26954. Alleged Misbranding of Pulvis Alkantis.    U. S. v. 99 Packages of Pulvis 
Alkantis.     Tried to  the  court.     Judgment for claimant.     (F. & D.  no.
33538.    Sample no. 4175-B.)
The label of this article bore representations regarding its curative or 
therapeutic effects that were alleged to be false and fraudulent.
On September 22, 1934, the United States attorney for the Eastern District 
of Louisiana, acting upon a report by the Secretary of Agriculture, filed in 
the district court a libel praying seizure and condemnation of 99 packages of 
Pulvis Alkantis at New Orleans, La., alleging that it had been shipped in inter- 
state commerce on or about June 1 and July 2, 1934, by Lafayette Pharmacal, 
Inc., from Lafayette, Ind., and that it was misbranded in violation of the 
Food and Drugs Act as amended.
Analysis of a sample of the article by this Department showed that it con- 
sisted essentially of magnesium carbonate and small proportions of bismuth 
subcarbonate, calcium carbonate, and cerium oxalate flavored with oil of 
peppermint.
The article was alleged to be misbranded in that the following statements 
regarding its curative or therapeutic effects, on the box labels were false and 
fraudulent: "A Symptomatic Treatment Gastric Ulcer—Acute Gastric Catarrh
Acute Enteritis * * * Reflex Vomiting Dosage Average dose: One tea- 
spoonful in water, three times a day or more often if necessary. In acute 
attacks, dose may be doubled."
On December 14, 1936, the Lafayette Pharmacal Co., Inc., claimant, having 
filed an answer to the libel, and the cause having been tried to the court, a 
jury trial having been waived, judgment was entered against the United States.
The court made the following findings of fact and conclusions of law:
FINDINGS OF FACT
(1) Lafayette Pharmacal Inc., of Lafayette, Indiana, on or about the 1st 
day of June and the 2nd day of July, 1934, shipped and caused to be trans- 
ported in Interstate commerce for sale, from Lafayette in the State of Indiana, 
to McKesson, Parker, Blake Corporation in the City of New Orleans, State of 
Louisiana, via parcel post, ninety-nine (99) packages, more or less, of a certain 
article of drug labeled in part "Pulvis Alkantis."
(2) Thereafter, on September 22nd, 1934, a libel for the condemnation of said 
packages of Pulvis Alkantis was filed by the United States Attorney with the 
Clerk of this Court and ninety-two (92) packages so shipped and in possession 
of McKesson, Parker, Blake Corporation, New Orleans, Louisiana, in the origi- 
nal and unbroken packages, were seized by the United States Marshal and are 
now in the custody of this Court.
(3) The libel filed alleged that the product was an article of drugs within 
the meaning and intent of the Act of Congress approved June 30, 1906, known 
as the Food and Drugs Act and amendments thereof; that an analysis of the 
product showed that it consisted essentially of cerium oxalate and carbonates 
of bismuth, calcium, and magnesium, flavored with menthol; that the product 
was misbranded In violation of Section 8 of the act as amended, and Para- 
graph Third, in that certain statements on the box label regarding the curative 
and therapeutic effects of the article were false and fraudulent.
(4) The label on the packages seized by the Government reads In part as 
follows: "Pulvis Alkantis. A symptomatic treatment Gastric Ulcer Acute 
Gastric Catarrh Acute Enteritis Hyperacidity Reflex Vomiting Dosage 
Average dose: One teaspoonful in water, three times a day or more often if 
necessary. In acute attacks, dose may be doubled." The Government charged 
that this portion of the label is false and fraudulent, omitting, however, any 
complaint with reference to the word "hyperacidity."
(5) The law under which the Government's libel is brought is known as 
the Sherley Amendment to the Food and Drugs Act, being contained in 21 
U. S. C. 10, which reads In part as follows: "* * * an article shall be 
deemed to be misbranded; * * * Drugs. In the case of drugs: * * * 
False statement of curative or therapeutic effect. 3rd. If its package or label 
shall bear or contain any statement, design, or device regarding the curative or 
therapeutic effect of such article or any of the ingredients or substances con- 
tained therein, which is false or fraudulent."
