National Council for Improved Health v. Shalala, 95-4151

• Citation: 122 F.3d 878
• Decision Date: 11 August 1997
• Docket Number: No. 95-4151,95-4151
• Parties: 25 Media L. Rep. 2268 NATIONAL COUNCIL FOR IMPROVED HEALTH, Stanley Malstrom, Clive J. Buchanan, Plaintiffs-Appellants, v. DONNA SHALALA, Secretary of the U.S. Department of Health and Human Services; David Kessler, Commissioner, U.S. Food & Drug Administration, Defendants-Appellees. American Cancer Society, American Heart Association, Center For Science In The Public Interest, Public Citizen, And Consumer Federation Of America, Amici Curiae.
• Court: United States Courts of Appeals. United States Court of Appeals (10th Circuit)

Page 878

122 F.3d 878

25 Media L. Rep. 2268

NATIONAL COUNCIL FOR IMPROVED HEALTH, Stanley Malstrom, Clive J. Buchanan, Plaintiffs-Appellants, v. DONNA SHALALA, Secretary of the U.S. Department of Health and Human Services; David Kessler, Commissioner,

U.S. Food & Drug Administration,

Defendants-Appellees.

American Cancer Society, American Heart Association, Center

For Science In The Public Interest, Public

Citizen, And Consumer Federation Of

America, Amici Curiae.

No. 95-4151.

United States Court of Appeals, Tenth Circuit.

Aug. 11, 1997.

Kirkpatrick W. Dilling, Dilling and Dilling, Chicago, IL, (Michael J. Lennard, Karen A. Weaver, Dilling and Dilling, Chicago, IL; M. Richard Walker and Ralph R. Tate, Jr., Salt Lake City, UT, with him on the briefs) for Plaintiffs-Appellants.

Susan Strawn, Attorney, Office of Consumer Litigation, Civil Division, U.S. Department of Justice, Washington, DC, (Drake Cutini, Attorney, Office of Consumer Litigation, Civil Division, U.S. Department of Justice, Washington, DC; Douglas Letter, Attorney, Appellate Staff, Civil Division, U.S. Department

of Justice, Washington, DC; Margaret Porter, Chief Counsel, Philip S. Defler, Louisa T. Nickerson, Associate Chief Counsels, Food and Drug Administration, Rockville, MD, Of Counsel, with her on the brief) for Appellees.

(Allison M. Zieve, Public Citizen Litigation Group, Washington, DC, [Bruce Silverglade, Center for Science in the Public Interest, Washington, DC, with her on the brief] for Amici Curiae.)

Before BALDOCK, HOLLOWAY, and MURPHY, Circuit Judges.

MURPHY, Circuit Judge.

Plaintiffs, National Council for Improved Health ("NCIH"), Stanley Malstrom, and Clive J. Buchanan, bring a facial challenge to the constitutionality of 21 C.F.R. § 101.14, which requires sellers of dietary supplements to obtain Food and Drug Administration ("FDA") authorization before labeling supplements with "health claims." ¹ The district court dismissed plaintiffs' complaint, ruling that the health claims regulations did not violate the First Amendment. Although the district court reached the merits of plaintiffs' claims, we conclude that plaintiffs do not have standing and therefore reverse the district court's order on standing and vacate the remainder of its decision on the constitutionality of the health claims regulations.

I. Background

In 1990 Congress enacted the Nutrition Labeling and Education Act of 1990 ("NLEA") which amended the Federal Food, Drug and Cosmetic Act ("FDCA"). See Pub.L. No. 101-535, 104 Stat. 2353 (codified as amended at 21 U.S.C. 301, 321, 337, 343, 371). The NLEA was passed to "clarify and to strengthen [FDA's] authority to require nutrition labeling on foods, and to establish the circumstances under which claims may be made about the nutrients in foods." See H.R.Rep. No. 101-538, at 7 (1990), reprinted in 1990 U.S.C.C.A.N. 3336, 3337. The NLEA places limits on health claims that may be made on food and dietary supplement labels.

Specifically, a claim may be asserted "in the label or labeling ² of [a] food [that] ... characterizes the relationship of any nutrient ... to a disease or a health-related condition," only if such claims are made in accordance with 21 U.S.C. § 343(r)(3), for foods in conventional form, or 21 U.S.C. § 343(r)(5)(D), for dietary supplements. 21 U.S.C. § 343(r)(1). Section 343(r)(5)(D) mandates 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 ... established by regulation."

In response to section 343(r)(5)(D)'s mandate, the Food and Drug Association ("FDA") promulgated 21 C.F.R. § 101.14 and 101.70. ³ See 59 Fed.Reg. 395, 425 (1994). These regulations require persons desiring to make health claims on labels of dietary supplements to petition the FDA to authorize each claim. The FDA will promulgate regulations authorizing the petitioned-for health claim if the FDA

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 C.F.R. § 101.14(c) (1996). ⁴ Thus, if the FDA finds that a proposed nutrient-disease relationship is supported by significant scientific agreement among experts, it will promulgate, through notice and comment procedures, a regulation authorizing claims to be made about that relationship. 21 C.F.R. § 101.14(d)(1). If the FDA determines that such agreement does not exist among experts, the claim will not be permitted. Plaintiffs assert that the health claims regulations violate their First Amendment right of free speech.

