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November 30, 1959

UNITED STATES of America, Libelant,

The opinion of the court was delivered by: WORTENDYKE

Pursuant to Section 304 of the Federal Food, Drug and Cosmetic Act (21 U.S.C.A. § 334) the Government filed a libel of information praying seizure and condemnation of what is thereon alleged to be an article of drug, shipped in interstate commerce by Cornell Drug Corporation, of 71 West 23rd Street, New York City, and 5 Davis Street, Cambridge, Massachusetts, consisting of 354 bulk cartons, more or less, containing retail packages of an article labeled 'Trim Reducing-Aid Cigarettes.' Acting in compliance with a warrant of seizure and monition, the United States Marshal for the District of New Jersey seized the articles listed in the libel which were, at the time of seizure, in the possession of Trenton Tobacco Company at the City of Trenton, in the District of New Jersey.

Cornell Drug Corporation claimed the articles seized as owner thereof, and admits in its answer that the articles had been shipped by claimant to New Jersey in interstate commerce, for purposes of sale. After discovery proceedings had been availed of by the parties, claimant noticed a motion, returnable September 14, 1959, and thereafter from time to time adjourned, for an order 'for partial summary judgment * * * striking out Paragraph designated '5' of the libel of information.' The paragraph of the libel referred to in the notice of that motion alleged that the Trim Reducing-Aid cigarettes was a New Drug, as defined in 21 U.S.C.A. § 321(p)(1), for which an application was required to be filed by § 355(a) of that Title, and that such an application with respect to the article seized in these proceedings was not effective as required by subsection (b) of the latter section. Before the argument on claimant's said motion, libelant moved for summary judgment for the relief prayed for in the libel, basing its motion upon the pleadings, and moving affidavits and upon claimant's answers to libelant's interrogatories. Both of these motions were heard and have been considered together.

 Upon its motion libelant contends that the articles seized consisted of a drug shipped in interstate commerce, misbranded in violation of 21 U.S.C.A. § 334(a), when introduced therein, and constituting a new drug with respect to which an effective new drug application was not on file, as required by 21 U.S.C.A. § 355(a). In support of said motion there are submitted the respective affidavits of four physicians and two other individuals dealing with the question whether volatilized tartaric acid or the product of pyrolysis of tartaric acid is generally recognized as safe for human inhalation. It is the expressed opinion of each of these expert medical deponents, and by each of them stated to be the consensus of informed medical and scientific opinion, that tartaric acid in cigarettes is not safe for use in cases of obesity.

 In support of claimant's motion to strike the aforementioned 'new drug' allegations from the libel, there were submitted affidavits, respectively of claimant's president, Murry Abbott, copies of letters to claimant from a drug manufacturer and from a tobacco manufacturer, as well as affidavits of two Doctors of Medicine and one Bachelor of Science in Chemistry. From these documents it appears that Trim cigarettes are composed of tobacco to which is added, as a flavoring, a substance or substances, including trataric acid, among the components thereof. Each of the claimant's medical deponents expresses the opinion that Trim cigarettes are safe for use by human beings, as prescribed by claimant, and the affidavit of the Chemist states that to the best of his knowledge the amount of tartaric acid found in Trim cigarettes is absolutely harmless.

 The subject of these condemnation proceedings is a quantity of cigarettes intended to be smoked by human beings for the purpose of achieving and represented by claimant to be effective for a reduction in weight of the body of the users. These cigarettes are offered for sale in packages of twenty. The exterior of each package bears a legend that the contents are 'trim reducing-aid cigarettes'; that the active ingredients of each of these cigarettes are 'combustible tartaric acid, combined with tobacco and flavoring'. Upon the back of each package are directions for the use of the contents, viz.: 'Smoke one cigarette shortly before meals * * * and whenever you are tempted to reach for a late evening snack. Trim reducing-aid cigarettes contain a patented appetite satient that takes the edge off your appetite. Clinically tested * * * Trim reducing-aid cigarettes are 'Guaranteed' to satisfy you or your money back.' The exterior of the package further discloses that the contents are manufactured for Cornell Drug Corp., United States Patent No. 2,773,785. Two panels of the display card of Trim cigarettes seized in this action advertise that the cigarettes sell for Two Dollars per pack, plus tax, and inform intending purchasers that these reducing aid cigarettes are not intended to replace the purchaser's favorite cigarettes nor to change his present smoking habits. The notice further suggests that the user smoke three or four reducing aid cigarettes a day, that the article has been clinically tested, that satisfaction is guaranteed, and that the cigarettes consist of a scientific blend of finest quality tobacco. A window display streamer, to be employed for purposes of retail marketing of Trim cigarettes, which was also seized in this proceeding, is designed to attract the attention of a prospective purchaser by the following exhortative language. 'Overweight? Lose weight without pills or diet. Smoke Trim reducing-aid cigarettes. Absolutely harmless. Five years of successful clinical tests. A full week's supply in one package. Smoke three a day. Patented by United States Government. Enjoy along with your favorite cigarettes -- as advertised on T.V..' Salesmen's catalogue sheet, also seized with the articles here proceeded against, addresses the retailer as follows: 'Mr. Retailer out to get your share of a * * * $ 500,000,000 market,' and then presents, over the name Cornell Drug Corp., 5 Davis St., Cambridge, Mass., printed and graphically illustrated information that Trim reducing aid cigarettes are a scientifically proven reducing aid backed by a national advertising campaign with radio, T.V., magazine and newspaper saturation, point-of-sale merchandising, and window displays, and a statement that there is a full $ 6.66 per carton profit for the retailer. The same circular reiterates the admonition to users 'Puff your pounds away, Smoke 3-4 a day,' gives assurance that by so doing pills and drugs are eliminated, represents that the product has been clinically tested, and announces that one package contains a week's supply, that the product is patented by United States Government, is scientifically blended and is backed by five years of successful clinical tests. Following the further admonition 'Watch your weight go up in smoke,' the retailer is assured that the product sells everywhere, on drug counters, in tobacco departments and in cosmetic departments.

