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January 3, 2003

JULIAN M. WHITAKER, M.D., et al., Plaintiffs,
TOMMY G. THOMPSON, Secretary, Department of Health and Human Services, et al., Defendants.

The opinion of the court was delivered by: GLADYS KESSLER, United States District Judge


Plaintiffs are individuals and companies with a direct financial interest in dietary supplements containing saw palmetto extract as well as a non-profit therapeutic health organization composed of physician members who sell dietary supplements containing saw palmetto extract.*fn1 They bring this action against the Food and Drug Administration ("FDA"), Jane E. Henney, Commissioner of the FDA,*fn2 the Department of Health and Human Services ("HHS"), Tommy G. Thompson, Secretary of the HHS, and the United States of America. Plaintiffs challenge the FDA's denial of a health claim application for saw palmetto.

  This matter is before the Court on Plaintiffs' Motion for Summary Judgment and Defendants' Motion to Dismiss. Plaintiffs claim the FDA's decision violates the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. (1972), the Administrative Procedure Act ("APA"), 5 U.S.C. § 706 et seq. (1996), the First Amendment, canons of statutory interpretation, and the Supremacy Clause. Defendants move to dismiss for failure to state a claim upon which relief can be granted, Fed.R.Civ.P. 12(b)(6), arguing that the FDA properly denied Plaintiffs' health claim application based on its classification of the saw palmetto claim as a drug claim. Upon consideration of Plaintiffs' and Defendants' Motions, Oppositions, Replies, the October

[239 F. Supp.2d 45]

      28, 2002, Motions Hearing, and the entire record herein, for the reasons discussed below, Defendants' Motion to Dismiss is granted, and Plaintiffs' Motion for Summary Judgment is denied.

 I. Background

  A. Statutory and Regulatory Framework

  Prior to November 8, 1990, the FDCA provided that dietary supplements — including the saw palmetto supplements at issue in this case — would be regulated as a food, unless their intended use was as a drug.*fn3 In other words, if a dietary supplement's label contained a disease-specific claim,*fn4 that supplement was subject to the FDA's drug approval and drug labeling requirements. See H.R. Rep. No. 101-538, at 9 (1990) ("House Rep."); 21 U.S.C. § 321(g)(1)(B) and 355 (1996).

  However, during the mid-1980s companies began making disease-specific claims about foods with increasing frequency and without the approval of the FDA. See House Rep. at 9. In response, Congress amended the FDCA through enactment of the Nutrition Labeling and Education Act ("NLEA") on November 2, 1990. Pub.L. No. 101-535, 104 Stat. 2353 (1990). Passage of the NLEA was intended to address concerns that the FDA had brought "virtually no enforcement actions" against the types of claims it had previously prohibited by clarifying and strengthening "the [FDA's] legal authority . . . to establish the circumstances under which claims may be made about the nutrients in foods." House Rep. at 7, 9.

  The NLEA liberalized the FDCA to permit health claims to be "made in the label or labeling of [a] food which expressly or by implication . . . characterizes the relationship of any nutrient . . . to a disease or a health-related condition." 21 U.S.C. § 343(r)(1)(B). However, Congress clearly stated that the NLEA and FDA regulatory standards were to concern "only nutrients or substances in foods that `nourish' and . . . [not] other, non-nutritive substances in foods." House Rep. at 7. Congress delegated to the FDA the task of developing a procedure and standard for approving health claims for dietary supplements, providing that health claims

made with respect to a dietary supplement of vitamins, minerals, herbs, or other similar nutritional substances . . . 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). Thus, under the NLEA, a dietary supplement health claim is not automatically subject to the FDCA's far more extensive and demanding approval and labeling requirements for drugs so long as the claim is made in accordance with other sections of the statute, including 21 U.S.C. § 343(r)(5)(D).

  In 1993, the FDA responded to the NLEA by promulgating 21 C.F.R. § 101.14 and 101.70, which explained the standards and procedures for FDA consideration of nutrient-disease claims. The FDA chose the same standard for authorizing dietary supplement health claims as the NLEA prescribed for authorizing food health claims — significant scientific agreement.

