United States v. ARTICLES OF DRUG, ETC.

• Citation: 263 F. Supp. 212
• Decision Date: 04 January 1967
• Docket Number: Civ. No. 01485.
• Parties: UNITED STATES of America, Libelant, v. ARTICLES OF DRUG, ETC., Claimant.
• Court: U.S. District Court — District of Nebraska

263 F. Supp. 212

UNITED STATES of America, Libelant, v. ARTICLES OF DRUG, ETC., Claimant.

Civ. No. 01485.

United States District Court D. Nebraska.

January 4, 1967.

Walter E. Byerly, Gen. Counsel, Dept. of Health, Education and Welfare, Washington, D. C., and R. J. Blumenthal, Asst. U. S. Atty., District of Nebraska, for libelant.

Robert C. McGowan, Omaha, Neb., and Kirkpatrick W. Dilling, Chicago, Ill., for claimant.

MEMORANDUM

RICHARD E. ROBINSON, Chief Judge.

This action arose under the provisions of the Federal Food, Drug, and Cosmetic Act, Title 21, U.S.C. § 301 et seq. Specifically, Libelant asks this Court to condemn certain articles alleged to be misbranded under the terms of the Act.

Seizure and condemnation are provided for at Title 21 U.S.C. § 334:—

"Any article of food, drug, device, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce or while held for sale whether or not the first sale after shipment in interstate commerce * * * shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and condemned in any district court of the United States within the jurisdiction of which the article is found * * *."

The libel charges that the products are drugs, and that they are misbranded in that their labeling is false and misleading, 21 U.S.C. § 352a, and because the labeling does not bear adequate directions for use, 21 U.S.C. § 352f 1.

On May 18, 1962, the United States Marshal seized the items which were the subject of this action. The articles seized where 1 can of "Vit-Ra-Tox 19", 1 bottle of "Vit-Ra-Tox 19a", 6 bottles of "Vit-Ra-Tox 21", 10 bottles of "Vit-Ra-Tox 53", and 20 bottles of "Vit-Ra-Tox 16". The Marshal also seized certain pamphlets which described the "Vit-Ra-Tox" products and which were used in their promotion.

The interstate shipment of the articles seized has been stipulated to by the claimant. The claimant further stipulated that "Vit-Ra-Tox" #16, #21, and #53 were held for sale after interstate shipment. The evidence shows that "Vit-Ra-Tox" #19 was offered for sale by reference to the Vit-Ra-Tox program described in the booklet "Your Life". No evidence was presented to establish that Vit-Ra-Tox 19a was so offered.

The pamphlets, one entitled "Your Life" and the other "Hydrated Bentonite", are claimed to be labeling for the Vit-Ra-Tox products and one of the sources of the alleged misbranding. Claimant has stipulated that "Your Life" is labeling for "Vit-Ra-Tox 21", and that "Hydrated Bentonite" is labeling for "Vit-Ra-Tox 16". We find that "Your Life" is labeling for all of the seized products with the exception of "19a". Labeling is defined at Title 21 U.S.C. § 321m:

"The term `labeling' means all labels and other written, printed, or graphic matter * * * 2 accompanying such article."

There need not be a physical attachment to the product to constitute "accompanying" Kordel v. United States, 335 U.S. 345, 69 S.Ct. 106, 93 L.Ed. 52 1948. Claimant's position, that "Your Life" is labeling for "21" only, would appear to be grounded on the fact that the greater portion of the text is concerned with that product than the others. The brochure is divided into two major sections; Chapter one, entitled "The Problem" is 14 pages in length; Chapter two, "Our Recommendation" extends another 35 pages. Chapter one describes the need for improved nutrition. Chapter two first explains how Vit-Ra-Tox 21 is processed, then why natural vitamins are superior to their synthetic counterpart, and concludes with a section called "Vit-Ra-Tox Accessory Products". The final transition is accomplished in this manner:

"Vit-Ra-Tox Accessory Products

Your Automobile has many valuable accessories that add to your pleasure and convenience but are not absolutely essential to your transportation."

