Nve, Inc. v. Department of Health and Human Serv.

Decision Date07 February 2006
Docket NumberNo. 04-4481.,04-4481.
Citation436 F.3d 182
PartiesNVE INC., Appellant v. DEPARTMENT OF HEALTH AND HUMAN SERVICES; Tommy G. Thompson, Secretary Department of Health and Human Services; Food and Drug Administration; <SMALL><SUP>*</SUP></SMALL>Lester M. Crawford, Jr., Acting Commissioner, Food and Drug Administration; John Does, 1-10 fictitious individuals and ABC Agencies 1-10 fictitious agencies and/or entities.
CourtU.S. Court of Appeals — Third Circuit

Walter F. Timpone [Argued], McElroy, Deutsch, Mulvaney & Carpenter, Morristown, NJ, for Appellant.

Douglas N. Letter, Christine N. Kohl [Argued], U.S. Department of Justice, Civil Division, Washington, DC, for Appellees.

Before RENDELL, FUENTES and GARTH, Circuit Judges.


RENDELL, Circuit Judge.

In 1994, Congress passed the Dietary Supplement Health and Education Act ("DSHEA"), declaring dietary supplements that "present[] a significant or unreasonable risk of illness or injury" to be "adulterated food" under the Food, Drug, and Cosmetic Act ("FDCA"). DSHEA § 4, 21 U.S.C. § 342(f)(1) (2000). In 2004, the Food and Drug Administration ("FDA") promulgated a final regulation stating that dietary supplements containing ephedrine alkaloids ("EDS") were adulterated under the "unreasonable risk" standard of DSHEA. 21 C.F.R. § 119.1. The effect of the regulation was to prohibit the distribution of these supplements. NVE, a former manufacturer and distributor of EDS, brought this suit seeking to set aside the regulation.

Relying on a provision of DSHEA that states a "court shall decide any issue under [21 U.S.C. § 342(f)(1)] on a de novo basis," NVE sought to supplement the administrative record by offering affidavits, expert testimony, and other evidence. In orders dated August 4, 2004 and August 12, 2004, the District Court declined NVE's request, limiting its review to the 133,000-page administrative record for the challenged rule. However, pursuant to 28 U.S.C. § 1292(b), the District Court certified these orders for interlocutory appeal and identified four questions of law for our review:

1. May the party challenging the rule supplement the administrative record?

2. May the party challenging the rule present expert affidavits and/or testimony?

3. May the reviewing court conduct a trial or is its review limited to a review of the administrative record?

4. May the party challenging the rule conduct discovery?

Because we conclude that the de novo standard of 21 U.S.C. § 342(f)(1) does not apply to a private action brought under the APA to challenge administrative rulemaking, we will answer the first, second, and fourth questions posed by the District Court in the negative and conclude with respect to the third question the District Court's review is limited to the administrative record.

We also address the District Court's ruling that it owed no deference in this case to the FDA's legal or factual conclusions. Though this issue was not one of the questions of law certified to us by the District Court, it was a part of the orders from which NVE appeals and is closely related to the question of whether NVE may supplement the record. Under 28 U.S.C. § 1292(b), we are not limited to the specific questions of law identified by the District Court when reviewing the orders certified for appeal. Howard Hess Dental Labs. Inc. v. Dentsply Int'l, Inc., 424 F.3d 363, 368-369 (3d Cir.2005). We therefore take up the question of deference here as part of our review of the District Court's orders of August 4, 2004 and August 12, 2004 and conclude that the normal rules for judicial deference regarding agency action apply in the instant suit.


We begin with a discussion of the regulatory scheme at issue. The FDCA prohibits "[t]he introduction or delivery for introduction into interstate commerce of any food ... that is adulterated." 21 U.S.C. § 331(a). The United States enforces this provision through suits for injunctive relief, id. § 332, fines or imprisonment id. § 333, or seizure of the adulterated food, id. § 334. It is well-established that the government bears the burden of proving that a food is adulterated in enforcement actions brought directly under the FDCA. See United States v. Two Plastic Drums, More or Less of an Article of Food ..., 984 F.2d 814, 816 (7th Cir.1993) (noting that the FDA has the burden of showing that food is injurious to health).