In the proceedings before the district court, defendants brought a motion to dismiss, arguing plaintiffs lacked standing and that the health claims regulations did not violate the First Amendment. The district court held that plaintiffs did have standing but agreed with defendants that the regulations were constitutional. We review the district court's ruling on standing de novo. Chrisman v. Commissioner of Internal Revenue, 82 F.3d 371, 372 (10th Cir.1996).

II. Standing

Article III of the Constitution grants federal courts authority to adjudicate only actual "Cases" and "Controversies." U.S. Const. art. III, § 2; United States Nat'l Bank v. Independent Ins. Agents of America, Inc., 508 U.S. 439, 446, 113 S.Ct. 2173, 2178, 124 L.Ed.2d 402 (1993). To ensure the case or controversy requirement is met, the Supreme Court has held that a plaintiff must allege the following: that the plaintiff has suffered an "injury in fact"; that there is a causal connection between the injury and the challenged conduct; and that it is likely, not speculative, that the injury will be redressed by a favorable decision. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61, 112 S.Ct. 2130, 2136-37, 119 L.Ed.2d 351 (1992).

Defendants challenge plaintiffs' standing to bring the instant case under the first and third prongs of this test. They assert that plaintiffs have never alleged injury from the prohibition of any specific claim under the health claims regulations. Defendants rely upon plaintiffs' failure to identify a single claim they wish to make that could possibly be prohibited under the regulations. Defendants also contend that plaintiffs lack standing because they have not alleged a credible, immediate threat of enforcement of the health claims regulations against them.

The district court ruled that although the plaintiffs had not identified a specific claim they wished to make, plaintiffs nevertheless had standing to challenge the regulations' constitutionality. The district court's ruling rested on "the expanded notion of standing under the 'overbreadth doctrine.' " 893 F.Supp. 1512, 1516 (D.Ut.1995). The court apparently interpreted the overbreadth doctrine as dispensing with the general requirement that the challenger show its own concrete injury resulting from the challenged statute or regulation. ⁵ The district court's conclusion rested on a flawed interpretation of the overbreadth doctrine.

A. Overbreadth and Standing

To satisfy Article III's case or controversy requirement, a litigant in federal court is required to establish its own injury in fact. Thus, under traditional constitutional notions, a litigant may invoke only its own constitutional rights and may not assert rights of others not before the court. See Laird v. Tatum, 408 U.S. 1, 14 n. 7, 92 S.Ct. 2318, 2326 n. 7, 33 L.Ed.2d 154 (1972). Under the overbreadth doctrine, however, a litigant may assert rights of individuals not before the court whose First Amendment rights may otherwise be infringed by an overly broad statute or regulation. ⁶ Village of Schaumburg v. Citizens for a Better Environment, 444 U.S. 620, 634, 100 S.Ct. 826, 834-35, 63 L.Ed.2d 73 (1980). Thus, "[i]t is well established in the area of freedom of expression an overbroad regulation may be subject to facial review and invalidation, even though its application in the case under consideration may be constitutionally unobjectionable." Forsyth County v. Nationalist Movement, 505 U.S. 123, 129, 112 S.Ct. 2395, 2400-01, 120 L.Ed.2d 101 (1992); see also Alexander v. United States, 509 U.S. 544, 555, 113 S.Ct. 2766, 2773-74, 125 L.Ed.2d 441 (1993); Broadrick v. Oklahoma, 413 U.S. 601, 612, 93 S.Ct. 2908, 2915-16, 37 L.Ed.2d 830 (1973).

The overbreadth exception to traditional notions of constitutional adjudication is based on a recognition that "the very existence of some broadly written laws has the potential to chill the expressive activity of others not before the court." Forsyth, 505 U.S. at 129, 112 S.Ct. at 2401. Although the overbreadth doctrine permits a party to challenge a statute or regulation that has not been unconstitutionally applied to that party, it does not dispense with the requirement that the party itself suffer a justiciable injury. Phelps v. Hamilton, 122 F.3d 1309, 1326 (10th Cir.1997) ("[A] plaintiff bringing a facial challenge to a statute on First Amendment grounds must still satisfy the 'injury in fact' requirement in order to demonstrate standing."); see 4 Ronald D. Rotunda & John E. Nowak, Treatise on Constitutional Law: Substance and Procedure § 20.8, at 35 (1992) ("The decision to grant standing is unrelated to the substantive first amendment determination of whether the statute is unconstitutionally overbroad.").

The Supreme Court explained this distinction well in Secretary of State of Maryland v. Joseph H. Munson Co., 467 U.S. 947, 104 S.Ct. 2839, 81 L.Ed.2d 786 (1984). In Munson, the Court considered a facial challenge to a Maryland statute that prohibited charitable organizations from paying or agreeing to pay expenses...