Nutrilab, Inc. v. Schweiker, Nos. 82-2746

CourtUnited States Courts of Appeals. United States Court of Appeals (7th Circuit)
Writing for the CourtBefore CUMMINGS, Chief Judge, POSNER, Circuit Judge, and FAIRCHILD; CUMMINGS
Citation713 F.2d 335
PartiesNUTRILAB, INC., et al. and Bio-Tech Laboratories, Inc., et al., Plaintiffs- Appellants, v. Richard S. SCHWEIKER, U.S. Secretary of Health and Human Services; and Arthur Hull Hayes, Jr., Commissioner of the U.S. Food and Drug Admin., Defendants- Appellees.
Decision Date08 August 1983
Docket Number82-2747,Nos. 82-2746

Page 335

713 F.2d 335
NUTRILAB, INC., et al. and Bio-Tech Laboratories, Inc., et
al., Plaintiffs- Appellants,
Richard S. SCHWEIKER, U.S. Secretary of Health and Human
Services; and Arthur Hull Hayes, Jr.,
Commissioner of the U.S. Food and Drug
Admin., Defendants- Appellees.
Nos. 82-2746, 82-2747.
United States Court of Appeals,
Seventh Circuit.
Argued April 22, 1983.
Decided Aug. 8, 1983.

Dennis M. Gronek, Dilling, Dilling & Gronek, Chicago, Ill., for plaintiffs-appellants.

Thomas P. Walsh, Asst. U.S. Atty., Chicago, Ill., Don O. Burley, Office of Consumer Litigation, Dept. of Justice, Washington, D.C., Stephan D. Terman, Assoc. Chief Counsel, FDA, Rockville, Md., for defendants-appellees.

Before CUMMINGS, Chief Judge, POSNER, Circuit Judge, and FAIRCHILD, Senior Circuit Judge.

CUMMINGS, Chief Judge.

Plaintiffs manufacture and market a product known as "starch blockers" which "block" the human body's digestion of starch as an aid in controlling weight. On July 1, 1982, the Food and Drug Administration ("FDA") classified starch blockers as "drugs" and requested that all such products be removed from the market until FDA approval was received. The next day plaintiffs filed two separate complaints in the district court seeking declaratory judgments that these products are foods under 21 U.S.C. § 321(f) and not drugs under 21 U.S.C. § 321(g). The cases were consolidated and the government counterclaimed for a temporary restraining order, which was denied. At the close of the hearing on the preliminary injunction, the parties stipulated to advancing the hearing as a trial on the merits. On October 5, 1982, the district court held that starch blockers were drugs under 21 U.S.C. § 321(g), plaintiffs were permanently enjoined from manufacturing and distributing the products, and they were ordered to destroy existing inventories. Nutrilab, Inc. v. Schweiker, 547 F.Supp. 880 (N.D.Ill.1982). The portion of the order requiring destruction of the products was stayed pending appeal.

The only issue on appeal is whether starch blockers are foods or drugs under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. Starch blocker tablets and capsules consist of a protein which is extracted from a certain type of raw kidney

Page 336

bean. That particular protein functions as an alpha-amylase inhibitor; alpha-amylase is an enzyme produced by the body which is utilized in digesting starch. When starch blockers are ingested during a meal, the protein acts to prevent the alpha-amylase enzyme from acting, thus allowing the undigested starch to pass through the body and avoiding the calories that would be realized from its digestion.

Kidney beans, from which alpha-amylase inhibitor is derived, are dangerous if eaten raw. By August 1982, FDA had received seventy-five reports of adverse effects on people who had taken starch blockers, including complaints of gastro-intestinal distress such as bloating, nausea, abdominal pain, constipation and vomiting. Because plaintiffs consider starch blockers to be food, no testing as required to obtain FDA approval as a new drug has taken place. If starch blockers were drugs, the manufacturers would be required to file a new drug application pursuant to 21 U.S.C. § 355 and remove the product from the marketplace until approved as a drug by the FDA.

The statutory scheme under the Food, Drug, and Cosmetic Act is a complicated one. Section 321(g)(1) provides that the term "drug" means

* * * (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clauses (A), (B), or (C) of this paragraph; but does not include devices or their components, parts, or accessories.

The term "food" as defined in Section 321(f) means

(1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

Section 321(g)(1)(C) was added to the statute in 1938 to expand the definition of "drug." The amendment was necessary because certain articles intended by manufacturers to be used as drugs did not fit within the "disease" requirement of Section 321(g)(1)(B). Obesity in particular was not considered a disease. Thus "anti-fat remedies" marketed with claims of "slenderizing effects" had escaped regulation under the prior definition. See Food, Drugs, and Cosmetics: Hearings on S. 1944 before Subcomm. of Sen. Comm. on Commerce, 73d Cong., 2d Sess. 15-16 (1933) (Statement of Walter G. Campbell, Chief of FDA), reprinted in 1 Legislative History of Food, Drug and Cosmetic Act 105, 107-108 (hereinafter "L.H.F.D.C.A."). The purpose of part C in Section 321(g)(1) supra was "to make possible the regulation of a great many products that have been found on the market that cannot be alleged to be treatments for diseased conditions." Id.

It is well established that the definitions of food and drug are normally not mutually exclusive; an article that happens to be a food but is intended for use in the treatment of disease fits squarely within the drug definition in part B of Section 321(g)(1) and may be regulated as such. See, e.g., National Nutritional Foods Ass'n v. Mathews, 557 F.2d 325, 334 (2d Cir.1977); United States v....

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