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Alliance for Natural Health US v. Sebelius

May 27, 2010

ALLIANCE FOR NATURAL HEALTH US, ET AL., PLAINTIFFS,
v.
KATHLEEN SEBELIUS, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Ellen Segal Huvelle United States District Judge

MEMORANDUM OPINION

Plaintiffs Alliance for Natural Health US, Durk Pearson, Sandy Shaw, and Coalition to End FDA and FTC Censorship have sued the Food and Drug Administration ("FDA" or "Agency") and other defendants,*fn1 seeking review of the Agency's decision to deny plaintiffs' petition for authorization of qualified health claims regarding selenium-containing dietary supplements. Invoking both circuit and district court opinions that have addressed similar claims, plaintiffs seek a declaratory judgment that the FDA's final order denying plaintiffs' petition is invalid and a permanent injunction enjoining the Agency from "taking any action that would preclude [plaintiffs] from placing [their proposed selenium] health claims on [dietary supplement] labels." (Compl. at 29.) Before the Court are 1) plaintiffs' motion for summary judgment and 2) defendants' cross-motion for summary judgment. For the reasons set forth herein, the Court will grant plaintiffs' motion in part and deny defendants' motion.

BACKGROUND

I. STATUTORY AND REGULATORY FRAMEWORK

A "dietary supplement" is a "product (other than tobacco) intended to supplement the diet that bears or contains" one or more of certain dietary ingredients, including vitamins, minerals, herbs or botanicals, amino acids, concentrates, metabolites, constituents, or extracts. 21 U.S.C. § 321(ff)(1)(A)-(F). A dietary supplement is deemed to be "food," id. § 321(ff), which is defined in part as "articles used for food or drink for man or other animals," id. § 321(f)(1), except when it meets the definition of a "drug," which is defined in part as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals." Id. § 321(g)(1)(B). (See also Defs.' Cross-Mot. for Summ. J. & Opp'n to Pls.' Mot. for Summ. J. ["Defs.' Mot."] at 3 n.2). A "health claim" is "any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication . . . characterizes the relationship of any substance to a disease or health-related condition." 21 C.F.R. § 101.14(a)(1); see also 21 U.S.C. § 343(r)(1)(A)-(B).

Under the Federal Food, Drug, and Cosmetic Act ("FFDCA"), manufacturers wishing to market a new drug must undergo a "strict and demanding" process designed to ensure consumer safety and product efficacy in order to obtain FDA approval before introducing the product into interstate commerce. Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 618-19 (1973); see also 21 U.S.C. § 355(a); Pearson v. Shalala, 164 F.3d 650, 652 (D.C. Cir. 1999) ("Pearson I"). "Prior to 1984, the FDA took the position that a statement that consumption of a food could prevent a particular disease was 'tantamount to a claim that the food was a drug . . . and therefore that its sale was prohibited until a new drug application had been approved.'" Pearson I, 164 F.3d at 653 (quoting H.R. Rep. No. 101-538, at 9 (1990), reprinted in 1990 U.S.C.C.A.N. 3336, 3338). But in the mid-1980s, companies began making health claims on foods without seeking new drug approval, a practice the FDA supported. Id. Congress subsequently enacted the Nutrition Labeling and Education Act of 1990 ("NLEA"), Pub. L. No. 101-535, 104 Stat. 2353 (1990) (codified as amended at 21 USC §§ 301, 321, 337, 343, 343-1, 345, 371), amending the FFDCA to provide the FDA with authority to regulate health claims on food. Pearson I, 164 F.3d at 653.

The NLEA created a "safe harbor" from the "drug" designation for foods and dietary supplements labeled with health claims. Pearson v. Shalala, 130 F. Supp. 2d 105, 107 (D.D.C. 2001) ("Pearson II"); see also 21 U.S.C. § 343(r)(1). Under the Act, a manufacturer may make a health claim on a food without FDA new drug approval if the FDA determines that "significant scientific agreement," based on the "totality of publicly available scientific evidence," supports the claim. 21 U.S.C. § 343(r)(3)(B)(i). For dietary supplement health claims, however, Congress declined to establish an authorization process and instead left the creation of an approval "procedure and standard" to the FDA. Id. § 343(r)(5)(D). The FDA subsequently promulgated a regulation adopting the NLEA's standard for food health claims (i.e., "significant scientific agreement") for dietary supplement health claims. 21 C.F.R. § 101.14(c) ("FDA will promulgate regulations authorizing a health claim only when it determines, based on the totality of publicly available scientific evidence . . . that there is significant scientific agreement . . . that the claim is supported by such evidence."). The FDA may consider a dietary supplement labeled with an unauthorized health claim to be a misbranded food, 21 U.S.C. § 343(r)(1)(B); a misbranded drug, id. § 352(f); and/or an unapproved new drug. Id. § 355(a). A dietary supplement labeled with such a claim, or a claim that is false or misleading, is subject to seizure, and the Agency may enjoin the product's distribution or seek criminal penalties against its manufacturer. Id. §§ 331(a), 332, 334, 352(a); see also Def.'s Mot. at 3.

