United States v. 62 PACKAGES, ETC.

Decision Date23 February 1943
Docket NumberNo. 139.,139.
Citation48 F. Supp. 878
PartiesUNITED STATES v. 62 PACKAGES, MORE OR LESS, OF MARMOLA PRESCRIPTION TABLETS.
CourtU.S. District Court — Western District of Wisconsin

John J. Boyle, U. S. Atty., and Alvin M. Loverud, Asst. U. S. Atty., both of Madison, Wis., and Daniel P. Willis, Senior Atty., Federal Security Agency, of Washington, D. C., for libelant.

William H. Dougherty, Paul N. Grubb, and Stanley M. Ryan, all of Janesville, Wis., and Rockwell T. Gust and David A. Howell, both of Detroit, Mich., for Raladam Co., intervening claimant.

STONE, District Judge.

This is a libel for condemnation, under the provisions of the Federal Food, Drug and Cosmetic Act of June 25, 1938, c. 675, 52 Stat. 1040, Title 21 U.S.C.A. § 301 et seq., of 62 packages of Marmola Prescription Tablets which had been transported in interstate commerce from Detroit, Michigan, to La Crosse, Wisconsin, by the intervener, the Raladam Company. The libel charges that the Marmola Tablets under seizure were misbranded within the meaning of Section 502(j) of said Act, 21 U.S.C. A. § 352(j), in that the article is dangerous to health when used in the dosage or with the frequency prescribed, recommended or suggested in the labeling thereof, and within the meaning of Sections 502(a) and 201(n) of said Act, 21 U.S.C.A. § 352(a) and 321 (n), in that the labeling is false and misleading because it fails to reveal facts material with respect to consequences which may result from the use of the article under the conditions of use prescribed therein.

The Raladam Company intervened in this action as claimant of the seized article, and answered denying the allegations in the libel, and alleged that Sections 201(n) and 502(a) of said Act, 21 U.S.C.A. § 321(n) and 352(a), were not in force at the time of the alleged violation; that the Federal Food, Drug and Cosmetic Act and each section thereof relied upon by the Government in these proceedings, is unconstitutional for the reasons (a) it provides for unlawful search and seizure; (b) it is too indefinite and uncertain in its provisions; and (c) that said sections contemplate or constitute an unlawful delegation of legislative powers, all in violation of Articles I, II and III of the Constitution of the United States.

The parties stipulated that the tablets seized had been transferred in interstate commerce; that the Marmola Prescription Tablets contained the following ingredients:

                      1 grain   Extract Bladderwrack
                    ½ grain   Extract Phytolacca
                    ¼ grain   Extract Cascara Sagrada
                                Rx. 87 Spec
                    ½ grain   Desiccated Thyroid
                16/1000 min.    Oleoresin Ginger
                                Po. Saccharum special
                      3 grains  Calcium Carbonate Precipitated
                   1/24 min.    Methyl Salicylate
                   1/24 min.    Oil Anise
                   1/24 min.    Oil Sassafras
                                Talc Brown
                                Ivory Black
                                Aqua for Extracts
                                Po. Burnt Umber
                                Red Oxide of Iron
                                Syrupus Simplex
                                Lubricating Solution
                                Aqua for Granulating
                                Liquid Petroleum colorless
                

They further stipulated as follows:

"4. These tablets were manufactured for the Raladam Company by the Arner Company, Inc., from ingredients furnished by Parke, Davis & Company and Parke, Davis & Company has either supplied the active ingredients for or actually manufactured Marmola Prescription Tablets for more than twenty (20) years preceding the commencement of these proceedings, during which period over Twenty Million (20,000,000) packages have been sold by the Raladam Company.

"5. During the past twenty (20) years no change has been made in the ingredients or in the amounts thereof used in Marmola Prescription Tablets except that during the last World War when Cascara Sagrada was temporarily unavailable ¼ grain phenolphthalein was temporarily substituted for the ¼ grain of Cascara Sagrada in the Marmola formula.

