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Alliance For Natural Health Us, et al v. Kathleen Sebelius

April 13, 2011

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



The opinion of the court was delivered by: Beryl A. Howell United States District Judge

MEMORANDUM OPINION

Dietary supplement designers and industry groups brought this lawsuit challenging a decision of the Food and Drug Administration ("FDA") to deny a petition for authorization of certain qualified health claims regarding dietary supplements containing vitamin C and vitamin E. The plaintiffs assert the FDA's decision has violated their First Amendment rights. Invoking both circuit and district court opinions that have addressed similar claims, plaintiffs seek a declaratory judgment that the FDA's final order denying the petition is invalid and a permanent injunction enjoining the FDA from "taking any action that would preclude the Plaintiffs from placing [their proposed] health claims on the labels and in the labeling of their dietary supplements." Complaint ("Compl.") at 36. The plaintiffs' motion for summary judgment and the defendants' cross-motion for summary judgment are now before the Court. For the reasons explained below, the Court will grant in part and deny in part the parties' motions and remand certain claims to the FDA.

I.BACKGROUND

This case is the latest chapter in a lengthy saga of litigation concerning the FDA's regulation of the plaintiffs' marketing claims about the purported health benefits of various dietary supplements. Plaintiffs Durk Pearson and Sandy Shaw are scientists who design dietary supplement formulations and license them to manufacturers and retailers. Compl. ¶ 9. The other plaintiffs -- the Coalition to End FDA and FTC Censorship and the Alliance for Natural Health US -- are dietary supplement industry organizations. Id. ¶¶ 8, 10. The defendants are Kathleen Sebelius, in her official capacity as Secretary of the United States Department of Health and Human Services, the United States Department of Health and Human Services, Margaret A. Hamburg, M.D., in her official capacity as Commissioner of the United States Food and Drug Administration, the Food and Drug Administration, and the United States of America (collectively, the "FDA" or the "defendants"). Id. ¶ 11.

In this case, the plaintiffs challenge an FDA decision declining to approve several health claims concerning the relationship between vitamins C and E and the risk for certain types of cancer. Before turning to the particular facts of this case, however, it is necessary to review the legal background underlying the parties' dispute and the previous court rulings that have addressed the issues involved here.*fn1

A.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, and amino acids. 21 U.S.C. § 321(ff)(1). A dietary supplement is deemed to be "food," 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). 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).

In 1990, Congress enacted the Nutrition Labeling and Education Act of 1990 ("NLEA"), Pub.L. No. 101-535, 104 Stat. 2353 (1990) (codified as amended at 21 U.S.C. §§ 301, 321, 337, 343, 343-1, 345, 371), which amended the Food, Drug, and Cosmetic Act ("FDCA") to provide the FDA with authority to regulate health claims on food, including dietary supplements. Pearson v. Shalala, 164 F.3d 650, 653 (D.C. Cir. 1999) ("Pearson I"). The NLEA created a "safe harbor" from the "drug" designation for foods and dietary supplements labeled with health claims. Alliance for Natural Health US v. Sebelius, 714 F. Supp. 2d 48, 51 (D.D.C. 2010) ("Alliance I"); see also 21 U.S.C. § 343(r)(1). Under the NLEA, 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 FDA may enjoin the product's distribution or seek criminal penalties against its manufacturer. Id. §§ 331(a), 332, 334, 352(a).

B.Pearson v. Shalala and Its Progeny

The plaintiffs here and other individuals and groups affiliated with the production, sale, and use of dietary supplements have, for more than decade, sought judicial review of various FDA decisions denying a variety of proposed health claims. In the first of these lawsuits challenging the FDA's rejection of the plaintiffs' proposed claims on First Amendment grounds, the D.C. Circuit invalidated the FDA's then-existing approach to health claim review.

Pearson I, 164 F.3d at 655-61. 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.

