SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC Act InvolvED IN VIOLATIONS REPORTED IN D.D.N.J. 5781-5820

Adulteration, Section 501(b), the article purported to be and was represented as a drug, the name of which is recognized in an official compendium (United States Pharmacopoeia), and its strength differed from, and its quality and purity fell below, the standard set forth in such compendium; Section 501(c), the article was not subject to the provisions of Section 501(b), and its strength differed from, or its purity or quality fell below, that which it purported or was represented to possess; and Section 501 (d) (2), the article was a drug, and a substance had been substituted wholly or in part therefor.

Misbranding, Section 502(a), the labeling of the article was false and misleading; Section 502(b), the article was in package form, and it failed to bear a label containing (1) the name and place of business of the manufacturer, packer, or distributor, and (2) an accurate statement of the quantity of contents; Section 502(d), the article contained a chemical derivative of codeine, and its label failed to bear the name, and quantity of such derivative and in juxtaposition therewith the statement "Warning-May be habit forming"; Section 502(e), the article was a drug not designated solely by a name recognized in an official compendium, and its label failed to bear (1) the common or usual name of the drug; and (2) the drug was fabricated from two or more ingredients, and its label failed to bear the common or usual name of each active ingredient; Section 502(f), the labeling of the article failed to bear (1) adequate directions for use and (2) adequate warnings against use in those pathological conditions, or by children, where its use may be dangerous to health, or against unsafe dosage or methods of duration of administration or application, in such manner and form, as are necesssary for the protection of users; Section 502(g), the article purported to be a drug, the name of which is recognized in an official compendium (United States Pharmacopeia), and it was not packaged as prescribed therein; and Section 502(i) (3), the article was a drug offered for sale under the name of another drug.

DRUGS AND DEVICES ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE DIRECTIONS OR WARNING STATEMENTS

5781. Hoxsey treatment for internal cancer. (Inj. No. 311.) Supplement to D.D.N.J. No. 5202.

PETITION FILED: On 10-6-58, a petition for an order to show cause in criminal contempt was filed in the Western District of Pennsylvania, against Hoxsey Cancer Clinic, a corporation, Portage, Pa., and John J. Haluska, Samuel J. Einhorn, John H. Benko, Harold F. Galbraith, A. A. Nelson, and Harry A. Stegman, incorporators, directors, and trustees of the clinic.

DISPOSITION: On 10-30-58, the following supplemental consent decree was entered:

MILLER, District Judge: "AND NOW, to wit, this 30th day of October, 1958, the United States of America having filed a petition for order to show cause why the defendants should not be punished for criminal contempt of this Court's permanent injunction, which became effective November 1, 1957, and the Court being convinced that the terms of this supplemental decree and the provisions thereof are necessary to effectuate the operation of this Court's orders and decrees, and the defendants having expressed to the Court a willingness to dissolve the corporation and to wind up its business of delivering medicine to persons at Portage, Pennsylvania, and having consented to this supplemental consent decree;

XPOSITED BY THE

5781-5820]

NOTICES OF JUDGMENT

165

"It is ORDERED, ADJUDGED AND DECREED that the defendants shall dissolve the said corporation and on or before November 1, 1958 completely discontinue the operation of the Hoxsey Cancer Clinic at Portage, Pennsylvania; that the said defendants, and each of them, shall not after that date reopen the said clinic under the name of the Hoxsey Cancer Clinic or any other name for the treatment of any person or persons for cancer, and shall not assign, lease or sell the said clinic to any other persons or organization except with the approval of this court; that the decree entered October 2, 1957 shall continue in full force and effect; that defendants' failure to comply with this supplemental consent decree may be prosecuted as a criminal contempt, and that upon defendants' failure to comply with this supplemental consent decree the Court will immediately sign the order to show cause that is now pending and shall schedule the case for an early trial.

"The Food and Drug Administration is directed to report to the Court, not later than December 1, 1958, whether the defendants are in full compliance with this decree."

5782. Zina-Ray Oil, inhalers, and Ten Second Rub. (F.D.C. No. 42158. S. No. 24-906 P.)

INFORMATION FILED:

10-17-58, Dist. Minn., against William R. Hall, Minne

apolis, Minn.; amended information filed, 11-17-58.

