766. Adulteration  and misbranding  of Adiron  tablets;   misbranding  of Flora-
mucin. V. S. v. Lawrence M. Williams (Lawrence Laboratories). Plea of
guilty. Fine, $250 and costs. (F. D. C. No. 5531. Sample Nos. 60557-E to
60560-E, incl.) 
The Adiron tablets were deficient in vitamins A and D, and the labeling of
Floramucin bore false and misleading statements.
On February 27, 1942, the United States attorney for the Northern District of
Illinois filed an information against Lawrence M. "Williams, trading as Lawrence
Laboratories at Chicago, 111., alleging shipment in interstate commerce within the
* See also Nos. 755, 756, 759, 762.
533413-43 3
period from on or about January 27 to on or about March 7, 1941, from the State
of Illinois into the State of 'Washington of quantities of Floramucin which was
misbranded, and of a quantity of Adiron which was adulterated and misbranded.
The Adiron was alleged to be adulterated in that its. strength differed from
and its quality fell below that which it purported and was represented to possess
since it was represented to* contain in each tablet, 1,200 U. S. P. XI units of
vitamin A and 180 U. S. P. XI units of vitamin D, but did contain not more than
300 U. S. P. XI units of vitamin A and not more than 100 U. S. P. XI units of
vitamin D. It was alleged to be misbranded in that the statement on the label,
"Adiron * * * Tablets, each contain * * * 1200 U. S. P. XI Units Vita-
min 'A' 180 U. S. P. XI Units Vitamin 'D', " was false and misleading.
The information alleged that the Adiron was also adulterated and misbranded
under the provisions of the law applicable to foods, as reported in F. N. J. No. 3338.
Analysis of a sample of Floramucin showed that it consisted essentially of
the mucilaginous portion of psyllium seed, karaya gum, sugar, and dextrin.
Floramucin was alleged to be misbranded: (1) In that the statement (display
card) "Detoxification aids in getting rid of the poisons," and those in an accom-
panying circular which represented and suggested that it would detoxify and
aid in getting rid of poisons; that it would be efficacious in the treatment of
biliousness, sore stomach, indigestion, intestinal stasis, excess gas, colitis, torpid
liver, and stomach and intestinal troubles; that it would combat constipation and
colitis without laxatives, implying that it was not a laxative; that it would keep
the digestive tract vigorous and healthy and would restore it to vigor and health
if it were impaired; that it would be efficacious to insure quick and effective relief
from faulty elimination; would soothe and ease sore, inflamed, and irritated
conditions of the intestinal lining and assist natural healing processes; would
infiltrate into every wrinkle and fold of each pocket of the intestines and make
movement of the entire mass of the feces more easy and aid by its bulk in setting
up normal peristalsis; would detoxify by better elimination of stagnant and putre-
factive matter and would induce complete evacuation without irritating laxa-
tives ; would aid in combating auto-intoxication and resulting self-poisoning and
would help break the laxative habit; would enable the consumer to reduce the
quantity of laxatives and cathartics used and finally eliminate the necessity for
using it, were false and misleading since it would not be efficacious for such pur-
poses. (2) In that the statements, "with dextrine for its well-known flora-
changing properties in encouraging the growth of B. Acidophilus and similar
friendly organisms in the colon," "Dosage varies from 2 to 5 teaspoonfuls daily,"
"An adjuvant Food-Not a Drug," "Without Laxatives," "A Mucin-Not a Gum
The earlier attempts to aid nature in this direction were mere gums like
Karaya, * * ' * Bulk-but nothing else," were false and misleading since they
represented that in the dosage recommended, it would be efficacious in chang-
ing the flora in the intestines and encouraging the growth of B. acidophilus and
similar friendly organisms; that it was not a drug nor a laxative; and that it
did not contain a gum and was more than a bulk-producing laxative, but it would
not be efficacious in changing the flora in the intestines or encouraging the growth
of B. acidophilus, it did contain the mucilaginous part of psyllium seed and
karaya ?um, which are laxative drugs, and it was a bulk-producing laxative.
(3) In that the statement of the active ingredients, "Hexose Mucinoid fraction
of Plantago Ovata (Bast Indian psyllium) Dextrine, Karaya Gum and Raw Su-
gar," required by the law to appear on the label, was not prominently placed
thereon in such terms as to render it likely to be understood by the ordinary
individual under customary conditions of purchase and use, since the expression
"Hexose Mucinoid fraction of Plantago Ovata (East Indian psyllium)" was
not the common name of one of the ingredients, i. e., the mucilaginous part of
psyllium seed; dextrin and raw sugar were not active ingredients as implied in
said statement, and the statement of ingredients did not distinguish between its
active and nonactive constituents.
On March 3, 1942, a plea of guilty was entered to all charges and the court
imposed a fine of $250, which covered all counts of the information.