The principal question before us is whether plaintiffs-appellants may challenge the statute and regulations governing the labeling of dietary supplements^[1] before they have submitted any proposed health claims to the Food and Drug Administration ("FDA") pursuant to the regulations and before the FDA has undertaken any enforcement action against them.

Plaintiffs-appellants Nutritional Health Alliance ("NHA"), a nonprofit association of consumers, health professionals, natural product retailers, and natural product manufacturers, and New Nutrisserie, a natural product retailer that also markets a line of private label dietary supplement products, brought a facial First Amendment challenge to the statute and regulations against defendants-appellees Donna Shalala, Secretary of the U.S. Department of Health and Human Services, and David Kessler, then Commissioner of the FDA. The plaintiffs sought declaratory and injunctive relief. The defendants moved to dismiss for lack of standing, pursuant to Fed.R.Civ.P. 12(b)(1), and for failure to state a claim upon which relief could be granted, pursuant to Fed.R.Civ.P. 12(b)(6). Plaintiffs cross-moved for summary judgment.

The United States District Court for the Southern District of New York (Richard Owen, Judge) found that the plaintiffs had standing, denied defendants' motion to dismiss, and, in view of the absence of a deadline for final agency action under the statute and regulations, granted plaintiffs' summary judgment motion in part. In all other respects, the district court upheld the regulatory scheme as constitutional. See NHA v. Shalala, 953 F.Supp. 526 (S.D.N.Y.1997).

In response to the district court's ruling, the government established a regulatory deadline within which the FDA had to approve or disapprove any proposed health claim. And the district court found this timetable acceptable. See NHA v. Shalala, No. 95 Civ. 4950 (S.D.N.Y. Aug. 14, 1997) (unpublished Memorandum & Order). The court then denied the balance of the plaintiffs' motion, and entered judgment for defendants. See NHA v. Shalala, No. 95 Civ. 4950 (S.D.N.Y. Sept. 18, 1997) (unpublished Order). Plaintiffs appealed from this final judgment to the extent (1) that it denied plaintiffs' motion for summary judgment, and (2) that it incorporated previous court orders upholding the constitutionality of the government's regulatory deadline.

In 1990, Congress enacted the Nutrition Labeling and Education Act ("NLEA"), which amended the Federal Food, Drug and Cosmetic Act. See Pub.L. No. 101-535, 104 Stat. 2353 (1990), codified as amended at 21 U.S.C. §§ 301, 321, 337, 343, 371. The NLEA was passed to "clarify and to strengthen the Food and Drug Administration'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." See H.R.Rep. No. 101-538, at 7 (1990), reprinted in 1990 U.S.C.C.A.N. 3336, 3337.

At issue in this case are the NLEA provisions that permit the FDA to limit the health claims that may be made on dietary supplement labels.^[2] In 1993, the FDA promulgated regulations (pursuant to the NLEA) that require persons desiring to make health claims on labeling^[3] of dietary supplements to petition the FDA for authorization to make such a claim.^[4] The regulations state that the FDA will allow health claims to be made only when "there is significant scientific agreement ... that the claim is supported by [the scientific] evidence." 21 C.F.R. § 101.14(c).^[5] 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. See id. § 101.14(d)(1). If by contrast, the FDA determines that such agreement does not exist among experts, the claim will not be permitted on labels.

With respect to nutrient-disease claims, the FDA has adopted the following procedures and timetables: First, a party submits a petition with the proposed health claim and attached supporting evidence. The FDA must notify the applicant within 100 days whether the request will be denied or else "filed" for further review. Within the next 90 days, the FDA is required to deny the petition or else to publish a proposed regulation authorizing the health claim. See id. § 101.70(j). And within 270 days of the date of publication of a proposed rule authorizing a health claim, the FDA must publish a final regulation approving or denying the claim. See id. § 101.70(j)(4).^[6]

