VE Irons, Inc. v. United States

• Decision Date: 17 June 1957
• Docket Number: No. 5193.,5193.
• Citation: 244 F.2d 34
• Parties: V. E. IRONS, Inc., et al., Defendants, Appellants, v. UNITED STATES of America, Appellee.
• Court: U.S. Court of Appeals — First Circuit

244 F.2d 34 (1957)

V. E. IRONS, Inc., et al., Defendants, Appellants, v. UNITED STATES of America, Appellee.

No. 5193.

United States Court of Appeals First Circuit.

April 24, 1957.

Writ of Certiorari Denied June 17, 1957.

COPYRIGHT MATERIAL OMITTED

Milton A. Bass, New York City, and Vincent A. Kleinfeld, Washington, D. C., on the brief, for appellants.

George H. Lewald, Asst. U. S. Atty., Boston, Mass., with whom Anthony Julian, U. S. Atty., Boston, Mass., Joseph L. Maguire, Sp. Asst. U. S. Atty., and William W. Goodrich, Asst. Gen. Counsel, Department of Health, Education, and Welfare, Washington, D. C., were on the brief, for appellee.

Before MAGRUDER, Chief Judge, and WOODBURY and HARTIGAN, Circuit Judges.

Writ of Certiorari Denied June 17, 1957. See 77 S.Ct. 1383.

MAGRUDER, Chief Judge.

V. E. Irons, Inc., and V. Earl Irons in his individual capacity stand convicted, after a three-weeks trial, on a six-count information for causing the introduction into interstate commerce of misbranded food and drugs in violation of the Federal Food, Drug, and Cosmetic Act,¹ 52 Stat. 1040, as amended, 21 U.S.C.A. § 301 et seq.

Count I of the information charged that the defendants (appellants herein) caused to be introduced into interstate commerce articles of food, known as Vit-Ra-Tox 21A (raw veal bone, defatted wheat germ, and the concentrate of juices of young, green cereal shoots) and Vit-Ra-Tox 21B (garlic derivative, wheat germ, and lecithin as emulsifiers), which were misbranded under 21 U.S.C.A. § 343(j)² in that they "purported to be and were represented as a food for special dietary uses by man by reason of their vitamin and mineral content and their labels failed to bear such information concerning their vitamin and mineral properties as had been determined to be and by regulations³ prescribed as necessary in order fully to inform purchasers as to their value for such uses".

Count II charged that the appellants caused to be introduced into interstate commerce articles or drug known as Vit-Ra-Tox 21A and Vit-Ra-Tox 21B (the same products referred to in Count I) which were (a) misbranded under 21 U.S.C.A. § 352(a)⁴ in that their accompanying labeling — consisting of certain leaflets and various issues of a newsletter — falsely represented "when viewed in their entirety as well as through specific claims * * * that nearly everyone in this country is suffering from malnutrition or in danger of such suffering because of demineralization and depletion of soils and the refining and processing of foods, that particularly all illnesses and diseases of mankind are due to improper nutrition, that said articles possessed nutritive properties superior to any other vitamin and mineral supplement, that said articles would be effective in the cure, treatment, and prevention of the ills and diseases of mankind," including certain specific diseases; and which were (b) misbranded under 21 U.S.C.A. § 352(f) (1)⁵ in that their labeling failed to bear adequate directions for the use for which they were intended, namely, for treatment of the specific diseases which appellants represented that the drugs could cure or prevent.

Counts III and V named two products similar to the vitamin and mineral products specified in Counts I and II, and alleged that the said articles (being also articles of "drug" within the meaning of the statutory definition) were introduced into interstate commerce on or about July 28, 1953, and July 14, 1953, respectively, consigned to the Delvita Company, Wilmington, Delaware, and to one Joseph T. Stoeckl, of Buffalo, New York, respectively, and were (a) misbranded under 21 U.S.C.A. § 352(a) in that their labeling, when viewed in its entirety, falsely represented and suggested that "nearly everyone in this country is suffering from malnutrition or is in danger of such suffering because of the demineralization and depletion of soils and the refining and processing of foods, that practically all human ailments and diseases are traceable to improper nutrition, that the best way to treat, cure, and prevent all the diseases of mankind would be by using said articles of drug, that said articles possess nutritive properties superior to any other vitamin or mineral supplement, that said articles constituted an adequate and effective cure, preventive and treatment" for various specific diseases; and were (b) misbranded under 21 U.S.C.A. § 352(f) (1) in that their labeling failed to bear adequate directions for use.