 The claimant admits all of the foregoing representations, exhortations, suggestions and directions. In addition to the employment of the foregoing media and methods of advertising and sales inducements claimant admits that the following is typical of the text of its radio and television 'commercials': 'It's here * * * a great scientific discovery * * * Trim, reducing aid cigarettes that curb your appetite. Imagine * * * now you can lose up to twenty pounds or more, simply by smoking this delightful tasted cigarette * * * without giving up your favorite brand. Just light up a Trim reducing-aid cigarette before each meal. Watch your weight go up in smoke. Trim cigarettes contain a patented ingredient that stops that urge to eat fattening foods with your first puff. It's 'will-power' in tobacco form. Trim cigarettes have been clinically tested and medically approved. * * * The results are excellent. Patients have lost up to twenty pounds or more in eight weeks * * * the safe, simple way. Puff your pounds away with Trim cigarettes. Watch your weight go down, down, down. Harmless, non-habit forming. Light a Trim cigarette at night, when you're tempted to raid the ice box * * * they work instantly. Appease your appetite. Even non-smokers can reduce with Trims. You smoke only three a day. Trim reducing aid cigarettes make reducing fun. Get your first pack of Trim cigarettes today at drug counters. Safely lose up to twenty pounds or double your money back.'

 There is attached to claimant's answers to interrogatories a copy of United States Patent No. 2,773,785 issued December 11, 1956, to Edgar A. Ferguson, Jr., of Brooklyn, New York. One of the five claims of said patent reads as follows: '1. As a new article of manufacture a combustible substance adapted to be used in smoking having intimately admixed therewith and distributed therethrough tartaric acid in an amount of between 0.01-0.04 gram tartaric acid per each gram of said combustible substance which upon combustion of said combustible substance volatilizes to act in the mouth of the person smoking to reduce the appetite.' Another claim of the patent substitutes the word 'tobacco' for the words 'combustible substance' in the foregoing, and the fourth and fifth claims refer to 'a cigarette adapted upon smoking to cause reduction of appetite having intimately admixed with the tobacco thereof and distributed therethrough tartaric acid' in certain specified proportions. In this connection it is interesting to note that the title of this patent is 'Appetite Satient Composition' and describes the invention as relating to 'a new and improved therapeutic appetite satient composition designed to curb the appetite without supplying calories to the body and more particularly * * * a therapeutic appetite satient composition in combustible form which can be smoked and upon smoking causes loss of appetite.'

 Among its answers to interrogatories is an admission by claimant that the patented appetite satient referred to in its labelling is combustible tartaric acid in the proportions therein disclosed, but claimant denies that chemical analyses have been made of unburned Trim cigarettes and states that it is ignorant of the chemical formula of the combustible tartaric acid used in the cigarettes. Claimant epitomizes its contentions respecting the efficacy of its product in the statement that use of these cigarettes in accordance with its directions curbs the appetite and in consequence discourages food ingestion and thereby induces loss of weight. In support of these contentions claimant asserts that it relies upon medical opinions furnished to it by certain New York physicians. With regard to the physiological effects upon human beings of the inhalation or ingestion of the combustion products of any form of tartaric acid, claimant points out that tartaric acid is used in baking bread, in which process it volatilizes and causes bakery workers to inhale the fumes without apparent adverse effects. With respect to the text of the Trim cigarette radio and television commercials, claimant admits the language used therein, but insists that the phraseology consists of metaphors or figures of speech, not to be taken literally. Nothing in the language employed is even remotely suggestive that it is not to be accepted as unqualifiedly true.

 The cross-motions pending before me present the following questions:

 (1) Is the Trim reducing-aid cigarette, which was concededly shipped by claimant in interstate commerce and held for sale after such shipment, a drug as defined by 21 U.S.C.A. § 321(g)(3)?

 (3) Is the article sought to be condemned a new drug as defined in section 321(p)(1) of said Title?

 (4) Was there, at the time of the introduction of the article into interstate commerce, an effective application on file with respect to such drug, as required by section 355(a) of Title 21?

 None of the foregoing questions requires the resolution of any genuine issue of a material fact in view of the results of the discovery process and the content of the affidavits submitted upon the respective pending cross-motions for summary judgment. This Court's jurisdiction is obvious, arising as it does under the provisions of the Act already referred to, and with the claimant's concession that the articles which have been seized were introduced by claimant into interstate commerce and held for sale after shipment therein. The motions for summary judgment are, therefore, appropriately brought under Rule 56 of the Federal Rules of Civil Procedure, 28 U.S.C.A., without any complication through the persistence ...

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