Nutritional Health Alliance v. Shalala

• Decision Date: 15 May 1998
• Docket Number: Docket No. 97-6246
• Citation: 144 F.3d 220
• Parties: 26 Media L. Rep. 1843 NUTRITIONAL HEALTH ALLIANCE and Soo Man Shim, d/b/a New Nutrisserie, Plaintiffs-Appellants, v. Donna SHALALA, in her official capacity as Secretary, U.S. Department of Health and Human Services, and David Kessler, Commissioner, Food and Drug Administration, Defendants-Appellees.
• Court: U.S. Court of Appeals — Second Circuit

Page 220

144 F.3d 220

26 Media L. Rep. 1843

NUTRITIONAL HEALTH ALLIANCE and Soo Man Shim, d/b/a New Nutrisserie, Plaintiffs-Appellants, v. Donna SHALALA, in her official capacity as Secretary, U.S Department of Health and Human Services, and David Kessler, Commissioner, Food and Drug Administration, Defendants-Appellees.

Docket No. 97-6246.

United States Court of Appeals Second Circuit.

Argued April 23, 1998.

Decided May 15, 1998.

Milton A. Bass, Bass & Ullman, P.C., New York City (John M. Desiderio, Jacob Laufer, Marc Ullman), for Plaintiffs-Appellants.

Kay K. Gardiner, Assistant United States Attorney, for Mary Jo White, United States Attorney for the Southern District of New York (Marla Alhadeff, Assistant U.S. Attorney), for Defendants-Appellees.

Steven J. Rosenbaum, Covington & Burling, Washington, DC (James H. Skiles), for Amicus Curiae, Grocery Manufacturers of America, Inc., in support of Plaintiffs-Appellants.

David C. Vladeck, Public Citizen Litigation Group, Washington, DC; Bruce Silverglade, Center for Science in the Public Interest, Washington, DC, for Amici Curiae, The American Cancer Society; American Heart Association; Center for Science in the Public Interest; Public Citizen; and the Consumer Federation of America, in support of Defendants-Appellees.

Before: WALKER, CALABRESI, Circuit Judges, and RESTANI, ^* Judge.

CALABRESI, Circuit Judge:

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.

I. BACKGROUND

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.

1. Fitness for Judicial Review

To determine fitness for judicial review, we must examine, among other factors, whether "consideration of the underlying legal...