1009. Misbranding of McMillan's Nomoppin and Demytin, and adulteration and
misbranding: of effervescent solution of citrate of magnesia. IT. S. v.
'William Cicero McMillan   (McMillan Drug- Co.).    Plea of guilty.    Fine,
$1.     (F.  D.   C.   Nos.   5486,   10584.     Sample Nos.  254-E,  20499-E,  20925-E,
35609-F.)
The products "Nomoppin" and "Demytin" were misbranded because of false
and misleading curative and therapeutic claims in the labeling, and the effer-
vescent solution of citrate of magnesia was adulterated and misbranded because
of failure to conform with the Pharmacopoeia requirements, and because the
labeling failed to bear such adequate warnings as are necessary for the protection
of users.
On September 9 and November 3, 1943, the United States attorney for the
Eastern District of South Carolina filed two informations against William Cicero
McMillan, trading as the McMillan Drug Co. at Columbia, S. C, alleging shipment
within the period from on or about September 10 and 24,1940, March 3, 1941, and
August 24, 1943, from the State of South Carolina into the State of Georgia of
quantities of McMillan's Nomoppin and McMillan's Demytin which were mis-
branded, and of a quantity of effervescent solution of citrate of magnesia which
was adulterated and misbranded.
Analysis of a sample of the "Nomoppin" showed that it consisted essentially
of potassium arsenite containing 2.01 grams of arsenic trioxide per 100 cc., and
water. Analysis of samples of "Demytin" showed that it consisted essentially of
calcium thiosulfate, calcium polysulfide, and water.
The Nomoppin was alleged to be misbranded in that representations on the
bottle label and in the accompanying circular to the effect that it would be
efficacious as a remedy, cure, or preventative for chicken sorehead (chicken pox) ;
that it would be efficacious to aid egg production, hasten molting, and brighten
plumage; that it would prevent loss of flesh and vigor from sorehead; that it was
an internal remedy which would be efficacious in the treatment of sorehead with-
out the necessity of catching, greasing, and other local treatment; that it would
protect little and big chicks from mites; and that it would increase egg production
and improve the health of the flock so that more and stronger chicks would be
raised were false and misleading since the article would not be efficacious to ac-
comlish such purposes. It was alleged to be misbranded further in that it was
in package form and did not bear a label containing an accurate statement of the
quantity of the contents, since the label of the container bore no statement of
the quantity of the contents; and in that its label did not bear the common or
usual name of the article, potassium arsenite.   *
The Demytin was alleged to be misbranded in that representations on the bottle
label and in the accompanying circular to the effect that it would increase egg
yield by freeing hens from mites; that it would be efficacious in preventing
diarrhea; that it would promote prompter molting, and induce an earlier return
to laying conditions; that it would tend to brighten plumage; that it would protect
little and big chicks from mites; that it would increase egg production and im-
prove the health of the flock so that more and stronger chicks were raised; and
that it would supply a ration ingredient which is often absent and which is re-
quired to produce the egg, build bone, strength, and vigor, were false and mis-
leading since the article would not be efficacious for such purposes.
-The solution of citrate of magnesia was alleged to be adulterated in that it
purported to be and was represented as a drug the name of which is recognized
in the United States Pharmacopoeia, an official compendium, and its strength
differed from and its quality fell below the standard set forth in that compendium
since the article contained, in each 100 cc, an amount of magnesium citrate cor-
responding to not more than 0.653 gram of magnesium oxide, and 10 cc. of the
solution contained citric acid equivalent to not more than 13.1 cc. of half-normal
hydrochloric acid, whereas the Pharmacopoeia provides that solution of mag-
nesium citrate shall contain, in each 100 cc, an amount of magnesium citrate
corresponding to not less than 1.6 gram of magnesium oxide, and that 10 cc. of
the solution shall contain citric acid equivalent to not less than 26 cc. of half-
normal hydrochloric acid.
The solution of citrate of magnesia was alleged to be misbranded in that
its labeling did not bear adequate warnings against use in those pathological
conditions wherein its use might be dangerous to health, since it was a cathartic
or laxative drug and should not be used when abdominal pain, nausea, vomiting,
or other symptoms of appendicitis are present, and a statement that frequent and
continued use might result in dependence upon laxatives. It was alleged to be
misbranded further in that it was in package form and did not bear a label con-
taining an accurate statement of the quantity of the contents.
On November 3, 1943, the defendant having entered a plea of guilty, the court
imposed a fine of $1, which was applicable to the 2 informations, with the under-
standing that the defendant immediately discontinue interstate business and dis-
continue business entirely on or before January 1,1944.