1. Pearson I

In 1995, a group of dietary supplement designers and others filed suit against the FDA and other defendants under the First Amendment, challenging the FDA's rejection of four health claims that the manufacturers sought to include on certain dietary supplements.*fn2 Pearson v. Shalala, 14 F. Supp. 2d 10, 14 (D.D.C. 1998) ("First Pearson District Court Opinion"). The claims characterized a relationship between dietary supplements and the risk of particular diseases.*fn3 Id. The FDA, 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 FDA 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 supplement designers 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 their First Amendment rights. First Pearson District Court Opinion, 14 F. Supp. 2d at 14.

After the district court denied the supplement designers' motion for summary judgment, the D.C. Circuit reversed. The Court of Appeals, 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), 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' proposedhealth claims without consideration of disclaimers. Pearson I, 164 F.3d at 656-58. Specifically, the Court held that under 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 (internal quotation marks omitted). The FDA'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 a "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 FDA to consider whether disclaimers could sufficiently prevent consumer confusion and, if so, to specify 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 FDA to consider the adequacy of possible disclaimers accompanying the supplement designers' 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)).

2. Pearson II

In late 2000, several of the plaintiffs from Pearson I and other dietary supplement designers, sellers, and manufacturers filed a second lawsuit to challenge the FDA's decision prohibiting plaintiffs from including on their dietary supplements' labels a health claim concerning folic acid.*fn4 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 FDA also issued a guidance document, "Guidance for the Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements." 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, the FDA 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 FDA's decision "fundamentally misread and misapplied the legal standard articulated" in Pearson I and violated the First Amendment, the FDCA, 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 . . . 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 FDA'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.

3. 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 court denied the motion, pointing to the FDA's "fail[ure] to fully and accurately describe the record evidence" and "speculative" arguments. Id. at 109.

4. Whitaker v. Thompson

In June 2001, the plaintiffs filed another lawsuit to challenge the FDA's decision not to authorize an antioxidant claim that had been at issue in Pearson I.*fn5 Whitaker, 248 F. Supp. 2d at 2, 7. The FDA, after reviewing the antioxidant-cancer relationship studies submitted at its request subsequent to Pearson I, "found a lack of significant scientific agreement as to the relationship between antioxidant vitamin intake and reduction in the risk of developing cancer." Id. at 7. The FDA concluded "that the weight of the scientific evidence against the relationship [between cancer and antioxidant vitamins] was greater than the weight of evidence in favor of the relationship" and, similar to its analysis of the folic acid claim in Pearson I and II, it determined that the plaintiffs' antioxidant claim was therefore "inherently misleading and c[ould not] be made non-misleading with a disclaimer or other qualifying language." Id.; see also Pearson II, 130 F. Supp. 2d at 111-12. Plaintiffs argued that the FDA had again misapplied the standard articulated in Pearson I in violation of the First Amendment, and the district court agreed. Id. at 7-8.

Citing the Supreme Court's then-recent decision in Thompson v. Western States Medical Center, 535 U.S. 357 (2002), the court held that the FDA had not met its "burden . . . to prove that its method of regulating speech [wa]s the least restrictive means of achieving its goals." Whitaker, 248 F. Supp. 2d at 9 (citing Western States, 535 U.S. at 371-73). Specifically, the court held that the FDA had failed to present evidence that the proposed antioxidant claim, "if accompanied by a disclaimer, would be deceptive or unlawful." Id. In coming to its conclusion, the court reviewed the FDA's analysis of the claim in light of Pearson I, noting that "[t]he deference due to an agency's expert evaluation of scientific data does not negate 'the duty of the court to ensure that an agency . . . conduct a process of reasoned decision-making." Id. at 11 (quoting K N Energy, Inc. v. F.E.R.C., 968 F.2d 1295, 1303 (D.C. Cir. 1992)). As such, the court reviewed over 150 intervention and observational studies regarding the relationship between antioxidant vitamins and cancer relied upon by the FDA in reaching its conclusions and found that nearly one-third of the studies "supported" the antioxidant/cancer relationship. Id. The court determined that the FDA had "failed to follow its own [Guidance] Report and give appropriate weight" to these studies. Id. at 12. Furthermore, the court held that the FDA had improperly emphasized and de-emphasized the import of certain studies, directly contrary to the protocol it established in the Guidance Report. Id. In short, the court concluded that the "basic finding" on which the FDA rested its denial of the proposed claim was "unreasonable because it [wa]s not supported by an overall review of the available evidence or the FDA's own Guidance Report." Id. at 13. The court then found that the circumstances under which the FDA might ban a claim as misleading, described in Pearson I, were not present because (1) one-third of the evidence examined supported the claim; and (2) the FDA failed to provide "empirical evidence that an appropriate disclaimer would confuse customers and fail to correct for deceptiveness." Id. As a result, the court granted a preliminary injunction after concluding that the FDA's decision to suppress the claim did not "comport with the First Amendment's clear preference for disclosure over suppression of commercial speech." Id. at 15, 17 (remanding case to FDA to draft "short, succinct, and accurate alternative disclaimers").