Counts IV and VI involved a different product, known as Vit-Ra-Tox "16", whose label described it as "An Adsorbent Aid in Systematic Detoxification and An Intestinal Purificant", and alleged that said article of drug was introduced into interstate commerce on or about July 28, 1953, and December 3, 1952, respectively, and consigned to the Delvita Company, Wilmington, Delaware, and to one Joseph T. Stoeckl, of Buffalo, New York, respectively, and was (a) misbranded under 21 U.S.C.A. § 352(a) in that its labeling falsely represented that the article was an adequate and effective treatment for certain specific disorders and disturbances; and was (b) misbranded under 21 U.S.C.A. § 352(f) (1) in that its labeling failed to bear adequate directions for use.

At the trial it was shown that appellants were engaged in the manufacture and distribution of certain "natural" vitamin products (distinguished from synthetic vitamins in that they are produced from natural food sources), and that sales of the products were made to consumers by distributors who received from appellants both the product to be sold and supporting literature. The evidence indicated that appellants recruited salespeople from among their customers and acquaintances, as well as through advertisements in newspapers. Selling techniques were explained to these people at meetings and by printed material comprising the sales kit, which contained certain leaflets in addition to supplemental newsletters written at frequent intervals by appellants and sent to such distributors. The printed promotional material was shown to be an integral part of the selling process, and constitutes the major source of the government's proof of the charges contained in the information.

The written, printed, and graphic material used was all identified and introduced into evidence by a food and drug inspector of the Department of Health, Education, and Welfare, who had posed as a salesman in order to obtain the material from appellants. The inspector made application and became an accepted distributor; he obtained a complete sales kit, purchased products, attended a lecture by Irons, and received a series of newsletters.

At the conclusion of the trial the jury returned a verdict of guilty against both defendants on all six counts. The court sentenced V. Earl Irons to one year of imprisonment on each of the six counts, the sentences to run concurrently; and imposed upon the defendant corporation a fine of $1,000 on each count. Appeals were duly taken by both defendants.

The brief for appellants lists twelve major points as grounds for reversal, as well as a large number of subpoints. But after a complete reading of the voluminous record, we are satisfied that no error was committed by the district court.

Since appellants make no serious argument with respect to Count I, it may be dealt with summarily. The label on the carton introduced into evidence by the government states that Vit-Ra-Tox No. 21A retains "Nature's vitamins, living enzymes, synergists, and activating materials (except Vitamin D); a rich natural source of Carotene (pro-vitamin A) and the complete natural complexes of Vitamins B, C, E, F, and K with the P fractions of the C complex and the Wulzen factor of the F complex, plus the living enzymes, synergists and mineral activators. It contains organic iron, calcium, phosphorus, iodine and a host of other minerals in trace amounts * * *." The label thus represents that the product has special dietary uses for man, by reason of its vitamin and mineral properties, within the scope of the Administrator's regulations contained in note 3, supra; and because there is no claim that the label satisfied the requirements of the regulations, it is quite clear that there was a violation of the Act, so far as Count I is concerned.

Before proceeding further, it is to be noted that the Act makes a distinction between the terms "label" and "labeling". Under 21 U.S.C.A. § 321(k), "label" is defined to mean "a display of written, printed, or graphic matter upon the immediate container of any article * * *." But by 21 U.S.C.A. § 321(m), "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 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. "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." Kordel v. United States, 1948, 335 U.S. 345, 350, 69 S.Ct. 106, 109, 93 L.Ed. 52. There is no doubt that the printed circulars, pamphlets, brochures and newsletters distributed by appellants in the present case constituted "labeling" within the statutory definition, and thus may properly be received in evidence as proof of false or misleading statements.

In determining whether such labeling contained "false or misleading" statements, we must be careful not to read the literature with the eyes either of experts in nutrition or of overly skeptical buyers. What is pertinent is the effect the claims would have on those to whom they are addressed, namely, prospective purchasers and actual customers of appe...