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United States v. an Article of Drug Consisting of 47 Bottles

July 16, 1963


Author: Biggs

Before BIGGS, Chief Judge, and KALODNER and FORMAN, Circuit Judges.

BIGGS, Chief Judge.

This is an appeal from an order of the court below entered February 21, 1962, directing the condemnation of a drug and enjoining the claimant, Marvin Schere, doing business as Jenasol Company (Jenasol), from re-introducing the drug into interstate commerce as labeled or as accompanied with certain labeling materials. The case arises under the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. § 301 et seq.

On May 15, 1958, approximately 438 copies of promotional leaflets for a drug known as "Jenasol RJ Formula '60' Capsules" were shipped by Jenasol from New York City to the home of O.E. Haugh land, a Jensasol representative and sales agent, in Milton, Washington.*fn1

On July 7, 1958, 23 bottles each containing 30 capsules of the drug itself, "Jenasol RJ Formula '60'", were shipped from New York by Jenasol to Haughland's home in Washington. Haughland stored both the previously shipped leaflets and the capsules themselves in his bedroom closet and kept the items there as stock for future sales. The leaflets, broken by Haughland into sets consisting of one copy of each of three different circulars and stapled together, were to be distributed to each customer purchasing the drug and also were to be used for advertising and promotional purposes.

The drug, "Jenasol RJ Formula '60' Capsules", contains as its featured ingredient a substance known as "royal jelly", which, simply described, is the special food fed by worker bees to a newly-hatched bee destined to become a queen. The drug contains certain well-known vitamins and minerals in addition to "royal jelly".*fn2 The promotional leaflets shipped by Jenasol to its agent in the State of Washington for use with the capsules represent to the public that the drug would alleviate mental depression, loss of appetite, sexual weakness, nervousness, and several other ailments, and that it would increase "pep, energy and sexual drive".

Pursuant to an alias warrant of seizure and monition issued by the United States District Court for the Western District of Washington on August 7, 1958, the United States Marshal for that District seized 23 bottles of Jenasol capsules*fn3 and several hundred sets of the promotional literature*fn4 from the possession of Haughland, the Jenasol agent. The seizure was based on a libel of information filed by the United States which alleged that the capsules were misbranded in interstate commerce within the meaning of 21 U.S.C.A. § 352(a) in that the promotional literature accompanying the capsules constituted false and misleading labeling. The relief prayed for in the libel was that the court decree the condemnation of the article.

Jenasol Company intervened as claimant, and, pursuant to an order of the United States District Court for the Western District of Washington dated September 8, 1958, the case was transferred to the United States District Court for the District of New Jersey*fn5 where trial was had before Judge Reynier J. Wortendyke, Jr.

In its opinion, filed on December 14, 1961,*fn6 the court found as a fact that the literature was false and misleading as to the efficacy of the drug, concluded that the literature constituted "labeling" within the meaning of 21 U.S.C.A. § 321 (m), and stated that a decree of condemnation would be issued. Entry and issuance of the decree was stayed on motion by the claimant for clarification of findings of fact, pursuant to Fed.R.Civ.P. 52 (b), 28 U.S.C. Shortly after the stay, the United States moved to amend the libel to include a prayer for injunctive relief against the claimant. In a second opinion, filed February 6, 1962,*fn7 the court specifically found that the labeling was false and misleading in all respects, deemed the libel amended to include a prayer for injunctive relief in accordance with the motion of the United States and granted the injunction against Jenasol. An order of condemnation and injunction against the claimant was issued on February 21, 1962.*fn8 The appeal to this court followed.

Jenasol's first contention is that the leaflets seized with the drug do not constitute labeling within the meaning of the Federal Food, Drug and Cosmetic Act. Section 321(m), Title 21, U.S.C.A. provides: "The term 'labeling' means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article." It is clear from the stipulated facts that the material alleged to be labeling was not physically attached to the drug or its package. Determination of this issue, then, depends upon the construction to be given the statutory phrase "accompanying such article". We must, of course, have in mind the intent of Congress in enacting the Federal Food, Drug and Cosmetic Act. In United States v. Dotterweich, 320 U.S. 277, 280, 64 S. Ct. 134, 136, 88 L. Ed. 48 (1943), it was said "The purposes of this legislation * * * touch phases of the lives and health of people which, in the circumstances of modern industrialism, are largely beyond self-protection. Regard for these purposes should infuse construction of the legislation if it is to be treated as a working instrument of government and not merely as a collection of English words."*fn9

The written material alleged to be labeling was, as we have stated, shipped by Jenasol from New York to Haughland in Milton, Washington on May 15, 1958, and the 23 bottles of the drug were shipped on July 7, 1958. The leaflets and the drug were stored by Haughland in his bedroom closet, unquestionably with the intent to use the leaflets with the drug for sales and promotional purposes. There is no evidence, however, that the leaflets were actually used in either respect.