The FDCA also grants to the Secretary of Health and Human Services broad power "to promulgate regulations for the efficient enforcement of th[e] Act." 21 U.S.C. § 371(a). This provision authorizes the Secretary to issue substantive regulations, interpretive regulations, and statements of policy. Pharmaceutical Mfrs. Ass'n v. FDA, 484 F.Supp. 1179, 1182 (D.Del.1980). Because courts owe deference to an agency's interpretation of the statute and regulations it administers, Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc., 467 U.S. 837, 842-43, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984), regulations validly promulgated under the FDCA normally have the force of law in enforcement proceedings, United States v. Mead Corp., 533 U.S. 218, 227, 121 S.Ct. 2164, 150 L.Ed.2d 292 (2001). See also United States v. Algon Chem. Inc., 879 F.2d 1154, 1159 (3d Cir.1989) (deferring to FDA regulations in enforcement proceedings under the FDCA). Thus, where the FDA determines through rulemaking that a food is adulterated, the introduction of that food into interstate commerce violates the FDCA unless the rule is "procedurally defective, arbitrary or capricious in substance, or manifestly contrary to the statute." Mead Corp., 533 U.S. at 227, 121 S.Ct. 2164; see also United States v. Undetermined Quantities of Various Articles of Device ..., 800 F.Supp. 499, 502 (S.D.Tex.1992) (determining, based on FDA regulations, that medical device was adulterated and misbranded under FDCA).

Congress passed DSHEA after a long-running dispute with the FDA about how strictly dietary supplements should be regulated. Members of Congress believed the FDA had "pursued a heavy-handed enforcement agenda against dietary supplements for over 30 years" prior to DSHEA's enactment. S. Rep. 103-410, at 15 (1994). Both Congress and the courts consistently resisted the FDA's regulation of dietary supplements, yet the FDA continued its course. Id. at 16-17. Senator Orrin Hatch summarized the attitudes of many in Congress in 1994 when he stated that, with respect to dietary supplements, "[i]t is the U.S. Congress versus the Food and Drug Administration." 140 Cong. Rec. S11708, 11711 (1994); see also 140 Cong. Rec. S14780-01 (1994) (statement of Sen. Harkin) (criticizing the FDA for restricting access to information about dietary supplements). In response to what it perceived as an "inappropriate regulatory strategy," S. Rep. 103-410, at 22, Congress passed DSHEA in October 1994 with strong bipartisan support.

DSHEA changed very little about the basic administrative tools available to the FDA for the regulation of dietary supplements. The Agency could still regulate dietary supplements through enforcement actions or rulemaking. However, DSHEA provided substantive and procedural limits on the FDA's ability to restrict the use of dietary supplements. DSHEA identified the limited alternative conditions under which a dietary supplement or food containing a dietary supplement could be deemed adulterated. First, a dietary supplement is adulterated if it poses a significant or unreasonable risk of illness or injury. 21 U.S.C. § 342(f)(1)(A). Second, a dietary supplement is deemed adulterated if it is a new dietary ingredient for which there is inadequate information to establish that it does not pose a significant or unreasonable risk. Id. § 342(f)(1)(B). Third, the Secretary may declare that a dietary supplement is adulterated if it poses an imminent hazard to public health or safety, provided that the Secretary promptly initiates formal adjudication to affirm or withdraw the declaration. Id. § 342(f)(1)(C). Finally, a dietary supplement is deemed adulterated if it is poisonous or unsanitary. Id. § 342(f)(1)(D).1

In addition to providing substantive limits on the circumstances under which dietary supplements may be considered adulterated, Congress imposed new procedural checks on the FDA's ability to regulate dietary supplements through the courts. After listing the ways in which a dietary supplement can be deemed adulterated, the provision states:

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 paragraph on a de novo basis.

Id. § 342(f)(1) (emphasis added). Congress intended that these provisions would protect against "unreasonable regulatory barriers" limiting the flow of safe dietary supplements to consumers. DSHEA § 2(13) (codified in note to 21 U.S.C. § 321(ff)).

Beginning in 1997, the FDA began to consider regulatory action with respect to certain products containing EDS. The FDA chose to regulate EDS through administrative rulemaking rather than through enforcement actions brought directly under the FDCA. The FDA proposed several alternatives, including regulation of items containing certain threshold amounts of EDS, limitations on the duration of use and daily uses of EDS, labeling requirements on products containing EDS, and prohibition of mixing certain ingredients with EDS. See Dietary Supplements Containing Ephedrine Alkaloids, 62 Fed. Reg. 30678, 30692-30705 (proposed June 4, 1997) (to be codified at 21 C.F.R. pt. 111). In 2000, the FDA withdrew most of these proposals and ceased activity aimed at regulatory action in the face of a negative public response and questions about the sufficiency of evidence that EDS was unsafe. 65 Fed.Reg. 17474 (April 3, 2000).

In 2002, the FDA received a report from the RAND Corporation calling for more...

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