[239 F. Supp.2d 46]

      See 21 C.F.R. § 101.14.*fn5 In requesting authorization for a health claim, a party first submits a petition with the proposed health claim, accompanied by supporting evidence. See id. §§ 101.70(a)-(i). The FDA must then notify the applicant within 100 days whether the request will be denied or else "filed" for further review. See id. § 101.70(j)(2). If further review is warranted, within the next 90 days the FDA must either deny the petition or publish a proposed regulation authorizing the health claim. See id. § 101.70(j)(3). If the FDA publishes a proposed rule authorizing a health claim, the FDA must publish a final regulation approving or denying the claim within 270 days of the date of publication. See id. § 101.70(j)(4).

  In 1994, Congress passed the Dietary Supplement Health and Education Act of 1994 ("DSHEA"), Pub.L. No. 103-417, 108 Stat. 4325 (1994), to further recognize "the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention." Id. at § 2(2). The DSHEA clarified the FDA's role in authorizing health claims by creating "a rational Federal framework . . . to supersede the current ad hoc, patchwork regulatory policy on dietary supplements" to protect consumers' right of access to "safe dietary supplements . . . to promote wellness." Id. at § 2(15). Passage of the DSHEA attempted to further clarify the authorization of dietary supplement health claims by including within the FDCA a dietary supplement definition and an amended drug definition.*fn6

  B. Procedural History

  On May 25, 1999, Plaintiffs filed a health claim petition with the FDA seeking approval for the labels of saw palmetto supplements*fn7 to include the following health claim:
Consumption of 320 mg daily of Saw Palmetto extract may improve urine flow, reduce nocturia and reduce voiding urgency associated with mild benign prostatic hyperplasia (BHP).

[239 F. Supp.2d 47]

      Administrative Record ("A.R.") at 21-22. In accordance with FDA regulations, Plaintiffs included scientific evidence supporting their claim. See A.R. at 121-397. Plaintiffs also requested that the FDA "approve the claim with such disclaimer or disclaimers as the agency reasonably deemed necessary to avoid any potentially misleading connotation." A.R. at 10; see Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999) (Because the First Amendment favors speech disclosure over speech suppression, the FDA may not completely ban potentially misleading health claims but should allow such claims with an appropriate disclaimer.).

  On June 7, 1999, the FDA acknowledged receipt of the Plaintiffs' health claim petition, and on September 1, 1999, the FDA accepted the petition for filing. See A.R. at 398, 406. The Plaintiffs' petition was denied under operation of law on December 1, 1999, because the FDA allowed 90 days to pass without issuing a decision. See A.R. at 1175. The FDA stated that the denial was necessary because the prescribed time frame was insufficient to resolve the "important and novel issue . . . whether health claims for foods (including dietary supplements) may encompass [a claim of an effect on an existing disease] or whether such a claim is appropriate only on a product that has been shown to meet the safety and efficacy requirements for drugs." Id.

  On December 7, 1999, the Plaintiffs filed this suit seeking declaratory and injunctive relief in light of the FDA's denial of their health claim petition. The action was stayed pending FDA reconsideration of its decision, and on April 4, 2000, the FDA held public hearings to determine whether the Plaintiffs' saw palmetto claim was a health claim or a drug claim under the FDCA. Upon consideration of the hearings and other comments, the FDA issued a formal letter on May 26, 2000, providing further explanation of its refusal to process the Plaintiffs' saw palmetto petition. See A.R. at 721.

  The FDA concluded that "claims about effects on existing diseases do not fall within the scope of the health claims provisions in 21 U.S.C. § 343(r) and therefore may not be the subject of an authorized health claim." A.R. at 723. With regard to Plaintiffs' proposed health claim, the FDA found that
[The] petition clearly identifies the intended use of saw palmetto extract products bearing that proposed claim as the treatment of the urinary symptoms of BPH. The proposed model claim . . . explicitly describes the mitigation of disease by treating its symptoms and establishes the intended use of products bearing the claim as drugs.
A.R. at 728. The FDA stated that its decision was based on the language and ...

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