Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act. ... Drugs and Devices

5732. Cherefresh (cherry juice). (F.D.C. No. 43150. S. No. 55-670 P.) QUANTITY: 16 cases, 12 46-oz. cans each, and 178 cases, 24 12-oz. cans each, at Oklahoma City, Okla.

SHIPPED: 9-27-58 and 10-22-58, from Sturgeon Bay, Wis., by Reynolds Bros., Inc.

LABEL IN PART: (Can) "Cherefresh The Original Refreshing Cherry Drink * ** Reynolds Brothers, Inc., Sturgeon Bay, Wisconsin" or "Cherefresh *** Cherry Juice."

ACCOMPANYING LABELING: Leaflets entitled: "Arthritis Victims Ask for Cherry Information."

LIBELED: 5-21-59, W. Dist. Okla.

CHARGE: 502(a)—when shipped, the labeling which accompanied the article contained false and misleading representations that the article was an ade quate and effective treatment for arthritis, gout, and related ailments. DISPOSITION: 7-21-59. Consent claimed by Reynolds Brothers, Inc., and relabeled.

5733. Darcopherol tablets. (F.D.C. No. 41892. S. No. 14-394 P.)

QUANTITY: 39 50 tablet btls. and 1 180 tablet btl. at Chicago, Ill.

SHIPPED: Between 3-10-58 and 4-21-58, from Los Angeles, Calif., by Dartell Laboratories.

LABEL IN PART: "Net Contents ** DPS Formula 7 Darcopherol * * A dietary Food Supplement Providing Total Vitamin E from natural vegetable oils B Complex Factors Vitamin B-12 Vitamin B. Choline Vitamin B-2

Natural Iodine from Sea Vegetation Fatty Unsaturates from Wheat Germ and Soya Bean Dartrate Concentrate."

ACCOMPANYING LABELING: Pamphlets entitled "The Facts About Vitamin E." LIBELED: 6-26-58, N. Dist. Ill.

CHARGE: 502(a)—the labeling accompanying the article, when shipped, contained false and misleading representations that the article had nutritional properties which would prevent and correct heart disease, diabetes, muscular dystrophy, liver disorders, kidney disease, atherosclerosis and arteriosclerosis, sterility and many other disorders.

DISPOSITION: 7-25-58. Default-destruction.

5734. DPS Formula Lipotrate tablets. (F.D.C. No. 41842. S. No. 32-449 P.) QUANTITY: 8 cases, 12 btls. each, at Philadelphia, Pa.

SHIPPED: 1-8-58 and 4-4-58, from Los Angeles, Calif., by Dartell Laboratories. LABEL IN PART: (Btl) "DPS Balanced Formulae *** Formula 4 Lipotrate Net Contents 120 tablets A dietary Food Supplement providing Lipotropic Factors Choline Bitartrate Inositol Betaine dl-Methionine with B-Complex Vitamins Vitamin B-12 Vitamin B-6 Folic Acid Calcium Pantothenate and Minerals Iodine Calcium Phosphorus and containing Dartrate Concentrate."

ACCOMPANYING LABELING: Pamphlet entitled "From Nature Through Experimentation and Research comes Discovery * * * Lipotrate." LIBELED: 5-27-58, E. Dist. Pa.

CHARGE: 502(a)—the labeling accompanying the article, when shipped, contained false and misleading representations that the article was an adequate and effective treatment for the prevention and correction of jaundice, cirrhosis of the liver, atherosclerosis and diabetes mellitus.

DISPOSITION: 8-27-58. Default-destruction.

5735. Sugar-chek (urine sugar test tape). (F.D.C. No. 41901. S. Nos. 12-980 P, 14-601 P.)

QUANTITY: 385 ctns., each containing 144 retail ctns., at Elgin, Ill.

SHIPPED: 1-25-57 and 2-4-57, from St. Louis, Mo.

LABEL IN PART: "Sugar-Chek *** (Urine Sugar Test Tape) A specific test for urine glucose (sugar)."

ACCOMPANYING LABELING: (Leaflet in ctn.) "What is a Diabetic."

RESULTS OF INVESTIGATION: Examination showed that the article, while held for sale, was not effective for detecting small amounts of sugar in the urine as claimed in its labeling.

CHARGE: 502(a)—the labeling of the article, while held for sale, contained false and misleading representations that the article was effective for detecting the presence of sugar in the urine and thus acting as a diagnostic sign of diabetes.

DISPOSITION: 7-25-58. Default-destruction.

5736. Slenda-Matic devices. (F.D.C. No. 41794. S. Nos. 25-239 P, 26-551 P.) QUANTITY: 36 rectangular Slenda-Matic devices and 12 contour Slenda-Matic devices at Minneapolis, Minn.

SHIPPED: 5-7-58, from Chicago, Ill., by Grayline Co.

LABEL IN PART: (Ctn.) "Rectangular Hollco Slenda-Matic Distributed By S. S. Hollender, Inc., Chicago, Illinois" and "Contour Hollco Slenda-Matic"; (metal plate on each device) “Slenda-Matic Manufactured by Grayline Company, Chicago 33, Illinois *** Serial No."

ACCOMPANYING LABELING: Leaflet entitled "Hollco Slenda-Matic Vibrating Machine."

RESULTS OF INVESTIGATION: The labeling indicated that each device was a wooden frame box upholstered with polyurethane foam and covered with vinyl material, and that a rheostat-control electric motor providing vibration was enclosed in each box.

LIBELED: 64–58, Dist. Minn.

