(2) If the seized article is a drug, is it misbranded by misleading labelling within the meaning of subsection (m) of the same section?
(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 of a genuine issue of material fact. See United States v. 20 Cases, etc. Buitoni 20% Protein Spaghetti, D.C.Del.1955, 130 F.Supp. 715, affirmed per curiam 3 Cir., 1956, 228 F.2d 912.
The statute, 21 U.S.C.A. § 321(g), defines 'drug', as the term is used in the Act, as '(3) articles (other than food) intended to affect the structure or any function of the body of man * * *; and * * * (4) articles intended for use as a component of any article specified in clause * * * (3); * * *.' The Trim cigarette involved in this litigation is obviously an article intended to affect the structure and/or function of the human body and contains, as a component, tartaric acid which affects the structure and/or functions of the body. Claimant readily concedes that its product is intended to affect the structure and functions of the human body by reducing the appetite for the ingestion of food and thereby achieving a reduction in the body's weight. The component of the cigarette which the claimant asserts is critically effectual in satiating the appetite is tartaric acid, which is used and intended by the claimant to be used in the composition of its cigarette.
In United States v. 46 Cartons more or less, containing Fairfax Cigarettes, D.C.N.J.1953, 133 F.Supp. 336, Judge Meaney of this Court held that cigarettes which were shipped in interstate commerce with leaflets suggesting that the cigarettes were effective in preventing respiratory and other diseases, came within the term 'drug' as used in the Act, and were accordingly subject to seizure for misbranding. Judge Meaney's language, at page 338, is particularly apposite to the case before us: 'If claimant's labeling was such that it created in the mind of the public the idea that these cigarettes could be used for the mitigation or prevention of the various named diseases, claimant cannot now be heard to say that it is selling only cigarettes and not drugs.' To contend that the claimant's labelling in the case at bar would not create in the mind of a weight-conscious potential purchaser the idea that Trim cigarettes could be used for reducing his or her weight, is to speak with tongue in cheek, if not to display a most extraordinary naivete. In Bradley v. United States, 5 Cir., 1920, 264 F. 79, 82, cited in the Fairfax case, supra, mineral water was shipped in interstate commerce labelled as recommended in the treatment of Bright's disease. The court in that case stated that when false and fraudulent representations are made with respect to the curative effect of water 'it would be trifling to say that water ordinarily is not a drug in the true meaning of the word, and therefore does not fall within the condemnation of * * * the act.' The seized articles in the present case are drugs within the meaning of the Act.
The Government charges that the seized articles are misbranded because their labelling is misleading. The Act defines 'label' as 'a display of written, printed, or graphic matter upon the immediate container of any article;' 21 U.S.C.A. § 321(k), and subdivision (m) of the same section defines 'labelling' as meaning '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 succeeding subdivision of that section (n) provides that 'in determining whether the labeling is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are customary or usual.' Not only does claimant concede that the labels on the immediate containers of its cigarettes were inducive of use of its product for the purpose of weight reduction, but an inspection of the copies of the panels of the display cartons of the cigarettes, the window display streamer and the salesmen's catalogue sheet relating thereto clearly discloses that the primary, if not the sole inducement intended by the claimant to the purchase and use of its product was the representation of the product's efficacy to reduce human avoirdupois. See Kordel v. United States, 1948, 335 U.S. 345, 69 S. Ct. 106, 93 L. Ed. 52; and 62 cases, etc., of Jam v. United States, 1951, 340 U.S. 593, 71 S. Ct. 515, 95 L. Ed. 566. Upon the uncontested evidence in this case, I cannot avoid the conclusion that the accused articles are misbranded because the labels upon their containers and accompanying the articles are misleading, if not actually false and fraudulent. See United States v. 353 Cases etc. Mountain Valley Mineral Water, 8 Cir., 1957, 247 F.2d 473.
