act of 1994 (DSHEA), Pub. L. No. 103-417, 108 Stat. 4325 (1994), amending the
Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301-399. Under the
FDCA, “adulterated” describes a product that “presents a significant or unreasonable
risk of illness or injury under conditions of use recommended or suggested in
labeling,” or if the labeling does not discuss it, “under ordinary conditions of use[.]”
21 U.S.C. § 342(f)(1)(A).
The Final Rule became effective on April 12, 2004. Its effect was to ban the
sale and distribution of all dietary supplements containing ephedrine alkaloids and
to make those products subject to seizure and condemnation by the government. On
February 23, 2006, United States Marshals entered Hi-Tech’s premises and seized
some dietary supplement products and ingredients found there. Hi-Tech concedes
that the seized products and ingredients contain ephedrine alkaloids.
II. PROCEDURAL HISTORY
Prior to the seizure, Hi-Tech filed a declaratory relief action seeking relief from
enforcement of the Final Rule on the ground that the FDA had not complied with the
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Administrative Procedures Act (APA) in promulgating the Final Rule (“the APA
action”). The United States filed a separate action for forfeiture of dietary
supplement products and ingredients containing ephedrine alkaloids (“the
enforcement action”). After the property was seized, Hi-Tech filed a statement of
interest and a third-party complaint in the enforcement action. The district court
consolidated the APA action and the enforcement action.
On cross-motions for summary judgment, the district court denied Hi-Tech’s
motion and granted summary judgment to the FDA and the United States, finding that
all required administrative procedures were followed and that the seizure was proper
because the seized property was adulterated. See Hi-Tech Pharm., Inc. v. Crawford,
505 F. Supp. 2d 1341 (N.D. Ga. 2007). Hi-tech appeals.
III. STANDARD OF REVIEW
This court reviews a district court’s grant of summary judgment de novo,
applying the same legal standards used by the district court. See, e.g., Hilburn v.
Murata Elecs. N. Am., Inc., 181 F.3d 1220, 1225 (11th Cir.1999). Summary
judgment is appropriate where “‘there is no genuine issue as to any material fact and
the moving party is entitled to a judgment as a matter of law.’” Wooden v. Bd. of
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Regents of the Univ. Sys. of Ga., 247 F.3d 1262, 1271 (11th Cir.2001) (quoting Fed.
R. Civ. P. 56(c)).
IV. ISSUE ON APPEAL
Hi-Tech raises several issues on appeal, but only one merits discussion.1 Hi-
Tech contends that the district court erroneously relied on the Final Rule to find that
Hi-Tech’s dietary supplements were adulterated and, therefore, properly seized. Hi-
Tech argues that, in an enforcement proceeding under the statute, the Government
may not rely on the Final Rule to meet its burden to prove that a product is
adulterated. The Government must instead, Hi-Tech argues, present additional
evidence to the district court to prove, by a preponderance of the evidence, that the
product is adulterated.
In making this argument, Hi-Tech relies on the language of 21 U.S.C. §
342(f)(1), which states the conditions under which a dietary supplement or ingredient
shall be deemed to be adulterated. In this case, the Government relied on 21 U.S.C.
§ 342(f)(1)(A), which states that a dietary supplement will be deemed adulterated if
1
Hi-Tech’s other arguments on appeal are meritless. Hi-Tech contends that: (1) during the
administrative process, the FDA did not provide adequate notice that the Final Rule might ban
ephedrine alkaloids completely; (2) the Final Rule is not a logical outgrowth of the regulation
originally proposed by the FDA; and (3) the FDA’s use of a risk-benefit analysis to determine
whether a dietary supplement poses an “unreasonable risk” is contrary to congressional intent and
unreasonable itself. We find these arguments meritless for the reasons stated by the district court.
See Hi-Tech Pharm., 505 F. Supp. 2d at 1351-1353.
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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[.]” Id.
Later, the statute that applies to enforcement proceedings states, “In any proceeding
under [21 U.S.C. § 342(f)(1)], 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 paragraph on a de novo basis.” 21 U.S.C. § 342(f)(1).
Hi-Tech focuses on the use of the term de novo in the last sentence of 21
U.S.C. § 342(f)(1) and argues that it requires a district court to hear original evidence
on the question of adulteration, even where the FDA has conducted an administrative
rulemaking process and promulgated a valid rule declaring the product adulterated.
V. DISCUSSION
As a general matter, FDA regulations like the Final Rule, which have been
issued after proper administrative process, have the force and effect of law. See
Abbott Labs v. Gardner, 387 U.S. 136, 151-53, 87 S. Ct. 1507, 1517-18 (1967)
(stating that a final FDA regulation, if within the agency’s authority, has the status of
law). It is for this reason that violation of such regulations may “carry heavy criminal
and civil sanctions,” such as forfeiture. 387 U.S. at 152, 87 S. Ct. at 1517.
