4044. Misbranding of methyltestosterone tablets, dextro-amphetamine sulfate
tablets, thyroid tablets, and tablets containing a mixture of mannitol
hexanitrate and phenobarbital. U. S. v. Fay C. Dyes and Milton J.
Reynaud. Pleas of nolo contendere. Fine of $150 against each defend-
ant. (F. D. 0. No. 33742. Sample Nos. 31026-L, 34174-L, 34377-L to
34379-L, incl., 34382-L.)
INFORMATION FILED: January 19, 1953, Western District of Missouri, against
Fay C Dyes and Milton J. Reynaud, partners in the partnership of Dyes
Drug Store, Aurora, Mo.
ALLEGED VIOLATION : On or about March 19
 and 20, 1952, while a number of
methyltestosterone tablets, dextro-amphetamine sulfate tablets, thyroid tablets,
and tablets containing a mixture of mannitol hexanitrate and phenobarbital
were being held for sale at Dyes Drug Store, after shipment in interstate
commerce, the defendants caused various quantities of the drugs to be re-
*See also No. 4041.
in the repackaged drugs being misbranded.
NATURE OF CHARGE: Misbranding, Sections 502 (b) (1) and (2), all of the
repackaged drugs failed to bear labels containing the name and place of
business of the manufacturer, packer, or distributor, and an accurate state-
ment of the quantity of the contents; and, Section 502 (f) (1), the labeling
of all of the repackaged drugs failed to bear adequate directions for use.
Further misbranding, Section 502 (d), the tablets containing a mixture of
mannitoi hexanitrate and phenobarbital contained a chemical derivative of
barbituric acid, which derivative has been found to be, and by regulations
designated as, habit forming; and the label of the tablets failed to bear the
name, and quantity or proportion of such derivative and in juxtaposition
therewith the statement "Warning-May be habit forming."
DISPOSITION : April 2, 1953. Pleas of nolo contendere having been entered, the
court fined each defendant $150.
4045.?Action to enjoin and restrain the interstate shipment of Renesol or Rene-
sol Treatment.   U. S. v. Renesol Corp., Charles I. Goldblatt, and Nathan
Katz.  Consent decree of injunction.   (Inj. No. 233.)
COMPLAINT FILED : January 18,1952, District of New Jersey, against the Renesol
Corp., Jersey City, N. J., and Charles I. Goldblatt, president and treasurer,
and Nathan Katz, vice president and secretary of the corporation.
ALLEGED VIOLATION : The complaint alleged that the defendants were engaged
in the business of manufacturing, distributing, and selling an article of drug
consisting of a phenobarbital compound under the name of Renesol or Renesol
Treatment. The complaint alleged further that the defendants were intro-
ducing and delivering for introduction into interstate commerce the above-
mentioned article in a misbranded condition.
NATURE OF CHARGE: Misbranding Section 502, (f) (1), the labeling of the
article failed to bear adequate directions for use in the treatment of the
diseases and conditions for which the article was prescribed, recommended,
and suggested, namely, epilepsy and symptoms of epilepsy.
DISPOSITION : September 2, 1952. The defendants having consented to the
entry of a decree, the court entered a decree permanently enjoining and
restraining the defendants from introducing and delivering for introduction into
interstate commerce the above-mentioned article, or any similar article,
which was misbranded, as alleged in the complaint, and also from dispensing
such article contrary to the provisions of Section 503 (b). (This section
provides, in part, that certain drugs shall be dispensed only upon a written
prescription of a practitioner licensed by law to administer such drugs.)
It also was provided in the decree that nothing contained therein should be
deemed to prejudice any rights which the defendants might have under Sec-
tion 801 (d) of the Act, or of any other law, regulation, or requirement relat-
ing to export.
4046.?Action to enjoin and restrain the interstate shipment of Muscle-Rub.
U. S. v. Pauline Harrison (Muscle-Rub Distributors), and Herman H.
Kronberg.   Consent decree of injunction.   (Inj. No. 258.)
COMPLAINT FILED: January 5, 1953, Southern District of California, against
Pauline Harrison, trading as the Muscle-Rub Distributors, Los Angeles, Calif.,
and Herman H. Kronberg, general manager of the business.
ALLEGED VIOLATION: The complaint alleged that the defendants distributed a
certain counter-irritant drug under the name of Muscle-Rub, which consisted
of a mixture of isopropyl alcohol, ethyl alcohol, witch hazel, camphor, menthol,
and methyl salicylate. The complaint alleged further that the defendants were
introducing and delivering for introduction into interstate commerce the
above-mentioned article in a misbranded condition, and that the defendants
were doing acts with respect to the article while held for sale after shipment
in interstate commerce, which resulted in the article becoming misbranded.
NATURE OF CHARGE: Misbranding, Section 502 (a), the labeling of the article
was false and misleading since it represented, implied, and suggested that the
article was efficacious for the cure and relief of pains due to arthritis, rheu-
matism, lumbago, neuritis, sciatica, neuralgia, bruises, sprains, foot irritations,
and other crippling conditions, whereas the article was not efficacious for such
purposes; Section 502 (f) (1), the labeling of the article did not bear adequate
directions for use since it did not contain a statement of all the purposes
and conditions for which the article was intended by the defendants and
sufficient information to enable a layman to intelligently and safely attempt
self-medication for the purposes and conditions for which it was intended; and,
Section 502 (f) (2), the labeling failed to bear adequate warnings against
unsafe methods and duration of use since the labeling failed to state that
the article should be kept away from the eyes and mucous membranes and
should be rubbed in gently and not excessively.
DISPOSITION : January 6, 1953. The defendants having consented to the entry
of a decree, the court entered a decree permanently enjoining and restraining
the defendants from introducing and delivering for introduction into interstate
commerce the article in question or any similar article which was misbranded
as alleged in the complaint, and from doing any act with respect to any such
article while held for sale after shipment in interstate commerce, which would
result in the article becoming misbranded as alleged.