II. PEARSON V. SHALALA AND SUBSEQUENT CASE LAW

A. Introduction

Plaintiffs' lawsuit is the latest in a series of disputes between dietary supplement designers and the FDA regarding the Agency's regulation of health claims regarding dietary supplements after the passage of the NLEA. Pearson, Shaw, and other individuals and groups affiliated with the production, sale, and use of dietary supplements have, since 1995, sought judicial review of FDA decisions denying a variety of proposed health claims. The first of these lawsuits, challenging the FDA's rejection of the plaintiffs' proposed claims on First Amendment grounds, resulted in an invalidation of the Agency's regulations regarding health claim review by the D.C. Circuit. Pearson I, 164 F.3d at 661. Since then, the FDA has struggled to balance its concerns for consumer protection and dietary supplement manufacturers' First Amendment commercial speech rights as defined by Pearson I. An abbreviated summary of these cases follows.

B. Pearson I

In 1995, a group of dietary supplement manufacturers*fn2 filed suit against the FDA and other defendants under the First Amendment, challenging the FDA's rejection of four health claims*fn3 that the manufacturers sought to include on certain dietary supplements. Pearson v. Shalala, 14 F. Supp. 2d 10, 14 (D.D.C. 1998). The claims characterized a relationship between dietary supplements and the risk of particular diseases. Id. The Agency, applying the "significant scientific agreement" standard set forth in 21 C.F.R. § 101.14, determined that the evidence concerning the supplements "was inconclusive . . . and thus failed to give rise to 'significant scientific agreement.'" Pearson I, 164 F.3d at 653. The Agency therefore declined to authorize the claims, finding them to be "inherently misleading and thus entirely outside the protection of the First Amendment" as commercial speech. Id. at 655 (emphasis in original). The FDA also declined to consider the proposed alternative of "permitting the claim[s] while requiring . . . corrective disclaimer[s]," arguing that even if the proposed claims were only "potentially misleading," it had no obligation under the First Amendment to consider a "disclaimer approach," as opposed to suppression, where the claims at issue lacked significant scientific agreement. Id. at 654, 655, 657. The manufacturers sued, arguing that the FDA's "significant scientific agreement" standard was unconstitutionally vague and was tantamount to a blanket ban on commercial speech in violation of the manufacturers' First Amendment rights.*fn4

Pearson, 14 F. Supp. 2d at 14.

After the district court denied the manufacturers' motion for summary judgment, the D.C. Circuit reversed. The Court, applying the commercial speech test set forth in Central Hudson Gas & Electric Corporation v. Public Service Commission of New York, 447 U.S. 557 (1980),*fn5 held that there was not a "reasonable fit between the government's goals" of protecting public health and preventing consumer fraud and "the means chosen to advance those goals," namely, the rejection of plaintiffs' proposed health claims without consideration of disclaimers. Pearson I, 164 F.3d at 656-58. Specifically, the Court held thatunder the First Amendment commercial speech doctrine, there is a "preference for disclosure over outright suppression" and for "less restrictive and more precise means" of regulating commercial speech. Id. at 657-58. The Agency's rejection of disclaimers without a showing that they were insufficient to meet the government's goal of avoiding consumer confusion demonstrated a disregard for "less restrictive" means of speech regulation that violated the First Amendment. The Court remanded the case to the district court with instructions to remand it to the Agency to consider whether disclaimers could sufficiently prevent consumer confusion and, if so, the content of those disclaimers. Id. at 659. The Court also held that the APA requires the FDA to "giv[e] some definitional content to the phrase 'significant scientific agreement,'" because to "declare-without explanation-that a proposed course of private action is not approved" is arbitrary and capricious. Id. at 660-61.

