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NUTRILAB, INC. v. SCHWEIKER

October 5, 1982

NUTRILAB, INC.; NATURALIFE-ECOVITE LABORATORIES, INC., D/B/A PARAGON LABORATORIES; JEAN PIERRE PRODUCTS, INC., AND NATURAL RESEARCH, PLAINTIFFS AND COUNTERDEFENDANTS,
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 ADMINISTRATION, DEFENDANTS, THE UNITED STATES OF AMERICA, COUNTERPLAINTIFF. BIO-TECH LABORATORIES, INC.; VITA-LITE LABORATORIES, INC.; DYNAVEST; J. JOHN MARSHALL, PH.D.; J. ROBERT LEMON, R.PH., AND RONALD F. FRANTZ, PLAINTIFFS AND COUNTERDEFENDANTS, 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 ADMINISTRATION, DEFENDANTS, THE UNITED STATES OF AMERICA, COUNTERPLAINTIFF.



The opinion of the court was delivered by: Bua, District Judge.

MEMORANDUM AND ORDER

STATEMENT OF THE CASE

The instant litigation concerns those products which have become known generically as "starch blockers."*fn1 The plaintiffs, manufacturers and distributors of the products, initiated the lawsuit seeking a declaratory judgment pursuant to 28 U.S.C. § 2201 and 2202 and requesting this Court to declare that starch blockers are "foods" under 21 U.S.C. § 321(f) and not "drugs" as defined by 21 U.S.C. § 321(g). The lawsuit was initiated in response to the classification by the Food and Drug Administration (FDA) of the products as "drugs" and to the agency's request that all such products be removed from the market until FDA approval was received. Absent substantial scientific evidence demonstrating that the product was generally recognized as safe and effective, the FDA regarded the product as a "new drug" under 21 U.S.C. § 321(g) and considered further interstate distribution of the product a violation of 21 U.S.C. § 355(a).

The defendants counterclaimed seeking a temporary restraining order enjoining the plaintiffs from further distributing starch blockers in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act, ("the Act"), 21 U.S.C. § 301-392. The motion for the temporary restraining order was denied and a hearing was held on defendants' motion for a preliminary injunction. At the close of the hearing, the parties stipulated to advancing the hearing as a trial on the merits.

FINDINGS OF FACT AND CONCLUSIONS OF LAW

The Court, having heard the testimony of the witnesses and having examined the exhibits introduced in evidence does hereby make the following findings of fact and conclusions of law pursuant to Rule 52(a) of the Federal Rules of Civil Procedure.*fn2

"Starch blocker" is the generic name for the group of products manufactured from the protein contained in a certain type of raw kidney bean. The product is sold in both tablet and capsule form.

It is claimed that the protein which makes up the product acts to prevent the digestion of starch. Specifically, it is claimed, the protein acts as an alpha-amylase inhibitor. Alpha-amylase is an enzyme secreted by the pancreas which is necessary to the digestion of starch. When one or more starch blocker pills are ingested during a meal, the protein acts to prevent the alpha-amylase enzyme from acting, thus allowing the undigested starch to pass from the system. As digestion of starch, a complex sugar, is cited as a cause of weight gain, the passage of starch through the system in an undigested form allows the individual taking the starch blocker to consume foods containing starch and high in carbohydrates without the risk of putting on weight.*fn3

The safety and effectiveness of the product has yet to be tested by the FDA. As the plaintiffs consider their products to be foods, no testing as required to obtain FDA approval as a new drug has taken place. No new drug application has been filed for these products nor has any investigational new drug exemption been issued pursuant to 21 U.S.C. § 355(i).

The central issue in this case involves a determination of whether starch blockers are a drug under 21 U.S.C. § 321(g) or a food under 21 U.S.C. § 321(f). If a drug, the manufacturers of starch blockers would be required to file a new drug application pursuant to 21 U.S.C. § 355 and to be regulated as such. The immediate consequence of such a determination would be the issuance of a permanent injunction requiring plaintiffs to remove the product from the marketplace until approved as a drug by the FDA.

Under 21 U.S.C. § 321(g)(1)(C), drugs are defined as ". . . articles (other than food) intended to affect the structure or any function of the body of man . . ." Foods, on the other hand, are defined as "articles used for food or drink for man . . ." 21 U.S.C. § 321(f).

Because of the breadth and necessary vagueness of these statutory definitions, it is incumbent upon this Court to formulate usable working definitions for these terms which can be applied to the case at bar. In undertaking such a task, the Court is mindful of the policy requiring liberal construction of the terms consistent with the overriding purpose of the Act — the protection of public health. U.S. v. Bacto-Unidisk, 394 U.S. 784, 798, 89 S.Ct. 1410, 1418, 22 L.Ed.2d 726 (1969). As the Court there noted, ". . . the `natural way' to draw the line (between a food and a drug) `is in light of statutory purpose,'" 394 U.S. at 799, 89 S.Ct. at 1418, quoting S.E.C. v. Ralston Purina Co., 346 U.S. 119, 124-5, 73 S.Ct. 981, 984-85, 97 L.Ed. 1494 (1953).

The plaintiffs have urged the Court to make its determination of whether starch blockers are foods or drugs based upon the source from which the product has been derived and, apparently, upon the common perception of the category into which the main component of the product falls. Thus, it is argued that, as the product is manufactured from beans, indisputably a natural food, and is made up of mere protein, a substance often regarded as a food, the product must be considered a food. This argument must, however, be rejected.

  That a product is naturally occurring or derived from a
natural food does not preclude its regulation as a drug.
See, e.g., United States v. "Vitasafe Formula M", 226 F. Supp. 266
 (D.N.J. 1964), reversed on other grounds, 345 F.2d 864 (3d
Cir. 1965); United States v. Nutrition Service, Inc.,
227 F. Supp. 375 (W.D.Pa. 1964); United States v. 250 Jars, Etc., of
U.S. Fancy Pure Honey, 218 F. Supp. 208 (E.D.Mich. 1963), aff'd.
344 F.2d 288 (6th Cir. 1965). Nor does the fact that an item
might, in one instance, be regarded as a food prevent it from
being regulated as a drug in another. National Nutritional
Foods Association v. Mathews, 557 F.2d 325 (2d Cir. ...

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