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The question posed in this appeal is whether the de novo language in the last
sentence of 21 U.S.C. § 342(f)(1) somehow transforms the Final Rule into something
other than a regulation with the force of law. In other words, did Congress act to
diminish the effect of the FDA regulations regarding adulterated dietary supplements
by using the term de novo in the last sentence of the statute?
As the parties recognize, the meaning of the de novo language in the last
sentence of 21 U.S.C. § 342(f)(1) in an enforcement action is an issue of first
impression in the federal appellate courts. Two courts of appeals have held that the
provision applies only in enforcement proceedings, not in actions brought solely
under the APA.2 But no court has decided how the provision operates in an
enforcement action such as this one, where the FDA has promulgated a regulation
declaring a product adulterated.
Because there are no court decisions answering this question, the district court
turned to legislative history in an effort to determine the intent of Congress. The
Senate Report states:
Section 4 of the bill adds two new provisions to the Federal Food, Drug
and Cosmetic Act to provide further power to the Food and Drug
Administration to proceed where the safety of a dietary supplement
2
See NVE, Inc. v. Dep’t of Health and Human Servs., 436 F.3d 182, 192 (3d Cir. 2006);
Nutraceutical Corp. v. Von Eschenbach, 459 F.3d 1033, 1037 (10th Cir. 2006).
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poses risks to consumers. First section 4 provides new power to the
FDA to declare a dietary supplement adulterated through rulemaking.
FDA may use this power where it is determined that a dietary
supplement presents a “substantial and unreasonable risk of illness or
injury under conditions of use recommended or suggested in labeling.”
S. Rep. No. 103-410, at 35 (1994) (emphasis added). The Report also explains that
the section was intended “to codify current law that the government bear the burden
of proving dietary supplements adulterated.” Id. at 36. The Report further states,
“The government must produce the preponderance of the evidence as to the harmful
effects from the dietary supplement . . . .” Id. And, the Report cites United States v.
71/55 Gallon Drums of Stuffed Green Olives, 790 F. Supp. 1379 (N.D. Ill. 1992), a
case where there was no FDA regulation declaring the food at issue adulterated, in
support of its statements regarding the burden of proof. Thus, the legislative history
clearly states that the government has the burden of proof in an enforcement
proceeding. However, it provides no guidance as to whether and how an FDA-
promulgated regulation declaring a product adulterated may be used as evidence in
such a proceeding.
On appeal, Hi-Tech concedes, and we agree, that the de novo language in the
statute does not prevent the Government from using the Final Rule as evidence of
adulteration in an enforcement proceeding. What Hi-Tech argues is that the Final
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Rule alone cannot be sufficient evidence of adulteration and that the Government
must present the district court with some additional proof that the product subject to
forfeiture “presents a significant or unreasonable risk of illness or injury” under
recommended or ordinary conditions of use in order to satisfy its burden. 21 U.S.C.
§ 342(f)(1)(A).
We disagree. The statute does not say that the applicability of a regulation
promulgated by an executive agency, through an extensive administrative procedure,
cannot be sufficient proof of adulteration. And the legislative history does not so
indicate. Indeed, that history suggests the opposite: that the statute empowers the
FDA to settle the issue of adulteration through rulemaking and that additional proof
to a court will not be necessary. See S. Rep. No. 103-410, at 35.
Having considered the text of the statute and its legislative history, we
conclude that Congress used the term de novo to indicate that the Government had
the burden of proof, by preponderance of the evidence, that a dietary supplement
“presents a significant or unreasonable risk of illness or injury” under recommended
or ordinary conditions of use. 21 U.S.C. § 342(f)(1)(A). In the absence of a
regulation like the Final Rule, the Government would have to carry its burden by
submitting evidence of the risks of illness or injury under the recommended or
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ordinary conditions of use. See e.g., 71/55 Gallon Drums of Stuffed Green Olives,
790 F. Supp. 1379. But, as here, where the FDA has already considered evidence of
the risks, benefits and uses of a product; proposed a regulation addressing the
product; issued notice of the proposed regulation; considered comments on that
regulation and evidence relevant to that regulation over a considerable period of time;
and promulgated a valid Final Rule, it is sufficient for the Government to present
evidence that: (1) the regulation exists and (2) it applies to the product that is the
subject of the enforcement action. We do not read the statute to require more.
VI. CONCLUSION
Because the parties agree that the Final Rule applies to the seized property, no
genuine issue of material fact exists. The district court properly granted summary
judgment for the Government.
AFFIRMED.
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