4127. Misbranding of Bi-Lets tablets.  U. S. v. 1 Bottle, etc.   (F. D. C. No. 34877.
Sample No. 57113-L.)
LIBEL FILED :    March 6,1953, Southern District of Ohio.
ALLEGED SHIPMENT :    On or about October 15, 1952, from Buffalo, N. T.
PRODUCT: 1 bottle of Bi-Lets tablets, 3 cellophane envelopes containing 4 tab-
lets, 500 empty boxes labeled, in part, "Bi-Lets," and 400 circulars entitled
"Read This For Your Health's Sake!" at Cincinnati, Ohio, in the possession
of Medical Laboratories.
RESULTS OF INVESTIGATION : The bottle containing the Bi-Lets tablets was
shipped in interstate commerce as described above, and after receipt by
Medical Laboratories, a portion of the tablets in the bottle was repackaged
into small cellophane envelopes of 4 tablets each. The envelopes then were
attached to the above-mentioned circular and distributed by the consignee as
free samples. Upon request from customers desiring to purchase tablets, the
consignee would repackage the remaining tablets into the empty boxes.
LABEL, IN PAET: (Box) "Bi-Lets For Your Health Distributed By Medical
Laboratories Room 402-104 W. 4th Street Cincinnati 2, Ohio Contents
25 Tablets Directions: Take one (1) or one-half (?) Bi-Let at bedtime. In
obstinate cases, take one (1) at bedtime and one (1) before breakfast. Cau-
tion : In any condition where there has been abdominal pain and vomiting you
should see a physician. Formula: Extract cascara sagrada 2 gr., Phenolphtha-
lein 1 gr., Aloin ? gr., Extract Nux Vomica ? gr. (Strychnine 0.009 gr.)
Oxgall 1 gr."
NATURE OF CHARGE: Misbranding, Section 502 (a), the statement "For Your
Health" appearing on the box label and certain statements in the above-men-
tioned circular accompanying the article were false and misleading. The
statements represented and suggested that the article would be necessary
"For Your Health"; that disorders of the liver, gallbladder, and intestinal
tract cause constipation and other ailments; and that the article was an ade-
quate and effective treatment for such conditions and for overindulgence. The
article would not be necessary "For Your Health," and it was not an adequate
and effective treatment for the conditions stated and implied, including over-
indulgence.
Further misbranding, Section 502 (f) (1) and (2), the labeling of the
article, namely, the box labeling, failed to bear adequate directions for use;
and the box labeling and the above-mentioned circular failed to bear such ade-
quate warnings against use in those pathological conditions or by children
where its use may be dangerous to health, or against unsafe dosage or duration
of administration, in such manner and form, as are necessary for the protection
of users. The box label did not bear indications for use of the article; and the
box label and the circular did not bear adequate warnings against use of the
article when symptoms of appendicitis were present, where a skin rash would
appear, and against frequent or continued use to prevent formation of the
laxative habit. The article was misbranded in the above respects while held
for sale after shipment in interstate commerce.
DISPOSITION :   April 20,1953.   Default decree of condemnation and destruction.