Plaintiffs are designers, sellers, and manufacturers of dietary supplement formulations containing folic acid. *fn1 They bring this action against Defendants Donna E. Shalala, Secretary, United States Department of Health and Human Services ("HHS"), in her official capacity; HHS; Jane E. Henney, M.D., Commissioner of Food Drugs, Food and Drug Administration ("FDA"), in her official capacity; the FDA; and the United States of America.
Plaintiffs challenge an FDA decision prohibiting them from including on their dietary supplements' labels a particular folic acid health claim, contending that the FDA's decision violates the First Amendment, Fifth Amendment, and Supremacy Clause of the United States Constitution, as well as the Food, Drug and Cosmetic Act, 21 U.S.C. § 343(r)(5)(D), 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 Plaintiffs from using their desired folic acid health claim.
This matter is before the Court on Plaintiffs' Motion for a Preliminary Injunction [#3]. Upon consideration of the Motion, Opposition, Reply, the Excerpts of Record, the arguments of counsel during the motions hearing, and the entire record herein, for the reasons discussed below, Plaintiffs' Motion for a Preliminary Injunction is granted.
I. Statutory Framework and Procedural History
Prior to November 8, 1990, dietary supplements *fn2 --including the multi-vitamin supplements containing folic acid at issue in this case--were regulated as a "food," unless their intended use was as a "drug." *fn3
In other words, if a dietary supplement's label *fn4 contained a health claim, *fn5 that supplement became subject to the FDA's strict drug approval and drug labeling requirements. See 21 U.S.C. §§ 321(g)(1)(B) and 355.
On November 2, 1990, Congress enacted the Nutrition Labeling and Education Act ("NLEA" or "the Act"), *fn6 which amended the Federal Food, Drug, and Cosmetic Act ("FFDCA"), 21 U.S.C. § 301 et seq. The NLEA liberalized the FFDCA, 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). So long as a health claim is made in accordance with 21 U.S.C. § 343(r)(3), for foods in conventional form, or in accordance with 21 U.S.C. § 343(r)(5)(D), for dietary supplements, the claim is not subject to the FFDCA'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 under which the FDA would authorize and evaluate 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) (emphasis added).
Health claims for dietary supplements received a different authorization procedure, however. 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 provides simply 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).
In addition, Congress specifically directed the FDA to consider whether health claims could be authorized for a number of specified nutrient-disease relationships, including the connection between folic acid *fn7 and neural tube defects ("NTDs"). *fn8 See 21 U.S.C. § 343(r)(5)(D); NLEA, Pub. L. 101-535, § 3(b)(1)(A)(x).
The FDA responded to section 343(r)(5)(D) by promulgating 21 C.F.R. § 101.14, which applied the NLEA-prescribed procedure for food health claims (i.e., "significant scientific agreement") as the authorization procedure for dietary supplement health claims. The FDA responded to section 343(r)(5)(D) by publishing a proposed rule in the Federal Register on November 27, 1991, proposing not to authorize any health claim linking folic acid with a reduction in the risk of neural tube defects.
On January 6, 1993, the FDA adopted a final rule prohibiting claims associating folic acid with NTDs. See 58 Fed. Reg. 2606 (Jan. 6, 1993). On October 14, 1993, however, the FDA reversed its position and proposed authorizing certain claims associating folic acid with a reduction in the risk of NTDs. See 58 Fed. Reg. 53254 (Oct. 14, 1993). *fn9
On January 28, 1994, Plaintiffs Durk Pearson and Sandy Shaw and the American Preventive Medical Association ("Pearson Plaintiffs") filed comments asking the FDA to authorize the following claim: ".8 mg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form" (the "Folic Acid Claim"). Plaintiffs wished to use this claim on the labels and in the labeling of their dietary supplements. Compl. ¶ 40. The FDA rejected Plaintiffs' request, stating that "the scientific literature does not support the superiority of any one source [of folic acid] over others." 61 Fed. Reg. at 8760.
In a final rule, the FDA established the daily recommended intake ("RDI") for folate *fn10 to be 400 mcg (0.4 mg), and it identified 100% of the RDI as the "target intake goal." 21 C.F.R. § 101.79(b)(3), (c)(3)(iv). *fn11 The FDA also approved four "model" health claims, each of which essentially indicated that women who consume "healthful diets with adequate folate . . . may reduce their risk of having a child with birth defects of the brain or spinal cord." *fn12 21 C.F.R. § 101.79; Joint Excerpts of Record ("J.R.") at 17. The FDA authorized foods and dietary supplements to carry any of these model claims on their labels if they qualify as a "good source" of folate. 21 C.F.R. § 101.79(c)(2)(ii). A food or dietary supplement qualifies as a "good source" of folate if it contains 10% of the RDI ( i.e., 10% of 400 mcg, which equals 40 mcg or .04 mg).
