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