"`Green Life' Vit-Ra-Tox 21 is the building product of the Vit-Ra-Tox Line but accessories are needed."

The booklet then describes the entire "Vit-Ra-Tox Line" except 19a including those articles seized and subject to this condemnation proceeding. This section is three pages in length. The fact that the greatest number of pages of text is devoted to the "21" product does not mean that the booklet is labeling for it only. The other articles are described by the text and pictures in the brochure and, through the transitional device quoted above, linked to the entire text as "Accessories that are needed." The Supreme Court in the Kordel case supra emphasized that "Accompanying" could be by a textual relation, not merely by physical attachment. "Your Life" describes problems which are supposedly the product of poor nutrition, and recommends a "Vit-Ra-Tox Program" apparently as the solution to the problem. All of the seized articles are a part of the "Vit-Ra-Tox Program" with the exception of 19a. "Your Life" is labeling for all of them.

The libel charges that the products are misbranded in that their labeling is false and misleading 21 U.S.C. § 352a and because the labeling does not bear adequate directions for use, 21 U.S.C. § 352f 1. In order to come within the purview of these provisions, it must first be shown that the products are "drugs". "Drugs" are defined in the Food, Drug and Cosmetic Act at Title 21 U.S.C. § 321g 1 to mean:

"1 Articles recognized in the official United States Pharmacopoeia * * *

2 Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals * * *."

The principal ingredient of "Vit-Ra-Tox 16" Hydrated Aluminum Sulfate, is listed in the Pharmacopoeia of the U. S., therefore "#16" is a drug as a matter of law. Both "Vit-Ra-Tox 19" and "Vit-Ra-Tox 19a" are laxative products. Their intended use is shown by their labels, and by other "labeling" accompanying the article. They are, therefore, articles other than food which are intended to affect a function of the body and are drugs under 21 U.S.C. § 321g 3. We have also concluded that "Vit-Ra-Tox 21", and "53" are drugs within the meaning of the Act. Courts have uniformly held that the search for the "intended use" of a product is not limited to the label on the container and may extend to oral and written representations about the products. V. E. Irons, Inc. v. United States, 244 F.2d 34 1 Cir. 1957; United States v. Hohensee, 243 F.2d 367 3 Cir. 1957; United States v. 3 Cartons, etc., Formula G M, 132 F.Supp. 569 S.D.Cal., 1952. The products involved here were orally represented to be an effective cure for everything from a backache to cancer. In a sales pitch delivered to Inspector Emmitt G. Warner of the Food and Drug Administration at his home on February 15, 1962 the "Vit-Ra-Tox" products were represented to be a remedy for several diseases. The sales pitch was delivered by two distributors of the "Vit-Ra-Tox" products, Paul Zdan, and Robert Christenson, recorded, transcribed, and offered in evidence at the trial. The transcription shows conclusively that the products are drugs. Our finding that the products are drugs, however, need not rest on the sales pitch. The pamphlet, "Your Life", implies that the products are for use in prevention of disease and they are therefore drugs within the Act's definition. This conclusion remains unaltered by the statement contained in "Your Life" that "* * * Green Life Products are Foods not drugs". When healing powers are attributed to "foods", they become drugs within the meaning of the Act.

"Misleading" as used within the Act should be determined by the effect that the material label and labeling will have on prospective purchasers to whom the claims are addressed. V. E. Irons v. United States supra. It would defeat the obvious intent of the Act to hold such persons to special knowledge or ability. Nor should the Court assume that the buying public will exercise great selectivity and caution in what they choose to believe of what they hear or read. On the other hand, misbranding cannot be based on a strained and distorted interpretation of the text.

These principles were enunciated by Judge Delehant speaking for this Court in United States v. Vitamin Industries, Inc., 130 F.Supp. 755 D.Neb., 1955.

"It seems from the authorities * * * to be established that the test is neither the significance of the publicity to observers of notably superior intelligence nor its appeal to the mentally dull or infirm, but rather its attraction to people of ordinary understanding and discrimination. The reaction of the average person is thus made the test. But allowance has also to

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