U.S. Department of Health, Education, and Welfare

7120

FOOD AND DRUG ADMINISTRATION

LIBRARY

NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

I Given pursuant to section 705 of the Food, Drug and Cosmetic Act]

6081-6120

DRUGS AND DEVICES

The cases reported herewith were instituted in the United States district courts by United States attorneys, acting upon reports submitted by the Department of Health, Education, and Welfare. They involve drugs and devices which were adulterated or misbranded within the meaning of the Act when introduced into and while in interstate commerce or while held for sale after shipment in interstate commerce. These cases involve (1) seizure proceedings in which decrees of condemnation were entered after default or consent and (2) a criminal proceeding terminated upon a judgment of guilty after trial. The seizure proceedings are civil actions taken against the goods alleged to be in violation, and the criminal proceedings are against the firms or individuals charged to be responsible for violations.

Published by direction of the Secretary of Health, Education, and Welfare. GEO. P. LARRICK, Commissioner of Food and Drugs.

*For omission of, or unsatisfactory, ingredients statements, see Nos. 6088, 6090, 6094, 6106; failure to bear s label containing an accurate statement of the quantity of the contents, Nos. 6081, 6088, 6090, 6094, 6097; failure to bear a label containing the name and place of business of the manufacturer, packer, or distributor, Nos. 6088, 6094, 6119; cosmetic, actionable under the drug provisions of the Act, No. 6094.

569557-60

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SECTIONS of federal food, drug, and cosmETIC ACT INvolved in
VIOLATIONs reported IN D.D.N.J. NOS. 6081–6120

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 or National Formulary), and its strength differed from, or its quality and purity fell below, the standard set forth in such compendium; and Section 501(c), the article was not subject to the provisions of Section 501 (b), and its strength differed from, or its quality and purity fell below, that which it purported or was represented to possess.

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 (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 necessary for the protection of users; Section 502(j), the article was dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof; Section 502(1), the article consisted in part of penicillin and dihydrostreptomycin, and the article was not from a batch with respect to which a certificate or release had been issued pursuant to Section 507; and Section 503(b) (4), the article was subject to 503(b) (1), and its label failed to bear the statement "Caution: Federal law prohibits dispensing without prescription."

New-drug violation, Section 505(a), the article was a new drug within the meaning of Section 201(p), which was introduced into interstate commerce, and an application filed pursuant to Section 505(b) was not effective with respect to such drug.

DRUG AND DEVICES ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED ACCORDING TO DIRECTIONS

6881. Arthritis remedy. (F.D.C. No. 43531. S. No. 5–699 P.)

QUANTITY: 20-2-on, btls at Martinsville, Va.

SHIPPko: 8.20-39, from Price, N.C., by Myrtle Chemical Co.
LABEL IN PART: "Arthritis Remedy

Manufactured by Myrtle Chemical Ca, 802 Princeton Street, Martinsville, Va. *** Ingredients: Mono Butyl Kther, Synthetic Joint Fluid, Bichromatic Potash, Antimony, Trichloride and Tergitol"

Rastirs or INVESTIGATION; Examination showed that the article contained antimony chloride, diethylene glycol monobutyl ether, and Tergitol (a wetting agent), No potassium bichromate was present.

1188: XP: 918 39 W. Dist. Va.

China: &,a)-- when shipped, the name "Arthritis Remedy," and the label statement "Ingredients; ・ ・ ・ Richromatic Potash" were false and misleading

DEPOSITED BY THE

6081-6120]

NOTICES OF JUDGMENT

69

as applied to an article which was not an adequate and effective treatement for arthritis, and which contained no potassium bichromate; 502(b) (2)—the article failed to bear a label containing an accurate statement of the quantity of contents; 502 (j)—the article was dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in its labeling; and 505(a)-the article was a new drug within the meaning of the law, and an application filed pursuant to law was not effective with respect to the article.

DISPOSITION: 11-3-59. Default-destruction.

6082. Allure bust development device.

(F.D.C. No. 43795. S. No. 23-186 P.)

QUANTITY: 4 crated devices at Los Angeles, Calif.

