Whitaker v. Thompson
| Decision Date | 01 September 2004 |
| Docket Number | Civil Action No. 01-1539 (GK) |
| Parties | JULIAN M. WHITAKER, M.D., et al., Plaintiffs, v. TOMMY G. THOMPSON, Secretary, Department of Health and Human Services, et al., Defendants, |
| Court | U.S. District Court — District of Columbia |
TOMMY G. THOMPSON, Secretary, Department of Health and Human Services, et al., Defendants,
United States District Court, District of Columbia.
Plaintiffs are individuals and companies with a direct financial interest in dietary supplements containing vitamins C and E ("antioxidant vitamins") as well as a non-profit therapeutic health organization composed of physician members who sell dietary supplements containing antioxidant vitamins.1 They bring this action against Defendants Tommy F. Thompson, Secretary, United States Department of Health and Human Services ("HHS"), in his official capacity; HHS; Bernard A. Schwetz, Acting Principal Deputy Commissioner of the Food and Drug Administration ("FDA"), in his official capacity; Joseph A. Levitt, Director of the Center for Food and Safety and Applied Nutrition of the FDA, in his official capacity; Christine J. Lewis, Ph.D., Director of the Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition of the FDA, in her official capacity; and the United States of America.
Plaintiffs challenge the FDA decision prohibiting dietary supplements' labels from including the health claim that "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers" ("Antioxidant Vitamin Claim" or "Claim"). Plaintiffs contend that the FDA's decision violates the First Amendment, the Fifth Amendment, the Defendants' oaths of office to uphold the Constitution, 5 U.S.C. § 3331, the Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 343(r)(1)(B), and the Administrative Procedure Act ("APA"), 5 U.S.C. § 706. Plaintiffs seek a preliminary injunction enjoining the FDA from taking any action which would prevent the use of the desired antioxidant vitamin health claim as proffered or with reasonable disclaimers.
This matter is before the Court on Plaintiffs' Motion for a Preliminary Injunction [#4]. Upon consideration of the Motion, Opposition, Reply, the Excerpts of Record, and the entire record herein, for the reasons discussed below, Plaintiffs' Motion for a Preliminary Injunction is granted.
I. Background
Prior to November 8, 1990, the FDCA, 21 U.S.C. § 301 et seq., provided that dietary supplements—including the supplements containing the antioxidant vitamins at issue in this case—would be regulated as a "food," unless their intended use was as a "drug."2 If a food or dietary supplement label3 contained a health claim,4 the FDA deemed the product to be a drug, and it then became subject to the FDA's rigorous drug approval and drug labeling requirements. See 21 U.S.C. §§ 321(g)(1)(B) and 355.
On November 2, 1990, Congress amended the FDCA by enacting the Nutrition Labeling and Education Act ("NLEA" or "Act").5 The NLEA liberalized the FDCA, creating a "safe harbor" from "drug" designation for dietary supplements and foods that make health claims. See 21 U.S.C. § 343(r)(1)(B). Under the Act, so long as a health claim for dietary supplements is made in accordance with 21 U.S.C. § 343(r)(5)(D) as well as other sections of the statute, the claim is not subject to the FDCA's far more extensive and demanding approval and labeling requirements for drugs. See 21 U.S.C. § 321(g)(1)(B).
The NLEA also established the procedure for FDA authorization and evaluation of health claims for foods and dietary supplements. The Act directed that health claims for conventional foods shall be approved
only if the Secretary determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.
21 U.S.C. § 343(r)(3)(B)(i). However, a different authorization procedure was provided for health claims for dietary supplements. Instead of mandating a particular standard as it did for conventional foods in § 343(r)(3)(B)(i), Congress broadly delegated to the FDA the task of developing an appropriate procedure for evaluating and authorizing health claims for dietary supplements. The relevant section merely provides that health claims
made with respect to a dietary supplement . . . shall be subject to a procedure and standard, respecting the validity of such a claim, established by regulation of the Secretary.
21 U.S.C. § 343(r)(5)(D). The FDA responded to section 343(r)(5)(D) by promulgating 21 C.F.R. § 101.14, which adopted the same standard for authorizing dietary supplement health claims as the NLEA prescribed for authorizing food health claims—significant scientific agreement. The Act also specifically directed the FDA to consider whether health claims could be authorized for a number of specified nutrient-disease relationships, including the antioxidant vitamin/cancer relationship. See 21 U.S.C. § 343(r)(5)(D); NLEA, Pub. L. 101-535, § 3(b)(1)(A)(x).
