Hanson v. United States, 4-76-Civ. 11.

• Citation: 417 F. Supp. 30
• Decision Date: 20 February 1976
• Docket Number: No. 4-76-Civ. 11.,4-76-Civ. 11.
• Parties: Don HANSON and Donna W. Schuster, Plaintiffs, v. UNITED STATES of America et al., Defendants.
• Court: U.S. District Court — District of Minnesota

417 F. Supp. 30

Don HANSON and Donna W. Schuster, Plaintiffs, v. UNITED STATES of America et al., Defendants.

No. 4-76-Civ. 11.

United States District Court, D. Minnesota, Fourth Division.

February 20, 1976.

COPYRIGHT MATERIAL OMITTED

James Malcolm Williams, Minneapolis, Minn., for plaintiffs.

Daniel M. Scott, Asst. U. S. Atty., Minneapolis, Minn., for defendants.

MEMORANDUM ORDER

LARSON, District Judge.

The plaintiffs in this civil action for injunctive and declaratory relief operate as a Shaklee Distributing Agency located in Rochester, Minnesota. Among the items which they are in the business of selling and distributing in interstate commerce is a product known variously as amygdalin, laetrile, or prunasin or "Vitamin B-17", which they receive from a manufacturer in Mexico in tablet and liquid form (vials), and which they in turn sell to the ultimate users of the product. The product is comprised of an extraction from the kernels of apricot pits. The complaint alleges that:

"among the dramatic effects of a diet rich in Vitamin B-17 is the prevention, control, arrest and minimization of cancerous tissue growths . . .."

The defendants are the United States and various officers thereof responsible for the enforcement and administration of the Food, Drug, and Cosmetic Act, as amended. 21 U.S.C. §§ 301 et seq. They have taken the position that the laetrile tablets and vials which are being imported and distributed by the plaintiffs are "new drugs" within the meaning of 21 U.S.C. § 321(p), and that the plaintiffs' conduct is unlawful under 21 U.S.C. § 355(a) because the Food and Drug Administration FDA has not approved a new drug application with respect to the drug; indeed, say the defendants, no new drug application has ever been filed in accordance with 21 U.S.C. § 355(b). Because of their view that the importation and distribution of laetrile vials and tablets in interstate commerce is prohibited, Federal authorities obtained search warrants on December 23, 1975, for the plaintiffs' residences. Several items were seized in the execution of those warrants, including a quantity of the product laetrile. On January 9, 1976, the plaintiffs were indicted by the Grand Jury for the Southern District of California on charges of smuggling vials and tablets of laetrile, in violation of 18 U.S.C. §§ 371 and 545. That criminal prosecution is currently pending.

The plaintiffs do not deny that there is no approved new drug application with respect to the laetrile tablets and vials. They argue, however, that the tablets and vials are not a drug, are not "new drugs" within the meaning of the Act, and are not subject to restriction by the FDA. In this action, commenced on January 8, 1976, the plaintiffs seek injunctive relief along the following lines:

(1) An Order requiring that all items seized from the plaintiffs pursuant to the search warrants issued on December 23, 1975, be returned, and that no further search warrant be applied for against the plaintiffs without this Court's order.

(2) An Order enjoining all criminal prosecutions of whatsoever nature, for importing laetrile or selling it, and requiring this Court's authorization before any such proceeding may be commenced.

(3) A declaratory judgment that laetrile is a food, is not a new drug, is not prohibited in interstate commerce, is not harmful or toxic, that plaintiffs' source is not adulterated or mislabeled, and that the plaintiffs have the right to import it and the public has a right to use it.

(4) An Order decreeing that no agency of the United States has a right to interfere other than with reasonable import duties, enjoining any such interference, and retaining jurisdiction to assure that the duties so imposed are reasonable.

The plaintiffs sought a temporary restraining Order embodying the aforementioned relief, and such an Order was denied by this Court on January 15, 1976. Subsequently, various jurisdictional motions were filed by the defendants to dismiss the action against several or all of them.¹ Ordinarily, the Court would proceed first to jurisdictional issues as is the custom in the American judicial system. Cf. Ashwander v. Tennessee Valley Authority, 297 U.S. 288, 347, 56 S.Ct. 466, 80 L.Ed. 688 (1936) (Brandeis, J., concurring); Turbak v. Haines, No. 4-75-Civil 42 (D.Minn. December 31, 1975) at Slip Op. 2. Counsel for the plaintiffs has urged, however, that immediate relief in this action is of such extraordinary importance and that the wrongdoing of the defendants is so patently obvious, that the Court should first accord to the plaintiffs a full opportunity for a hearing on the request for a preliminary injunction. Such a hearing was held on January 30, 1976, at which time the plaintiffs presented testimony through several witnesses and introduced numerous documentary exhibits. For the reasons set forth herein, the motion for a preliminary injunction will be denied.

