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

LIBELED:

CHARGE:

12-5-58, S. Dist. Miss.

502(a)-when shipped, the device label and the labeling which ac companied the article contained false and misleading representations that it was an adequate and effective treatment for relocating the stomach into normal position by stretching the spine and lifting the diaphragm; realigning the bone structure to correct the posture; correcting pelvic dip and stooped shoulders; increasing circulation and overcoming poor elimination; tightening up loose and flabby muscles; firming the tissues; and reducing weight and slenderizing the figure.

DISPOSITION: 11-12-59. Consent-claimed by S. L. Varnado, Jackson, Miss., and brought into compliance with the law by destruction of the booklets and labels.

6077. Wonder Ease device. (F.D.C. No. 43301. S. No. 52-929 P.)
QUANTITY: 46 individually cartoned devices at North Hollywood, Calif., in
possession of Wonder Ease Co.

SHIPPED: 3-19-59 and 4-14-59, from Denver, Colo., by Cyclo Mfg. Co.
LABEL IN PART: (Device) "Cyclo Wonder Ease Model 5 Denver, Colo.
Serial No. 14671."

ACCOMPANYING LABELING: Booklets enclosed in each carton entitled “Wonder
Ease Slenderizer Instruction Booklet," also other booklets entitled "Beyond
the Magic Door," and a number of salesmen's manuals and diet and calorie
charts entitled "Suggested Diet" and "Wonder Ease Calorie Chart."
RESULTS OF INVESTIGATION: All of the accompanying labeling was printed in
Los Angeles, Calif., with the exception of the instruction booklets.

The device consisted of a motor to which was attached two soft rubber discs. Vibration was obtained by eccentric rotation of the two discs in a vertical plane. The motor was attached to a tubular aluminum frame in such manner that it could slide up or down so that different areas of the body could be reached for massage. The motor could also be removed and held in the hand while massaging parts of the body which could not be reached while the motor was attached to the frame. The aluminum frame holding the motor was mounted on a door by means of clamps and suction cups. For massaging the feet the motor could be placed on the floor and the feet placed against the vibrator.

LIBELED: 7-16-59, S. Dist. Calif.

CHARGE: 502(a)—when shipped and while held for sale, the labeling accompanying the article contained false and misleading representations that the article was an adequate and effective treatment for slenderizing, reducing weight, trimming inches “from hips, tummy, and legs with no strenuous diet," spot reducing, overcoming nervous tension, improving circulation, overcoming neuritis and rheumatism, providing a clear and radiant complexion, and providing general benefits to the entire body.

DISPOSITION: 10-28-59. Consent—claimed by Cyclo Mfg. Co. and relabeled.

6078. Furow health pillow. (F.D.C. No. 43359. S. No. 48-879 P.)

QUANTITY: 184 individually cartoned plastic-covered pillows at San Francisco, Calif.

SHIPPED: 11-5-58 and 6-26-59, from Osaka, Japan, by Osaka Kairiku Bussan Co., Ltd.

LABEL IN PART: (Ctn. and tag on pillow) "Furow Health Pillow No. 120 [or other model numbers] Made in Japan."

ACCOMPANYING LABELING: Brochure entitled "Preserve Your Youth and Healthfulness" and leaflet entitled "For Your Sound Sleep Bringing Health & Success."

RESULTS OF INVESTIGATION:

The pillows consisted of various models identified as 43/Model 120; 24/Model 150; 48/Model 160; 24/Model 180; 6/Model 190; 4/Model 195; 24/Model 300; and 11/Model 350.

Examination of Model 120 showed that it was a mat made of pieces of white china strung together with plastic-covered thread. It was 13 inches long, 6% inches wide, and 14 inches thick. The china pieces were backed with a piece of thin, flexible, blue plastic plate with oval cutouts. Back of this plate was a double thickness of green-covered plastic covered with woven wire to provide for cushioning and air circulation. The mat had plastic cords resembling light gauge electric cord attached to the top and bottom edges.

