3624. Misbranding of Special Prescription tablets and Aciduric tablets.   U. S.
v. 1 Drum, etc.    (F. D. O. No. 31719.   Sample Nos. 11314-L, 11315-L.)
LIBEL FILED :    September 23, 1951, Southern District of Ohio.
ALLEGED SHIPMENT: On or about January 3 and September 11, 1950, by the
Barlow-Maney Laboratories, from Cedar Rapids, Iowa.
PRODUCT : 1 drum containing 4,900 tablets designated "Special Formula tablets"
and 57 bottles of tablets which had been repackaged from this drum by the con-
signee and labeled Special Prescription, tablets; and 1 drum containing 14,900
tablets designated "Special Formula tablets" and 57 boxes of tablets which had
been repackaged from the latter drum by the consignee and labeled Aciduric
tablets. The products were located at Glendale, Ohio, and were accompanied
by a number of labels, circulars entitled "Price List," and leaflets entitled
"Special Notice."
Analysis indicated that the 4,900 tablets in one of the drums possessed es-
sentially the composition stated upon the drum label and that the 14,900 tablets
in the other drum contained approximately 5.4 grains of sodium salicylate per
tablet.
LABEL, IN PART : (4,900-tablet drum) "Special Formula Tablets C. C. T. Each
tablet contains as active ingredients: Po Iodized Lime 1/4 gr. (Represents a
mixture of Iodine and Iodide of Calcium) Sodium acetate 1/4 gr. Sodium
Nitrite 1 gr. Nitroglycerine Q. S. (1/1000 grain added at time of manufac-
ture) * * * From the Laboratories of Arlo Co. * * * Cedar Rapids,
Iowa"; (bottle) "Special Prescription Tablets * * * This package con-
tains '75 tablets Bach tablet contains: Iodized Lime 1/4 gr. Sodium Acetate
1/4 gr. Sodium Nitrite 1 gr. Sodium Bicarbonate 2 gr. Nitroglycerine
1-1000 gr.   F. E. Crataegus 1 min."
(14,900-tablet drum) "Special Formula Tablets Each tablet contains: So-
dium Salicylate, Powdered Cimicfugin, Powdered Phytolaccin and P. E. Bur-
dock Root ?* * * From the Laboratories of Arlo Co. * * * Cedar
Rapids, Iowa"; (box) "Landis Aciduric Tablets * * * Each Aciduric
tablet contains: Sodium Salicylate 5 grains Powdered Cimicfugin 1/2
grain Phytolaccin 1/8 grain P. E. Burdock Root 1 grain This package con-
tains 50 tablets."
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
labeling of the tablets in the drums, bottles, and boxes were false and mislead-
ing. The statements represented and suggested that the tablets in the 4,900-
tablet drum and in the bottles were an adequate and effective treatment for
high blood pressure, and that the tablets in the 14,900-tablet drum and in the
boxes were an adequate and effective treatment for rheumatism, joint pains,
stiffness, and similar ailments and complaints. The articles were not adequate
and effective treatments for such conditions.
Further misbranding, Section 502 (f) (1), the labeling of the tablets in the
4,900-tablet drum and in the bottles failed to bear adequate directions for use.
The tablets were misbranded in this respect when introduced into, while in,
and while held for sale after shipment in, interstate commerce.
Further misbranding, Section 502 fa), certain statements in the labeling of
the tablets in the 14,900-tablet drum were false and misleading. The state-
ments represented and suggested that powdered cimicifugin and phytolaccin
are the common or usual names of drugs and that "P. E. Burdock Root" was an
active ingredient. Powdered cimicifugin and phytolaccin are not th? common
or usual names of any substances, and'"P. B. Burdock Root" was hot an active
ingredient of the tablets. The tablets were misbranded in this respect when
introduced into and while in interstate commerce.
DISPOSITION : October 26, 1951. The R. Landis Co., Glendale, Ohio, claimant,
having consented to the entry of a decree and admitted the allegations of the
libel, judgment of condemnation was entered and the court ordered that the
tablets be released under bond for relabeling under the supervision of the
Federal Security Agency.