In 1994, Congress moved to narrow the reach of the FDA's preauthorization scheme, out of "[c]oncern over excessive regulation of dietary supplements and the suppression of truthful information." NHA v. Shalala, 953 F.Supp. at 528. In the Dietary Supplement Health and Education Act of 1994 ("DSHEA"), Pub.L. No. 103-417, 108 Stat. 4325 (amending the NLEA), it allowed certain health claims for dietary supplements to be made without petitioning the FDA. These included: (1) statements asserting a benefit related to a classical nutrient deficiency disease; (2) claims about the role of a nutrient or dietary ingredient with respect to the structure or function of the human body ("structure/ function claims"); and (3) declarations of general well-being from consumption of a nutrient or other dietary ingredient. See 21 U.S.C. § 343(r)(6)(A). Under the DSHEA, such claims are permitted if the manufacturer has "substantiation" that the assertion is truthful and non-misleading, if the label expressly states, inter alia, that the FDA has not evaluated the claim, and if the FDA was notified within 30 days of the first marketing of the product that bears the claim. See id. § 343(r)(6)(B), (C).^[7] In addition, DSHEA created an exemption for "third-party literature" under which manufacturers, without prior FDA approval, may, "in connection with the sale of a dietary supplement," provide consumers with publications such as articles, chapters from books, or abstracts from scientific publications. See id. § 343-2.^[8]

Despite DSHEA's amendments, it nonetheless remains true that, generally, "emerging health claims" are barred from labels absent prior approval by the FDA.^[9] And use of an unauthorized claim subjects the company and its officers to criminal prosecution for issuing a "misbranded" product. See id. §§ 331, 333, 343(a)(1), 343(r)(1)(B).II. DISCUSSION

Plaintiffs make two principal claims on appeal. First, they argue that the statute and regulations violate the strictures of Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557, 100 S.Ct. 2343, 65 L.Ed.2d 341 (1980), and impose an impermissible ban on truthful, non-misleading commercial speech.^[10] Second, they claim that the preauthorization scheme required by the FDA for all health claims (including those eventually approved by the FDA) constitutes an unconstitutional prior restraint on commercial speech.

The government renews its argument--rejected below--that the plaintiffs, since they have not identified to this court or to the FDA a single health claim that they actually wish to make and are prevented from putting on a label by the regulations, lack standing to bring this suit. If the suit were nonetheless deemed justiciable, the government argues that the district court was correct in its finding that the regulatory scheme passes muster under Central Hudson. The government further urges us to reject the plaintiffs' second argument on the ground that the prior restraint doctrine is inapplicable to commercial speech.

A. General Challenge to the NLEA: Justiciability

We must first consider whether plaintiffs' preenforcement facial First Amendment challenges to the NLEA and its regulations are ripe for our review. Ripeness is a constitutional prerequisite to exercise of jurisdiction by federal courts. See Abbott Labs. v. Gardner, 387 U.S. 136, 148-49, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967); Thomas v. City of New York, 143 F.3d 31, 34-35 (2d Cir.1998). The court, therefore, can raise the issue sua sponte. See Thomas, 143 F.3d at 34. In evaluating whether a declaratory judgment action is ripe, we consider (1) the fitness of the issues for judicial review, and (2) the injury or hardship to the parties of withholding judicial consideration. See Abbott Labs., 387 U.S. at 149, 87 S.Ct. at 1515-16.

To determine fitness for judicial review, we must examine, among other factors, whether "consideration of the underlying legal issues would necessarily be facilitated if they were raised in the context of a specific attempt to [apply and/or] enforce the regulations." Gardner v. Toilet Goods Assoc., 387 U.S. 167, 171, 87 S.Ct. 1526, 1528-29, 18 L.Ed.2d 704 (1967); see In re Combustion Equip. Assoc., Inc., 838 F.2d 35, 37-38 (2d Cir.1988); see also Abbott Labs., 387 U.S. at 149, 87 S.Ct. at 1515 (concluding that "the issues presented are appropriate for judicial resolution at this time," where the facial challenge to the regulation involved the purely legal question of whether the regulation at issue exceeded the scope permitted by the underlying statute).

