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SHAW v. SHALALA

January 12, 1998

DURK PEARSON and SANDY SHAW, ET AL., Plaintiffs
v.
DONNA E. SHALALA, SECRETARY, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, ET AL., Defendants.



The opinion of the court was delivered by: KESSLER

MEMORANDUM OPINION

 This matter is before the Court on Defendants' Motion to Dismiss [# 12], and Plaintiffs' Motion for Summary Judgment [# 28]. Plaintiffs, Durk Pearson and Sandy Shaw, the American Preventive Medical Association, Citizens for Health, and the National Health Federation, challenge the constitutional validity of several U.S. Food and Drug Administration ("FDA") regulations that require sellers of dietary supplements to obtain FDA authorization before labeling such supplements with "health claims". *fn1" Plaintiffs are manufacturers, distributors and organizations of consumers of dietary supplements.

 Plaintiffs challenge both the general rule issued by FDA for determining the validity of health claims for dietary supplements, 21 C.F.R. § 101.14, as well as four separate regulations addressing claims for specific disease-nutrient relationships, issued pursuant to that general rule under the Nutrition Labeling and Education Act of 1990 ("NLEA"), Pub. L. 101-535, 104 Stat. 2353 (1990). Plaintiffs claim that the regulations violate the First Amendment, violate the Fifth Amendment because they are unconstitutionally vague, and violate the NLEA and the Administrative Procedure Act ("APA"), 5 U.S.C. § 706 (1996). Plaintiffs seek review of the Final Rules of the FDA, which established the general health claim standard and denied approval for labeling containing the four specific health claims, as well as a declaratory judgment and injunctive relief.

 All Defendants (Donna E. Shalala, Secretary, Department of Health and Human Services ("HHS"), HHS itself, David A. Kessler, Commissioner of the FDA, the FDA itself, and the United States of America) move to dismiss pursuant to Fed. R. Civ. P. 12(b)(6), for failure to state a claim upon which relief can be granted. Upon consideration of Defendants' and Plaintiffs' Motions, Oppositions, Replies, Amici Curiae Memoranda, and the entire record herein, for the reasons discussed below, the Court grants Defendants' Motion to Dismiss, and denies Plaintiffs' Motion for Summary Judgment.

 I. Statutory and Regulatory Framework

 Prior to enactment of the NLEA, which amended the Federal Food, Drug, and Cosmetic Act ("FFDC Act"), 21 U.S.C. § 301 et seq. (1972), dietary supplements, such as Vitamin C tablets, were regulated as a food, unless their intended use was as a drug. *fn2" If a dietary supplement's label contained a disease-specific health claim, that supplement became subject to the FDA's drug approval and drug labeling requirements. See H.R. Rep. No. 538, 101st Cong., 2d Sess. at 9 (1990), reprinted in 1990 U.S.C.C.A.N. 3338 ("House Report"); 21 U.S.C. §§ 321(g)(1)(B) and 355 (1996). *fn3"

 During the mid-1980s companies began making health claims about foods without the approval of the FDA. See House Rep. at 9; see e.g. Kellogg Co. V. Mattox, 763 F. Supp. 1369 (N.D. Tex. 1991)(breakfast cereal "Heartwise" claimed to lower cholesterol), aff'd mem. sub nom. Kellogg Co. V. Morales, 940 F.2d 1530 (5th Cir. 1991). In order to "clarify and to strengthen [the FDA's] legal authority to require nutrition labeling on foods, and to establish the circumstances under which claims may be made about the nutrients in foods", Congress passed the NLEA. House Report at 7.

 The NLEA had two main goals: (1) to help consumers maintain healthy dietary practices by requiring food labeling to contain clear, consistent nutrition information, including information about the relationship of diet to disease; and (2) to protect consumers from fraud and misinformation by ensuring that claims made for foods are understandable, consistent, and scientifically valid. House Rep. at 8.

 The NLEA liberalized the FFDC Act to permit claims to be "made in the label or labeling of [a] food which expressly or by implication . . . characterize[] the relationship of [a] nutrient . . . to a disease or a health-related condition." 21 U.S.C. § 343(r)(1)(B). The claims, however, must be made in accordance with 21 U.S.C. § 343(r)(3) for foods in conventional form, and in accordance with 21 U.S.C. § 343(r)(5)(D) for dietary supplements. So long as a claim is made in accordance with either one of these two sections, the food or dietary supplement is not subject to the FFDC Act's far more extensive and onerous approval and labeling requirements for drugs. See 21 U.S.C. § 321(g)(1)(B).

 In order to assert health claims for conventional foods, the NLEA provides that products must obtain prior FDA authorization. 21 U.S.C. § 343(r)(3)(B)(i). Such claims may 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.

