## F I L E D United States Court of Appeals Tenth Circuit 

### AUG 11 1997 

### PATRICK FISHER Clerk PUBLISH
UNITED STATES COURT OF APPEALS

TENTH CIRCUIT

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. 95-4151-2- Appeal from the United States District Court

for the District of Utah (D.C. No. 94-CV-509-G)

Kirkpatrick W. Dilling of Dilling and Dilling, Chic ago, Illinois, (Michael J. Lennard, Karen A. Weaver, of Dilling and Dilling, C hicago, Illinois; M. Richard Walker and Ralph R. Tate, Jr., Salt Lake City, Utah , with him on the briefs) for Plaintiffs-Appellants. Susan Strawn, Attorney, of Office of Consumer Litig ation, Civil Division, U. S. Department of Justice, Washington, D.C., (Drake Cut ini, Attorney, of Office of Consumer Litigation, Civil Division, U. S. Departme nt of Justice, Washington, D.C.; Douglas Letter, Attorney, Appellate Staff, Ci vil Division, U. S. Department of Justice, Washington, D.C.; Margaret Porter, Chie f Counsel, Philip S. Defler, Louisa T. Nickerson, Associate Chief Counsels, Foodand Drug Administration, Rockville, Maryland, Of Counsel, with her on the br ief) for Appellees. (Allison M. Zieve, Public Citizen Litigation Group, Washington, D.C., [Bruce Silverglade, Center for Science in the Public Inter est, Washington, D.C., 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 cha llenge to the constitutionality of 21 C.F.R. § 101.14, which requires sellers of di etary supplements to obtain Food and Drug Administration (“FDA”) authorization before labeling1 Plaintiffs also contend on the first page of their brief that the FDA

“regulations” were promulgated “in excess of the st atutory jurisdiction, authority and limitations of defendants.” Brief for Appellants at 1. Plaintiffs do not, however, present any argument or authority in suppo rt of this contention. The argument is therefore waived. See United States v. Hardwell , 80 F.3d 1471, 1492 (10th Cir.), reh’g granted in part on other grounds , 88 F.3d 897 (10th Cir. 1996). -3- supplements with “health claims.” 1 The district court dismissed plaintiffs’ complaint, ruling that the health claims regulation s did not violate the First Amendment. Although the district court reached the merits of plaintiffs’ claims, we conclude that plaintiffs do not have standing an d 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 andEducation 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 am ended at 21 U.S.C. 301, 321, 337, 343, 371). The NLEA was pass ed to “clarify and to strengthen [FDA’s] authority to require nutrition l abeling 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 onhealth claims that may be made on food and dietary supplement labels.2 "Labeling” is defined as “all labels and other written, printed, or graphic

matter (1) upon any article or any of its container s or wrappers, or (2) accompanying such article.” 21 U.S.C. § 321(m).

3 Section 101.70 sets forth only the procedural guide lines for obtaining FDA approval for a health claim, not the substantive st andards for approval. It is therefore not prominent in our discussion. -4- 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). S ection 343(r)(5)(D) mandates that health claims “made with respect to a dietary supplement of vitamins, minerals, herbs, or other similar nutritional subst ances shall . . . be subject to a procedure and standard . . . established by regulat ion.” 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 pe rsons desiring to make health claims on labels of dietary supplements to petitionthe FDA to authorize each claim. The FDA will promulgate regulations authori zing the petitioned-for health claim if the FDA determines, based on the totality of publicly avail able scientific evidence (including evidence from well-designed studies cond ucted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific a greement, among experts4 Pursuant to 1994 amendments to the NLEA, certain he alth claims for

dietary supplements may be made without petitioning the FDA. 21 U.S.C. § 343(r)(6) (1996). These include statements that cl aim a benefit related to a classical nutrient deficiency disease, certain clai ms relating to the role of a nutrient or dietary ingredient intended to affect t he structure or function of the human body, and claims describing general well-bein g from consumption of a nutrient or dietary ingredient. Id. Such claims are permitted if the manufacturer has “substantiation” that the claim is truthful and not misleading, and the product bears certain disclaimers. Id. -5- 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 nutrientdisease relationship is supported by significant sc ientific agreement among experts, it will promulgate, through notice and com ment procedures, a regulation authorizing claims to be made about that relationsh ip. 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, defen dants 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 r egulations 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).-6-

