80998. Adulteration and misbranding of Oralsulin. U. S. v. Lafayette Pharmacal, 
Inc., and Bern B. Grubb. Pleas of nolo contendere. Corporation fined 
$50 and costs.    Bern B. Grubb fined $25 without costs.     (F. & D. No.
42546.   Sample Nos. 21735-C, 48552-C, 53661-C.)
The labeling of two of the three shipments of this product bore false and 
fraudulent statements regarding its curative and therapeutic effectiveness in 
the treatment of diabetes mellitus; that of a third shipment bore a device 
conveying the same false and fraudulent implication. The article was also 
labeled to indicate that it consisted of insulin or an insulin-like substance 
which was enclosed in a capsule that would resist the action of the gastric 
juices and protect the product from disintegration in the stomach but which 
would be dissolved in the intestinal tract; whereas it was not insulin nor did 
it possess the properties of insulin, its coating was soluble in gastric juices, 
and the product would dissolve in the stomach. A sample from one shipment 
was found to contain ginger and that from a second shipment was found to 
contain starch.
On January 11, 1939, the grand jurors of the United States within and for 
the Northern District of Indiana presented an indictment against Lafayette 
Pharmacal, Inc., Lafayette, Ind., and Bern B. Grubb, president of the cor- 
poration at the time of the shipments mentioned hereinafter, alleging shipment 
in violation of the Food and Drugs Act as amended, on or about January 2, 
January 6, and September 16,1937, from the State of New York into the States 
of Louisiana and Maryland, of quantities of Oralsulin which was adulterated 
and misbranded.
Analyses of the product showed in each instance that it consisted essentially 
of powdered animal tissues including a small proportion of an enzyme such as 
is found in pancreas tissue. A sample was found to contain starch and an- 
other was found to contain powdered ginger. Biological tests of the samples 
showed no evidence of insulin activity following oral administration, also that 
the coating dissolved in the stomach and that the contents disintegrated in the 
stomach.
The shipment of January 2, 1937, was alleged to be adulterated in that the 
strength and purity of the article fell below the professed standard and quality 
under which it was sold in that it was represented to consist of "Enterocap 
Oralsulin," namely, insulin or an insulin-like substance intended for oral ad- 
ministration, enclosed in a specially devised and perfected capsule which 
actually protected against gastric action and dissolved in the intestinal canal; 
whereas it was not insulin, did not contain insulin or any insulin-like substance, 
it did not possess the properties of insulin, was not enclosed in a capsule which 
protected it against gastric action and dissolved in the intestinal canal since 
the capsule was soluble in gastric juice and the said article would disintegrate 
in the stomach when administered orally. The said shipment was alleged to 
be misbranded in that the following statements appearing in the labeling, (circu- 
lar) "In the treatment of Diabetes Mellitus extreme interest was aroused by the 
introduction of Insulin. As in the case of anything original or novel in thera- 
peutics, many claims were made; and results anticipated have been modified
to a considerable degree as a result of practical use. Naturally enough, the 
advent of Insulin stimulated investigation and research having for its object 
the development of an Oral Medication, rather than the use of the hypodermic 
method. The main handicap was of course recognized to be the factor of gas- 
tric digestion or modification; because medicinal animal substances contain 
endocrine as well as chemical substances of a protein character. The intro- 
duction of these into the stomach unprotected, immediately exposes them to 
modification or even destruction. Can such substances be adequately protected- 
The answer to this vitally important question is found in the form of Enterocap 
Oralsulin. Pronounced En'-ter'-o-cap O'-ral'-su-lin. Oralsulin is a desiccation 
of the pancreas of young food animals, together with interdependent gland 
desiccations. This is enclosed in a specially devised and perfected capsule or 
Enterocap, which actually protects against gastric action and dissolves in the 
intestinal canal," (carton) "Oralsulin Enterocap * * * A Perfect Seal," and 
(bottle) "Enterocap Oralsulin," were false and misleading for the reasons in- 
dicated hereinbefore. It was alleged to be misbranded further in that certain 
statements in the labeling regarding its curative and therapeutic effects falsely 
and fraudulently represented that it was effective as a treatment for diabetes 
mellitus.
The shipment of January 6, 1937, was alleged to be adulterated in that the 
strength and purity of the article fell below the professed standard and quality 
under which it was sold in that it was represented to consist of "Enterocap 
Oralsulin," namely, insulin or an insulin-like substance intended for oral ad- 
ministration and enclosed in a specially devised and perfected capsule which 
actually protected against gastric action and dissolved in the intestinal canal; 
to contain a hormone secreted by and peculiar to the pancreas, namely, insulin; 
and to consist entirely of special desiccation of the pancreas of young food ani- 
mals, together with interdependent gland desiccations; whereas it was not 
insulin, it contained no insulin nor any insulin-like substance, it did not possess 
the properties of insulin, it was not enclosed in a capsule which protected 
against gastric action and dissolved in the intestinal canal since said capsule 
was soluble in gastric juice and the article would disintegrate in the stomach 
when administered orally, it did not contain a hormone secreted by and peculiar 
to the pancreas, namely, insulin, and it did not consist entirely of a special 
desiccation of the pancreas of young food animals, together with interdependent 
gland desiccation since it consisted in part of ginger. The said shipment was 
alleged to be misbranded in that the following statements in the labeling, (cir- 
cular) "Diabetes Therapy In the treatment of Diabetes Mellitus extreme inter- 
est was aroused by the introduction of Insulin. As in the case of anything 
original or novel in therapeutics, many claims were made, and results antici- 
pated have been modified to a considerable degree as a result of practical use. 
