6302.?Allure bust development device (4 seizure actions).    (F.D.C. Nos. 43512,
43513,43514,43515.    S. Nos. 71-806/7 P., 71-809/10 P.)
QUANTITY :   2 devices at Clearwater, Fla., and 5 devices at Tampa, Fla.
SHIPPED : Between the latter part of 1957 and January 1959, from Los Angeles
and Hollywood, Calif., by Dimco Kitchen Equipment, and Allure, Inc.
LABEL IN PAST :    "Allure   Mfd. by Allure Inc.   Hollywood, Calif."
ACCOMPANTING LABELING: Claim (one device) for patent application and (one
device) circulars entitled "Allure Salon Bust Developing and Firming."
RESULTS OP 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, 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 36" x 22" x 18".
LIBELED :    8-31-59, S. Dist. Fla.
CHARGE: 502(a)-when shipped and while held for sale, the labeling, namely,
the circular entitled "Allure Salon Bust Developing and Firming," which
accompanied one device at Tampa, Fla., contained false and misleading
representations that the device was a safe, adequate, and effective treatment
for increasing the size of the female breast; for developing the breasts without
surgery, hormones, creams, or exercise; 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 use of the device was healthful; and
the labeling, namely, the claim for patent application, which accompanied
another device at Tampa, Fla., contained false and misleading representations
that the article was an adequate and effective treatment for development of
the human female breast; 502(f)(1)-the labeling of the article (all lots)
failed to bear adequate directions for use for the purposes for which it was
intended; and 502(j)-the article (all lots) was dangerous to health when
used in the dosage, or with the frequency or duration prescribed, recom-
mended, or suggested in the labeling.
DISPOSITION : 12-7-59. Default-delivered to the Food and Drug Admin-
istration.
NEW DRUGS SHIPPED WITHOUT EFFECTIVE APPLICATION
DRUGS FOR HUMAK USB