II. Standing Article III of the Constitution grants federal cou rts authority to adjudicate only actual “Cases” and “Controversies.” U.S. Cons t. art. III, § 2; United States Nat’l Bank v. Independent Ins. Agents of America, I nc. , 508 U.S. 439, 446 (1993). To ensure the case or controversy requirement is me t, the Supreme Court has held that a plaintiff must allege the following: that th e 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, th at the injury will be redressed by a favorable decision. Lujan v. Defenders of Wildlife , 504 U.S. 555, 560-61 (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 u nder the health claims regulations. Defendants rely upon plaintiffs’ fail ure to identify a single claim they wish to make that could possibly be prohibitedunder the regulations. Defendants also contend that plaintiffs lack standi ng because they have not alleged a credible, immediate threat of enforcementof the health claims regulations against them. The district court ruled that although the plaintif fs had not identified a specific claim they wished to make, plaintiffs neve rtheless had standing to challenge the regulations’ constitutionality. The district court’s ruling rested on5 The cases cited in the district court opinion may h ave isolated language

supporting the district court’s approach ( e.g. O’Connor v. City & County of Denver , 894 F.2d 1210, 1214 (10th Cir. 1990) (“Parties ‘w ho have not actually engaged in protected activity are allowed to challe nge a statute that inhibits others from engaging in protected speech or expression.’”) ). The full text of each of the cases cited, however, makes clear that the overbrea dth doctrine does not permit the plaintiff to bring an action without identifyin g its own concrete injury. Indeed, in each case that the district court cited, the plaintiff suffered its own concrete, justiciable injury, which provided standi ng to bring a facial challenge. See Alexander v. United States , 509 U.S. 544, 546 (1993) (plaintiff prosecuted fo r violating federal obscenity laws and the Racketeer Influenced and Corrupt Organizations Act (RICO), subsequently challenged c onstitutionality of RICO’s forfeiture provisions); Forsyth County v. Nationalist Movement , 505 U.S. 123, 127 (1992) (plaintiff who had been charged with a f ee for rally permit challenged constitutionality of ordinance imposing such fee); O’Connor , 894 F.2d at 1213 (movie theaters and cashier challenged amusement li censing scheme after their licenses had been revoked). In none of these cases did the plaintiff bring a facial challenge without establishing its own identifiable injury to provide standing. -7- “the expanded notion of standing under the ‘overbre adth doctrine.’” 893 F. Supp. 1512, 1516 (D. Ut. 1995). The court apparently int erpreted the overbreadth doctrine as dispensing with the general requirementthat the challenger show its own concrete injury resulting from the challenged s tatute or regulation. 5 The district court’s conclusion rested on a flawed inte rpretation of the overbreadth doctrine. A. Overbreadth and Standing To satisfy Article III’s case or controversy requir ement, a litigant in federal court is required to establish its own injury in fa ct. Thus, under traditional constitutional notions, a litigant may invoke only its own constitutional rights and6 The overbreadth doctrine does not, however, apply t o commercial speech.

Murphy v. Matheson , 742 F.2d 564, 568 (10th Cir. 1984) (citing Village of Hoffman Estates v. The Flipside, Hoffman Estates, I nc. , 455 U.S. 489 (1982)). The rationale for this limitation was articulated i n Central Hudson Gas & Electric Corp. v. Public Serv. Comm’n , 447 U.S. 557 (1980): The overbreadth doctrine derives from the recogniti on that unconstitutional restriction of expression may deter protected speec h by parties not before the court and thereby escape judicial review. This restraint is less likely where the expression is linked to “commercial well- being” and therefore is not easily deterred by “overbroad regulation.” Id. at 565 n.8 (citations omitted) (quoting Bates v. State Bar, 433 U.S. 350, 381 (1977)). Because plaintiffs have not even alleged a justiciable injury, we do not reach the applicability of the overbreadth doctrine to this case. -8- may not assert rights of others not before the court. See Laird v. Tatum , 408 U.S. 1, 14 n.7 (1972). Under the overbreadth doctrine, however, a litigant may assert rights of individuals not before the court whose Fi rst Amendment rights may otherwise be infringed by an overly broad statute o r regulation. 6 Village of Schaumburg v. Citizens for a Better Environment , 444 U.S. 620, 634 (1980). Thus, “[i]t is well established in the area of free dom of expression an overbroad regulation may be subject to facial review and inva lidation, even though its application in the case under consideration may be constitutionally unobjectionable.” Forsyth County v. Nationalist Movement , 505 U.S. 123, 129 (1992); see also Alexander v. United States , 509 U.S. 544, 555 (1993); Broadrick v. Oklahoma , 413 U.S. 601, 612 (1973).-9-