ALLEGED VIOLATION: On 1-23-58, at a public sales talk in Minneapolis, Minn., the defendant caused oral representations to be made holding the articles out to the public as a treatment for the diseases, symptoms, and conditions set forth below, which act resulted in the articles being misbranded while held for sale after shipment in interstate commerce.

LABEL IN PART: (Drug) “Zina-Ray Oil * * * Contains Eucalyptus Oil, Menthol, Pine Needle Oil, Peppermint Oil. Contents 3 Fl. Oz."; (device) "25¢ Inhaler 254"; (tube) "Ten Second Rub *** Net Weight 3 fluid oz." CHARGE: 502 (f) (1)—the labeling of the articles failed to bear adequate directions for use in the treatment of the diseases, symptoms, and conditions for which the articles were intended, namely, (Zina-Ray Oil and inhalers) for preventing headaches, pain in the gums, neuralgia, deafness, arthritis, rheumatism, formation of crystal deposits in the bones, inflammation of the ear, pneumonia, "flu", and overcoming sinus infection and asthma; and (Ten Second Rub) for overcoming arthritis, rheumatism, and all aches and pains to which the body is subject.

PLEA: Guilty.

DISPOSITION: 1-26-59. $500 fine and sentence of 4 months in prison.

5783. Dasin C. S. capsules. (F.D.C. No. 41740. S. No. 79–505 M.) INDICTMENT FILED: 7-31-58, E. Dist. N.Y., against Charles P. Greenberg, and Marvin Goldstein, partners in the partnership of Page Drugs, Bethpage, N.Y. ALLEGED VIOLATIONS: On 10-19-57, while a number of Dasin C. 8. capsules were being held for sale by the defendants after shipment in interstate commerce, the defendants caused to be dispensed, delivered, and sold to a customer, a number of such tablets in place of the Panalba capsules called for in the prescription which was presented by the customer to the defendants for filling. Such acts resulted in the Dasin C. S. capsules being adulterated and misbranded as described below.

CHARGE:

501 (c)-the strength of the article differed from that which it purported and was represented to possess; 501(d) (2)—Dasin C. S. capsules had been substituted for Panalba capsules; 502(a)—the statement on the vial label of the article contained false and misleading representations and suggestions

that the article was Panalba capsules: 502(b) (2)—the label of the article 1 bore no statement of the quantity of contents; 502 (d)-the article contained a chemical derivative of codeine, namely, codeine sulfate, which derivative had been found to be, and by regulations designated as, habit forming. and the label of the article failed to bear a statement of the quantity of such a derivative and in juxtaposition therewith the statement "Warning-May be i habit forming"; 502(e) (1)—the label of the article failed to bear the common or usual name of the article, namely, Dasin C. S.: 502(e) (2)-the label of the article failed to bear the common or usual name of each active ingredient in each capsule of the article, including the name, quantity, kind, and proportion of acetophenetidine and atropine or any derivative of any such substances contained therein; 502(f) (1)—the labeling of the article failed to bear adequate directions for use; 502(f) (2)—the labeling of the article failed to bear such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods of administration or application, in such manner and form, as are necessary for the protection of users; and 502 (i) (3)—the article was offered for sale under the name of another drug.

PLEA: Guilty.

DISPOSITION: 12-5-58. Each defendant was fined $1,500, given a jail sentence of 1 year, which was suspended, and placed on probation for 3 years. 5784. Vitamin-mineral supplement, Special Formula dietary supplement, inhalant & rubbing oil, and salve. (F.D.C. No. 42231. S. Nos. 25-277/80 P.) QUANTITY: 318 60-tablet btls. of vitamin-mineral supplement, 18 btls. Special Formula dietary supplement, 136 1-oz. vials inhalant & rubbing oil, and 144 2-oz. tins of salve, at Mitchell, S. Dak.

