879. Adulteration and misbranding of Vi-Penta drops. IT. S. v. Hoffman-La Roche,
Inc. Plea of nolo contendere. Fine, $250 on count 1. Imposition of
sentence suspended on remaining IS counts. (F. D. C. No. 7656. Sample
Nos. 56804-E, 69145-E, 74168-E, 89116-E.)
On September 4, 1942, the United States attorney for the District of New
Jersey filed an information against Hoffman-^La Roche, Inc., Nutley, N. J.,
alleging shipment of Vi-Penta drops within the period from on or about March
18, 1941, to January 15, 1942, from the State of New Jersey into the State of
New York. The article was labeled in part: "Each 0.6 cc. (approximately 10
minims) equals 1 Vi-Penta Perle and contains Vitamins: A . . . 9,000 (or
"4,000") U. S. P. Units."
Examination of samples taken from each of the 3 shipments labeled as con-
taining 9,000 U. S. P. Units of Vitamin A per 0.6 cc. showed the presence of not
more than 2,700, 4,500 and 4,500 U. S. P. Units of Vitamin A, respectively, per
0.6 cc. The shipment labeled as containing 4,000 U. S. P. Units of Vitamin A
per 0.6 cc. contained not more than 2,000 Units of Vitamin A per 0.6 cc.
Portions of the article were alleged to be misbranded in that the statements
in the labeling which represented and suggested that it was efficacious to bring
about normal growth and development of infants and children; that it was
efficacious in the cure, mitigation, treatment, or prevention of malnutrition,
lowered resistance, and rundown states, and for use during prolonged illnesses
such as infections, anemias, tuberculosis, and typhoid; that it was efficacious
in the treatment of gastro-intestinal conditions such as diarrhea and colitis, and
for use when restrictions in diet become necessary, as in obesity, diabetes, and
catarrhal jaundice, and whenever the total food intake must be increased as in
hyperthyroid conditions; that it was efficacious in the cure, mitigation, treat-
ment, or prevention of skin diseases such as eczema, for certain allergic condi-
tions such as those due to milk, eggs, and wheat, and for temporary or persistent
vomiting, especially during infancy, childhood, and pregnancy; and that it was
efficacious as a prophylaxis or treatment of abnormal dentition, or gum and
tooth conditions were false and misleading since the article was not efficacious
for the conditions indicated.
All shipments of the article were alleged to be adulterated and misbranded
in that its strength differed from and its quality fell below that which it pur-
ported and was represented to possess, and the labeling was false and mislead-
ing since it was represented to contain 9,000 (or 4,000) U. S. P. units of vitamin
A per 0.6 cc, whereas it contained in each 0.6 cc. less than the declared amount
of vitamin A.
The article was also alleged to be adulterated and misbranded under the pro-
visions of the law applicable to foods, as reported in notices of judgment on foods.
On November 6, 1942, a plea of nolo contendere having been entered, a fine of
$250 was imposed on the first count of the information and imposition of sentence
was suspended on the remaining 15 counts.