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UNITED STATES v. 250 JARS, OF U.S. FANCY PURE HONEY, (E.D.Mich. 1963)

United States District Court, E.D. Michigan, S.D.
May 29, 1963
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Factual and Procedural Background

This case arises from a libel proceeding initiated by the United States government under § 304(a) of the Federal Food, Drug and Cosmetic Act, seeking condemnation of approximately 198 jars and tins of honey alleged to be misbranded. The honey was sold by Detroit Vital Foods, Inc. at its Detroit, Michigan store. The government seized the honey along with six copies of a booklet titled "About Honey" and 71 copies of a newspaper mailing leaflet promoting honey’s health benefits. The seized honey had been shipped in interstate commerce and was displayed throughout the store. The claimant did not dispute the affidavits introduced by the government that honey is not effective as a medicinal treatment for various ailments. The parties stipulated to the facts and the case was orally argued before the court.

Legal Issues Presented

  1. Whether the seized honey qualifies as a "drug" under the Federal Food, Drug and Cosmetic Act.
  2. Whether the seized literature (booklet and newspaper leaflets) constitutes "labeling" under the Act.
  3. The appropriate evidentiary standard the government must meet to condemn the goods: preponderance of the evidence or clear and convincing proof.

Arguments of the Parties

Claimant's Arguments

  • The seized literature does not constitute labeling because it was not physically or integrally connected with the honey.
  • The booklet was displayed for independent sale in the store's book section and bore a price, indicating it was not part of the honey's labeling.
  • The newspaper leaflets were located in a back room and constituted only general advertising for honey, not labeling.
  • The literature referred to honey in a generic sense rather than any specific brand, so it cannot be labeling.
  • Defenses of entrapment and insufficiency of the libel were raised but found untimely or without merit.

Libelant's Arguments

  • The seized honey qualifies as a drug because it was intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases, as evidenced by the accompanying literature.
  • The literature constitutes labeling because it accompanied the honey and functioned to supplement or explain it, regardless of physical attachment.
  • The government need only prove its case by a preponderance of the evidence, though it met the higher standard of clear and convincing proof.
  • The literature was part of an integrated distribution and promotion program for the honey, making it labeling under the statute.

Table of Precedents Cited

Precedent Rule or Principle Cited For Application by the Court
United States v. 4 Cases Slim-Mint Chewing Gum, 300 F.2d 144 (7th Cir. 1962) Government must prove libel by preponderance of evidence. Supported the court’s conclusion on the evidentiary standard required.
United States v. Wood, 226 F.2d 924 (4th Cir. 1955) Preponderance of evidence standard for condemnation. Reinforced the evidentiary standard applied by the court.
United States v. 449 Cases, Etc., 212 F.2d 567 (2d Cir. 1954) Preponderance of evidence standard. Used to affirm the government’s burden of proof.
Van Camp Sea Food Company v. United States, 82 F.2d 365 (3d Cir. 1936) Suggested clear and convincing proof standard in forfeiture cases. Distinguished by the court as not persuasive for this case.
C.C. Co. v. United States, 147 F.2d 820 (5th Cir. 1944) Discussed evidentiary standards and application of "clearly erroneous" rule. Used to explain forfeiture statutes and evidentiary burdens.
United States v. Stowell, 133 U.S. 1 (1890) Statutes enacted for public good are not strictly construed in favor of defendant. Supported the court’s conclusion that clear and convincing proof is not required here.
V.E. Irons, Inc. v. United States, 244 F.2d 34 (1st Cir. 1957) Relevant sources beyond labels may be considered to determine drug intent. Allowed the court to consider the booklet and leaflet in determining the honey was a drug.
United States v. Hohensee, 243 F.2d 367 (3rd Cir. 1957) Definition of drug and labeling; liberal interpretation of the Act. Supported the court’s interpretation of "article" and rejection of claimant's narrow reading.
Alberty Food Products v. United States, 194 F.2d 463 (9th Cir. 1952) Consideration of evidence beyond labels to determine drug status. Supported court’s use of literature in determining drug intent.
United States v. 3 Cartons, Etc., 132 F. Supp. 569 (D.C.S.D. Cal. 1952) Use of extrinsic evidence in drug determination. Supported court’s approach to evidence.
Kordel v. United States, 335 U.S. 345 (1948) Broad interpretation of "labeling" to include accompanying matter without physical attachment. Key precedent defining labeling as including literature that supplements or explains the product.
United States v. 353 Cases, Etc., 247 F.2d 473 (8th Cir. 1957) Literature used to promote sale constitutes labeling. Supported inference that literature was used to promote honey sales.
United States v. Urbuteit, 335 U.S. 355 (1948) Practical consumer protection over technical interpretation. Supported liberal construction of the Act to protect consumers.

