royal jelly is not therapeutically effective for the conditions claimed in the labeling, and that the evidence discloses that there exists a conflict of scientific opinion as to the efficacy of the substance for the purposes enumerated.
Claimant affirmatively asserts that its witnesses are the only qualified experts upon the critical issue, and that their opinions, which rest upon clinical observations, are conclusive of the therapeutic efficacy of royal jelly for the conditions claimed in the labeling.
It is the efficacy of the royal jelly component in the Jenasol formula which is the bone of contention in this case. Indeed, it is the unknown constituent in royal jelly which is relied upon by the claimant as the efficient cause of the therapeutic benefits recited in the labeling. Claimant's contention respecting the beneficence of royal jelly is a deduction from an assumption that because the queen bee thrives upon the substance, while the other members of the hive, without it, fail to enjoy her vigor and longevity, its administration to human beings must be productive of comparable results. There has been no showing in the evidence in this case that a human being is likely to react to the ingestion of royal jelly in any manner, direction or degree similar to the reaction of the queen bee to the inclusion of such a substance in her diet. If, as the claimant contends, the results of the administration of royal jelly to rats are irrelevant to the effects of the substance upon human beings, the effects of the substance upon the queen bee are certainly not to be compared to those which may be expected in the case of human babies or old people. Recognizing, however, that the burden of proof of inefficacy is imposed upon the Government in this case, we look to the net effect of the evidence proffered in support of its contention as compared with that offered by the claimant. The latter argues that because no one has succeeded in completely analyzing the composition of royal jelly, it cannot be said that it lacks a component which might be efficacious in the treatment of the conditions set forth in the labeling. The Government contends, however, that reliable medical opinion negatives the efficacy of the substance for some, if not for all of the objects set forth in the labeling.
The statute, 21 U.S.C.A. § 352 (a) defines as misbranding a drug whose labeling is false or misleading in any particular and renders the drug liable to seizure if it is misbranded. Labeling, as used in the statute 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' 21 U.S.C.A. § 321(m). In order to justify the present seizure, the Government is required to show by the preponderance of the evidence that the labeling of the drug is false or misleading in some particular. No fraudulent intent on the part of the claimant need be shown as is required to sustain a fraud order of the Postmaster General. American School of Magnetic Healing v. McAnnulty, 1902, 187 U.S. 94, 23 S. Ct. 33, 47 L. Ed. 90. See also Reilly v. Pinkus, 1949, 338 U.S. 269, 70 S. Ct. 110, 94 L. Ed. 63. To sustain its burden of proof in the present case, the Government must show by the greater weight of the believable evidence that the Jenasol labeling is false or misleading in some particular. United States v. Kaadt, 7 Cir. 1948, 171 F.2d 600.
I conclude from the substantial evidence which has been produced before me in this case that the Government has sustained its burden of proof. Whether a consensus of medical opinion exists respecting the effectiveness of the seized drug for the purpose claimed in the labeling, and whether there is a conflict in the medical opinion in that regard, are issues of fact which I am called upon to resolve in the case. Seven Cases v. United States, 1916, 239 U.S. 510, 36 S. Ct. 190, 60 L. Ed. 411, L.R.A.1916D, 164; United States v. Kaadt, supra; United States v. Dr. David Roberts Veterinary Co., 7 Cir., 1939, 104 F.2d 785. The substantiality of the evidence inducive of my conclusion finds support in the criteria enunciated in venerable authority. 3 Wigmore, Evidence § 687 at 3 (3d Ed. 1940); United States v. Wood, 4 Cir., 1955, 226 F.2d 924; Irwin v. Federal Trade Commission, 8 Cir., 1944, 143 F.2d 316; John J. Fulton Co. v. Federal Trade Commission, 9 Cir., 1942, 130 F.2d 85, cert. den. 1942, 317 U.S. 679, 63 S. Ct. 158, 87 L. Ed. 544; Neff v. Federal Trade Commission, 4 Cir., 1941, 117 F.2d 495.
That the printed material in which the alleged false and misleading representations were set forth constitutes labeling within the meaning of the Act is obvious, because that material, together with the drug itself, constitute 'parts of an integrated distribution program' as disclosed on the face of the material and in the stipulated facts. Kordel v. United States, 1948, 335 U.S. 345, 350, 69 S. Ct. 106, 110, 93 L. Ed. 52; United States v. Urbeteit, 1948, 335 U.S. 355, 69 S. Ct. 112, 93 L. Ed. 61; United States v. 353 Cases * * * Mountain Valley Mineral Water, 8 Cir., 1957, 247 F.2d 473; United States v. 4 Devices * * * Color-Therm, 10 Cir., 1949, 176 F.2d 652; United States v. 10 Cartons * * * Black Tablets, D.C.Pa.1957, 152 F.Supp. 360.
To discharge its burden of proof under the statute, the government was required to adduce substantial evidence tending to show that the labeling was 'false or (note disjunctive) misleading in any particular.' 21 U.S.C.A. § 352(a); United States v. Hoxsey Cancer Clinic, 5 Cir. 1952, 198 F.2d 273, cert. den. 1952, 344 U.S. 928, 73 S. Ct. 496, 97 L. Ed. 714; United States v. Six Dozen Bottles * * * Dr. Peter's Kuriko, 7 Cir., 1947, 158 F.2d 667; Goodwin v. United States, 6 Cir. 1924, 2 F.2d 200. The ample evidence to be found in the testimony of the witnesses for libelant that the drug was not an effective agent in the treatment of headaches, tired eyes, spiritual or physical convulsions was not even contradicted by claimant, who did not even explain what was meant by 'spiritual convulsions' as used in the labeling.
Despite the ostensible relation of the representations in the labeling to the synergistic effect of all the ingredients of the Jenasol capsule, a careful reading of the printed matter in conjunction with a fair interpretation of claimant's evidence leads one to the inevitable conclusion that it is the royal jelly in the formula which renders the drug efficacious for the represented purposes. Although in its circular entitled 'Miracle Bullets', claimant states that it makes no claims for Royal Jelly, all of claimant's evidence related only to the efficacy of royal jelly in the field of pediatrics and gerontology. In any event, the labeling, when read as a whole is, at best, misleading. United States v. 38 Dozen Bottles * * * Tryptacin, D.C.Minn.1953, 114 F.Supp. 461.
A decree of condemnation will be entered against the articles seized in this case, which shall direct the destruction thereof, and for the award of costs to libelant against the claimant. This opinion shall constitute the findings of fact and conclusions of law required by F.R.Civ.P. rule 52(a), 28 U.S.C.A.