The overbreadth exception to traditional notions of constitutional adjudication is based on a recognition that “the ve ry existence of some broadly written laws has the potential to chill the express ive activity of others not before the court.” Forsyth , 505 U.S. at 129. Although the overbreadth doctri ne permits a party to challenge a statute or regulation that h as not been unconstitutionally applied to that party, it does not dispense with th e requirement that the party itself suffer a justiciable injury. Phelps v. Hamilton , No. 95-3251, Slip Op. at 37 (10th Cir. 1997) (“[A] plaintiff bringing a facial challe nge to a statute on First Amendment grounds must still satisfy the ‘injury infact’ 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 f irst amendment determination of whether the statute is unconstitutionally overbroad .”). The Supreme Court explained this distinction well i n Secretary of State of Maryland v. Joseph H. Munson Co. , 467 U.S. 947 (1984). In Munson , the Court considered a facial challenge to a Maryland statute that prohibited charitable organizations from paying or agreeing to pay expens es exceeding 25% of an amount raised in a fundraising activity. Id. at 950. Munson, a professional forprofit fundraising company, brought a facial challe nge under the First and Fourteenth Amendments. Munson had entered contract s that called for payment-10-

in excess of 25% of funds raised for a given event, and the Secretary of State of Maryland had informed Munson it would be prosecutedupon 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. Despite these injuries to Munson, it wa s not a charity and did not claim its own First Amendment rights had or would b e infringed by the statute. Id. at 955. The Court nevertheless concluded that Mun son had standing to raise First Amendment concerns affecting charities. The Court explained: Facial challenges to overly broad statutes are allo wed not primarily for the benefit of the litigant, but for the benefit of soc iety--to prevent the statute from chilling the First Amendment rights of other p arties 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 requirementof “injury in fact,” and whether it can be expected satisfactorily to fr ame 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 ch arity. Id. at 958 (emphasis added). The Court went on: The requirement that a statute be “substantially ov erbroad” before it will be struck down on its face is a “standing” que stion only to the extent that if the plaintiff does not prevail on th e merits of its facial challenge and cannot demonstrate that, as applied t o it, the statute is unconstitutional, it has no “standing” to allege th at, as applied to others, the statute might be unconstitutional. Id. at 959. Thus, although the overbreadth doctrine allows one whose First Amendment rights have not been violated to assert afacial challenge on behalf of7 The requirement that a plaintiff assert its own leg al rights prevents a court

from “premature interpretations of statutes in area s where their constitutional application might be cloudy, and it assures the cou rt that the issues before it will be concrete and sharply presented.” Secretary of State v. Munson , 467 U.S. 947, 955 (1984) (citations omitted). The dangers of advi sory opinions are clear in this case. For example, a critical issue in evaluating the constitutionality of commercial speech is whether the speech at issue is truthful or misleading. See, e.g., Central Hudson , 447 U.S. at 566 (“For commercial speech to come w ithin [the First Amendment’s protections], it at least mu st concern lawful activity and not be misleading.”). Without knowing what claims plaintiffs seek to disseminate, this court cannot assess whether such claims are truthful and not misleading. Therefore, an analysis of this issue w ould rest on mere speculation. -11- others whose rights may be infringed, it does not e liminate 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 b y 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 f act and thus cannot raise constitutional issues pertaining to them or to anyo ne else. 7 B. Concreteness and Particularity As noted above, to establish injury in fact, a party must first and foremost establish an invasion of a legally protected intere st that is concrete, particularized, and actual or imminent. Arizonans for Official English v. Arizona , 117 S. Ct. 1055 (1997) (quotations omitted). The Supreme Court addressed this aspect of-12-