(6) Lafayette Pharmacal, Inc. appeared as claimant for the seized goods, 
admitting the shipment alleged by the United States that the article was a 
drug within the meaning and intent of the Food and Drugs Act and amend- 
ments thereof, and in general admitting the analysis proffered by the United 
States, but denying that the product was misbranded or that any of the state- 
ments on the box label were either false or fraudulent.
(7) The parties by a stipulation waived a jury and the case was tried before 
and submitted to this Court.
(8) The witnesses were in substantial accord regarding the analysis of the 
product Pulvis Alkantis, the drugs contained therein being bismuth subcar- 
bonate, magnesium carbonate, precipitated calcium carbonate, and cerium 
oxalate, flavored with oil of peppermint.
(9) Cerium oxalate, a drug included in Purvis Alkantis, is used by reputable 
members of the medical profession and recommended by writers of medical 
text books In the treatment of reflex vomiting; however, according to the pre- 
ponderance of the testimony, the dosage required in order to have any cura- 
tive or therapeutic effect In the treatment of reflex vomiting exceeds many 
times the amount of cerium oxalate in a dose of Pulvis Alkantis.
(10) Reflex vomiting is itself a symptom of certain diseases, therefore, it is 
false to say that Pulvis Alkantis is a symptomatic treatment for reflex vomiting.
(11) Some of the experts produced by plaintiff testified that they had pre- 
scribed Pulvis Alkantis.
(12) Lafayette Pharmacal, Inc. is a concern of high standing, with excel- 
lent commercial and professional connections; its President, who was present 
and testified at the trial, is an individual of high standing. The United States 
has no complaint to make except as to the specific language of the label as 
above set forth.
(13) The President of Lafayette Pharmacal, Inc., a graduate and registered 
pharmacist, recounted on the witness stand his conferences with various doc- 
tors in regard to the statements on the label, and his conclusion derived 
therefrom that no change in the wording of the label was required.
(14) The President of Lafayette Pharmacal, Inc. also described on the 
witness stand his company's policy of no exploitation to the laity, of no 
advertising of any character to the laity.
(15) The label complained of had been used by Lafayette Pharmacal, Inc. 
for twelve years. The United States, without lodging any complaint with 
Lafayette Pharmacal, Inc., and without any warning, had effected a prior 
seizure of Pulvis Alkantis and when Lafayette Pharmacal, Inc., discovered 
what was the complaint of the Food and Drug Administration, Lafayette 
Pharmacal, Inc. protesting that the label was in all respects correct, agreed 
to change it and accordingly the label was changed to one with respect to 
which the Food and Drug Administration declared it took no exception. The 
instant seizure was made after this had taken place. The President of 
Lafayette Pharmacal, Inc., explained the use of the old label on the seized 
shipment as the mistake of some employee at the factory of Lafayette Pharma- 
cal, Inc., which explanation the Court accepts as correct.
CONCLUSIONS OF LAW
(1) In view of the foregoing Findings of Fact relative to reflex vomiting, 
the Court finds as a matter of law that the label is false. It is unnecessary 
for the Court to rule on the question of falsity. As to the other statements 
of the label, since the Court finds that where a label contains a list of ail- 
ments for which the drug is recommended, the charge of falsity is sustained 
by proof of the false character on any one of the claims.
(2) In a case of this kind it is not sufficient to establish merely the falsity 
of the claim; it must also appear that this false claim was made fraudulently; 
that is, either the defendant knew it was false, or without knowledge of its 
truth or falsity, made the claim recklessly and without a firm and honest 
belief in its truth. In the instant case, no knowledge of falsity, recklessness 
of statements, or lack of a firm and honest belief in the truth of the label 
statement can be attributed to Lafayette Pharmacal, Inc., or its President, 
and the label statement, therefore, cannot be regarded as fraudulent
HAEET L. BROWN, Acting Secretary of Agriculture.