In the instant case, plaintiffs' complaint did not allege any particular health claims that plaintiffs wished to state. Nor did plaintiffs contend that they had ever sought the FDA's authorization to make any such health claim on dietary supplement labels and that permission had been denied or delayed by the FDA.

In the absence of any specific proposed health claim, it is extremely difficult for the court to conduct a Central Hudson analysis. Speech that is found to be non-truthful or misleading is not constitutionally protected under the first prong of the Central Hudson test. See Central Hudson, 447 U.S. at 566, 100 S.Ct. at 2351 ("At the outset, we must determine whether the expression is protected by the First Amendment. For commercial speech to come within that provision, it at least must concern lawful activity and not be misleading."). And, as the Tenth Circuit noted in the context of a First Amendment challenge to the same statute and regulations as those in the instant case,

a critical issue in evaluating the constitutionality of commercial speech is whether the speech at issue is truthful or 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 would rest on mere speculation.

National Council for Improved Health v. Shalala, 122 F.3d 878, 883 n. 7 (10th Cir.1997) (citation omitted).

We agree with the Tenth Circuit.^[11] For, without a specific proposed health claim to review, on evidence of record before the FDA, we cannot determine whether the "significant scientific agreement" requirement actually bars any truthful, non-misleading speech. In particular, we note that the parties have here argued at length over whether hypothetical health claims would, when combined with disclaimers of FDA acceptance, be misleading. That question seems to turn in part on whether the claims would confuse consumers with respect to possible side effects. And this issue is particularly difficult to resolve in the abstract and without a full record. We, therefore, conclude that plaintiffs' claim that the NLEA and FDA regulations ban certain categories of commercial speech in violation of the First Amendment is preferably deemed not to be ready for judicial review.

Even if resolution of a dispute could be facilitated if a court waited for a specific application of the issues in contention, the question may, nonetheless, perhaps be justiciable under the second ripeness factor if the challenged action creates a direct and immediate hardship for the parties.^[12] In the instant case, it is undisputed that if plaintiffs do not comply with the statute and regulations, they are subject to criminal liability. See 21 U.S.C. §§ 331, 333, 343(a)(1), 343(r)(1)(B). It is, moreover, also true that traditional ripeness analysis has been relaxed somewhat in cases involving facial challenges based on First Amendment grounds. See Sanger v. Reno, 966 F.Supp. 151, 161 (E.D.N.Y.1997) (collecting cases). We must, therefore, examine what specific harm, if any, will be done to the plaintiffs if judicial review is withheld until such time as they have submitted an actual health claim to the FDA. Plaintiffs have alleged much less hardship than the plaintiffs in Abbott Laboratories. In that case, a number of drug companies brought a facial challenge to an FDA regulation requiring the inclusion of generic names for prescription drugs on labels and other printed materials. The Supreme Court observed that "[i]f petitioners wish to comply [with the FDA regulation] they must change all their labels, advertisements, and promotional materials; they must destroy stocks of printed matter; and they must invest heavily in new printing type and new supplies." Abbott Labs., 387 U.S. at 152, 87 S.Ct. at 1517. Plaintiffs in the instant case, however, have alleged no such hardship if we were not to review their claim on the merits.

In fact, the only real burden that denying immediate judicial review imposes on the plaintiffs before us is that they are subjected to a potential 540-day prior restraint while their claim is evaluated.^[13] Such a burden does not suffice to render ripe a dispute that is as manifestly unfit for decision as this one is. It may, however, on its own constitute a valid constitutional claim. In effect, then, the second ripeness factor in the case before us becomes the same as plaintiffs' second claim--that the statute and regulations impose an unconstitutional prior restraint.