Libelant contends that the seized articles are a new drug. Claimant contends to the contrary, and upon their respective contentions each party has moved for summary judgment. The statute, 21 U.S.C.A. § 321(p)(1) defines a new drug as 'any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof, * * *.' Having determined that the seized articles are a drug, we look to the record upon which the pending cross-motions depend to ascertain whether 'such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended, or suggested in the labeling thereof.' It has already been found and concluded that the Trim cigarette is a drug, which claimant recommends and suggests, in the labelling thereof, for use for the purpose of human body weight reduction. That use necessarily involves the combustion of the tobacco and the other ingredients in the cigarette by smoking, and thereby bringing into contact with the members in the person's oral cavity, if not in his throat and/or lungs, the combustion products of the appetite satient tartaric acid, which is not only concededly an ingredient of claimant's product, but intended by the claimant to have the effect for which its use is recommended. It the Trim cigarette laden with the ingredient appetite satient and intended to become effective through smoking and the contact of the products of such combustion with the membranes of the oral cavity, generally recognized as safe for use under such conditions? It is obvious that there is disclosed in the supporting affidavits a direct contrariety of medical and scientific opinion respecting the answer to this question. The existence of such a conflict of expert opinion does not create a genuine issue of material fact obstructive of the motions here confronting us. Assuming that each of the deponents is duly qualified to express an opinion respecting the safety of the drug for the purposes recommended by claimant, the genuine difference of opinion among the medical experts disclosed by the affidavits, indicating lack of the 'general recognition' required, brings the seized articles clearly within the statutory definition of a new drug. Merritt Corp. v. Folsom, D.C.D.C.1958, 165 F.Supp. 418. In the cited case the Court was confronted with the question whether topical neomycin sulfate was safe for treatment of acne. The evidence disclosed a genuine difference of opinion among medical experts respecting the safety of the particular drug for the treatment of the particular disease. The Court concluded that because of this difference of opinion, it could not be concluded that the drug was generally recognized as safe for the use in the treatment of acne. Since, therefore, we have a similar genuine difference of opinion among experts qualified by scientific training and experience to evaluate the safety of drugs, as to the product here under consideration, that product becomes a new drug by the very terms of the statutory definition, i.e., because it does not appear that it is generally recognized as safe for the purposes for which the claimant recommends it.
Respecting the requirement of 21 U.S.C.A. § 355(a) that no person shall introduce into interstate commerce any new drug unless an application filed pursuant to subsection (b) of that section is effective with respect to such drug, claimant's president admits in his affidavit that no such application was filed before the commencement of the sale of Trim cigarettes. He would, however, explain such failure to file such an application by the statement that it was orally excused, by telephone, by Dr. Ralph G. Smith, of the Medical Division of the Federal Drug Administration. Abbott says that before the execution of the contract between claimant and Riggio Tobacco Corporation, for the manufacture by the latter of Trim cigarettes, counsel for the manufacturer insisted that the Administration be contacted for the purpose of ascertaining whether there was anything dangerous to human beings in their proposed ingredients. It appears that on December 12, 1957, in a telephone call to Mr. Harold O'Keefe, of the Administration, by claimant's attorney, the proposed use of a flavoring ingredient, 'coumarin', in the formula at that time was disapproved and 'vanillin U.S.P.' was suggested by O'Keefe as a substitute for the disapproved coumarin. O'Keefe then requested that the same facts which had been presented to him be also presented by Dr. Smith for his medical opinion as to whether or not there was anything dangerous in the ingredients of Trim cigarettes. Abbott's affidavit states that Dr. Smith advised that it was unnecessary for a new drug application to be filed since the ingredients of the cigarette disclosed to him were all well-known and harmless for human use in the form prescribed. The amount of tartaric acid in the formula which Abbott sets forth in his affidavit is 0.0005 gram per cigarette. I shall assume that this formula was disclosed in the telephone conversation referred to, to Dr. Smith. In his affidavit, Dr. Smith admits that his business diary reveals his receipt of a telephone call from claimant's attorney, on the date mentioned by Abbott, with reference to a cigarette containing flavoring and tartaric acid, but that this diary 'does not reveal' that he advised the attorney that a new drug application would be unnecessary for the product, but the doctor expresses the opinion that the use of tartaric acid in cigarettes is not generally recognized among experts qualified to evaluate the safety of drugs, as safe for use in a recurring condition such as obesity. Assuming that Dr. Smith, a Government employee, told claimant's attorney that it would be unnecessary for claimant to file a new drug application with the Administration, claimant's failure to comply with the statute in that regard cannot be excused under the theory of estoppel against the Government. See Wilber National Bank v. United States, 1935, 294 U.S. 120, 55 S. Ct. 362, 79 L. Ed. 798.
For the reasons expressed in the foregoing opinion, I conclude that libelant's motion for summary judgment should prevail. An appropriate order may be presented accordingly.
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