In requiring the Agency to consider the adequacy of possible disclaimers accompanying the manufacturers' proposed health claims, the Court recognized that "where evidence in support of a claim is outweighed by evidence against the claim, the FDA could deem it incurable by a disclaimer and ban it outright." Id. at 659. Similarly, the Court "s[aw] no problem with the FDA imposing an outright ban on a claim where evidence in support of the claim is qualitatively weaker than evidence against the claim." Id. at 659 n.10. However, the Court stated that the Agency "must still meet its burden of justifying a restriction on speech," and a "conclusory assertion" as to misleadingness is inadequate. Id. (citing Ibanez v. Fla. Dep't of Bus. & Prof'l Regulation, 512 U.S. 136, 146 (1994) ("If the protections afforded commercial speech are to retain their force, we cannot allow rote invocation of the words 'potentially misleading' to supplant the [government's] burden to demonstrate that the harms it recites are real and that its restriction will in fact alleviate them to a material degree.") (citations and internal quotation marks omitted)).

C. Pearson II

In late 2000, several of the plaintiffs from Pearson I and other dietary supplement designers, sellers, and manufacturers*fn6 filed a second lawsuit to challenge the Agency's decision prohibiting plaintiffs from including on their dietary supplements' labels a health claim concerning folic acid.*fn7 Pearson v. Shalala, 130 F. Supp. 2d 105, 107 (D.D.C. 2001) ("Pearson II"). After the decision in Pearson I, the FDA published a notice requesting submission of scientific data concerning the four health claims at issue in that case, including the folic acid claim. Id. at 110. The Agency also issued "Guidance for the Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements."*fn8

Id. at 111. After reviewing the newly submitted scientific data and applying the "significant scientific agreement standard" described in its guidance document and modified by an October 6, 2000 rule,*fn9 the Agency issued a decision stating that it would not authorize the manufacturers' folic acid claim, even with clarifying disclaimers, because it found the claim to be inherently misleading. Id. The plaintiffs argued that the Agency's decision "fundamentally misread and misapplied the legal standard articulated" in Pearson I and violated the First Amendment, the FFDCA, and the APA. Id. at 107, 112. They sought a preliminary injunction "enjoining the FDA from taking any action which would prevent Plaintiffs from using their desired folic acid health claim." Id. at 107.

The district court agreed with the plaintiffs, finding that the FDA "failed to comply with the constitutional guidelines outlined in Pearson [I]" when it concluded, without explanation, that the "weight of the evidence is against both aspects*fn10 of the proposed [folic acid] claim" and that the claim was therefore "inherently misleading" and not susceptible to correction by disclaimer. Id. at 112, 114. Although the court deferred to the Agency's "method of dissecting" and reading the folic acid claim per the APA, id. at 114 n.24, it disagreed with the FDA's weighing of the scientific data and found "as a matter of law that [the folic acid claim] is not 'inherently misleading.'" Id. In coming to this conclusion, the court analyzed the scientific data regarding folic acid and concluded that "[t]he mere absence of significant affirmative evidence in support of a particular claim . . . does not translate into negative evidence 'against' it." Id. at 115. Moreover, the court held that the "question which must be answered under Pearson [I] is whether there is any 'credible evidence'" in support of the claim. Id. at 114, 118 (quoting Pearson I, 164 F.3d at 658). If so, unless that evidence is "outweighed by evidence against the claim" or is "qualitatively weaker" than evidence against the claim, the claim "may not be absolutely prohibited." Id. at 114-15.

Because the court found that there was credible evidence to support the folic acid claim, it held that the FDA's determination that the folic acid claim was "inherently misleading" and could not be cured by disclaimers was "arbitrary and capricious" under the APA and that the FDA had not "undertake[n] the necessary analysis required by Pearson [I]." Id. at 119. The court granted the plaintiffs' motion for a preliminary injunction and remanded the case to the FDA to "draft one or more appropriately short, succinct, and accurate disclaimers." Id. at 120.

D. Pearson III

After the preliminary injunction was entered in Pearson II, the FDA filed a motion for reconsideration, arguing that the district court had "assign[ed] undue weight to a particular clinical study and fail[ed] to consider the relevant scientific evidence in totality" and "creat[ed] a legal standard which is inconsistent with [Pearson I]." Pearson v. Thompson, 141 F. Supp. 2d 105, 108 (D.D.C. 2001) ("Pearson III"). The district denied the motion, pointing to the FDA's "fail[ure] to fully and accurately describe the record evidence" and "speculative" arguments. Id. at 109. The district court also restated the holdings in Pearson I, which included 1) the obligation of the Agency to "demonstrate with empirical evidence that disclaimers . . . would bewilder consumers and fail to correct for ...


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