5.Alliance I

In Alliance for Natural Health US v. Sebelius, 714 F. Supp. 2d 48 (D.D.C. 2010) ("Alliance I"), the same plaintiffs present in this action filed suit against the FDA challenging the FDA's denial of approval for certain health claims regarding the relationship between cancer risk and selenium supplements. Id. at 57. The plaintiffs had proposed their selenium health claims as "qualified" claims, which are health claims that include one or more disclaimers designed to eliminate potentially misleading assertions.*fn6 Id. at 56 n.13. The FDA created the category of "qualified" claims in response to the D.C. Circuit's holding in Pearson I. Id. In the time between the decision in Whitaker and the filing of the lawsuit in Alliance I, the FDA had issued a new guidance document governing the evaluation of health claims, including "qualified claims." See Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims (hereinafter "2009 Guidance Document") at Administrative Record ("A.R.") 2422-51. Applying its new "evidence-based review system" to the plaintiffs' selenium claims, the FDA banned certain of the plaintiffs' claims entirely, concluding that there was no credible scientific evidence supporting them, Alliance I, 714 F. Supp. 2d at 57-58, and the FDA exercised its "enforcement discretion" to permit modified versions of other claims that the FDA found to be supported by some credible evidence. Id.

The plaintiffs objected both to the FDA's decision to ban certain claims entirely as well as to the FDA's modified claims, contending that, in both instances, the FDA violated the plaintiffs' First Amendment rights. Id. The plaintiffs contended that the language of the modified claims infringed their First Amendment rights by constructively suppressing their claims "with the imposition of an onerous, value laden set of qualifications that only allow Plaintiffs to propound a false, negatively value-laden, and inaccurate claim to the public." Id.

The Alliance I court, in applying the relevant analysis dictated by the Central Hudson test as elaborated by the D.C. Circuit in Pearson I, "conduct[ed] an independent review of the record . . . without reliance on the [FDA's] determinations as to constitutional questions." Id. at 60. In accordance with binding precedent, however, the court gave "deference to the [FDA's] interpretation of scientific information, provided such interpretation [was] reasoned and not arbitrary or capricious." Id.

With respect to the claims that the FDA banned entirely, the Alliance I court began by noting that Pearson I suggested that when "'credible evidence' supports a claim, that claim may not be absolutely prohibited." Id. at 65 (citing Whitaker, 248 F. Supp. 2d at 10; Pearson I, 164 F.3d at 658-59 (where "credible evidence" supported a proposed claim, "a clarifying disclaimer could be added" to note that the evidence was inconclusive)). Since the FDA had justified its decision to ban the plaintiffs' claims on the grounds that the claims were not supported by any credible evidence, the court reviewed the record to evaluate whether the FDA's process of determining that the claims were not supported by credible evidence had been arbitrary and capricious. Alliance I, 714 F. Supp. 2d at 65. While the court found that many aspects of the FDA's determinations for each claim were not ...


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