United States v. Vitasafe Corporation, No. 14964

CourtUnited States Courts of Appeals. United States Court of Appeals (3rd Circuit)
Writing for the CourtMcLAUGHLIN, KALODNER and HASTIE, Circuit
Citation345 F.2d 864
PartiesUNITED STATES of America v. An Undetermined Number of Shipping Packages, Etc., VITASAFE CORPORATION, Appellant. UNITED STATES of America v. VITASAFE CORPORATION, a Corporation, Nutritional Quality Controls, Inc., a Corporation, the Dollar Vitamine Plan, Inc., a Corporation, Life Nutrition, Inc., a Corporation, International Oil and Metals Corporation, a Corporation, Dr. Parker Medicine Company, a Corporation, Philip S. Volosov, an Individual and Henry D. Cohen, an Individual, Appellants.
Docket NumberNo. 14964,15066.
Decision Date27 May 1965

345 F.2d 864 (1965)

UNITED STATES of America
v.
An Undetermined Number of Shipping Packages, Etc., VITASAFE CORPORATION, Appellant.

UNITED STATES of America
v.
VITASAFE CORPORATION, a Corporation, Nutritional Quality Controls, Inc., a Corporation, the Dollar Vitamine Plan, Inc., a Corporation, Life Nutrition, Inc., a Corporation, International Oil and Metals Corporation, a Corporation, Dr. Parker Medicine Company, a Corporation, Philip S. Volosov, an Individual and Henry D. Cohen, an Individual, Appellants.

Nos. 14964, 15066.

United States Court of Appeals Third Circuit.

Argued October 19, 1964.

Decided May 27, 1965.


345 F.2d 865

Milton A. Bass, Bass & Friend, New York City, for appellants.

Vincent J. Commisa, Asst. U. S. Atty., Newark, N. J., for appellees.

Dilling & Dilling, Chicago, Ill., on the brief, for amicus curiae.

Before McLAUGHLIN, KALODNER and HASTIE, Circuit Judges.

KALODNER, Circuit Judge.

The District Court, in an in rem proceeding under the Federal Food, Drug

345 F.2d 866
and Cosmetic Act1 (Appeal No. 14964), condemned and forfeited (1) some 900 seized packages of Vitasafe vitamin-mineral capsules, which it found to be "foods"2 and "drugs"3 introduced into interstate commerce, with "labeling" claims that were false and misleading, and with inadequate directions for their use;4 and (2), approximately 3,730,000 pieces of written, printed and graphic material designed to promote the sale of the capsules, seized in the warehouse of the Vitasafe Corporation in Middlesex, New Jersey, which were held to be "labeling".5

The District Court, in a subsequent injunction proceeding (Appeal No. 15066), granted a Preliminary Injunction imposing restrictions on the defendants named therein with respect to the distribution of their products, their "labeling," and accompanying literature.

The critical issues presented by this consolidated appeal from the Condemnation Decree and Preliminary Injunction are:

(1) Were the District Court's fact-findings that the condemned capsules were misbranded "clearly erreoneous."

(2) Did the District Court err in ruling that the 3,730,000 pieces of promotional literature seized in the warehouse of Vitasafe Corporation constituted "labeling".

(3) Did the District Court, in its Preliminary Injunction, abuse its legal discretion in imposing challenged restraints on the defendants' sale and distribution of its vitamin-mineral capsules.

The record discloses that the Vitasafe Corporation carried on a mail-order business for the sale of a vitamin-mineral dietary supplement. It purchased large quantities of vitamins from various manufacturers, and repackaged them under its own label at its headquarters in Middlesex, New Jersey. It thereafter sold to persons who responded to its advertising and promotional literature which appeared in magazines, newspapers and Sunday supplements throughout the United States. It also made sales to persons to whom it had mailed its promotional literature. It did not retain a record of persons to whom the literature was sent.

The Libel of Information alleged that the "labeling" which accompanied the Vitasafe product, a series of ten different pieces of promotional literature, falsely implied and suggested (1) that Vitasafe "Formula M" and Vitasafe "Formula W" were designed to satisfy the special nutritional needs of men and women respectively; (2) that the nutritional value of the Vitasafe capsule was enhanced by the addition of several ingredients which were in fact of "no nutritional significance for dietary supplementation;" (3) that the minimum adult daily requirements of vitamins and minerals, specified in the "labeling", were the recommendations of the Food and Nutrition Board, National Academy of Science, National Research Council and (4) that large amounts of common foods would be needed to provide the nutrients supplied by one Vitasafe capsule.

