United States v. 47 BOTTLES, MORE OR LESS, ETC.

• Decision Date: 06 February 1962
• Docket Number: Civ. A. No. 1042-58.
• Parties: UNITED STATES of America, Libellant, v. An Article of Drug consisting of 47 BOTTLES, MORE OR LESS, each containing 30 capsules OF an article labeled in part: "* * * JENASOL RJ FORMULA `60' * * *", Respondent.
• Court: U.S. District Court — District of New Jersey

201 F. Supp. 915

UNITED STATES of America, Libellant, v. An Article of Drug consisting of 47 BOTTLES, MORE OR LESS, each containing 30 capsules OF an article labeled in part: "* * * JENASOL RJ FORMULA `60' * * *", Respondent.

Civ. A. No. 1042-58.

United States District Court D. New Jersey.

February 6, 1962.

David M. Satz, Jr., U.S. Atty., by Jerome D. Schwitzer, Asst. U.S. Atty., Newark, N. J., and William Goodrich, General Counsel Department of Health, Education & Welfare, Food and Drug Administration, Washington, D. C., by William J. Risteau, Washington, D. C. (Illinois Bar), for the Government.

Bass & Friend, by Milton Bass, New York City, for respondent.

WORTENDYKE, District Judge.

In its opinion, filed December 14, 1961, 200 F.Supp. 1, this Court found that Jenasol capsules, an article of drug, seized under 21 U.S.C.A. § 301 et seq., was misbranded because the claims set forth in its labelling were false and misleading.

On December 18, 1961 respondent obtained an order to show cause why the entry of judgment should not be stayed pending clarification of the Court's findings of fact; clarifying said findings of fact; permitting relabelling of the articles seized; and staying the execution of the decree of condemnation pending an appeal from said decree of condemnation.

The Government now moves to amend the prayers for relief in the libel to include an injunction to prevent the sale of respondent product. Such a form of relief is authorized by 21 U.S.C.A. § 332(a).

The issues presented on return of the order to show cause were orally argued on January 22, 1962, and decision reserved thereon, excepting the application for a stay of entry of judgment, which was denied. (The judgment order when submitted should provide for a stay of destruction of the product under condemnation pending appeal, if taken within time.)

The motion to clarify and expand the Court's opinion was not opposed by the Government, for the apparent reason that the Food and Drug Administration, now seeking an injunction, recognizes the necessity of specific findings with regard to each of the alleged false representations in the labelling in order to render enforceable the injunctive relief which it seeks. Whether or not an injunction could properly issue barring the future sale of Jenasol RJ Formula "60" capsules with each of the representations presently contained in the labelling thereof without more specific findings of fact, was not argued by the parties. However, it was impliedly conceded by the Government than an injunction against the labelling in toto might be too broad in scope in view of the findings already made.

The Court has found that a decree of condemnation should issue upon "the ample evidence to be found in the testimony of the witnesses for libellant that the drug was not an effective agent in the treatment of headaches, tired eyes, spiritual or physical convulsions" which evidence "was not even contradicted by claimant." It was not incumbent upon the Court to specifically "find" with regard to each and every allegation of misbranding contained in the libel, but in view of the present applications, explicit findings will be made as to the efficacy of Jenasol RJ Formula "60" Capsules as an adequate and effective treatment for: — increasing sexual vitality irritability, insomnia, depression, restoring vitality, alleviating ills of old age improving memory, stimulating the appetite, normalizing growth of underdeveloped children, extending the span of human life, digestive disturbances, activating glands of the body, physical and mental symptoms of approaching old age; and whether it is a "natural super-tonic"...