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.
United States Court of Appeals, Second Circuit.https://leagle.com/images/logo.png
Argued April 23, 1998.
Decided May 15, 1998.
Attorney(s) appearing for the Case
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.
United States Court of Appeals, Second Circuit.
CALABRESI, Circuit Judge:
The principal question before us is whether plaintiffs-appellants may challenge the statute and regulations governing the labeling of dietary supplements1 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...
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