FOOD AND DRUG ADMINISTRATION
1945
*ffi?Sj
APR
945
NOTICES OF JUDGMENT UNDER THE FEDEIfVl^OD/^lt&^AT^.,
AND COSMETIC ACT     t_!l^*   ^     SIAIIUN
[Given pursuant to section 705 of the Food, Drug, and Cosmetic Act]
1001-1050
DRUGS AND DEVICES
The cases reported herewith were instituted in the United States district
courts by the United States attorneys acting upon! reports submitted by direction
of the Federal Security Administrator.
WATSON B. MILDER, Acting Administrator, Federal Security Agency.
WASHINGTON. D. C, December 12, 1944.
CONTENTS*
Page
Drags actionable because of potential danger
when used according to directions 
187
Drags actionable because of failure to bear ade-
quate directions or warning statements 196
Drags actionable because of deviation from
official or own standards 
204
Page
Drugs actionable because of false and misleading
claims 
 218
Drags for human use  
218
Drugs for veterinary use 
232
Index 
233
DRUGS ACTIONABLE BECAUSE OF POTENTIAL DANGER WHEN USED
ACCORDING TO DIRECTIONS
1001. Action to enjoin and restrain distribution of Sekov products. U. S. v. Sekov
Corporation and Hazel Ruth Vokes (Sekov Studios). Permanent injunc-
tion granted.   (Inj. No. 53.)
On April 17, 1943, the United States attorney for the Southern District of
California filed a complaint for injunction against the Sekov Corporation and
Hazel Ruth Vokes, trading under the name of the Sekov Studios, Hollywood,
Calif. (The complaint also joined as party defendant Edwin Hoskin Vokes, but
after hearing, the court ruled that it did not have jurisdiction over that person.)
The complaint alleged: (1) That the defendants were engaged in the manu-
facture of various capsules which contained desiccated thyroid, which were
designated by the names "Sekov," "Sekov Reducer," "Sekov Reducer for Men,"
"Sekov Formula P," "Sekov Formula R," and "Sekov Formula T," and which
were being introduced and delivered for introduction into interstate commerce
in capsule form, for sale to the general public for self-medication in the treatment
of obesity.
(2) That "Sekov" and "Sekov Reducer" each consisted of two types of capsules,
designated as Capsule No. 1 and Capsule No. 2; that the No. 1 capsules contained
glandular material including thyroid, the thyroid content varying from 1.87
grains to 2 grains per capsule, the recommended dosage suggested being 1 capsule
before the noon meal; that the No. 2 capsules contained rhubarb, cascara sagrada,
asafetida, and other ingredients, the recommended dosage being 1 capsule every
other night (just before retiring) ; that the "Sekov Reducer for Men" consisted
of 2 types of capsules, the No. 1 containing, in addition to other ingredients,
thyroid and aloin, the thyroid content varying from 1.84 grains to 1.95 grains
per capsule, the dosage recommended being "One capsule morning and one
capsule evening (preferably half to one hour before meals)"; that the No. 2
capsule was identical with the "Sekov Reducer" No. 2 capsule, and the dosage
recommended was "One capsule every night (just before retiring)"; that the
"Sekov Formula P" contained, in addition to other ingredients, thyroid in an
amount of approximately 1.73 grains per capsule; that/the "Sekov Formula R"
contained ingredients similar to the "Sekov Formula P," with a thyroid content
of approximately 1 grain per capsule; that the "Sekov Formula T" contained
ingredients similar to the "Sekov Formula P," with a thyroid content of 1.87
grains per capsule; and that the dosages recommended in the labeling of
formulas "P," "R," and "T," were identical, "One capsule per day-taken ? to 1
hour before morning meal."
*For omission of, or unsatisfactory, ingredients statements, see Nos. 1003,1005,1009,1010,1011,1022,1043.
1044; deceptive packaging, Nos. 1003,1011; failure to bear accurate statement of quantity of contents, Nos.