standing in United Public Workers v. Mitchell , 330 U.S. 75 (1947). In Mitchell , employees of the federal executive civil service an d the United Public Workers of America sought a declaratory judgment that a portio n 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 a ny active part in political management or in political campaigns”) was unconsti tutional. Id. at 82. Plaintiffs challenged the statute, inter alia , on First Amendment grounds, asserting it violated their rights of freedom of sp eech, the press, and assembly. Plaintiffs alleged a desire to engage in political campaigns and acts of political management, but did not allege specifically attempt ed but statutorily prohibited actions or statements. Id. at 82. The Supreme Court stated: [T]he federal courts . . . do not render advisory o pinions. For adjudication of constitutional issues, “concrete le gal issues, presented in actual cases, not abstractions” are re quisite. This is as true of declaratory judgments as any other field. .

. . The power of courts, and ultimately of this Court t o pass upon the constitutionality of acts of Congress arises on ly 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 circumstanc es of their publication. Id. at 89-90 (footnotes omitted) (emphasis added). The same is true here. Plaintiffs do not advance asingle claim they wish to make, or receive, which could be prohibited under t he health claims regulations.8 We have previously found standing where a plaintiff has not yet violated an ordinance but has “shown an unmistakable intenti on to engage in activities that are prohibited by each of the challenged ordinances .” ACORN v. City of Tulsa , 835 F.2d 735, 739 (10th Cir. 1987). In this case, however, there has been no showing of an “unmistakable intention” to make any particular claim at all, much less one that may be prohibited under the health cl aims regulations. Without allegations of a claim that could be affected by th e regulations, no injury as envisioned by Article III has occurred.

9 Plaintiffs have not specifically argued that the re gulations chill their own speech. If they had made such an allegation, that alone would be insufficient to bestow standing. An allegation of inhibition of sp eech, without more, will not support standing. Laird v. Tatum , 408 U.S. 1, 13-14 (1972) (“Allegations of a subjective ‘chill’ are not an adequate substitute f or a claim of specific present objective harm or a threat of specific future harm. ”). All of the Supreme Court cases employing the concept of “chilling effect” in volve situations in which the plaintiff had suffered actual or imminent concrete harm (past or immediately threatened) separate from the “chill” itself. See United Presbyterian Church v. Reagan , 738 F.2d 1375, 1378 (D.C. Cir. 1984) (collecting cases). The purpose of the chilling concept is to enable even those who have not been inhibited to vindicate the First Amendment interests of those wh o have. It is only in this respect that “‘chilling effect’ has anything to do with the doctrine of standing: It permits a person, who has standing to challenge gov ernmental action because of the concrete harm it causes him, to assert a defici ency which may not affect him but only others.” Id. at 1379. -13- 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 hypoth etical claim may receive under the regulations, plaintiffs have failed to al lege a sufficient injury in fact. 9 See Wilson v. Glenwood Intermountain Properties, In c. , 98 F.3d 590, 596 (10th Cir. 1996) (holding purely abstract injury claims d o not provide particular, direct,-14-

concrete injury necessary to confer standing). Without an allegation of specific, concrete harm, plaintiffs do not have standing. C. Fear of Prosecution Plaintiffs also lack standing because they have fai led to allege a credible threat of prosecution. “When plaintiffs ‘do not cl aim that they have ever been threatened with prosecution, that a prosecution is likely, or even that a prosecution is remotely possible,’ they do not alle ge a dispute susceptible to resolution by a federal court.” Babbitt v. United Farm Workers Nat’l Union , 442 U.S. 289, 298-99 (1979) (quoting Younger v. Harris , 401 U.S. 37, 42 (1971)). Plaintiffs’ failure to specify a particular claim t hey wish to make or receive that is prohibited under the health claims regulations proh ibits them from clearing this hurdle. When no potentially prohibited claim has b een 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 (finding no standing where plaint iffs had not alleged an “intention to engage in a course of conduct . . . proscribed by statute [or regulation],” let alone any “credible t hreat 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 conduc t in which plaintiffs intended to engage and alleged nothing more than speculative risk of prosecution).-15-

Plaintiffs’ failure to allege a credible threat of prosecution deprives them of standing. III. Conclusion Plaintiffs have not made allegations that establishthey have suffered the required injury in fact to confer standing upon the m 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.