958. Misbranding; of Ramazzotti.    tJ. S. v. 3 Cases of Ramazzotti.   Consent decree
of condemnation.     Product ordered released under bond for relabeling;*
(P. D. C. No. 8615.    Sample Nos. 17861-F, 18845-F.)
On or about October 22, 1942, the United States attorney for the District of
Connecticut filed a libel against 3 cases, each containing 24 bottles, of Ramaz-
zotti at Stamford, Conn., alleging that the article had been shipped in inter-
state commerce on or about July 24. 1942, by the Banfi Products Corporation
from New York, N. Y.; and charging that it was misbranded.
Examination showed that, the article contained extracts of plant drugs, in-
cluding a laxative drug such as rhubarb, and 38.2 percent of alcohol.
The article was alleged to be misbranded in that the statement "originated
by FLLI. RAMAZZOTTI, MILANO, ITALY" and various other statements in
the Italian language, together with designs including the Papal seal and the
State seal of Italy, appearing in the labeling, were false and misleading since
they created the impression that the article was prepared in Milan, Italy, whereas
it was manufactured in New York, N. Y.
The article was alleged to be misbranded further (1) in that the statements
on the bottle label, "FAMOUS SINCE 1815," and on the bottle wrapper, "Used
throughout the World since 1815," were false and misleading since the article
had not been produced and marketed over the period since 1815; (2) in that
the name of each active ingredient, including the name and quantity or propor-
tion of alcohol contained in the article, required by law to be declared on the
label, was not prominently placed thereon with such conspicuousness (as com-
pared with other words, statements, designs, and devices in the labeling) and
in such terms as to render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use, since the names
of the active ingredients and the quantity or proportion of alcohol did not appear
on the bottle wrapper and did not appear in the Italian language in any of the
labeling; and (3) in that its labeling failed to bear adequate directions for
use since the directions in English, "Dose: ? to 1 oz. taken straight, in black
coffee, or hot lemonade before or after meals, upon retiring or any time during
the day," and the directions in Italian "puro e misto all'acqua, al seltz, alle
acque minerali, al Vermouth e col caffe" (translation: "pure and mixed with
water, seltzer, with mineral waters, with Vermouth and with coffee"), did not
provide for a definite amount of frequency or duration of administration, but
were indefinite and therefore not adequate.
It was alleged to be misbranded further in that-its labeling failed -jto bear
adequate warnings ^against use in those pathological conditions, or by children,
wherein its'use might be dangerous to health, or against unsafe dosage or duration
of administration, in such manner and form as are'necessary for the protection, of
thfe user, since its labeling bore no warning against use by children for. whom,
by reason of its large proportion of alconol, it would be especially unsuitable; its
labeling bore no warning against use in case of abdominal pain, nausea, vomiting,
or other symptoms of # appendicitis, whereas, by reason of its content of a laxa-
tive drug such as rhubarb it would be dangerous when used in such circum-
stances; and it bore no warning against frequent or continued use which might
result in the establishment of dependence upon laxatives to move the bowels.
On January 7, 1943, Banfi Products Corporation, claimant, having admitted
the allegations of the libel, judgment of condemnation was entered and the
product was ordered released under bond for relabeling under the supervision
of and in form satisfactory to the Food and Drug Administration.