1153. Adulteration   and   misbranding   of   Akerite   Glycerin   Alternate   B-100
(glycerin substitute or alternate). U. S. v. Akerite Chemical Works,
Inc. Plea of guilty. Fine, $3,004 and costs. (F. D. C. No. 9679. Sample
Nos. 6594-F, 2333-F, 23346-F.)
On October 25, 1943, the United States attorney for the Northern District of
Illinois filed an information against the Akerite Chemical Works, Inc., Chicago,
111., alleging shipment of quantities of the above-named product from the State
of Illinois into the States of Missouri and Pennsylvania on or about September
9,1942, and January 20 and February 4,1943.
It was also alleged in the information that prior to the dates of the 1943
shipment the defendant represented the article as a nontoxic substitute for
glycerin by causing to be prepared and distributed a circular entitled "Akerite
Glycerin Substitute," which contained the following statements: "Akerite
Glycerin Substitute is an aqueous solution derived from dextrin, starch and
corn sugar by a special process. It is non-toxic"; and that prior to the date
of the 1942 shipment the defendant represented the article as a nontoxic
alternate for glycerin by means of a written communication, addressed by the
defendant to the consignee, which contained the following statement: "Glycerin
Alternate * * * Akerite Glycerin Alternative, an aqueous nontoxic liquid
derived mainly from corn."
The article was alleged to be adulterated in that it was represented as a
nontoxic substitute or nontoxic alternate for glycerin, which is a nonpoisonous
substance, whereas the article consisted in large part of diethylene glycol, a
poisonous chemical compound. It was alleged to be further adulterated in that
a toxic substance, i. e., a substance containing diethylene glycol, had been
substituted in whole or in part for the article.
A portion of the article (two shipments) was alleged to be misbranded because
of false and misleading statements on the labels which represented and sug-
gested that it was a substitute for glycerin, a nonpoisonous substance.
It was also alleged in the information with respect to the two shipments that
the article was a new drug since it was not generally recognized, among experts
qualified by scientific training and experience to evaluate the safety of drugs,
as safe for use under the conditions suggested in its labeling, i. e., "Glycerin
Substitute," and application filed pursuant to the law was not effective with
respect to the article.
On December 30, 1943, the defendant having entered a plea of guilty, the court
imposed a fine of $1,000 on each of the 3 counts charging adulteration, and a
fine of $1 on each of the other counts, a total fine of $3,004 plus costs.
DRUGS ACTIONABLE  BECAUSE  OF FAILURE TO BEAR ADEQUATE
DIRECTIONS OR WARNING STATEMENTS