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.

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 labeling2 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).

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.

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 exceeding 25% of an amount raised in a fundraising activity. Id. at 950, 104 S.Ct. at 2843-44. Munson, a professional for-profit fundraising company, brought a facial challenge under the First and Fourteenth Amendments. Munson had entered contracts that called for payment in excess of 25% of funds raised for a given event, and the Secretary of State of Maryland had informed Munson it would be prosecuted upon failure to comply with the statute. In addition, a potential client of Munson's had expressed reluctance to enter a contract with Munson because of the statute's limitation. Id. at 954-55, 104 S.Ct. at 2845-46. Despite these injuries to Munson, it was not a charity and did not claim its own First Amendment rights had or would be infringed by the statute. Id. at 955, 104 S.Ct. at 2846. The Court nevertheless concluded that Munson had standing to raise First Amendment concerns affecting charities. The Court explained:

Facial challenges to overly broad statutes are allowed not primarily for the benefit of the litigant, but for the benefit of society--to prevent the statute from chilling the First Amendment rights of other parties not before the court. Munson's ability to serve that function has nothing to do with whether or not its own First Amendment rights are at stake. The crucial issues are whether Munson satisfies the requirement of "injury in fact," and whether it can be expected satisfactorily to frame the issues in the case. If so, there is no reason that Munson need also be a charity. If not, Munson could not bring this challenge even if it were a charity.

Id. at 958, 104 S.Ct. at 2847 (emphasis added). The Court went on:

The requirement that a statute be "substantially overbroad" before it will be struck down on its face is a "standing" question only to the extent that if the plaintiff does not prevail on the merits of its facial challenge and cannot demonstrate that, as applied to it, the statute is unconstitutional, it has no "standing" to allege that, as applied to others, the statute might be unconstitutional.

Id. at 959, 104 S.Ct. at 2848.

Thus, although the overbreadth doctrine allows one whose First Amendment rights have not been violated to assert a facial challenge on behalf of others whose rights may be infringed, it does not eliminate the need for the plaintiff to demonstrate its own cognizable injury in fact. Plaintiffs here have attempted to challenge the constitutionality of the health claims regulations without identifying any specific harm caused them by the regulations. Unlike Munson, which alleged its own identifiable injury and thereby provided the vehicle to bring a First Amendment facial challenge premised on the statute's overbreadth, plaintiffs have alleged no injury in fact and thus cannot raise constitutional issues pertaining to them or to anyone else.7

As noted above, to establish injury in fact, a party must first and foremost establish an invasion of a legally protected interest that is concrete, particularized, and actual or imminent. Arizonans for Official English v. Arizona, --- U.S. ----, 117 S. Ct. 1055, 137 L. Ed. 2d 170 (1997) (quotations omitted). The Supreme Court addressed this aspect of standing in United Public Workers v. Mitchell, 330 U.S. 75, 67 S. Ct. 556, 91 L. Ed. 754 (1947). In Mitchell, employees of the federal executive civil service and the United Public Workers of America sought a declaratory judgment that a portion of § 9(a) of the Hatch Political Activity Act (providing "[n]o officer or employee in the executive branch of the Federal Government ... shall take any active part in political management or in political campaigns") was unconstitutional. Id. at 82, 67 S.Ct. at 560. Plaintiffs challenged the statute, inter alia, on First Amendment grounds, asserting it violated their rights of freedom of speech, the press, and assembly. Plaintiffs alleged a desire to engage in political campaigns and acts of political management, but did not allege specifically attempted but statutorily prohibited actions or statements. Id. at 82, 67 S.Ct. at 560. The Supreme Court stated:

[T]he federal courts ... do not render advisory opinions. For adjudication of constitutional issues, "concrete legal issues, presented in actual cases, not abstractions" are requisite. This is as true of declaratory judgments as any other field....

The power of courts, and ultimately of this Court to pass upon the constitutionality of acts of Congress arises only when the interests of the litigants require the use of this judicial authority for their protection against actual interference. A hypothetical threat is not enough. We can only speculate as to the kinds of political activity the appellants desire to engage in or as to the contents of their proposed public statements or the circumstances of their publication.

Id. at 89-90, 67 S.Ct. at 564-65 (footnotes omitted) (emphasis added).

The same is true here. Plaintiffs do not advance a single claim they wish to make, or receive, which could be prohibited under the health claims regulations. Instead, plaintiffs make generalized assertions that they will be "adversely affected" by the health claims regulations. R. at 4. Such assertions are simply insufficient.8 When we are left to speculate as to the nature of the claim plaintiffs may desire to make, and the treatment such a hypothetical claim may receive under the regulations, plaintiffs have failed to allege a sufficient injury in fact.9 See Wilson v. Glenwood Intermountain Properties, Inc., 98 F.3d 590, 596 (10th Cir.1996) (holding purely abstract injury claims do not provide particular, direct, concrete injury necessary to confer standing). Without an allegation of specific, concrete harm, plaintiffs do not have standing.

Plaintiffs also lack standing because they have failed to allege a credible threat of prosecution. "When plaintiffs 'do not claim that they have ever been threatened with prosecution, that a prosecution is likely, or even that a prosecution is remotely possible,' they do not allege a dispute susceptible to resolution by a federal court." Babbitt v. United Farm Workers Nat'l Union, 442 U.S. 289, 298-99, 99 S. Ct. 2301, 2309, 60 L. Ed. 2d 895 (1979) (quoting Younger v. Harris, 401 U.S. 37, 42, 91 S. Ct. 746, 749-50, 27 L. Ed. 2d 669 (1971)). Plaintiffs' failure to specify a particular claim they wish to make or receive that is prohibited under the health claims regulations prohibits them from clearing this hurdle. When no potentially prohibited claim has been made, there is no possible violation of the health claims regulations and thus no possibility of prosecution. United Farm Workers, 442 U.S. at 298, 99 S.Ct. at 2308-09 (finding no standing where plaintiffs had not alleged an "intention to engage in a course of conduct ... proscribed by statute [or regulation]," let alone any "credible threat of prosecution thereunder"); see McCollester v. City of Keene, 668 F.2d 617, 620-21 (1st Cir.1982) (finding no standing where complaint failed to allege conduct in which plaintiffs intended to engage and alleged nothing more than speculative risk of prosecution). Plaintiffs' failure to allege a credible threat of prosecution deprives them of standing.

Plaintiffs have not made allegations that establish they have suffered the required injury in fact to confer standing upon them to challenge the health claims regulations. Consequently, we REVERSE the district court's ruling on standing, VACATE the district court's judgment and order addressing the constitutionality of the health claims regulations, and REMAND to the district court to dismiss the Second Amended Complaint for lack of jurisdiction.