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]
5201-5220
DRUGS AND DEVICES
The cases reported herewith were instituted in th& United States district
courts by United States attorneys, acting upon reports submitted by the Depart-
ment of Health, Education, and Welfare. They relate to drugs and devices
which were adulterated or misbranded within the meaning of the Act when
introduced into and while in interstate commerce, or while held for sale after
shipment in interstate commerce. These cases involve (1) seizure proceedings
in which decrees of condemnation were entered after default, consent, or trial;
(2)?criminal proceedings which were terminated with a plea or verdict of guilty;
(3)?injunction proceedings terminated with the entry of an injunction. The
seizure proceedings are civil actions taken against the goods alleged to be in
violation, and the criminal and injunction 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, July 25,1958.
Page
Drug in  violation of prescription
labeling requirements
126
Drugs actionable because of failure
to bear adequate directions or
warning statements
127
Drugs and devices actionable be-
cause of deviation from official
or own standards
 132
CONTENTS *
Page
Drugs and devices actionable be-
cause of false and misleading
claims 
 135
Index 
  161
?For omission of, or unsatisfactory, ingredients statements, see Not.. 5201, 5217; failure
to bear a label containing the name and place of business of the manufacturer, packer, or
distributor, No. 5201; cosmetic, actionable under the drug provisions of the Act, No. 5217.
470085-58 1 
125
SUCTIONS OF FEDERAL FOOD, DRUG, AND COSMETIC ACT INVOLVED IN VIOLATIONS
REPORTED IN D. D. N. J. NOS S201-5220
Adulteration, Section 501 (b), the article purported to be and was repre-
sented as a drug, the name of which is recognized in an official compendium
(United States Pharmacopeia or National Formulary), and its strength differed
from, or its quality fell below, the standard set forth in such compendium; Sec-
tion 501 (c), the article was not subject to the provisions of Section 501 (b),
and its strength differed from, or its quality fell below, that which it purported or
was represented to possess; Section 501 (d), the article was a drug, and a sub-
stance had been substituted wholly or in part therefor.
Misbranding, Section 502 <a), the labeling of the article was false and mis-
leading; Section 502 (b) (1), the article was in package form, and it failed to
bear a label containing the name and place of business of the manufacturer,
packer, or distributor; Section 502 (e) (2), the article was not designated solely
by a name recognized in an official compendium and was fabricated from two or
more ingredients, and its label failed to bear the common or usual name of each
active ingredient; Section 502 (f) (1), the labeling of the article failed to bear
adequate directions for use; Section 502 (f) (2), the labeling of the article
failed to bear adequate warnings against use in those pathological conditions or
by children where its use may be dangerous to health, or against unsafe dosage
or methods or duration of administration or application, in such manner and
form, as are necessary for the protection of users; Section 503 (b) (4), the
article was subject to Section 503 (b) (1), and its label failed to bear the state-
ment "Caution: Federal law prohibits dispensing without prescription."
DRUG IN VIOLATION OF PRESCRIPTION LABELING REQUIREMENTS
5201. R-20 hair treatment.    (F. D. C. No. 39640.    S. No. 40-913 M.)
QUANTITY : 2 btls., containing 20 oz. total, of R-20 hair treatment, and 2 jugs,.
1 containing 1 gal. and the other containing 28 oz., of diluted R-20 hair treat-
ment, at Minneapolis, Minn.
SHIPPED :   8-23-56, from Rouses Point, N. Y., by Dr. R. E. Liefmann.
LABEL IN PAST: (Btl.) "R-20 Batch #17, 8-27-56 Regular"; (jug) "the
Frommes formula R-20 by Frommes Scalp Specialists   Minneapolis."
REStn,T8 OF INVESTIGATION : Analysis showed that the drug consisted of an iso-
propyl alcohol solution of alpha-estradiol. The drug was shipped unlabeled,
and, upon arrival, the handwritten bottle labeled "R-20 Batch #17 8-27-56
Regular" was affixed by the consignee, Frommes Method, Inc.
The diluted material was prepared by the consignee by adding an additional
quantity of isopropyl alcohol to a portion of the shipped drug. The "Frommes
formula R-20" labels were printed locally for the consignee, who applied them
to the diluted material.
LIBELED :    10-24-56, Dist. Minn.
CHARGE: 502 (b) (1)-the label of the article, when shipped, failed to bear the
name and place of business of the manufacturer, packer, or distributor r
502 (e) (2)-the article was fabricated from 2 or more ingredients, and it&
label, when shipped, failed to bear the common or usual name of each active
ingredient; 502 (f) (1)-the labeling of the article, when shipped, failed ta
bear adequate directions for use; and 503 (b) (4)-the article was a drug-
which was not safe for use except under the supervision of a practitioner li-
censed by law to administer such drug, and its label failed to bear the state-
ment "Caution:     Federal law prohibits dispensing without prescription."
DISPOSITION :   12-14-56.   Default-destruction.
DRUGS ACTIONABLE BECAUSE OF FAILURE TO BEAR ADEQUATE
DEtECTIONS OR WARNING STATEMENTS*