 Id. (emphasis added). In addition, Congress directed that any authorizing regulation promulgated by the FDA:

 
require such claim to be stated in a manner so that the claim is an accurate representation of [the nutrient-disease relationship] and so that the claim enables the public to comprehend the information provided in the claim and to understand the relative significance of such information in the context of a total daily diet.

 Id. at § 343(r)(3)(B)(iii).

 In order to assert health claims for dietary supplements, Congress adopted a slightly different approach. Instead of specifically mandating a particular standard as it did with respect to conventional foods in § 343(r)(3)(B)(i), Congress delegated to the FDA the task of developing a procedure and standard for health claims for dietary supplements. Section 343(r)(5)(D) provides that health claims

 
made with respect to a dietary supplement of vitamins, minerals, herbs, or other similar nutritional substances shall not be subject to subparagraph (3) but shall be subject to a procedure and standard, respecting the validity of such a claim, established by regulation of the Secretary.

 Id. (emphasis added). It is the regulation promulgated by the FDA pursuant to this provision which is at issue in this case.

 Thus, Congress directed the FDA to establish, through rulemaking, the general health claim procedure and standard to be applied to all dietary supplements, and to determine whether ten specific health claims regarding nutrient-disease relationships in both conventional foods and dietary supplements met the requirements of the NLEA. *fn4" Only four of those ten specific nutrient-disease relationship claims are at issue in this case: folic acid and neural tube defects; antioxidant vitamins and cancer; omega-3 fatty acids and coronary heart disease; and dietary fiber and cancer.

 II. Procedural History

 Following Congress' mandate to issue regulations implementing Section 343(r)(5)(D), the FDA published a proposed rule in the Federal Register on June 18, 1993, defining a standard to evaluate health claims for dietary supplements. The FDA proposed to adopt the same standard for dietary supplements which Congress had already adopted for foods in conventional form in Section 343(r)(3). Plaintiffs submitted comments, arguing that dietary supplements should not be subject to the same procedure and standard as conventional foods, and that the term "significant scientific agreement" should, if adopted, be defined with specificity. (Compl. PP 52-57.) After extensive proceedings, which included the receipt of comments and hearings to consider plaintiffs' arguments, the FDA followed its initial approach, used the same standard Congress had already adopted for conventional foods, and defined "significant scientific agreement" on a case-by-case basis. The FDA explained its decision as follows:

 
the agency believes, however, that any standard involving the evaluation of scientific evidence and opinions derived from that evidence must be somewhat subjective. FDA, in proposing not to define "significant scientific agreement" among experts [citations omitted] noted that each situation may differ with the nature of the claimed substance/disease relationship. The agency believes that in deciding whether significant scientific agreement about the validity of a claim exists, it is necessary to consider both the extent of the agreement and the nature of the disagreement on a case-by-case basis.

 48 Fed. Reg. 2506 (1993).

 Plaintiffs also filed comments before the FDA objecting to the provisions in the FDA's proposed Final Rules denying approval for the specific health claims Plaintiffs wanted to place on the labels of certain dietary supplements. (Compl. P 27.) In particular, Plaintiffs sought permission for the following health claims on dietary supplement labels: (1) "Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers" (Compl. PP 40, 45); (2) "Consumption of dietary fiber may reduce the risk of colorectal cancer" (Compl. PP 41, 47.); (3) "Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease" (Compl. PP 42, 46.); (4) "The U.S. Public Health Service has estimated that fifty percent of neural tube defects may be averted annually if all women maintained an adequate intake of folate during childbearing years"; *fn5" and (5) ".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." (Compl. PP 43, 48.)

 In the FDA Final Rules, the FDA again rejected Plaintiffs' comments and again prohibited the use of each of Plaintiffs' health claims. (Compl. PP 28, 44, 49, 50, 51.) Plaintiffs submitted additional comments objecting to the Final Rules issued by the FDA, and filed "Emergency Petitions for Stay of Actions", with supporting scientific evidence. (Compl. PP 73, 82, 84.) The FDA refused to stay the Final Rules (Compl. PP 73, 85.), and Plaintiffs filed the instant suit.

 III. Analysis

 Plaintiffs argue that the central issue in this case is whether the FDA may impose blanket commercial speech bans without adopting procedural safeguards to protect truthful and nonmisleading commercial speech from suppression. Plaintiffs contend that the FDA's general health claim standard for dietary supplements--"significant scientific agreement"--violates the NLEA, APA, First Amendment, and is unconstitutionally vague under the Fifth Amendment. Plaintiffs further argue that since the "significant scientific agreement" requirement constitutes a blanket ban on commercial speech, the FDA's application of this standard also violates ...


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