After a lengthy rule-making procedure under the APA, the FDA adopted a final rule prohibiting claims associating antioxidant vitamins with cancer on January 6, 1993. See 58 Fed. Reg. 2622 (Jan. 6, 1993); Excerpts of the Record ("E.R.") Tab 5. The FDA found significant scientific agreement that there was evidence supporting the relationship between a decreased risk of several types of cancer and " diets rich in fruits and vegetables, which are generally low in fat and high in vitamin A (as beta-carotene), vitamin C, and dietary fiber." 58 Fed. Reg. at 2622 (emphasis added). However, the FDA did not find that such evidence was "sufficient to attribute the reduction in risk specifically to...vitamin C, or vitamin E, alone or in combination, or to other components of these diets." 58 Fed. Reg. at 2622. Nine months later, the FDA reiterated its refusal to authorize health claims associating antioxidant vitamins with cancer. See 58 Fed. Reg. 53296 (Oct. 14, 1993); E.R. Tab 6.
On November 16, 1995, Plaintiffs Durk Pearson, Sandy Shaw, and the American Preventive Medical Association ("Pearson Plaintiffs") brought suit arguing that the FDA had violated the First Amendment, the APA, and other laws through its unlawful suppression of four health claims, including the Antioxidant Vitamin Claim,6 and requesting that the court invalidate the FDA's decision. On January 12, 1998, this Court upheld the FDA's decision and granted summary judgment in its favor. See Pearson v. Shalala, 14 F. Supp. 2d 10 (D.D.C. 1998).
On January 15, 1999, the Court of Appeals for the District of Columbia Circuit reversed and remanded the case with instructions to remand it in turn to the FDA for reconsideration of the prohibited health claims, including Plaintiffs' Antioxidant Vitamin Claim, in light of its discussion of the relevant legal issues. See Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) ("Pearson I").
The Court of Appeals in Pearson I strongly suggested, without explicitly holding, that Plaintiffs' Antioxidant Vitamin Claim was only "potentially misleading," not "inherently misleading," and therefore the FDA's refusal to authorize the Antioxidant Vitamin Claim (or to propose a disclaimer to accompany the Claim) violated the First Amendment. Specifically, while Pearson I recognized the FDA's concern that the antioxidant health claim lacked "significant scientific agreement because existing research had examined only the relationship between consumption of foods containing these components and the risk of these diseases," the Court stated that the FDA's concern "could be accommodated...by adding a prominent disclaimer to the label." Id., 164 F.3d at 658 (emphasis in original).
Pearson I left the task of drafting precise disclaimers to the agency and acknowledged that in some circumstances a complete ban of a claim might be appropriate. Id., 164 F.3d at 659. While recognizing the possibility that a disclaimer could be an inadequate guard against deceptiveness, the Court was "skeptical that the government could demonstrate with empirical evidence that disclaimers similar to the ones [suggested by the Court] would bewilder consumers and fail to correct for deceptiveness." Id., 164 F.3d at 659-60.
In addition, Pearson I held that the FDA acted arbitrarily and capriciously in violation of the APA by failing to adequately define the "significant scientific agreement" standard for reviewing health claims that it had adopted pursuant to 21 U.S.C. § 343(r)(5)(D). Id., 164 F.3d at 660-61. Accordingly, the Court of Appeals directed the FDA on remand: (1) to determine whether a disclaimer could be added to the Antioxidant Vitamin Claim and other health claims to cure them of potentially misleading connotations, and (2) to explain "what it means by significant scientific agreement or, at minimum, what it does not mean." Id., 164 F.3d at 655, 660.
As directed by the Court of Appeals, this Court remanded the case to the FDA on April 20, 1999. In response to the first order in Pearson I, the FDA published a notice requesting that interested parties submit scientific data concerning the four substance-disease relationships at issue in Pearson I, including the antioxidant vitamin/cancer relationship.7 64 Fed. Reg. 48841 (Sept. 8, 1999); E.R. Tab 8. The FDA also contracted with a non-government entity "to conduct a literature search to identify for each of the four claims relevant scientific information that became available after the agency's initial review of these claims." Govt's Mem. in Opp'n to Pls.' Mot. for a Prelim. Inj. ("Govt's Opp'n") at 4-5. As a result of these two information-gathering measures, the FDA received a large number of post-1992...
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