5442. Form-Allure bust developers.    (F.D.O. No. 40528.    S. No. 74-321 M.)
QUANTITY :   9 devices at Portland, Oreg.
SHIPPED :   4-13-57 and 4-18-57, from Los Angeles, Calif., by Marbrook Co., Ltd.
LABEL IN PAST :    "The Marbrook Co. Ltd.   form-allure of Hollywood."
ACCOMPANYING LABELING : Leaflets designated "Form-Allure" and printed sheets
designated "Instructions and Suggestions."
RESULTS OF INVESTIGATION : The article consisted of two hemispherical plastic
cups, approximately 4 inches in diameter at the open end, which were connected
by meajis of rubber tubing to a treadle-operated vacuum pump. In use, the
plastic cups were pressed against the chest wall so that each enclosed one of
the breasts and the edge of the cup formed an airtight seal against the chest.
Operation of the foot treadle caused a vacuum to be formed inside the plastic
cups.
LIBELED:   8-28-57, Dist. Oreg.
CHARGE: 502(a)-the labeling accompanying the article, when shipped, con-
tained false and misleading representations that the device was effective for
developing the breasts, increasing the size of the breasts, and improving the
appearance of the breasts; and 502(j)-the article was dangerous to health
when used in the dosage and with the frequency and duration prescribed,
recommended, and suggested in its labeling, namely, "One application daily
should suffice but when convenient to do so, use twice daily-morning and
evening. The time required for each user is determined by the length of time
necessary to produce a flush over the area. When the breasts are pink-
that is sufficient. In use, count ten to twenty strokes-remove cups (break
vacuum) and wait for a few seconds-then repeat the operation. In the
majority of cases three or four such applications is sufficient to produce the
desired flush. Do not assume that if a short period is good, a longer period
will be better. And, always control the length and number of strokes to your
comfort. Regular, daily use for several months is suggested, then taper off and
use only occasionally, as required."
DISPOSITION : 10-10-57. Default-delivered to the Food and Drug Administra-
tion.
DRUG FOR VETERINARY USE