We note first that this claim is clearly ripe. It involves a purely legal question that is eminently fit for judicial review. Plaintiffs will necessarily be subjected to the prior restraint as a result of our conclusion that we will not consider their underlying argument until they submit an actual health claim for FDA approval. This follows from the fact that even those claims that will eventually be authorized by the FDA--and that are presumably truthful--are nevertheless subject to the allegedly unconstitutional FDA preclearance procedure. We therefore can consider this second challenge on the merits.^[14] See FW/PBS, Inc. v. City of Dallas, 493 U.S. 215, 223-25, 110 S.Ct. 596, 603-05, 107 L.Ed.2d 603 (1990) (permitting facial challenge to prior restraint).

Plaintiffs contend that the NLEA/ FDA requirement for prior approval of all health claims appearing on dietary supplement labels (including those that the FDA eventually approves, and are thus presumably truthful and non-misleading) is an unconstitutional prior restraint of commercial speech.^[15] The government counters that the prior restraint doctrine does not apply to commercial speech.

The government's contention is, however, overbroad. For our court has stated that the prior restraint doctrine does play a role in evaluating the regulation of commercial speech. As we explained in New York Magazine v. MTA, 136 F.3d 123 (2d Cir.1998):

Although the Supreme Court has indicated that commercial speech may qualify as one of the exceptions to the bar on prior restraints, see Central Hudson, 447 U.S. at 571 n. 13, 100 S.Ct. at 2354 n. 13, we see no reason why the requirement of procedural safeguards [in prior restraint cases] should be relaxed whether speech is commercial or not....

In fact, the test that the Supreme Court regularly applies to commercial speech supports continuing to require procedural safeguards for prior restraints even where commercial speech is involved. That test requires us to consider "whether the regulation ... is not more extensive than is necessary to serve [the asserted governmental] interest."

Id. at 131-32 (citations omitted).

The critical question is, therefore, whether the prior restraint of up to 540 days is acceptable under the fourth prong of Central Hudson. In this respect, it is significant that the speech involved is indisputably "pure commercial" speech, and that the regulation pertains to health and safety.^[16] Under the circumstances, and given the need to protect consumers before any harm occurs, we conclude that the 540-day prior restraint is sufficiently narrowly tailored. It grants a limited, but reasonable, time within which the FDA can evaluate the evidence in support of labeling claims. And it allows for the development of a record on the matter so that a court can determine whether the regulated speech is, in fact, truthful and non-misleading, as is required by the first prong of the Central Hudson test. Significantly, the statutory scheme does not "place[ ] unbridled discretion in the hands of" the FDA to evaluate proposed claims, which is another evil prohibited by prior restraint doctrine. FW/PBS, Inc., 493 U.S. at 225-26, 110 S.Ct. at 604-05 (internal quotation marks and citation omitted). For the "significant scientific agreement" standard for evaluating claims is sufficiently definite to constrain the FDA within reasonable bounds.

We agree with the district court's earlier decision, in effect holding that the absence of a final deadline constituted a prior restraint of unlimited duration, and that without such a deadline, the preauthorization scheme would not pass constitutional muster. See NHA v. Shalala, 953 F.Supp. at 530. But we also find that a restraint of up to 540 days, in the context of evaluating, pursuant to defined standards, whether commercial health claims are truthful and non-misleading, is constitutionally valid.^[17]

We, therefore, hold that plaintiffs' first claim--that the NLEA and FDA regulations impose an unconstitutional ban on certain categories of speech--is not ripe for review. Plaintiffs' second claim--that the regulatory scheme constitutes an unconstitutional prior restraint on speech--is ripe for review, and we hold that the 540-day prior restraint is, in this context, constitutional. Accordingly, we AFFIRM the part of the judgment below that approved the FDA's regulatory deadline, we VACATE the part of the judgment that reached the question of the statute's and regulations' comportment with the First Amendment, and we DISMISS that part of the plaintiffs' action as unripe.