803. Misbranding of Ju-Van capsules.    TJ. S. v. 292 Boxes of Ju-Van Capsules.
Consent decree of condemnation.    Product ordered destroyed.     (F. D. C.
Nos. 1528, 1691, 1847, 1849, 1910.   Sample Nos. 90103-D, 4003-E, 4119-E, 4437-E,
4442-E.)
Within the period from on or about February 29 to May 5, 1940, the United
States attorneys for the Northern District of Illinois and the Eastern District
of Michigan filed libels against the following quantities of Ju-Van capsules: 85
boxes at Chicago, 111., 142 boxes at Detroit, Mich., 31 boxes at Flint, Mich., and
13 boxes at Lansing, Mich. The libel against the last-named shipment was
amended on May 14,1940, to include an additional 21 boxes of the product. The
libels alleged that the article had been shipped in interstate commerce within
the period from on or about February 8 to April 20, 1940., by the Mid-West Drug
Company, Inc.* from Ft. Wayne, Ind.; and charged that it was misbranded.
Examination, of samples of the article showed that in 4 of the 5 shipments
the capsules contained 1.5 grains of thyroid of United States Pharmacopoeia
potency, and plant material, and that in the fifth shipment they contained thyroid
equivalent to 1.3 grains of thyroid of the same potency, together with plant
material.
The article was alleged to be misbranded in that the statements and designs
appearing on the carton labels, "For Overweight Caused by Myxedematous Hypo-
thyroidism (Advanced stage of thyroid deficiency) * * * DIRECTIONS:
One capsule after each meal and before retiring, or as directed by physician.
In the event distress such as nervousness, insomnia, palpitation, or increased
pulse develop, decrease number of capsules taken until condition disappears.
If these conditions persist, or if any symptoms of excess thyroid activity appear,
or when normal weight is approached, discontinue taking capsules. Advisability
of treatment should be determined by physician. WARNING: Not to be used
by children nor by persons with Heart Defects, Kidney Diseases, Pregnancy,
Diabetes, Goiter, Hyperthyroidism, or any disease or affliction other than over-
weight as mentioned above," together with further and similar statements con-
tained in the circular shipped with the article, were false and misleading in
that they created the impression that the article was a safe and appropriate
remedy for overweight, whereas it was not such a safe and appropriate remedy
for overweight, but was a dangerous drug, and its labeling failed to reveal the
material fact that the use of the article might result in harmful consequences
to the user.
It was alleged to be misbranded further in that it was dangerous to health
when used in the dosage or with the frequency or duration prescribed, recom-
mended, or suggested in the labeling, "One capsule after 'each meal and before
retiring, or as directed by physician."
On April 29, 1940, no claim having been entered at that time, judgment of
condemnation was entered with respect to 69 boxes of the product located at
Chicago, and the product was ordered destroyed. However, on May 1, 1940,
the Mid-West Drug Co., Inc., having entered an appearance, an order was entered
to vacate the default order and the claimant was given further time to answer.
On December 3, 1940, on motion of the claimant, the cases instituted in the
Eastern District of Michigan were ordered transferred to the Northern District
of Illinois for consolidation with the 2 libels filed in the latter District. On June
23,1943, the claimant having consented to the entry of a decree in the consolidated
case, judgment of condemnation was entered and the product was ordered
destroyed.