The definitive test of whether literature can be said to accompany an article and thus constitute labeling within the meaning of the Act was set forth in Kordel v. United States, 335 U.S. 345, 350, 69 S. Ct. 106, 109, 93 L. Ed. 52 (1948): "One article or thing is accompanied by another when it supplements or explains it, in the manner that a committee report of the Congress accompanies a bill. No physical attachment one to the other is necessary. It is the textual relationship that is significant." The textual relationship and supplemental nature of the literature in the appeal at bar, the leaflets entitled "Miracle Bullets", "Jenasol Co.", "This is Our Unconditional Guarantee", and "Royal Jelly Passport to Health",*fn10 is made obvious by a reading of these materials. Each explains the uses of the royal jelly product and the purported health benefits to be derived from it. It is clear then, that these materials together with the drug constitute parts of an "integrated distribution program". Kordel v. United States, supra, 335 U.S. at p. 350, 69 S. Ct. at p. 109; United States v. Lee, 131 F.2d 464 (7 Cir. 1942).*fn11

It is true that the literature and the drugs shipped from Jenasol in New York to its agent in the State of Washington were sent on different dates and in different packages. This, however, does not alter the status of the literature as labeling, for there need not be physical accompaniment of the literature and the drugs to which they relate during the interstate journey. Kordel v. United States, supra. In V. E. Irons, Inc. v. United States, 244 F.2d 34, 39 (1 Cir. 1957), certiorari denied, 354 U.S. 923, 77 S. Ct. 1383, 1 L. Ed. 2d 1437 (1957), the Court stated: "It is clear that the term 'labeling' must be given a broad meaning to include all literature used in the sale of food and drugs, whether or not it is shipped into interstate commerce along with the article." See also United States v. Urbuteit, 335 U.S. 355, 357-358, 69 S. Ct. 112, 93 L. Ed. 61 (1948). In United States v. 7 Jugs, Etc., Dr. Salsbury's Rakos, 53 F.Supp. 746, 755 (D.Minn.1944), the Court said: "* * * [The] printed matter and the drugs had a common origin. They had a common destination in that both were intended to come together * * *. They were interlocking units of a distributional scheme the objective of which was ultimate association and distribution together. * * * [These] booklets were prepared, shipped and distributed to dealers with the ultimate expectation and intention * * * that they would serve the purpose of labeling for the * * * articles * * * here involved. Without the booklets, the products themselves lacked labeling, at least in so far as informing purchasers of the purposes and uses of the remedies. The mere fact that the products were shipped at a different time, over a different route and were received at a different time from the booklets should not be permitted to confuse or obscure the substance of the matter."*fn12

Jenasol insists, however, that for literature to be said to have accompanied a drug within the meaning of the Act there must have been actual use of the literature as labeling, and, it points out that the record is barren of any evidence of such actual use. United States v. Urbuteit, 336 U.S. 804, 69 S. Ct. 840, 93 L. Ed. 1052 (1949), and Kordel v. United States, 335 U.S. 345, 69 S. Ct. 106, 93 L. Ed. 52 (1948), are cited in support of this position. In both cases, the Supreme Court referred to an actual use of the literature. A careful reading of the opinions, however, reveals that the Supreme Court was commenting on the fact that the literature had in fact been used as labeling. Due consideration was given to this factor of use by the Court, but it cannot be said that in doing this the Court promulgated or intended to promulgate a requirement that there be an actual use in order that the literature constitute labeling. Moreover, in United States v. 353 Cases * * * Mountain Valley Mineral Water, 247 F.2d 473, 478 (8 Cir. 1957), the same argument raised by Jenasol in the appeal at bar was asserted, and rejected by the court. The claimant urged that leaflets could not properly be deemed to be labeling "because of evidence that they had not been used by the distributor in connection with selling the [mineral] water * *. However, all of the pamphlets were obviously printed for use generally in promoting the sale of the water, and were useful for no other purpose. All of them were found in the place of business of the local distributor * * *." The Court concluded, supra, 247 F.2d at p. 480, that "all of the sales literature * * * ...

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