872. Misbranding1 of thiamin chloride tablets, A and D vitamin concentrate tab-
lets, and Valtiva. U. S. v. Harlow B. Boyle and Charles E. Boyle (Boyle
& Co.). Pleas of nolo contendere. Each defendant fined $100 on 1 count.
Imposition of sentence suspended on remaining counts for 1 year, to be-
come permanent at the end of 1 year in event of no further violation.
(F. D. C. No. 5545.    Sample Nos. 32972-E, 32973-E, 53348-E.)
These thiamin chloride tablets and the A and D vitamin concentrate tablets
fell below their declared potency; and the thiamin chloride tablets and another
product, Valtiva, bore misleading curative and therapeutic claims.
On August 10, 1942, the United States attorney for the Southern District of
California filed an information against Harlow B. Boyle and Charles B. Boyle,
copartners trading as Boyle & Co., Los Angeles, Calif., alleging shipments on or
about November 15 and December 9, 1940, and May 12, 1941, from the State of
California into the State of Arizona of quantities of the above-named products
which were misbranded.
The thiamin chloride tablets were alleged to be misbranded (1) in that the
statement, "Thiamin Chloride 1.0 Mgm. Vitamin Bi 333 International Units
per tablet," borne on the bottle label was false and misleading since each tablet
contained less than 1 milligram, namely, .06 milligram of thiamin chloride, the
equivalent of not more than 200 International Units of vitamin Bi; and (2) in
that the statement "Lack of Vitamin Bi may result in retarded growth, mal-
nutrition, loss of appetite, constipation, and certain other abnormal conditions,"
borne on the label was misleading since it represented and suggested and created
in the minds of the readers the impression that retarded growth, malnutrition,
loss of appetite, constipation, and the other abnormal conditions suggested by
the statement are commonly caused by lack of vitamin Bi, and that readers
might reasonably expect to obtain benefit from the use of the article in the
treatment of such conditions; whereas such renditions are rarely caused by lack
of vitamin Bi, and readers might not reasonably expect to obtain benefit from
the use of the article in their treatment since it would not ordinarily be efficacious
for such purposes.
The A and D vitamin concentrate tablets were alleged to be misbranded (1)
in that the statement, "Each Tablet Contains: Vitamin A-6250 U. S. P. Units,
Vitamin D-625 U. S. P. Units," borne on the bottle label and carton was false
and misleading since each tablet contained not more than 140 U. S. P. units of
vitamin A and not more than 300 U. S. P. units of vitamin D; (2) in that the
statement, "Each Boyle A and D tablet supplies 1? times the minimum daily
adult requirement and twice the minimum daily requirement for children, of
adults and children," borne on the carton was false and misleading since each
tablet would supply less than one-tenth the amount of vitamin A required daily
by an infant, and less than one-twenty-fifth the amount of vitamin A required
daily by a person 12 or more years of age, and would supply less than three-
fourths the amount of vitamin D required daily by any person irrespective of
age; and (3) in that the statement "Each tablet is equal in vitamin potency
and therapeutic effect to about 2 teaspoonfuls of U. S. P. cod liver oil," borne
on the carton was false and misleading since the statement represented that
each tablet contained the vitamin potency equivalent in therapeutic effectiveness
to about 2 teaspoonfuls of cod liver oil, which would be approximately 6,200
U. S. P. units of vitamin A and not less than 620 U. S. P. units of vitamin D,
whereas each tablet contained not more than 140 U. S. P. units of vitamin A,
and not more than 300 U. S. P. Units of vitamin D.
The Valtiva was alleged to be misbranded in that the statements "Latest
scientific research tells us that at times lack of sufficient dietary intake of vitamins
results in run down conditions in the system, such as certain nervous disorders,
skin troubles, loss of appetite, loss of weight, indigestion, constipation, sus-
ceptibility to colds or infection and general weakness. * * * Valtiva is
* * * rich in essential health-building vitamins," appearing in the labeling
were misleading in that they represented and suggested and created the im-
pression in the minds of the readers that nervous disorders, skin troubles, loss of
appetite, loss of weight, indigestion, constipation, susceptibility to colds or
infection, general weakness, and ill health, are commonly caused by the lack of
the vitamins A, Bi, G, and D contained in such article, and that readers might
reasonably expect to obtain benefit from the use of the article in the treatment
of such conditions, whereas these conditions are rarely caused by lack of
vitamins A, Bi, G and D, and readers might not reasonably expect to obtain
benefit from the use of the article in the treatment of such conditions since it
would not ordinarily be efficacious for such purposes.
On December 19, 1942, pleas of nolo contendere having been entered by the
defendants, the court imposed a fine of $100 on the count charging misbranding
of the thiamin chloride tablets, and suspended imposition of sentence on the
counts charging misbranding of the remaining products, such suspension to be
permanent after 1 year in the event of no further violations of the law by the
defendants.