The first category of relief sought by the plaintiffs — the return of the items seized in execution of the December 23, 1975, search warrants — must be rejected on the authority of Chief Judge Devitt's Order of January 28, 1976, in United States v. 1617 Fourth Avenue Southwest, D.Minn., 406 F.Supp. 527, 1-76-Mag-1. That Order was in response to the motion of the plaintiffs herein pursuant to Federal Rule of Criminal Procedure 41(e) for return of the seized property. Judge Devitt refused to rule on their motion, reasoning that the plaintiffs have an adequate remedy in the trial court in the Southern District of California, pursuant to Rule 12. This Court subscribes to that reasoning, and will not create a third method for obtaining the return of seized property in circumvention of the Order of the Chief Judge in this District.

The second category of relief sought by the plaintiffs — the enjoining of criminal prosecution by the defendants — must be denied on the authority of the general rule that equity will not act to restrain a criminal prosecution when the moving party has an adequate remedy at law and will not suffer irreparable injury if denied equitable relief. See O'Shea v. Littleton, 414 U.S. 488, 499, 94 S.Ct. 669, 38 L.Ed.2d 674 (1974); Roe v. Wade, 410 U.S. 113, 126, 93 S.Ct. 705, 35 L.Ed.2d 147 (1973); Younger v. Harris, 401 U.S. 37, 43-44, 91 S.Ct. 746, 27 L.Ed.2d 669 (1971); Stefanelli v. Minard, 342 U.S. 117, 120, 72 S.Ct. 118, 96 L.Ed. 138 (1951); Douglas v. City of Jeannette, 319 U.S. 157, 163, 63 S.Ct. 877, 87 L.Ed. 1324 (1943); Ripley v. Stidd, 308 F.Supp. 854, 857 (D.Minn.1970); Alexander v. Zimpfer, No. 4-69-Civil 405 (D.Minn.1969), aff'd per curiam, 431 F.2d 704 (8th Cir. 1970). The plaintiffs seek to avoid this rule by alleging in their complaint that the defendants are engaging in a course of bad faith and harassment. See Dombrowski v. Pfister, 380 U.S. 479, 88 S.Ct. 1116, 14 L.Ed.2d 22 (1965). This allegation is insufficient to trigger the Dombrowski exception to the rule of equitable restraint in light of this Court's conclusion, set forth below, that the plaintiffs have failed to show a substantial probability of success on the merits of their claim that laetrile tablets and liquid cannot be regulated by the FDA.

The plaintiffs' right to a preliminary injunction along the lines sought in the third and fourth categories of relief is dependent on their showing of a substantial probability of success concerning their claim that the FDA has no power to regulate the importation, distribution in interstate commerce, and sale of laetrile tablets and liquid. The relief will be denied because the Court concludes on the basis of all the evidence that the plaintiffs have not made such a showing.

The plaintiffs have not shown a substantial probability of success with respect to their claim that laetrile tablets and liquid as sold by them are not "drugs" within the meaning of the Food, Drug, and Cosmetic Act. The word "drug" is defined in 21 U.S.C. § 321(g)(1) to include:

". . . (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals . . .." (emphasis supplied).

Countless court decisions emphasize that it is the intended use of an article which determines whether or not it is a "drug," and that even the most commonly ingested foods and liquids are "drugs" within the meaning of the Act if the intended use of such articles when distributed in interstate commerce falls within the definition of § 321(g)(1). See, e. g., Kordel v. United States, 335 U.S. 345, 69 S.Ct. 106, 93 L.Ed. 52 (1948) (compounds of minerals, vitamins, and herbs); Seven Cases v. United States, 239 U.S. 510, 518, 36 S.Ct. 190, 60 L.Ed. 411 (1916) (alcoholic solution); United States v. Millpax, Inc., 313 F.2d 152, 153-54 (7th Cir. 1963), cert. denied, 373 U.S. 903, 83 S.Ct. 1291, 10 L.Ed.2d 198 (1963) ("iron tonic"); United States v. Hohensee, 243 F.2d 367 (3d Cir. 1957), cert. denied, 353 U.S. 976, 77 S.Ct. 1058, 1 L.Ed.2d 1136 (1957) ("health foods"); Bradley v. United States, 264 Fed. 79 (5th Cir. 1920) (mineral water); United States v. Vitasafe Formula M, 226 F.Supp. 266, 278 (D.N.J.1964), remanded on other grounds, 345 F.2d 864 (3d Cir. 1965), cert. denied, 382 U.S. 918, 86 S.Ct. 290, 15 L.Ed.2d 232 (1965) (vitamin and mineral capsules); United States v. 250 Jars . . Fancy Pure Honey, 218 F.Supp. 208, 211 (E.D.Mich.1963), aff'd 344 F.2d 288 (6th Cir. 1965) (honey); United States v. 46 Cartons . . . Fairfax Cigarettes, 113 F.Supp. 336, 338 (D.N.J.1953) (cigarettes). From these cases, it is apparent that the plaintiffs' argument that laetrile is a "vitamin" or a food does not preclude its being a drug if the tablets and vials at issue here are peddled for the intended uses set forth in the statute.

It is also well established that the "intended use" of a product, within the meaning of the Act, is determined from its label, accompanying labeling, promotional claims, advertising, and any other relevant source....