345 F.2d 867

The Libel also alleged that the "labeling" falsely and misleadingly implied and suggested that Vitasafe, as a drug, was an adequate and effective treatment for several common maladies; that practically everyone in the country was suffering from, or in danger of suffering from, a dietary deficiency of vitamins, minerals and proteins, which was likely to cause certain deficiency diseases; and that the deficiencies suggested were caused by a loss of nutritive value due to the soil in which food was grown, and the storage, processing and cooking of foods.

The Libel further alleged that the "labeling" represented Vitasafe to be "a lipotropic factor or agent" without adequately stating directions for its use as such.

The Government, in condemnation proceeding, presented several expert witnesses in support of its position. Vitasafe Corporation, as claimant, also presented expert witnesses.

The District Court, 226 F.Supp. 266 (D.N.J.1964) found that Vitasafe was a "food" within the meaning of 21 U.S. C.A. § 321(f) because its "labeling" recommended "its use and represented it to be of value as a dietary and nutritional supplement;" that it was also a "drug" within the meaning of 21 U.S.C.A. § 321(g) because its "labeling" recommended "its use and represented it to be of value as a curative or preventive of disease conditions in man affecting the structure and function of the body of man". It further found that the seized packages of Vitasafe were "misbranded when introduced into, while in, and while held for sale after shipment in interstate commerce," in that their "labeling" was false and misleading,6 and that there did not appear adequate directions for the use of Vitasafe as a lipotropic factor or agent.7

The District Court on the basis of the stated fact-findings, held that the seized 900 packages of Vitasafe capsules were subject to condemnation as "misbranded", under 21 U.S.C.A. § 334, and so ordered. The record amply supports both the fact-findings and the order of condemnation with respect to these seized packages. It would serve no useful purpose to dwell on this aspect of this appeal in view of the exhaustive analysis relating to these packages in the District Court's opinion.

We are, however, of the opinion that the District Court erred as a matter of law in ruling that the 3,730,000 pieces of promotional literature seized while at rest in the Vitasafe warehouse in Middlesex, New Jersey, were "labeling" within the meaning of 21 U.S.C.A. § 321(m), and as such subject to condemnation under 21 U.S.C.A. § 334.

The Government urges with respect to these 3,730,000 pieces that "all of the promotional matter seized was obviously intended to promote Vitasafe, and had no other useful purpose," and that "it supplements the label on the bottle of capsules, and was intended by the claimants to be ultimately used in the sale of Vitasafe," and thus it was "labeling" subject to condemnation under the Act.

The claimant, Vitasafe Corporation, does not deny the alleged intended use of the seized material, but contends that

345 F.2d 868
it was never actually employed for such purposes, and therefore could not have been subject to condemnation under the Act

Under Section 321(m) the term "labeling" applies inter alia to "written, printed, or graphic matter" which appears upon any article or any of its containers or wrappers or "accompanying such article." (emphasis supplied)

Section 331, 21 U.S.C.A. which prohibits, in subsection (a) "The introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded", also proscribes in subsection (1) the use of "any advertising" matter thus used relating to the misbranded article. Section 334 provides for the seizure and condemnation of "labeling" as defined in Section 321(m).

Section 334(a) specifically provides that misbranded articles of food or drugs, "when introduced into or while in interstate commerce or while held for sale * * * after shipment in interstate commerce", may be condemned.

Critical here is the second clause "accompanying such article" in Section 321(m).

The 3,730,000 pieces of literature...

