6715. Rubber prophylactics.    (Inj. No. 407.)
COMPLAINT FOR INJUNCTION FILED : 7-3-61, W. Dist. Mo., against M & M Rubber 
Co., Inc., and Neil F. Murry, Jr., Kansas City, Mo.
CHARGE : The complaint alleged that the defendants were engaged in the business 
of receiving bulk shipments of rubber prophylactics, made in Puerto Rico and 
Japan, and thereafter testing, packaging, labeling, selling and distributing the 
articles in interstate commerce; and that when introduced into interstate 
commerce, by the defendants, the articles were adulterated under 501(c) in 
that their quality fell below that which they purported and were represented to 
possess in that they contained holes, and were misbranded under 502(a) in 
that the labeling contained false and misleading representations that the 
articles were effective in the prevention of disease.
It was alleged further that the adulterated and misbranded condition of the 
articles resulted from, among other things, the defendants' failure to test 
all lots of the articles for the presence of holes; the use of insufficient electric 
current and insufficient electrolyte solution in the operation of the electronic 
testing machine used for the detection of holes in the articles; dumping cap- 
type rubber prophylactics, after testing, into a squirrel cage-type tumbler 
with hardwood sawdust for drying purposes; the dumping of the cap-type 
prophylactics and sawdust, after drying, into another tumbler made of hard- 
ware cloth and the operation of such tumbler until the sawdust had been 
removed; the rolling of regular length prophylactics while partly wet, and the 
presence of untested prophylactics in the room used for the packaging of the 
tested prophylactics.
The complaint alleged also that the defendants had been warned of the 
conditions by several inspections and  by numerous seizures of defective 
prophylactics. 
DISPOSITION :   On 7-3-61, the court entered a temporary restraining order, with- 
out notice, restraining the defendants from the acts complained of.
On &-15-61, the defendants having consented, the court entered a temporary 
injunction enjoining the defendants from introducing or causing to be intro- 
duced and delivering or causing to be delivered for introduction into interstate 
commerce any prophylactics which are (a) adulterated in that they contain 
holes, and (b) misbranded in that their labeling contains false and misleading 
representations that the articles are effective in the prevention of disease.
The defendants were enjoined further from introducing or causing to be 
introduced and delivering or causing to be delivered for introduction into 
interstate commerce, prophylactics, unless or until:
(a) Procedures are established which will assure that each prophylactic 
received by the defendants is adequately tested to determine the presence of 
holes therein.
(b) Written instructions for the proper operation of the electronic machine 
used in testing the prophylactics for the presence of holes are posted on, or 
adjacent to, such machine.
(c) Tests for the presence of holes in the prophylactics are conducted by 
competent trained employees under the supervision of a designated supervisory 
employee.
(d) The electronic testing machine is operated with sufficient electric cur- 
rent and sufficient electrolyte solution, and in an otherwise proper manner so 
as to assure the detection of holes in the prophylactics. T
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(e) The tested prophylactics are dried in a manner which will remove all 
moisture and will not cause holes in the prophylactics.
(f) Any untested prophylactics now being held in the packing room of de- 
fendants' plant are removed to a different room for storage until tested.
(g) Procedures are established which will assure that no untested pro- 
phylactics are placed in the packing room prior to being tested for the presence 
of holes; and,
(h) All prophylactics which have been the subject of prior detention under 
the provisions of Chapter 801 of the Act [21 U.S.C. 381], and which purport 
to have been subsequently tested and packaged under the supervision of rep- 
representatives of the Food and Drug Administration and released from import 
detention by the Food and Drug Administration, have been resampled by the 
Food and Drug Administration for the purpose of determining that the said 
released lots are free from holes and can be accurately identified with specific 
lots previously tested by the Food and Drug Administration under the provi- 
sions of 21 U.S.C. 381; and any such lots so resampled and retested shall not 
be introduced or delivered for introduction, or caused to be introduced or de- 
livered for introduction into interstate commerce, if upon the above described 
retesting they fail to comply with the Act, unless and until such defective lots 
shall have been processed in the manner set forth in paragraph (i) hereinafter; 
and all costs of resampling and testing as hereinbefore set forth, shall be borne 
by the defendants.
(i) All prophylactics which purport to have been tested for the presence of 
holes, except such detained lots as are hereinbefore described in paragraph 
(h), and which are now held in defendants' plant in packaged or unpackaged 
form are retested for the presence of holes, and the retested prophylactics 
which contain no holes are dried in a manner which will remove all moisture 
and will not cause holes in the prophylactics, and the retested prophylactics 
which contain holes are destroyed, with such retesting, drying, and destruction 
being done under the supervision of an authorized representative of the Food 
and Drug Administration, Department of Health, Education, and Welfare, and 
all costs of said supervision being borne by the defendants; and,
(j) All stocks which are to be tested and/or retested as hereinbefore set 
forth in paragraphs (h) and (i) shall be retained intact in the defendants' 
plant until a release in writing has been furnished covering said lots by the 
Food and Drug Administration; such releases to be furnished promptly upon 
completion of such examinations as may be required.
The decree of temporary injunction provided also that it may be dismissed 
upon motion of the defendants, jointly and seasonably made, upon a satis- 
factory showing that the stocks of imported prophylactics now held in the 
firm's plant, or elsewhere under its control, have been satisfactorily brought 
into compliance with the Federal Food, Drug, and Cosmetic Act and the terms 
of this Order and a release in writing furnished by the Kansas City District 
of the Food and Drug Administration as hereinbefore set forth, and upon 
further showing that the firm has conducted its operations in compliance with 
the Act and the terms of this Order for a period of seven months following 
the release in writing of all stocks of imported prophylactics now held in 
defendants' plant or elsewhere under the control of the defendants.
DRUG FOR VETERINARY BSE