"6. The ½ grain of Desiccated Thyroid contained in each Marmola Prescription Tablet is and was at all times during the last twenty (20) years a product of Parke, Davis & Company, and during all of said time all Desiccated Thyroid manufactured and sold by Parke, Davis & Company, which amounts to many millions of grains annually, has contained approximately fifty per cent (50%) more Organic Iodine than the mean average for Desiccated Thyroid as specified in the United States Pharmacopoeia.

"7. The only ingredient of Marmola Prescription Tablets that is involved in this action is the ½ grain of Desiccated Thyroid contained in each tablet."

The following provisions of the Federal Food, Drug and Cosmetic Act are involved in these proceedings:

Section 201, 52 Stat. 1040, 21 U.S.C.A. § 321:

"(g) The term `drug' means (1) articles recognized in the official United States Pharmacopœia, official Homœopathic Pharmacopœia of the United States, or official National Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (4) articles intended for use as a component of any article specified in clause (1), (2), or (3); but does not include devices or their components, parts, or accessories."

"(n) If an article is alleged to be misbranded because the labeling is misleading, then 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."

Section 304 of the Act, 21 U.S.C.A. § 334, which pertains to the method of seizure and disposition of misbranded food and drugs moving in interstate commerce; and Section 502, 21 U.S.C.A. § 352, which reads in part as follows:

"A drug or device shall be deemed to be misbranded —

"(a) If its labeling is false or misleading in any particular.

* * * * *

"(j) If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof."

Section 902 of the Act, 21 U.S.C.A. § 392 note, provides for the effective date of the Act, and reads in part: "* * * That sections 502(j), 505, and 601(a), * * * and all other provisions of this Act to the extent that they may relate to the enforcement of such sections, shall take effect on the date of the enactment of this Act * * *" which was June 25, 1938.

Section 201(b), 21 U.S.C.A. § 321(b), defines interstate commerce as follows: "The term `interstate commerce' means (1) commerce between any State or Territory and any place outside thereof * * *."

The labeling involved consists of the printed matter found on the box containing the Marmola Prescription Tablets and in the booklet accompanying same. The portions that are material to the disposition of the issues herein are as follows:

(On Box)

"Directions

"Take one tablet before each meal and at bedtime with enough water to swallow easily or as directed by a physician. Marmola is recommended only as a treatment for adult fat persons whose excess fatness is caused by hypothyroidism with accompanying subnormal metabolic rates but who are otherwise normal and healthy. Marmola should not be taken by persons suffering from any abnormal condition except abnormal excess fat caused as above stated. We make no diagnosis as that is the function of your physician who must be consulted for that purpose. Marmola is not recommended for children. Before taking be sure to read enclosed circular."

(In Booklet)

"The Purpose of Marmola

"Marmola prescription tablets have been sold to the public for more than thirty years and more than twenty million boxes have been distributed during that period. Marmola is not sold as a cure-all. It is intended for use only by obese (Obesity is the term used by the medical profession for an excessive development of fat throughout the body) persons who are otherwise normal and healthy and whose obesity is caused by hypothyroidism with accompanying subnormal metabolism, and our statements and representations made herein or otherwise are strictly limited to this treatment under these conditions and according to the dosage as recommended. We do not make any diagnosis as that is the function of your physician, who must be consulted for that purpose. Marmola should not be taken by persons suffering from any abnormal condition except obesity (abnormal excess fat) caused as above stated. The complete formula will be found on page 25. Purchasers who decide or are advised they do not need Marmola may obtain refund of the purchase price of any unused package by returning it to the Raladam Company at Detroit.

"Important Directions

"First. Take one Marmola tablet before each meal and one at bedtime — four a day. Do this regularly.

"Second. For best results we recommend that Marmola be used as directed over a period of sixty to ninety days — if needed that long.

"Marmola is intended to be used as a week-by-week treatment. The dosage is not intended to cause rapid reduction of weight. Most authorities advise a moderate rate of reduction so the body and skin may adapt themselves to the changed conditions.

"The rate of reduction differs with individuals. Habits also affect it. To some results appear rapid, to others slow. No food, drug or other substance which has any physiological effect may be taken internally or applied externally without the possibility of unpleasant or harmful results in some persons if they happen...

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