Court's Reasoning and Analysis

The court first addressed the evidentiary burden, concluding that the government need only prove its case by a preponderance of the evidence, though it found the evidence here clear and convincing. The court analyzed the statutory definitions of "drug" and "labeling" under 21 U.S.C.A. §§ 321(g) and 321(m). It held that the honey was a drug because the accompanying literature explicitly promoted it as a cure or treatment for numerous ailments, thus demonstrating intent to use as a drug beyond mere food use.

Regarding labeling, the court rejected the claimant’s argument that physical attachment or exclusive integration was required. Citing Kordel v. United States, the court emphasized that labeling includes all written matter accompanying the product that supplements or explains it, regardless of physical attachment. The literature’s role in promoting and explaining the honey established it as labeling. The court also found that generic references to honey in the literature did not preclude it from being labeling, as the statute’s use of "article" encompasses commodities generally.

The court further dismissed claimant’s defenses of entrapment and insufficiency of the libel, noting the latter was untimely. Ultimately, the court underscored the Act’s purpose of consumer protection, applying a liberal construction to prevent circumvention of the law by technicalities.

Holding and Implications

The court’s final decision was IN FAVOR OF THE LIBELANT, condemning the seized honey as a misbranded drug under the Federal Food, Drug and Cosmetic Act, along with the accompanying literature as labeling.

This ruling directly results in the forfeiture of the seized honey and associated literature. No new legal precedent was established, but the decision reinforces the broad interpretation of "drug" and "labeling" under the Act, emphasizing the protection of consumers from misleading health claims regardless of how promotional literature is distributed or displayed.

Show all summary ...

FREEMAN, District Judge.

This matter is before the Court on a libel proceeding brought by the United States for the condemnation under § 304(a) of the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C.A. § 334(a), of a quantity of allegedly misbranded honey, sold by the claimant, Detroit Vital Foods, Inc., at one of its stores located at 22,200 Grand River Avenue, Detroit, Michigan.

The parties have entered into a stipulation of facts which was presented to this Court on the day this case was orally argued. The essential facts are as follows. On October 12, 1961, Food and Drug Inspector, Gerald E. Vince, visited claimant's store and, posing as an ordinary or prospective customer, asked a clerk on duty whether they had any material about honey. In response to this request, the clerk pointed out a booklet entitled "About Honey" by P.E. Norris and gave Inspector Vince a copy of a newspaper mailing piece containing an article entitled "Eat Honey and Increase Your Vitality," which was sent to the customers on claimant's mailing list.

On November 8, 1961, the government seized some 198 jars and tins of honey, along with six copies of the booklet by Norris and 71 copies of the newspaper-type mailing leaflet, which were the same articles that were pointed out and given to Inspector Vince. The seized honey, which had been shipped from other states and countries in interstate commerce, was located in the store on shelves displaying honey, jams, jellies, etc., along the wall to the right and left and in the center of the store, in a storeroom at the back of the main store premises, and in the hallway near the basement stairs. The six booklets "About Honey", which sold at $1.00 per copy, were displayed with other books upon a fiber pegboard rack atop stock shelves containing honey along the wall on the right side of the store as one faces the back. The newspaper mailing pieces were located on a table in a small room in back of the cash register, which was located at the rear of the store and constituted a surplus of copies sent to claimant's customers.