SHIPPED: 10-6-59, from Tulsa, Okla., by Mrs. Mabel Ward.

LABEL IN PART: (Device) "Allure Mfd. by Allure Incorporated, Hollywood, California, Model 1097, Serial No. 7959 [or other numbers]."

RESULTS OF INVESTIGATION: The article consisted of rubber-ringed plastic cups of various sizes which had small openings for connection to rubber hoses attached to an air compressor or electrically operated pump. Attached to the compressor was a pressure regulator, vacuum gauge, and a valve to regulate the amount of vacuum produced in each of the two breast cups while in use. The plastic cups were pressed over the breasts against the chest and the rubber-ringed edge formed an airtight seal. The air compressor was then operated to form a vacuum inside the cups to exercise the breasts by contraction and relaxation. The air compressor and accessory equipment were contained in a metal cabinet 36' x 22'' x 18''.

LIBELED: 11-6-59, S. Dist. Calif.

CHARGE: 502(f) (1)—when shipped, the labeling of the article failed to bear adequate directions for use for the purpose for which it was intended, namely, for developing the human breasts; and 502(j)—the article was dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in its labeling. DISPOSITION: 12-3-59. Default-destruction.

6083. Allure bust development device.

(F.D.C. No. 43331. S. No. 53–228 P.)

QUANTITY: 2 devices at Phoenix, Ariz., in possession of Allure Salon. SHIPPED: During December 1958, from Hollywood, Calif., by Allure, Inc. LABEL IN PART: "Allure Mfd. Allure Incorporated, Hollywood, Calif. Model 1053 [or "1052"] Serial No. 9358 [or "82058"]" and "Allure Inc. Switzer Machines."

ACCOMPANYING LABELING: White cards containing the words "I the undersigned do hereby request 'Allure Salon' to administer to me that certain treatment known as 'Switzer Method for Bust Development'."; pink colored folders headed "Free Consultation and Demonstration."; and leaflet entitled "Be Proud of Your Bust."

RESULTS OF INVESTIGATION: The article consisted of rubber-ringed plastic cups of various sizes which have small openings for connection to rubber hoses attached to an air compressor or electrically operated pump. Attached to the compressor is a pressure regulator and a vacuum gauge, and a valve to regulate the amount of vacuum produced in each of the two breast cups while in use. The plastic cups are pressed over the breasts against the chest and the

Fulda tinged edge forms an airtight seal. The air compressor is then operwist to form a vacuum inside the cups to exercise the breasts by contraction and relaxation. The air compressor and accessory equipment are contained in a metal cabinet 36′′ x 22′′ x 18".

The pink-colored folders were printed locally for the dealer.

SR-39 Dist. Artz: libel amended 9-10-59.

NV 1 —The shipped and while held for sale, the labeling of the article contained false and misleading representations that the article was a sat adequate and effective treatment for increasing the size of the breasts, for underdeveloped sgging breasts, an increase circulation to feed the underfed breast tissues so that they would grow naturally and normally; 502(f) (t)- the #beling of the article failed to bear adequate directions for use; 3020 the article was dangerous to health when used in the dosage, or with the Pequency or duration prescribed, recommended, or suggested in the labeling therevi

DISPOSITION: 12-3-59. Defaul-delivered to the Food and Drug Administra

6984 Allure bust development device. (F.D.C. No. 43605. S. No. 82-812 P.) CLAN PUPY 2-3 devices at Kansas City, Mo.

Spent: 7-10-59 and 7-14-52, from Alhambra, Calif., by Allure, Inc.

LAL IN PAKT: (Front panel) “Allure Inc. Switzer Machine" and (back panel) Mfd. by Allure Incorporated Hollywood, Calif. Model 1100 [or *** or “1098"] Serial No. 7959."

AN ANYING LABELING: Booklet entitled “Allure.”

