American Health Products Co. v. Hayes, R-K

Decision Date11 September 1984
Docket NumberR-K,No. 1100,D,1100
Citation744 F.2d 912
PartiesAMERICAN HEALTH PRODUCTS CO., General Nutrition Center, Inc., General Nutrition Corp., Melva Natural Products, Inc., Nature's Bounty, Inc., Nutrition Headquarters, Inc., Phoenix Laboratories, Inc.,ane, Inc., Sunrise Chemical, Inc., Total Success, Inc., Plaintiffs, General Nutrition Center, Inc., General Nutrition Corp., Nutrition Headquarters, Inc., Sunrise Chemical, Inc., Plaintiffs-Appellants, v. Arthur Hull HAYES, Commissioner of Food and Drugs, Food And Drug Administration, Defendants-Appellees. ocket 84-6018.
CourtU.S. Court of Appeals — Second Circuit

Milton A. Bass, New York City (Robert Ullman, Lawrence H. Roth, Bass, Ullman & Lustigman, New York City, of counsel), for plaintiffs-appellants.

Janis P. Farrell, Asst. U.S. Atty., S.D.N.Y., New York City (Rudolph W. Giuliani, U.S. Atty., Peter C. Salerno, Asst. U.S. Atty., S.D.N.Y., New York City, J. Patrick Glynn, Director, Don O. Burley, Atty., Office of Consumer Litigation, Civil Div., Dept. of Justice, Washington, D.C.; Thomas Scarlett, Chief Counsel, Food and Drug Admin., Stephen D. Terman, Associate Chief Counsel for Enforcement, Food and Drug Admin., Washington, D.C., of counsel), for defendants-appellees.

Before OAKES, VAN GRAAFEILAND and PIERCE, Circuit Judges.


Plaintiffs brought this action seeking a declaratory judgment that "starchblockers" are a "food" rather than a "drug" for purposes of 21 U.S.C. Sec. 321(g)(1)(C). Defendants counterclaimed for permanent injunctive relief. In a published memorandum opinion and order, filed November 14, 1983, the district court denied plaintiffs' claim, holding that starchblockers are a drug under section 321(g)(1)(C). American Health Products Co. v. Hayes, 574 F.Supp. 1498 (S.D.N.Y.1983). Judgment on plaintiffs' claim was filed on November 18, 1983.

In a subsequent order, filed June 15, 1984, the district court granted the permanent injunctive relief sought by defendants' counterclaim. Judgment thereon was entered on July 26, 1984.

After considering both parties' arguments, we affirm the district court's holding that starchblockers are a drug under section 321(g)(1)(C) substantially for the reasons set forth in Judge Sofaer's thorough opinion. We note that arguments similar to those raised by plaintiffs also were rejected in a comprehensive opinion by the United States Court of Appeals for the Seventh Circuit. Nutrilab, Inc. v. Schweiker, 713...

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  • US v. Ten Cartons, Ener-B Nasal Gel
    • United States
    • U.S. District Court — Eastern District of New York
    • 24 Marzo 1995
    ... ... 385 Bounty that the Act provided for the seizure of illegal products, and for an injunction against the distributor of such products ... to have "the everyday meaning of food." Report at 25 (citing American Health Products v. Hayes, 574 F.Supp. 1498, 1504 (S.D.N.Y. 1983) ... ...
  • Association of Amer. Phys. v. U.S. Food and Drug
    • United States
    • U.S. District Court — District of Columbia
    • 17 Octubre 2002
    ... 226 F.Supp.2d 204 ... ASSOCIATION OF AMERICAN, PHYSICIANS AND SURGEONS, INC., et al., Plaintiffs, ... UNITED STATES ... Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients" ("Pediatric Rule"), 21 C.F.R. §§ 201, 312, 314, ... drugs for which additional pediatric information may produce health benefits." § 355a(b). The statute also contained a requirement that the ... Health Prods. Co. v. Hayes, 574 F.Supp. 1498, 1505 (S.D.N.Y.1983), aff'd on other grounds, 744 ... ...
  • United States v. General Nutrition, Inc.
    • United States
    • U.S. District Court — Western District of New York
    • 27 Mayo 1986
    ... ... , distribution and sale of nutritional, personal care and related products." Defendants' Summary Memorandum, pp. 2-3. The other 638 F. Supp. 558 ... was promoted in the media and elsewhere for its supposed beneficial health effects. For example, it is alleged that Gammaprim was sold in conjunction ... See, e.g. American Health Products Co., Inc. v. Hayes, 574 F.Supp. 1498 (S.D.N.Y.1983), ... ...
  • US v. Undetermined Quantities of Cal-Ban 3000***
    • United States
    • U.S. District Court — Eastern District of North Carolina
    • 17 Septiembre 1991
    ... ... in the United States for several years by a company known as Health Care Products, Inc., doing business as Anderson Pharmacals, of Lutz, ... v. Schweiker, 713 F.2d 335 (7th Cir.1983); American Health Products Company v. Hayes, 574 F.Supp. 1498 (S.D.N.Y.1983), ... ...
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