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20 practice notes
  • U.S. v. Varela-Cruz, Criminal No. 98-278(JAF).
    • United States
    • United States District Courts. 1st Circuit. District of Puerto Rico
    • September 2, 1999
    ...a reasonable construction to effectuate its salutary purposes." Sanders, 196 F.2d at 898; see also United States v. Vitasafe Corp., 345 F.2d 864, 870 (3rd Cir.1965) citing United States v. Urbuteit, 335 U.S. 355, 358, 69 S.Ct. 112, 93 L.Ed. 61 (1948) (stating that "that the proble......
  • Rutherford v. United States, No. CIV-75-0218-B.
    • United States
    • United States District Courts. 10th Circuit. Western District of Oklahoma
    • December 5, 1977
    ...Cir. 1920) (mineral water); United States v. "Vitasafe Formula M," 226 F.Supp. 266, 278 (D.N.J.1964) remanded on other grounds, 345 F.2d 864 (3rd Cir. 1965) cert. denied, 382 U.S. 918, 86 S.Ct. 290, 15 L.Ed.2d 232 (1965) (vitamin and mineral capsules); United States v. 250 Jars . ......
  • US v. UNDETERMINED QUANTITIES OF AN ART. OF DRUG, No. 87 Civ. 7779 (RWS).
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • July 11, 1989
    ...from natural ingredients is capable of regulation as a drug. See United States v. Vitasafe Formula M, 226 F.Supp. 266, 277 (D.N.J. 1964), 345 F.2d 864 (3d Cir.1965); National Nutritional Foods, 557 F.2d at 334. Regardless of the physical effect of the product, once it is established that it......
  • Hanson v. United States, No. 4-76-Civ. 11.
    • United States
    • United States District Courts. 8th Circuit. United States District Court of Minnesota
    • February 20, 1976
    ...79 (5th Cir. 1920) (mineral water); United States v. Vitasafe Formula M, 226 F.Supp. 266, 278 (D.N.J.1964), remanded on other grounds, 345 F.2d 864 (3d Cir. 1965), cert. denied, 382 U.S. 918, 86 S.Ct. 290, 15 L.Ed.2d 232 (1965) (vitamin and mineral capsules); United States v. 250 Jars . . F......
  • Request a trial to view additional results
20 cases
  • U.S. v. Varela-Cruz, Criminal No. 98-278(JAF).
    • United States
    • United States District Courts. 1st Circuit. District of Puerto Rico
    • September 2, 1999
    ...given a reasonable construction to effectuate its salutary purposes." Sanders, 196 F.2d at 898; see also United States v. Vitasafe Corp., 345 F.2d 864, 870 (3rd Cir.1965) citing United States v. Urbuteit, 335 U.S. 355, 358, 69 S.Ct. 112, 93 L.Ed. 61 (1948) (stating that "that the problem of......
  • Rutherford v. United States, No. CIV-75-0218-B.
    • United States
    • United States District Courts. 10th Circuit. Western District of Oklahoma
    • December 5, 1977
    ...F. 79 (5th Cir. 1920) (mineral water); United States v. "Vitasafe Formula M," 226 F.Supp. 266, 278 (D.N.J.1964) remanded on other grounds, 345 F.2d 864 (3rd Cir. 1965) cert. denied, 382 U.S. 918, 86 S.Ct. 290, 15 L.Ed.2d 232 (1965) (vitamin and mineral capsules); United States v. 250 Jars .......
  • US v. UNDETERMINED QUANTITIES OF AN ART. OF DRUG, No. 87 Civ. 7779 (RWS).
    • United States
    • United States District Courts. 2nd Circuit. United States District Courts. 2nd Circuit. Southern District of New York
    • July 11, 1989
    ...from natural ingredients is capable of regulation as a drug. See United States v. Vitasafe Formula M, 226 F.Supp. 266, 277 (D.N.J. 1964), 345 F.2d 864 (3d Cir.1965); National Nutritional Foods, 557 F.2d at 334. Regardless of the physical effect of the product, once it is established that it......
  • Hanson v. United States, No. 4-76-Civ. 11.
    • United States
    • United States District Courts. 8th Circuit. United States District Court of Minnesota
    • February 20, 1976
    ...79 (5th Cir. 1920) (mineral water); United States v. Vitasafe Formula M, 226 F.Supp. 266, 278 (D.N.J.1964), remanded on other grounds, 345 F.2d 864 (3d Cir. 1965), cert. denied, 382 U.S. 918, 86 S.Ct. 290, 15 L.Ed.2d 232 (1965) (vitamin and mineral capsules); United States v. 250 Jars . . F......
  • Request a trial to view additional results

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