SHIPPED: At various times, from outside the State of South Dakota. LABEL IN PART: (Btl.) "Napier's 14 & 10 (Improved) Vitamins-Minerals A dietary supplement * * * Prepared for Chief D. A. Napier, R.R. #3—Tahle quah, Okla." and "Napier's Special Formula E.P. A high potency dietary supplement furnishing a wide range of vitamins and minerals *** Distributed by Chief D. A. Napier"; (tin) "Napier's Family Salve Active Ingredients: Methyl Salicylate, Oil Pine Tar and Balsam Peru in a Petrolatum base *** Chief D. A. Napier"; (vial) “Napier's Inhalant & Rubbing Oil Active Ingredients: Eucalyptus Oil, Menthol, Peppermint Oil, Thymol, Camphor *** Chief D. A. Napier."

ACCOMPANYING LABELING:

Booklets entitled "Napier's Health Book” and leaflets entitled "Chief Don A. Napier and Family * How Vitamins & Minerals Help The Whole Family-The Price of Health." LIBELED:

10-21-58, Dist. S. Dak.

CHARGE: 502(a)—the labeling accompanying the vitamin-mineral supplement and the Special Formula dietary supplement, while held for sale, contained false and misleading representations that the articles were effective in the prevention and treatment of tuberculosis, heart disease, liver and kidney disorders, gout, jaundice, skin diseases, indigestion, sexual weakness or impotence, mental deficiency, diabetes, catarrh, sores that do not heal, arthritis, rheumatism, chronic bronchitis, and cirrhosis of the liver; and 502(f) (1)— while held for sale, all the articles failed to bear adequate directions for the uses for which they were intended, namely, (vitamin-mineral supplement) for

treatment of arthritis and rheumatism, high blood pressure, improving eyesight, and insuring general good health; (Special Formula dietary supplement) as a "make man" remedy to restore lost manhood, improve sexual powers, and for sexual rejuvenation generally; (inhalant and rubbing oil) for the treatment of sinus trouble, catarrh, asthma, hay fever, colds, grippe, earache, chest colds, chilblains, pain in the back, neck, or leg; and (salve) for all kinds of burns or scalds, eczema, impetigo, skin rashes, poison oak, poison ivy, ringworm, itching, bleeding, blind or protruding hemorrhoids, and varicose vein sores; which were the purposes and conditions for which the articles were offered for sale orally by the distributor, Don A. Napier, in a sales talk at Mitchell, S. Dak. DISPOSITION: 12-2-58. Default-the vitamin-mineral supplement and the Special Formula dietary supplement were delivered to a public institution for its use, and the other articles were destroyed.

5785. Integrated therapy capsules and ointment. (F.D.C. No. 42239. S. Nos. 42-104/5 P.)

QUANTITY: 4 pkgs., each containing 1 jar of ointment and 1 30-capsule btl., and 13 90-capsule btls., at Billings, Mont.

SHIPPED: 8-14-58, from Paris, Tenn., by Golden Peacock Toiletries. LABEL IN PART: (Pkg.) "Integrated Therapy Capsulate & Ointment * * Mitchum Distributors Paris, Tennessee"; (jar) “Net Wt. 1 Oz. Integrated Therapy Ointment *** Contains 1% Ammoniated Mercury, Sorbitol, Hexachlorophene, and Natural Estrogens, Principally Estrone, equivalent to 10,000 I.U. per ounce. Directions * * 3223"; (btl.) "30 [or "90"] Capsules Integrated Therapy Capsulate *** Each Capsule Contains Palmitate 12,500 USP Units Irradiated Ergosterol 1,000 USP Units Thiamine Hydrochloride USP 5.0 mg. Riboflavin USP 2.5 mg. Pyridoxine Hydrochloride .5 mg. Vitamin B-12 1.0 mg. Ascorbic Acid USP 75.0 mg. Niacinamide USP 40.0 mg. Calcium Pantothenate 4.0 mg. d-alpha Tocopheryl Acetate . . . equivalent to 2 I.U. Vit. E Folic Acid USP 0.5 mg. Dicalcium Phosphate, Anhydrous 260.0 mg. Calcium 75.0 mg. Phosphorous 58.0 mg. Choline Bitartrate 31.4 mg. Inositol 15.0 mg. di-Methionine 10.0 mg. Ferrous Sulfate * (iron 30 mg.) 102.0 mg. Cobalt Sulfate ***.193 mg. Copper Sulfate * * * 1.257 mg. Manganese Sulfate *** 1.573 mg. Sodium Molybdate .253 mg. Potassium Iodide USP * ** .099 mg. Zinc Sulfate ** 1.388 mg. Magnesium Sulfate *** 21.583 mg."

