3190. Action to enjoin and restrain the interstate shipment of Acidofilac.   U. S.
v. Helen A. Walters (Radiance Products Co.).   Consent decree granting
injunction.    (Inj. No. 220.)
COMPLAINT FILED:   Between December 1, 1949, and January 26, 1950, Southern
District of California, against Helen A. Walters, an individual, and as ad-
ministratrix of the estate of William It. Walters, doing business under the
name, Radiance Products Co., Los Angeles, California.
NATURE OF CHARGE : The defendant had been and was at the time of filing
the complaint introducing and delivering for introduction into interstate com-
merce at Los Angeles, Calif., consignments of a drug designated as "Acidofilac,"
which was a culture of lactic acid-forming organisms and which was adul-
terated and misbranded in the following respects:
Adulteration, Section 501 (c), the strength of the article differed from that
which it was represented to possess since it was represented to possess a count
of seven billion eight-hundred million viable acidophilus bacteria in each fluid
ounce, whereas the article contained substantially less viable acidophilus bac-
teria in each fluid ounce.
Misbranding, Section 502 (a), the statements in the accompanying leaflet
entitled "Acidofilac A vitalized pure aciduric bacterial milk food" repre-
sented and suggested that the use of the article would result in the prolonga-
tion of life; in outwitting middle age; and in keeping the system free from
putrefactive bacteria and toxic poisons, resulting in the prolongation of the
vigorous period of life; and that the article was useful in the treatment of
certain stomach disorders, which statements were false and misleading since
the article was not capable of fulfilling such promises of benefit.   In addition,
* See also No. 3200.
the statement "A recent test made by the Truesdail Laboratories, Inc., of
August 31, 1943, shows a count of seven billion eight hundred million viable
acidophilus bacteria in each fluid ounce of bottle tested," contained in the
accompanying leaflet, was misleading since the article contained only a small
proportion of the number of viable acidophilus bacteria represented, by
such statement; and, the statement "Acidofilac A vitalized aciduric bacterial
food A composite culture of selected strains of Lactobacilli-Acidophilus and
Bulgaricus in skim milk. It is best to use before Oct. 11, 1949," appearing
on the label of the article, was misleading since the statement represented
and suggested that in the recommended dose stated on the label the article
would supply prior to the date stated a therapeutically significant number
of viable Lactobacilli acidophilus and bulgaricus, whereas it would not
do so.
The complaint alleged further that unless restrained, the defendant would
continue to introduce and deliver for introduction into interstate commerce
the adulterated and misbranded article.
PRAYER OP COMPLAINT: That the defendant be perpetually enjoined from com-
mission of the acts complained of.
DISPOSITION: August 1, 1950. The defendant having consented to the entry
of a decree, the court issued an order permanently enjoining the defendant
from shipping in interstate commerce any Acidofilac or any like drug which
was adulterated and misbranded as alleged in the complaint.