Without in any way disparaging the use of Insulin, and encouraging its use 
as an emergency agent certain considerations attending its use must of necessity 
have to be considered by the practical physician in general practice. In the first 
place, the use of Insulin has to be more or less continuous or constant in the 
average case of diabetes. It is not a question of the administration of a few 
doses and subsequent arrest of the disease. Many and continuous injections 
have to be employed and the natural result is that the method of administration 
becomes irksome and repulsive, in fact, not infrequently, patients complain that 
the remedy is worse than the disease. Then again there is the question of 
expense, for the cost of these frequent injections amounts in most cases to a 
severe strain on the average person's financial resources. Naturally enough, the 
advent of Insulin stimulated investigation and research having for its object 
the development of an Endocrine Hormone effect, rather than direct chemical 
action. It was of course, important to find not only an agent but a method of 
administering that agent by the mouth instead of by the needle. The main 
handicap was of course recognized to be the factor of gastric digestion or modi- 
fication; because medicinal animal substances contain endocrine as well as 
chemical substances of a protein character. The introduction of these into the 
stomach unprotected, immediately exposes them to modification or even destruc- 
tion. Can such substances be adequately protected? The answer to this vitally 
important question is found in the form of Enterocap Oralsulin. Pronounced 
En'-ter'-o-cap O'-ral'-su-lin. Oralsulin is a hormone treatment prepared by a 
special desiccation, of the pancreas of young food animals, together with inter- 
dependent gland desiccations. This is enclosed in a specially devised and per- 
fected capsule or Enterocap, which actually protects against gastric action but
just as actually dissolves in the intestinal canal," (carton) "Oralsulin * * * 
Enterocap * * * A Perfect Seal," and (bottle) "Enterocap Oralsulin," were 
false and misleading for the reasons indicated hereinbefore. It was alleged to 
be misbranded further in that certain statements in the labeling regarding its 
therapeutic and curative effects falsely and fraudulently represented that it 
was effective as a treatment for diabetes mellitus.
The shipment of September 16, 1937, was alleged to be adulterated in that 
its strength and purity fell below the professed standard and quality under 
which it was sold in that it was represented to consist of "Enterocap Calc- 
uli," namely, insulin or an insulin-like substance intended for oral adminis- 
tration and enclosed in an "enteric investure" which released the medicament 
in the bowel beyond stomach or gastric digestive functioning and to consist 
entirely of a desiccated pancreas substance the raw materials of which were 
derived from animals; whereas it was not insulin, did not contain insulin or 
any insulin-like substance, it did not possess the properties of insulin, was not 
enclosed in an "enteric investure" which released the medicament in the bowel 
beyond stomach or gastric digestive functioning in that the said "investure," 
namely, capsule, was soluble in gastric juice and said article would disintegrate 
in the stomach when administered orally and said article did not consist 
entirely of desiccated pancreas substance, the raw materials of which were 
derived from animals, but did consist in part of starch. The said shipment 
was alleged to be misbranded further in that the following statements in the 
labeling, (circular) "Enterocap Oralsulin is an enteric investure of desiccated 
pancreas substance * * * The raw materials used are from animals," 
and "Enterocap is the offer of a method to attempt the release of the medica- 
ment in the bowel beyond stomachy or gastric digestive functioning," (carton) 
"Oralsulin," and "Enterocap * * » A Perfect Seal," and (bottle) "Entero- 
cap Oralsulin," were false and misleading for the reasons indicated herein- 
before. The said shipment was alleged to be misbranded further in that the 
letters "Oralsulin," borne on the bottle, carton, and in the circular constituted 
a device regarding the therapeutic and curative effects of the article and meant 
to purchasers of said article that the article was effective in the treatment 
of diabetes mellitus when used as directed in the circular—the device having 
acquired such meaning through former representations and claims recommend- 
ing and claiming that the article was efficacious for such purpose—which were 
made by the defendants in certain circulars enclosed with previous consign- 
ments of the article; and said device and statements were false and fraudulent 
in that they represented falsely and fraudulently that the article was effective 
as a treatment for diabetes mellitus.
On December 11, 1939, the Lafayette Pharmacal, Inc. entered a plea of 
nolo contendere as to all the charges aforesaid and the court imposed a fine 
of $50 and costs against the corporation. On the same date the defendant 
Bern B. Grubb entered a plea of nolo contendere to the counts charging false 
and fraudulent curative and therapeutic representations and was fined $25 
without costs.
GROVER B. HUX, Acting Secretary of Agriculture.