757. Misbranding: of Nomo For Piles, Sanafrio, and Asmolac. U. S. v. Albert B.
Hirscbman (Hirschman Laboratories and Sanafrio Laboratories). Plea
of nolo contendere. Fine, $75 on each of 3 counts; sentence suspended
on all bnt first count. (F. D. C. No. 5491. Sample Nos. 26467-E, 26469-E,
32632-E.)
The labeling of the Asmolac failed to bear adequate directions for use, such
adequate warnings as are necessary for the protection of users, and a declara-
tion of the alkaloids of atropine, hyoscine, and hyoscyamine that were present.
The labeling of all three products bore false and misleading curative and thera-
peutic claims.
On November 3, 1941, the United States attorney for the Southern District of
California filed an information against Albert B. Hirschman, trading as Hirsch-
man Laboratories and as Sanafrio Laboratories, San Pedro, Calif., alleging
shipment within the period from on or about May 14 to on or about July 1, 1940,
from the State of California into the States of Arizona and Oregon of quantities
of the above-named drugs which were misbranded.
Analyses of samples showed that the Asmolac consisted essentially of water,
alcohol, plant extractives, alkaloids, reducing sugars, potassium iodide, and
sodium iodide; that the Sanafrio consisted essentially of fat, zinc oxide, cam-
phor, and menthol; and that the Nomo For Piles consisted essentially of benzo-
caine, boric acid, eucalyptus oil, fixed oils, and zinc oxide.
The Asmolac was alleged to be misbranded: (1) In that the directions for
use,contained no limitation as to duration of administration. (2) In that it
contained (a) iodine or iodides and the labeling failed to warn that it should
not be used in case of goiter except upon the advice of a physician and should
be discontinued if skin rash appears; and (b) the alkaloids of belladonna and
hyoscyamus and the labeling failed to warn that frequent or continued use
should be avoided, that it should be used cautiously if dryness of the throat
occurs, that it should be discontinued if rapid pulse or blurring of the vision
occurs, and that it should not be taken by elderly people except upon competent
advice. (3) In that the name "Asmolac" and the statements in the accom-
panying circular, "Where it is not deemed necessary to use Asmolac continuously,
you should watch for the approaching of attacks such as nervousness, headache,
itching of the nose or skin, severe sneezing, yawning, and other suggestive symp-
toms. If this is noticeable take half a teaspoon of Asmolac twice a day. In this
way the actual spasms are usually to the greatest extent and often completely
prevented," were false and misleading since they represented that when used
as directed in the above-named conditions, it often would completely prevent the
actual spasms of asthma; whereas if used as directed, it would not often, nor
at all, completely prevent the actual spasms of asthma. (4) In that it contained,
the alkaloids of atropine, hyoscine, and hyoscyamine, but the labeling did not
contain the name and quantity or proportion of said alkaloids or, in lieu thereof,
the quantity or proportion of total alkaloids of belladonna and hyoscyamus that
it contained.
The Nomo For Piles was alleged to be misbranded: (1) In that the name "Nomo
For Piles" and the statements in the labeling, (carton only) "Astringent,"
(carton, tube, and circular) "To Believe * * * Soreness * * * Asso-
ciated with Piles," and (circular) "For the relief of pain it is highly recom-
mended," were false and misleading since they represented and suggested that
it was a competent treatment for all cases of piles and would be efficacious to
relieve the soreness and pain associated with piles; whereas it would not ac-
complish such results. (2) In that the labeling was misleading since it failed
to reveal the fact, material in the light of the representations which it con-
tained, that the preparation did not constitute a treatment for all kinds of piles
and that competent advice should be secured in cases of excessive bleeding.
in the labeling, (carton) "For * * * Chest Colds * * * Eelieves Head-
ache, Neuralgia, Inflammation in Head Colds, and similar conditions. * * *
Directions Apply externally to the chest. Acts much like a plaster and helps to
relieve local congestion," and (jar) "Relieves Headache, Neuralgia, Congestion,
and Inflammation in * * * Chest Colds and similar conditions * * *
Chest Colds, Cough, Sore Throat," were false and misleading since it would not be
efficacious as a treatment or relief for such conditions.
On May 19, 1842, the defendant having entered a plea of nolo contendere,
the court imposed a fine of $75 on each of the 3 counts and suspended the sen-
tence on counts 2 and 3 on condition that the defendant comply with instructions
of the Government