FOOD AND DRUG ADMINISTRATION
NOTICES OF JUDGMENT UNDER THE FEDERAL FOOD,
DRUG, AND COSMETIC ACT
[Given pursuant to section 705 of the Food, Drug, and Cosmetic Act]
5381-5400
DRUGS AND DEVICES
The cases reported herewith were instituted in the United States district courts
by United States attorneys, acting upon reports submitted by the Department of
Health, Education, and Welfare. They involve drugs and devices which were
?adulterated or misbranded within the meaning of the Act when introduced into
1 and while in interstate commerce or while held for sale after shipment in inter-
state commerce. These cases involve (1) seizure proceedings terminated with
the entry of default decrees of condemnation; (2) criminal proceedings termi-
nated with a verdict of guilty; (3) injunction proceedings terminated with the
entry of an injunction; (4) contempt proceedings for violation of an injunction
which were terminated with a verdict of guilty. The seizure proceedings are
civil actions taken against the goods alleged to be in violation; and the criminal,
injunction, and contempt proceedings are against the firms or individuals charged
to be responsible for violations.
Published by direction of the Secretary of Health, Education, and Welfare.
GEO. P. LARBICK, Commissioner of Food and Drugs.
WASHINGTON, D. C, January 26, 1959.
CONTENTS
Page
Page
New drug shipped without effective
application 
280
Drugs actionable because of failure
to bear adequate directions or
warning statements 
281
Drugs and devices actionable be-
cause of deviation from official
i      or own standards 
293
492095-59 1 
279
Drugs actionable because of false
and misleading claims 
309
Drugs for human use 
309
Drugs for veterinary use 
310
Index 
310
SECTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS (
REPORTED IN D. D. N. J. NOS. S381S400
'   \
Adulteration, Section 501 (b), the article purported to be and was represented
as a drug, the name of which is recognized in an official compendium (United
States Pharmacopeia or National Formulary), and its strength differed from
the standard set forth in such compendium; Section 501 (c), the article was not
subject to the provisions of Section 501 (b), and its strength differed from, or ita
purity or quality fell below, that which it purported or was represented to possess.
Misbranding, Section 502 (a), the labeling of the article was false and mis-
leading; Section 502 (f) (1), the labeling of the article failed to bear adequate
directions for use.
New-drug violation, Section 505 (a), the article was a new drug within the
meaning of Section 201 (p), which was introduced into interstate commerce, and
an application filed pursuant to Section 505 (b) was not effective with respect to
such drug.
NEW DRUG SHIPPED WITHOUT EFFECTIVE APPLICATION
5381. Pega Palo vine.    (F. D. O. No. 40311.   S. No. 65-347 M.)
QUANTITY :   68 pliofilm pkgs. at Elyria, Ohio.
SHIPPED:   3-30-57, from A-l Import Co., Chicago, 111., by Joe C. George, Jr.
LABEL IN PART:    "Pega Palo Vine   Packed by A-l Import Company   Chicago,
Illinois   Contents:   7 grams."
RESULTS OF INVESTIGATION :    Examination of the article disclosed that it was. (
Pega Palo vine (Rhynohosia pyramidalis).
\ -
LIBELED :   6-4-57, N. Dist. Ohio.
CHARGE: 502 (f) (1)-the labeling of the article, when shipped and while held
for sale, failed to bear adequate directions for use as an aphrodisiac, which was
the purpose for which the article was intended; and 505 (a)-the article was
a new drug which may not be introduced into interstate commerce since an
application filed pursuant to law was not effective with respect to the drug.
DISPOSITION:   7-23-57.   Default-destruction.