Alliance For Natural Health Us v. Sebelius

• Citation: 786 F.Supp.2d 1
• Decision Date: 13 April 2011
• Docket Number: Civil Action No. 09–1546(BAH).
• Parties: ALLIANCE FOR NATURAL HEALTH US, et al., Plaintiffs,v.Kathleen SEBELIUS, et al., Defendants.
• Court: U.S. District Court — District of Columbia

786 F.Supp.2d 1

ALLIANCE FOR NATURAL HEALTH US, et al., Plaintiffs,

v.Kathleen SEBELIUS, et al., Defendants.

Civil Action No. 09–1546(BAH).

United States District Court, District of Columbia.

April 13, 2011.

Jonathan W. Emord, Emord & Associates P.C., Clifton, VA, for Plaintiffs.Carol L. Wallack, U.S. Department of Justice, Washington, DC, for Defendants.

MEMORANDUM OPINION

BERYL A. HOWELL, District Judge.

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.¹

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 U.S. 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.² 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.³ 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, 100 S.Ct. 2343, 65 L.Ed.2d 341 (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' proposed health 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...