1003, 1009, 1010, 1033, 1034, 1040, 1043, 1047, 1049; contamination with filth, No. 1011; cosmetics, subject to
the drug provisions of the Act, Nos. 1021,1040,1043,1047.
625042-45 1 
187
(3)?That on February 17,1940, on complaint of the Federal Trade Commission     ; {
a preliminary injunction was issued by the United States District Court for the    j
Southern District of California, enjoining the Sekov Corporation, Edwin Hoskin
Vokes, and Hazel Ruth Yokes, as officers of the corporation and as individuals
trading as "Sekov Reducing Studios," their agents, etc., from causing to be
disseminated any advertisement by any means tending to induce the purchase
in interstate commerce of the drug sold under the name of "Sekov Reducer", or
"Sekov," or any other name, which advertisement represented directly or in-
directly that such preparations were a safe, competent, and scientific treatment
for obesity; and that on March 12, 1940, the Federal Trade Commission issued
a complaint against the Sekov Corporation, Edwin Hoskin Vokes, and Hazel
Ruth Vokes, as officers of the corporation and as individuals trading as "Sekov
Reducing Studios," and on September 8, 1940, pursuant to a stipulation of facts,
the Federal Trade Commission issued its order against the defendants to cease and
desist from, directly or indirectly, doing, among other things, disseminating or
causing to be disseminated any advertisement, (a) by means of the United States
mail, or (b) by any means in commerce, as commerce is defined by the Federal
Trade Commission Act, which advertisement represented directly or through
individuals that said preparation was a safe, competent, and scientific treatment
for obesity.
(4)?That on July 21, 1941, a libel had been filed in the District Court of the
United States for the Southern District at Houston, Texas, against capsules
similar to those aforesaid, and on May 28,1942, final judgment was entered order-
ing the libeled articles destroyed. On June 5, 1942, a little more than a month
after the decision of the Texas court, the defendant shipped to Houston, Texas,
a stock of drug products similar to those condemned by the Texas court, and
a libel was filed by the United States against this shipment on July 29, 1942, to
which an answer was filed by the Sekov Corporation. At the pre-trial hearing
on October 24, 1942, counsel for the claimant, the Sekov Corporation, agreed to
stipulate that the facts alleged in the libel were true, excepting the question of
misbranding. On or about January 8, 1943, the defendants, trading as "Sekov
Studios," shipped 6 cartons of Sekov to Reno, Nev., labeled "Manufactured for-
Packed by-Sekov Corporation," and a libel was filed against this shipment on
March 6, 1943, in the District Court of the United States for the District of
Nevada.
(5)?That the products were misbranded as follows: (a) that the "Sekov
Reducer," "Sekov Formula T," and "Sekov Reducer for Men" were dangerous to
health when used in the dosage and with the frequency and duration prescribed,
recommended, or suggested in the labeling (this allegation was based on the fact
that the capsules, when taken according to the directions, would supply a danger-
ous amount of thyroid); (b) in that the label on the carton of each of the prepara-
tions, including the design of a slender female figure, was false and misleading
since it created the impression that the articles were safe and appropriate treat-
ments for the reduction of weight, whereas they were not safe and appropriate
treatments, but were dangerous drugs and could not be depended upon to reduce
weight; and (c) that the "Sekov Formula P" and "Sekov Formula R" were
misbranded in that the label on each carton, including the design of a slender
female figure, was false and misleading since it created the impression that the
articles were dependable and appropriate treatments for the reduction of weight,
whereas they were not dependable and appropriate treatments, and could not be
depended upon to reduce weight.
(6)?That the defendants had attempted and were still attempting to circumvent
the protection intended to be given for the health and welfare of the public, and
that the Government had endeavored to have the defendants refrain from shipping
the aforesaid products in interstate commerce, without success, over a period
of years, and, by reason of the failure of the defendants to refrain from shipping
the products, it became necessary for adequate protection to the general public
that the defendants be forever enjoined from shipping such misbranded products
in, or introducing or delivering them for introduction into, interstate commerce
to be used as food or drugs.