The claimant makes no contention with respect to the medicinal and curative properties of honey for the prevention and treatment of diabetes, high blood pressure, arthritis, kidney and bladder ailments, nervous conditions, weakening of potency and virility, loss of appetite, heartburn, gastric catarrh, obesity, throat and bronchial ills, premature death, lack of vitality, gout, digestive upsets, sciatica, rheumatism, arteriosclerosis, weak heart, or for any medical purposes. The claimant did consent to the libelant's introducing into evidence affidavits of medical doctors attesting to the fact that honey is not adequate and effective for these purposes, waiving any right to cross-examination of the affiants.

Both the claimant and the libelant agree that in order for the latter to properly condemn the seized goods, it must establish that the honey was a drug and that the literature constituted labeling, as these terms are respectively defined by Title 21 U.S.C.A. § 321(g) and (m).

Before disposing of the above issues, this Court is faced with the initial problem of whether the libelant must establish its case by a mere preponderance of the evidence or by clear, convincing proof. The better view and weight of authority definitely holds that the government need only prove the allegations of its libel by a preponderance of the evidence. United States v. 4 Cases * * * Slim-Mint Chewing Gum (CA 7, 1962), 300 F.2d 144; United States v. Wood (CA 4, 1955), 226 F.2d 924; United States v. 449 Cases, Etc. (CA 2, 1954), 212 F.2d 567, 45 A.L.R.2d 846; United States v. 5 Cases, Etc. (CA 2, 1949), 179 F.2d 519; United States v. 46 Cases, More or Less, "Welch's Nut Caramels" (D.C.R.I., 1962), 204 F. Supp. 321; United States v. 11 1/4 Dozen Packages, Etc. (D.C.W.D.N.Y., 1941), 40 F. Supp. 208. The contra authority upon which the claimant relies is not persuasive. In the case of Van Camp Sea Food Company v. United States (CA 3, 1936), 82 F.2d 365, the court did hold that the government should establish its case by clear and convincing proof, but went on to hold that even under the mere preponderance standard, there was not sufficient evidence for the jury. The case of C.C. Co. v. United States (CA 5, 1944), 147 F.2d 820, involved an interesting situation. On the original hearing, the court tried the case de novo and reversed the decree of condemnation, but on a rehearing, the court applied the "clearly erroneous" rule and affirmed the condemnation decree. In its opinion on rehearing, the court points out that since forfeiture statutes are generally construed strictly in favor of the defendant, it follows as a natural corollary of this rule of construction that forfeiture proceedings demand a higher degree of proof than a mere preponderance, and cites the Van Camp decision. However, the Court then goes on to cite United States v. Stowell, 133 U.S. 1, 10 S.Ct. 244, 33 L.Ed. 555, for the proposition that statutes enacted for the public good to suppress a public wrong, although they impose penalties or forfeitures, are not to be strictly construed in favor of the defendant. Consequently, though it does not specifically state, the court appears to be saying, and it must logically follow, that where a forefeiture arises out of a statute enacted to protect the public from a wrong, clear and convincing evidence is not required.

Therefore, this Court concludes that the libelant need only establish its case that the seized honey was a drug and that the seized literature constituted labeling by a mere preponderance of the evidence. Nevertheless, this Court holds that the libelant not only established its case by a preponderance of the evidence, but also by clear and convincing proof.

Title 21 U.S.C.A. § 321(g), defines a drug to include "* * * (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases in man or other animals."

In determining that a particular article was intended to be used as a drug, a court is not limited to the labels on such article or to the labeling which accompanies it, but may look at all relevant sources. V.E. Irons, Inc. v. United States, (CA 1, 1957), 244 F.2d 34; United States v. Hohensee (CA 3, 1957), 243 F.2d 367; Alberty Food Products v. United States (CA 9, 1952), 194 F.2d 463; United States v. 3 Cartons, Etc. (D.C.S.D.Cal., 1952), 132 F. Supp. 569. Therefore, in the present case, this Court may utilize the newspaper leaflet and the booklet, regardless of whether they constitute labeling under the Act, in order to determine whether the seized honey was intended to be used as a drug. A reading of the booklet and mailing leaflets results in the inescapable conclusion that such honey was intended to be used as a drug, since this literature makes the rather remarkable claim that honey is a panacea for various diseases and ailments that have plagued man from time immemorial. The fact that the seized honey is a food cannot take it out of the statutory definition of the word "drug", since such honey was intended to be used in the capacity of a drug.