The Pearson Plaintiffs contended that these model claims were themselves misleading and otherwise unsatisfactory, and that the FDA's refusal to authorize Plaintiffs' Folic Acid Claim violated the First Amendment, the APA and other laws. Accordingly, on November 16, 1995, the Pearson Plaintiffs brought suit against the FDA, arguing that the FDA had unlawfully suppressed their Folic Acid Claim and requesting that the court invalidate the FDA's decision. *fn13 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) (Kessler, J.).
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 Plaintiffs' Folic Acid Claim, among other health claims. See Pearson v. Shalala, 164 F.3d 650, 661 (D.C. Cir. 1999) ("Pearson" or "Court of Appeals Opinion").
The Court of Appeals strongly suggested, without declaring so explicitly, that Plaintiffs' Folic Acid Claim was only "potentially misleading," not "inherently misleading," and therefore the FDA's refusal to authorize the Folic Acid Claim (or to propose a disclaimer to accompany the Claim) violated the First Amendment. Specifically, the Court of Appeals stated:
The FDA's concern regarding the fourth claim--"0.8 of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form"--is different from its reservations regarding the first three claims; the agency simply concluded that "the scientific evidence does not support the superiority of any one source [of folic acid] over others." 61 Fed. Reg. at 8760. But it appears that credible evidence did support this claim [citation omitted], and we suspect that a clarifying disclaimer could be added to the effect that "the evidence in support of this claim is inconclusive." 164 F.3d at 659 (emphasis added).
The Court of Appeals went on to state:
We do not presume to draft precise disclaimers for each of appellants' four claims; we leave that task to the agency in the first instance. Nor do we rule out the possibility 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.
In addition, the Court of Appeals held that the FDA failed to adequately define the standard for reviewing health claims that it had adopted pursuant to 21 U.S.C. § 343(r)(5)(D) ("significant scientific agreement"), and thus acted arbitrarily and capriciously in violation of the APA.
Accordingly, the Court of Appeals directed the FDA on remand: (1) to determine whether a disclaimer could be added to the Folic Acid 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." 164 F.3d at 655, 660.
On April 20, 1999, this Court remanded the case to the FDA, in accordance with the Court of Appeals Opinion. Thereafter, the Pearson Plaintiffs sent a series of letters to the FDA, asking by what "date certain" the agency intended to comply with the Court of Appeals Opinion. Compl. ¶ 53. The Pearson Plaintiffs also asked if the FDA would be willing to authorize their Folic Acid Claim, accompanied by one of the disclaimers suggested by the Court of Appeals ("The evidence in support of this claim is inconclusive") or other appropriate disclaimers.
On September 8, 1999, the FDA published a notice requesting that interested parties submit scientific data concerning the four substance-disease relationships at issue in Pearson, including the relationship between folic acid and NTDs. *fn14 64 Fed. Reg. 48841 (Sept. 8, 1999); J.R. at 150. The FDA also contracted with a non-government entity "to conduct a literature review for the four claims to identify 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 Prelim. Inj. ("Govt's Opp'n") at 6. As a result of these two information-gathering measures, the FDA received a large number of post-1992 scientific studies describing the relationship between folate and NTDs, including a 1998 study conducted by the Institute of Medicine of the National Academy of Sciences *fn15 ("IOM/NAS Study") *fn16 and a 1999 follow-up study ("Berry Study") *fn17 . Govt's Opp'n at 7-8. The FDA received over 600 pages of scientific submissions from Plaintiffs, including documentation of a 1992 human clinical intervention trial conducted on Hungarian women ("Cziezel Study") *fn18 . Compl. ¶ 63-64.
On December 22, 1999, in response to the Court of Appeals' order that the FDA further define the "significant scientific agreement" standard for evaluating dietary supplement health claims, the FDA issued "Guidance for the Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements" ("Guidance Report") and announced its availability in the Federal Register. 64 Fed. Reg. 71794 (Dec. 22, 1999); J.R. at 163, 165-186.
On March 31, 2000, the Pearson Plaintiffs filed an application for a preliminary injunction before this Court, contending that the FDA's continuing refusal, subsequent to the Court of Appeals Opinion, to authorize Plaintiffs' Folic Acid Claim and the three other claims, with or without disclaimers, violated the First Amendment. On May 23, 2000, the Court denied the Pearson Plaintiffs' application, declaring, among other things, that "[b]ecause FDA has not yet exhausted the 540-day period within which they must make a final decision on Plaintiffs' health claims, . . . Plaintiffs have not suffered any First Amendment injury which this Court can address." Pearson v. Shalala, Civ. A. No. 95-1865, 2000 WL 767584, at *3 (D.D.C. May 24, 1999) (Kessler, J.).
On October 3, 2000, the FDA published a notice revoking the four rules held unconstitutional by the Court of Appeals in Pearson, over 18 months after that Court's decision. 65 Fed. Reg. 58917, 58918 (Oct. 3, 2000); J.R. at 158-159. The FDA continued to refuse to ...