ACCOMPANYING LABELING: Leaflets entitled "Valuable Free Merchandise Certificate," "Happy Days are Here Again Since We Discovered Integrated Therapy Capsulate," and "Instructions for Use."

LIBELED: 10-27-58, Dist. Mont.

CHARGE: 502(a)—the labeling of the articles, when shipped, contained false and misleading representations that the articles were an adequate and effective treatment for making one feel and look younger, combating signs of age, lack of sleep, loss of mental and physical ambition, aches and pains, needless worry and sexual weakness, and that the articles would produce a new glow of inner health and vitality and would eliminate wrinkles and firm the skin; and 502(f) (2)-the ointment contained a mercury compound, and its labeling failed to warn that users should discontinue the use of the article if irritation of the skin developed, and that frequent or prolonged use or application to large areas may cause serious mercury poisoning.

DISPOSITION: 12-1-58. Default-destruction.

DRUG FOR VETERINARY USE

5786. Blue Seal Growing Mash. (F.D.C. No. 42201. S. No. 7-887 P.) QUANTITY: 132 100-lb. bags at Ellsworth, Maine.

SHIPPED: 7-9-58, from Lawrence, Mass., by H. K. Webster Co.

LABEL IN PART: (Tag) "BLUE SEAL GROWING MASH"; (bag) “BLUE SEAL GRAIN PRODUCTS * * * Manufactured by H. K. Webster Company." RESULTS OF INVESTIGATION: The article was invoiced as "1 Lb. G.C. per ton." LIBELED: 10-1-58, Dist. Maine.

CHARGE: 501 (c)-when shipped, the quality of the article fell below that which it purported and was represented to possess since the article contained sulfaquinoxaline in place of glycarbylamide; 502 (e) (2)—the label of the article failed to bear the common or usual name of each active ingredient contained therein since the presence of sulfaquinoxaline was not declared; and 502(f) (1)—the labeling of the article failed to bear adequate directions for use.

DISPOSITION: 11-18-58. Default-destruction.

DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM OFFICIAL OR OWN STANDARDS

DRUGS FOR HUMAN USE*

5787. Digitalis powder, digitalis tablets, and digitalis capsules. (F.D.C. No. 42223. S. Nos. 35-138/9 P.)

QUANTITY: 2 5-lb. tins, and 2 3-lb. tins of digitalis powder, 17 2,000-tablet btls., 1 1,500-tablet btl., 72 1,000-tablet btls., 1 500-tablet btl., and 1 100tablet btl. of digitalis tablets, and 15 1,000-capsule btls., and 1 500-capsule btl. of digitalis capsules, at Philadelphia, Pa.

SHIPPED: The digitalis powder was shipped on 11-12-57, from Montreal, Canada, by F. E. Cornell & Co., Ltd.

LABEL IN PART: (Tin) "Allen's Selected Digitalis Leaves in Powder

E 62330 This Digitalis Powder contains 14.2 International Units per gramme, or one unit is contained in 0.07 gramme, which is equivalent to 0.076 gramme of the 3rd International Standard Digitalis Powder as determined by a biologic test carried out by the School of Pharmacy, University of London Stafford Allen & Sons, Ltd., London & Louis Medford, England Batch Number 9/M 3/56 2nd November 1956," (btl.) "Tablets [or "Capsules"] Allen's English Digitalis 11⁄2 Grains * ** Standardized to U.S.P. requirements for Powdered Digitalis * ** Raymer Pharmacal Company, Philadelphia, Pa." RESULTS OF INVESTIGATION: The digitalis tablets and digitalis capsules were manufactured at Philadelphia, Pa., by the Raymer Pharmacal Co., from digitalis powder which had been shipped as described above.

LIBELED: 10-13-58, E. Dist. Pa.

CHARGE: 501 (b)—the strength of the articles, when shipped and while held for sale, differed from the standards for digitalis powder, digitalis tablets, and digitalis capsules set forth in the United States Pharmacopeia; and 502(a)— the following label statements: (powder) "This Digitalis Powder contains 14.2 International Units per gramme," and (tablets & capsules) "Digitalis

See also Nos. 5783, 5786.