Models 160, 195, 300, and 350 were mounted on ventilated latex rubber. LIBELED: 8-25-59, N. Dist. Calif.

CHARGE:

502(a)-when shipped, the labeling which accompanied the article contained false and misleading representations that the article was an adequate and effective treatment for headache, sleeplessness, hysteria, stiff shoulder, neurosis, "prinnipus," apoplexy, and hypertension; that it would preserve one's health and youthfulness, calm nerves, regulate blood circulation, and make the brain clear.

DISPOSITION: 10-27-59. Consent-claimed by F. M. Nonaka Co., Inc., t/a Crown Import Co., San Francisco, Calif., and relabeled.

6079. Electric massage pillow. (F.D.C. No. 43399. S. No. 23-181 P.) QUANTITY: 1,714 individually cartoned devices at Los Angeles, Calif.

SHIPPED: 6-2-59 and 6-8-59, from Boston, Mass., by the Bandwagon Mfg. Co. LABEL IN PART: (Leaflet in ctn.) "Trim Electric Massage Pillow * Bandwagon, Boston 10, Mass."

RESULTS OF INVESTIGATION: Examination showed the article to be a rectangularshaped corduroy-covered foam rubber cushion about 10% x 10%1⁄2 x 311⁄2 inches in size, containing an electrically operated vibrating mechanism.

LIBELED: 7-24-59, S. Dist. Calif.

CHARGE:

502(a)—when shipped, the labeling of the article contained false and misleading representations that the article was an adequate and effective treatment for firming the figure; firming flabby muscles; toning sagging muscles; as an aid in reducing; to restore normal circulation; to rid the abdomen and hips of excess flabbiness; and to bring about renewed vigor. DISPOSITION: 8-17-59. Consent-claimed by Sunset House Distributing Corp. of Los Angeles, Calif., and relabeled.

6080. Filtex vacuum cleaner. (F.D.C. No. 43363. S. No. 65-146 P.) QUANTITY: 12 individually cartoned devices at Salt Lake City, Utah. SHIPPED: 5-19-59, from Los Angeles, Calif., by Filtex Corp.

LABEL IN PART (Device) "MODEL 19-B SERIAL NUMBER 95 485 (THRU 95 496) THE FILTEX CORPORATION, 417-423 EAST 15TH STREET, LOS ANGELES 15, CALIF." and (etn.) "HYGIENIC AIR PURI

FIER FILTEX * ** THE FILTEX CORP., 417-423 E. 15TH St. LOS
ANGELES 15, CALIF."

ACCOMPANYING LABELING: An instruction booklet entitled "FILTEX AMER-
ICA'S MOST MODERN HOME CLEANING MACHINES"; and leaflets en-
titled "PROTECT YOUR FAMILY THE FILTEX WAY," "PROTECT YOUR
FAMILY FROM DANGEROUS, DISEASE-BREEDING DUST GERMS," and
"THE AMAZING FILTEX."

RESULTS OF INVESTIGATION: The article was a cannister-type, electrically
operated, vacuum cleaner with a filter and attachments.

LIBELED: 8-31-59, Dist. Utah.

CHARGE: 502 (a)-when shipped, the labeling contained false and misleading
representations that the article was capable of preventing staphylococcus in-
fections such as boils, abscesses, osteomyelitis (bone infection), etc.; strepto-
coccus infections such as "strep" throat, scarlet fever, erysipelas, tonsillitis.
etc.; that it would remove all disease germs from the home, keep the home
germ-free, cut down sickness in the home, prevent spreading of infections.
safeguard the childrens' health, and protect against disease-producing germs
causing tuberculosis, pneumonia, influenza, and the common cold.
DISPOSITION: 11-27-59. Consent-claimed by Filtex Corp., and relabeled.

INDEX TO NOTICES OF JUDGMENT D.D.N.J. NOS. 6041 TO 6080