717. Adulteration and misbranding of Endocrine Extract Formula Tios. 2, 131,
and 157; misbranding of Colloidal Dextro Calcium Bleytbing. U. S. v.
The Bleything Laboratories.    Plea of guilty.     Fine, $520.     (F. D. C. No.
4150.    Sample Nos. 44102-E, 44425-E, 65833-E to 65835-E, incl.)
This case involved three shipments of endocrine extracts that were deficient
in potency, and one of colloidal dextro calcium that contained a smaller amount
of calcium than that indicated and implied in the labeling.
On April 28, 1942, the United States attorney for the Southern District of
California filed an information against the Bleything Laboratories, a corporation
at Los Angeles, Calif., alleging shipment within the period from on or about
October 17, 1940, to on or about July 2, 1941, from the State of California into
the State of Colorado of quantities of endocrine extracts that were adulterated
and misbranded, and of colloidal dextro calcium that was misbranded.
Endocrine Extract Formula No. 2 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 33 cc,
3 milligrams of the crystalline principle of thyroid and 20 milligrams of the
crystalline principle of entire ovary; whereas it contained no detectable amount
of the crystalline principle of thyroid or of entire ovary. It was alleged to be
misbranded in that the statements in the labeling, "Endocrine Extract * * *
For Sublingual Use * * * Extracted principles of glands from government
inspected animals and distilled water. * * * Extracted Crystalline Prin-
ciples of the following glands: Thyroid ... 3 mgm. * * * Entire Ovary
... 20 mgm.," were false and misleading.
Formula No. 131 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 33 cc, 3 milligrams of the
crystalline principle of thyroid and 10 milligrams of the crystalline principle
of the male orchic gland; whereas it contained no detectable amount of the
crystalline principle of the thyroid or of the male orchic gland. It was alleged to
be misbranded in that the statements in the labeling, "Endocrine Extract * * *
For Sublingual Use * * * Extracted principles of glands from government
inspected animals and distilled water. -* * * Extracted Crystalline Principles
of the following glands: Thyroid ... 3 mgm. * * * Male Orchic ... 10
mgm.," were false and misleading.
Formula No. 157 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 33 cc, 3 milligrams of the
crystalline principle of thyroid, 10 milligrams of the crystalline principle of the
pineal gland, and 5 milligrams of the crystalline principle of the male orchic
gland; whereas it contained no detectable amounts of the crystalline principles
of the thyroid, pineal, or male orchic glands. It was alleged to be misbranded
in that the statements in the labeling, "Endocrine Extract * * * For Sub-
lingual Use * * * Extracted principles of glands from government inspected
animals and distilled water. * * * Extracted Crystalline Principles of the
following glands: Thyroid ... 3 mgm. Pineal ... 10 mgm. * * * Male
Orchic ... 5 mgm.," were false and misleading.
The colloidal dextro calcium was alleged to be misbranded; (1) In that the
statements, (bottle label) "Colloidal Dextro Calcium Bleything * * * Dos-
age: One teaspoonful three times daily before meals.   May be taken in milk or
513868?-43?2
fruit juices, if preferred. In pronounced cases dosage may be doubled for two
weeks. Dosage for children is the same as for adults," were false and misleading (~~
since they represented and suggested that in the dosages recommended, it would <
supply the user with sufficient calcium to be of therapeutic value in cases of
ordinary calcium deficiency and even in cases of pronounced calcium deficiency;
whereas in the maximum daily dosage recommended, namely, 6 teaspoonfuls, it
would supply not more than V750 of the amount of calcium required daily by an
adult human being, which would be inconsequential for therapeutic purposes.
(2) In that the statement on the label, "1-20 of 1? Sodium Benzoate," was false
and misleading since it represented that the article contained not more than ?o
of 1 percent of sodium benzoate; whereas the two shipments of the product
contained *4 and ? of 1 percent, respectively, of sodium benzoate.
On May 21, 1942, a plea of guilty having been entered on behalf of the
defendant, the court imposed a fine of $65 on each of the 8 counts of the
information,  totaling $520.