OF INVESTIGATION: The article consisted of rubber-ringed plastic cups arous sizes which had small openings for connection to rubber hoses attheded to an air compressor or electrically operated pump. Attached to the compressor was a pressure regulator, a vacuum gauge, and a valve to regulate the amount of vacuum produced in each of the two breast cups while in use. The plastic cups were pressed over the breasts against the chest and the rubber-ringed edge formed an airtight seal. The air compressor was then

operated to form a vacuum inside the cups to exercise the breasts by contraction and relaxation. The air compressor and accessory equipment were contained in a metal cabinet 35'' x 22'' x 18".

LIBELED: On or about 10-20-59, W. Dist. Mo.

CHARGE: 502(a)—when shipped, the labeling of the article contained false and misleading representations that the article was a safe, adequate and effective treatment for increasing the size of the breasts; for under-developed, sagging breasts; for developing the breasts; improving the appearance of the breasts; inverted nipples; and to increase circulation to feed the underfed breast tissues so that they would grow naturally and normally; that it was capable of bringing about complete bust correction and a beautiful bust line; that it would restore youth, beauty, and glamour and that its use would prevent cancer in the breasts, 302D) (1)--the labeling of the article failed to bear adequate directions for use; and 502()—the article was dangerous to health when used in the dose or with the frequency or duration prescribed, recommended, or

sted in its labeling.

PESHOREN 12739 Default-delivered to the Food and Drug Administration.

NEW DRUGS SHIPPED WITHOUT EFFECTIVE APPLICATION*

6085. Pabacaine. (F.D.C. No. 44147. S. No. 66–712 P.)

QUANTITY: 1,550 ampuls at Los Angeles, Calif., in possession of Brown Phar maceutical Co.

SHIPPED: 10-19-59, from Philadelphia, Pa., by the Philadelphia Ampule Lab,

oratories, Inc.

LABEL IN PART:

(Ampul) "5 cc Ampule Pabacaine each ampule contains: Pabacaine 100 mg. Ascorbic Acid 50 mg. * * * Glutamic Acid 50 mg Exclusive U.S. Distributors-The Brown Pharmaceutical Co., Los Angeles, Calif. 9966."

ACCOMPANYING LABELING: Brochures entitled "Research On The Use of H3 In The Treatment Of Old Age And Other Diseases."

RESULTS OF INVESTIGATION: The brochures were printed locally for the dealer. LIBELED: 12-31-59, S. Dist. Calif.

CHARGE: 502 (a)—while held for sale, the labeling which accompanied the article contained statements that the article appeared to make old people younger than their natural age; usually they experienced a marked improvement in general health; some elderly patients found their new hair growth was youthfully dark in color; in certain kinds of baldness, hair growth was restored dramatically; often the patients showed a marked improvement in their skin texture; a large percentage became strong enough to resume work again; many people crippled with arthritis had been strikingly helped; heart action and blood circulation were usually much improved; treatment had cured many cases of stomach ulcers; profound effects were shown in the central nervous system, with some men and women achieving greater improvement in eyesight and hearing; the brain functions frequently improved, with most elderly patients exhibiting notable strengthening of memory and attention; and treatment was also given to younger men and women suffering from arthritis, neuralgia, stomach ulcers, premature baldness, and other ailments; which statements were false and misleading since the article was not capable of fulfilling the promises of benefit stated and implied; 505 (a)—the article was a new drug within the meaning of the law, since its safety for use in the treatment of old age and other conditions mentioned in its accompanying labeling had not been established and an application filed pursuant to the law was not effective with respect to such drug.

DISPOSITION: 1-26-60.

6086. Hope's Worm-Rid.

Default-destruction.

(F.D.C. No. 43458. S. No. 69–683 P.)

QUANTITY: 12 cases, each containing 1 display ctn. which contained 12 btls.. at Minneapolis, Minn.

SHIPPED: 9-4-59, from Clayton, Mo., by Hope Co.

LABEL IN PART: (Btl.) "Hope's Worm-Rid 4 ounces *** A Safe *

Syrup for the eradication of Pin and Roundworms Each Teaspoonful (5 cc). Contains: Piperazine Citrate Equivalent to 500 mg. Piperazine Hexahy drate *** The Hope Company, Clayton 5, Missouri."

LIBELED: 10-1-59, Dist. Minn.

*See also No. 6081.