4668. Voluptae device.   (In. No. 288.)
COMPLAINT FOR INJUNCTION FILED : 3-11-55, S. Dist. Calif., against Hollywood 
Models, Inc., doing business under the fictitious name of Voluptae at Los 
Angeles, Calif., and against Lois Schwartz, also known as Anne Harris, 
president of the corporation.
CHARGE: The complaint alleged that the defendants were the interstate pro- 
moters and distributors of the device designated by the name of Voluptae,
which consisted of a large transparent plastic cup with a rubber gasket 
around the edge and a plastic vacuum pump attached to the cup. In use, 
the plastic cup was pressed against the chest so that it would enclose one 
of the breasts and the rubber gasket would form an airtight seal-against the 
chest, after which the plastic pump was manipulated in a manner that 
created a partial vacuum inside the plastic cup. 
The complaint further alleged—
(a) That the defendants were engaged in the interstate sale of the device 
through two principal techniques, i. e., (1) by a direct mail-order promo- 
tion initiated from their principal place of business at Los Angeles, Calif., 
and (2) by similar promotions initiated by distributors of the device at 
such cities as Chicago, Ill., Boston, Mass., and Cleveland, Ohio;
(b) That in conducting their direct mail-order promotion of the device 
from Los Angeles, Calif., the defendants (1) caused newspaper advertise- 
ments relating to the device to be printed in cities throughout the United 
States, (2) utilized extensive mailing lists which included the names and 
addresses of thousands of women residing in various parts of the United 
States who would likely be interested in the purchase of drugs and devices 
represented as effective for breast enlargement, and (3) caused to be mailed 
to women on such mailing lists certain circulars relating to the device, 
which circulars were designated as "Voluptae If You're Flat Chested" and 
"At Last! A Safe . . . New . . . Easy Way That Has Enabled Other 
Women to Develop a Full Firm Bust!" ;
(c) That when the defendants received orders for the device in response 
to the mail-order promotion, they caused the device to be shipped interstate 
from Los Angeles, Calif., to persons residing in various States throughout 
the country, and with each such shipment, the defendants enclosed a tie-on 
tag designated "Voluptae";
(d) That in conducting their sales promotion through distributors, the 
defendants would furnish the distributors with written, printed, and graphic 
matter consisting of copies of the above-mentioned advertising, circulars, 
and tie-on tag, photographs of certain "before and after" pictures of women, 
as well as copies of testimonial letters, physicians' statements, physicians' 
prescriptions, and physical therapists' letters; and that from such materials, 
the distributors would compile a Voluptae Sales Brochure ;
(e) That the defendants caused bulk interstate shipments of the device 
to be made from time to time from Los Angeles, Calif., to such distributors; 
and
(f) That when the defendants caused the device to be introduced into 
interstate commerce, the labeling of the device included the above-mentioned 
circulars and tie-on tags and in some instances the materials used for the 
compilation of the Voluptae Sales Brochure.
The complaint alleged further that the defendants were violating Section 
301 (a) of the Act by causing the introduction and delivery for introduction 
into interstate commerce of the device which was misbranded; that they were 
also violating Section 301 (k) of the Act by causing the association of the 
device with labeling consisting of the above-mentioned circulars, tie-on tags, 
and sales brochure, while the device was held for sale by the distributors after 
shipment in interstate commerce, which resulted in the device being mis- 
branded. The device was alleged to be misbranded as follows:
502  (a)—the labeling of the device was false and misleading since it. 
represented and suggested-
(a) That the device was effective for increasing the size of the breasts, 
for providing shape, growth, and expansion for underdeveloped breasts so 
that they would become full, round, and firm, and for improving the tone of 
the breast tissue, whereas the device was not effective for such purposes;
(b) That the device could be used safely without the supervision of a 
physician, whereas it could not be used safely without the supervision of a 
physician;
(c) That the directions for the use of the device would assure its safe 
use without medical supervision, whereas the labeling failed to reveal the 
material fact that the contraindications suggested in the labeling, including 
symptoms which were signs of early cancer, could only be detected by a 
competent physician and that the device should therefore never be used 
except upon the prescription of a physician;
(d) That physicians and surgeons commonly prescribed the use of the 
device in the regular course of their practice, whereas physicians and 
surgeons do not commonly prescribe the use of the device in the regular 
course of their practice; and
(e) That a number of physicians and surgeons whose letters were quoted 
in the labeling had approved the device as safe for use by women without 
the supervision of a physician, whereas such physicians and surgeons had 
not approved the device as safe for use by women without the supervision 
of a physician; and
502 (f) (1)—the labeling of the device failed to bear adequate directions 
for use, and the device was not eligible for an exemption from the require- 
ment that its labeling bear adequate directions for use.
DISPOSITION: On 3-11-55, the court issued a temporary restraining order en- 
joining the defendants against the commission of the acts complained of. On 
4-1-55, the defendants having given notice that they would not contest the 
case, the court entered a default decree of permanent injunction enjoining 
the defendants (1) from introducing into interstate commerce the Toluptae 
-device, any similar device, or any device or drug offered for similar purposes, 
which would be misbranded as alleged in the complaint, and (2) from causing 
the association of labeling with any such device or drug while held for sale by a 
distributor after shipment in interstate commerce which would result in such 
device or drug being misbranded as alleged in the complaint.
DRUGS FOR VETERINARY USE