The only remaining significant issue which this Court must decide is whether the seized literature constituted labeling. Title 21 U.S.C.A. § 321(m) states that "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."

The claimant contends that in order for this seized literature to constitute labeling, it must be interdependently and actually integrated with the seized honey, and that it must be actually used in the distribution or sale of such honey. More specifically, the claimant argues that: (1) the literature referred to honey in the generic sense and not to any specific brand; (2) the booklet was displayed for independent sale, as evidenced by the fact it appeared in the store's so-called book department and contained a $1.00 price designation; and (3) the newspaper leaflets were in a back room of the store and, at best, constituted advertising for honey generally.

Under the statute, the literature need only accompany the seized product. The word "accompany" has been given a very broad interpretation by the Supreme Court. In Kordel v. United States, 335 U.S. 345, 350, 69 S.Ct. 106, 109, 93 L.Ed. 52 (1948), the Court stated:

"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 claimant cannot escape the conclusion that the literature was "labeling", even though the booklets were held for sale, and that the newspaper leaflets constituted "advertising". In Kordel the Court forcefully disposed of similar contentions in the following language, which appears at pp. 350-351, 69 S.Ct. at pp. 109-110 of the opinion:

"Moreover, the fact that some of the booklets carried a selling price is immaterial on the facts shown here. As stated by the Court of Appeals, the booklets and drugs were nonetheless interdependent; they were parts of an integrated distribution program. The Act cannot be circumvented by the easy device of a `sale' of the advertising matter where the advertising performs the function of labeling.
"Petitioner points out that in the evolution of the Act the ban on false advertising was eliminated, the control over it being transferred to the Federal Trade Commission. 52 Stat. 114, 15 U.S.C. § 55(a). We have searched the legislative history in vain, however, to find any indication that Congress had the purpose to eliminate from the Act advertising which performs the function of labeling. Every labeling is in a sense an advertisement. The advertising which we have here performs the same function as it would if it were on the article or on the containers or wrappers. As we have said physical attachment or contiguity is unnecessary under § 201(m)(2)."

Since both a copy of the booklet and the leaflet were shown to the Food and Drug Inspector when he passed as a prospective customer and asked for information concerning honey, a permissible and reasonable inference is that this literature was shown to the Inspector to induce him to purchase claimant's honey. In other words, this literature which was found in the store was generally used in promoting the sale of the honey and was approved advertising matter, available upon request. United States v. 353 Cases, Etc. (CA 8, 1957), 247 F.2d 473. Further, the newspaper leaflets were mailed to prospective customers in order to promote the sale of the seized honey.

The claimant's argument that since the literature only refers to honey in its generic term, it cannot constitute labeling, is without merit. § 321(m) specifically states that if the written, printed, or graphic matter accompanies the article, such matter constitutes labeling, and § 334 subjects to forfeiture "[a]ny article of * * * drug * * * that is * * * misbranded * * *." (Emphasis supplied) The word article is defined by Webster's New International Dictionary (2nd Edition) as "A thing of a particular class or kind, as distinct from a thing of another class or kind; a commodity; as, an article of merchandise; salt is a necessary article." In other words, honey itself is an article under the statute. To give to the word "article" the very restricted meaning that claimant attempts to do indirectly would not only result in disregarding its literal meaning, but it would do violence to the noble purpose of the Food, Drug and Cosmetic Act. That Act was passed for the purpose of protecting unwary customers in vital matters of health and, consequently, it must be given a liberal interpretation to effectuate this high purpose. United States v. Hohensee, supra, 243 F.2d 367. This Court will not open a loophole through which those who prey upon the weakness, gullibility and superstition of human nature can escape the consequences of their actions. As the Court in United States v. Urbuteit, 335 U.S. 355, 358, 69 S.Ct. 112, 114, 93 L.Ed. 61 (1948), stated: "The problem is a practical one of consumer protection, not dialectics."

Claimant's remaining defenses of (1) entrapment, and (2) insufficiency of the libel, are without merit. Furthermore, the latter defense asserted on the day of trial was not timely in view of an earlier filing date required for filing such motions specified in the pretrial order.

An appropriate order may be submitted.