On April 19,1943, the court issued a temporary restraining order and an order
to show cause why, pending final determination, a preliminary injunction should
not be entered.   On May 3, 1943, the court denied the motion for a preliminary?{
injunction and the case was sat for trial.   On June 12, 1943, after hearing the?*
testimony, the court gave its opinion in the following minute order:
LEON R. YANKWICH, District Judge:
"The above-entitled cause heretofore tried and submitted, is hereby decided
as follows:
"Judgment is ordered entered for the plaintiff as prayed for in its complaint,
restraining and enjoining the defendants, their servants, agents, officers, em-
ployees, attorneys and assigns, and each of them, from the introduction or delivery
for introduction into interstate commerce of any of their said products herein
before designated and described as 'Sekov', 'Sekov Reducer', 'Sekov Reducer for
Men', 'Sekov Formula P\ 'Sekov Formula R', and 'Sekov Formula T,' in violation
of or contrary to Title 21, U. S. C. A., Sections 301 to 392.
"I am of the view that the evidence shows clearly that the preparation is mis-
branded because 'it is dangerous to health when used in the dosage or with the
frequency or duration prescribed and recommended or suggested in the label
thereof.' (21 U. S. C. A. Sec. 352 (j).) Even the physicians who testified for
the defendants admitted that the use of thyroid extracts in the quantity pre-
scribed by obese persons, whose obesity was not due to hypothyroidism, might
prove injurious to health. The physicians who testified for the Government, each
of whom is an expert in his field,-were emphatic in their statement that such use
not only might be detrimental, but in all likelihood would be so. If the defendants
limited sales to persons who are suffering from obesity due to hypothyroidism,-
either by requiring a physician's certificate to that effect, or by conducting an
examination of the person before making a sale, it could well be contended that,
with such precaution, any detrimental results would be only those incident upon
any selfmedication, which the law does not prohibit. As the sale is not made
through general outlets, but through agencies conducted by the defendants-
studios located in various cities throughout the United States, such safeguards
could easily be enforced. As it is, the record shows that any obese person who
calls at one of these studios can obtain the product without any inquiry as to
whether the conditions for which the product is intended as a remedy, co-existing
obesity and hypothyroidism,-are present. In view of this, the statement on the
carton that the preparation is 'a reducer for overweight due to a thyroid defi-
ciency' and similar statements in the pamphlet are inadequate to forestall the evil
inherent in the use of this preparation by persons whose hypothyroidism has not
been established by a competent physician. It is to be noted, as stated by me
during the argument, that nowhere is there a warning couched in imperative
negatives such as are found in products which may have a deleterious effect.
Nowhere is there a statement 'Do not use this unless a physician has told you that
your obesity is due to hypothyroidism'. The reference to the consultation of a
physician is ineffective. It reads: 'We recommend that you consult physician
to determine the cause of your overweight as the use of THYROID by a person
not deficient in THYROID may result in serious or irreparable injury to the
health of the user'.
"I am also satisfied that the contra-indications are inadequate. In the light
of the expert testimony, I do not think that the average person seeking to reduce
would be competent to detect the evils resulting from its use. Bearing in mind
that the defendants in their advertising and literature, appeal especially to the
vanity of women, I am of the view that the average woman, in her desire to
achieve a beauty of form, would be more inclined to consider the manifestations
of ill effect as the natural price to pay for the results to be achieved. So that
if we consider the warnings in relation to the persons to whom they are ad-
dressed, as counsel bids us to, it is quite evident that they are ineffective for the
purpose."
On June 25, 1943, the court handed down findings of fact substantially sus-
taining the allegations in the complaint, and conclusions of law sustaining the
prayer of the complaint. On the same day a decree for permanent injunction
was filed, ordering the defendants forever restrained and enjoined from intro-
ducing or delivering for introduction into interstate commerce any of their prod-
ucts designated and described as "Sekov," "Sekov Reducer," "Sekov Reducer for
Men," "Sekov Formula P," "Sekov Formula R," and "Sekov Formula T."