CHARGE: 502(a)—the labeling of the devices, when shipped, contained false and misleading representations that the devices were capable of providing an adequate and effective treatment for improving circulation, easing tensions, reducing weight, regaining a firm, trim, slender figure and removing fatty tissues.

DISPOSITION: 7-22-58. Consent-claimed by E. B. Meyrowitz, Inc., St. Paul, Minn., and relabeled.

(F.D.C. No. 41454. S. No. 41-302 P.)

5737. Ozone generator.

QUANTITY: 11 devices at Seattle, Wash.

SHIPPED: 10-21-57, from Germany.

LABEL IN PART: "ELT Mod. TOS-1 *** Made in Germany."

ACCOMPANYING LABELING: Leaflets entitled "Health Promoting Ozonator" and "Atme Dich Gesund."

RESULTS OF INVESTIGATION:

Each device consisted of a horizontally mounted mercury-containing glass tube, completely enclosed and covered with a protective plastic shield.

LIBELED: 3-4-58, W. Dist. Wash.

CHARGE: 502(a)—the labeling accompanying the devices, while held for sale, contained false and misleading representations that the devices were effective for overcoming coughs, headache, whooping cough, tuberculosis, bronchitis, diseases of respiratory organs, rickets, and metabolic disturbances, and for promoting health.

DISPOSITION: 7-14-58. Default-destruction.

5738. Relax-Or cushion.

(F.D.C. No. 41817. S. No. 26-558 P.)

QUANTITY: 137 devices at Minneapolis, Minn., in possession of John W. Thomas Co.

ACCOMPANYING LABELING: Newspaper tearsheets reading in part "Save While You Slim Relax Away Tensions Pains and Inches With Our 'Vibra' Pillow." RESULTS OF INVESTIGATION: The newspaper tearsheets were used by the consignee with a counter display of the devices. The device appeared to be an upholstered cushion containing an electric motor providing vibration. LIBELED: 6-23–58, Dist. Minn.

CHARGE: 502(a)—the labeling accompanying the article, while held for sale, contained false and misleading representations that the article was an ade quate and effective treatment for relaxing away tensions, pains, and inches, easing nervous tension instantly, trimming the body, and reducing weight. DISPOSITION: 7-10-58. Consent-claimed by John W. Thomas Co. and relabeled.

5739. Electric massage pillows. (F.D.C. No. 41913. S. Nos. 25–944/6 P.) QUANTITY: 13 electric massage pillows, 11 Travel-Mate electric massage pillows, and 7 Vibra-Therm electric massage and heat pillows at Waterloo, Iowa. SHIPPED: 5-14-58., from Chicago, Ill., by Edson, Inc.

LABEL IN PART: (Ctn.) "SLIM-TRIM Electric Massage Pillow", "Slim-Trim
Travel-Mate Electric Massage Pillow"; "Slim-Trim Vibra-Therm Electric
Massage and Heat Pillow."

ACCOMPANYING LABELING: Leaflets in ctn. entitled "Slim-Trim Electric Mas-
sage Pillow How to use and enjoy it," "How to use and enjoy your new
Slim-Trim Travel-Mate Electric Massage Pillow," "Slim-Trim Vibra-Therm
Electric Massage and Heat Pillow How to use it for best results."
RESULTS OF INVESTIGATION: The articles (all models) consisted of an up-
holstered cushion containing an electric motor providing vibration, and the
Vibra-Therm pillows also contained a dial control switch for heat.
LIBELED: 7-8-58, N. Dist. Iowa.

CHARGE: 502(a)-when shipped, the labeling of the articles contained false
and misleading representations that the electric massage pillows were an
adequate and effective treatment for reducing fatty spots and unsightly
bulges, relieving aches due to muscular strain, easing nervous tension, in-
creasing blood circulation, and for trimming the figure; that the Travel-Mate
pillows were an adequate and effective treatment for stimulating circulation,
firming up flesh, reducing unsightly bulges, and trimming the figure; and
that the Vibra-Therm pillows were an adequate and effective treatment for
spot reducing, relieving muscle ache, easing tension, stimulating blood cir-
culation to carry away excess fatty tissues, and slimming and trimming the
figure.

DISPOSITION: 8-9-58. Consent-claimed by Edson, Inc., and released for re-
labeling. The electric massage pillows and Vibra-Therm pillows were re-
labeled and the vibrating mechanisms of the Travel-Mate massage pillows
were removed and dismantled in lieu of relabeling such pillows.

5740. Electric vibrator pillow. (F.D.C. No. 41791. S. No. 25–229 P.)

QUANTITY: 18 devices at Madison, Wis.

SHIPPED: 3-28-58, from Chicago, Ill., by P. J. Gould Co.

LABEL IN PART: (Ctn.) "Tailorized Tru Fit Electric Vibrator Pillow Helps
Massage Away Excess Pounds - Relaxes and Eases Nervous Tension *

P. J. Gould Co., Chicago, Ill."

RESULTS OF INVESTIGATION:

The label indicated that the device was a corduroy-
covered polyether foam-filled cushion containing an electric motor capable of
providing vibration action.

LIBELED: 64–58, W. Dist. Wis.

CHARGE: 502 (a)—the label of the article, when shipped, contained false and
misleading representations that the device was an adequate and effective
treatment for reviving sore and tired muscles, relaxing and easing nervous
tension, and massaging away excess pounds.

DISPOSITION: 6-27-58. Default-delivered to the Food and Drug Administra-
tion.

INDEX TO NOTICES OF JUDGMENT D.D.N.J. NOS. 5701 TO 5740