5434. Nulsar.   (Inj. No. 309.)
COMPLAINT FOR INJUNCTION FILED: 4-25-57, E. Dist. Mich., against Appletone
Drugs, Inc., and Appletone Drug Laboratories, Inc., of Detroit, Mich., and
Samuel Krone, president of the corporations and owner of the businesses oper-
ated under the names of Appletone Drugs and Nulsar Drug Laboratories, at
Detroit, Mich.
LABEL IN PART: (Ctn.) "Nulsar-6 Special Tablets * * * For each full ounce
of the enclosed product, the following ingredients are included: Powdered
extracts of cattle organs in the following manner: Brain substance 2 grains
Suprarenal substance ? grain Desiccated liver 20 grains Hemoglobin 5
grains Gastric mucin 4 grains also: Ferrous gluconate 1 grain Pure de-
hydrated cream and milk containing not less than 53? up to 60? milk fat at
the time of manufacture 325 grains Powdered cocoa, flavoring, sucrose, pre-
servative, added."
?See also NOB. 5481, 5482, 5484, 5485, 5487-5489, 5492, 5493.
ACCOMPANYING LABELING : Leaflet headed "THE 'NULSAR-6' STORY To You-
With an Ulcer problem-Here is wonderful news"; two sheets consisting of a
reprint of a portion of an article published in the July 1956 issue of Confiden-
tial Magazine and headed "The end of 20,000,000 American bellyaches * * *
an amazing new pill that banishes ulcers without drugs or surgery!" and a
sheet headed "Nulsar Drug Laboratories, 18444 Sorrento Avenue, Detroit 35,
Michigan-Dear Doctor: You have probably seen the enclosed publicity given
to the imported tablets that are being taken for ulcers."
CHARGE : The complaint alleged that the defendants were violating the Act by
causing the introduction and delivery for introduction into interstate commerce
of the drug Nulsar which was misbranded as follows:
502(a)-the labeling of the article, including the designation "Nulsar," the
statement " 'Nulsar-6' Tablets are most helpful in stomach and duodenum
conditions that need a highly absorbent coating over any painful lesions or
areas," appearing on the carton, and the statements in the accompanying
labeling, were false and misleading since such labeling, when viewed in the
setting in which used, represented and suggested that the article was adequate
and effective in the treatment of ulcers in humans and in the treatment of
stomach and duodenum conditions that need a highly absorbent coating over
painful lesions and areas, whereas the article was not adequate and effective
in the treatment of such conditions.
The complaint alleged also that if the defendants were forced by an injunc-
tion to refrain from using the above-mentioned labeling on interstate shipments
of the article, the defendants would not discontinue interstate distribution of
the article but would, unless enjoined, continue to ship the article in interstate
commerce without labeling stating the conditions and purposes for which the
article was intended; and that in such case, the article would be misbranded
under 502(f) (1) in that its labeling would fail to bear adequate directions for
.use, because of the omission from the labeling of statements of the conditions
and purposes for which the article was intended.
DISPOSITION : On 4-26-57, a temporary restraining order was issued against
the defendants. On 5-14-57, the defendants having consented, a decree of
permanent injunction was entered enjoining the defendants against using the
names, "Nulsar," " 'Nulsar-6' " "Nulsar Drug Laboratories," or "Nulsar Prod-
ucts Company," in any capacity in interstate commerce, and against introducing
and delivering for introduction into interstate commerce the article of drug
designated as "Nulsar," and against causing the introduction or delivery for
introduction into interstate commerce of Nulsar or any article of similar com-
position which-
(1)?is accompanied by the above-mentioned accompanying labeling, or any
written, printed, or graphic matter substantially to the same effect;
(2)?bears or is accompanied by written, printed, or graphic matter which
suggests use of the article in the treatment of ulcers, or which contains the
false and misleading representations referred to above, or which is otherwise
false and misleading; or
(3)?does not have labeling that clearly states every disease, condition,
symptom, and purpose for which the article is intended to be used and for
which it is represented by any means to the public.
5495. Smylax tablets, Smylax tonic, and Ardine tablets.    (Inj. No. 313.)
COMPLAINT FOR INJUNCTION FILED : 6-25-57, N. Dist. 111., against Alexander P.
McArthur, t/a Smylax Co. and Ardine Co., Chicago, 111.
ACCOMPANYING LABELING: (Smylax tablets and Smylax tonic) Leaflets entitled
"Smylax Tonic Good For Many Ailments * * * Why Grow Old? Be Age-
less-Defeat Time Forget The Calendar" and "A Hidden Secret Disclosed";
(Ardine tablets) leaflets entitled "Ardine For Feminine Hygiene and Health"
and "Ardine For Ideal Feminine Hygiene and Health" and a booklet entitled
"Ardine * * * A Boon To Happy Womanhood."
CHARGE : The complaint alleged that the defendant was engaged in the business
of distributing and selling Ardine tablets, consisting of chloramine T, starch,
and sodium bicarbonate; Smylax tablets, consisting of an extract of sarsapa-
rilla root and powdered licorice; and Smylax tonic, consisting of sarsaparilla
extract and flavoring in a simple sirup; and, further, that the defendant had
been causing the introduction and delivery for introduction into interstate com-
merce of such articles which were misbranded as follows:
Smylax tablets and Smylax tonic. 502(a)-the labeling of the articles con-
tained false and misleading representations that the articles were adequate
and effective treatments for retarding old age; overcoming the lack of hormones
in the body; enabling one to keep alive and healthy for a longer life; feeding
the glands; overcoming emotional, physical, sexual, and mental difficulties;
overcoming a condition of tired muscles, starving nerves, impaired blood circu-
lation, and low resistance to infection; providing vitality; overcoming skin
eruptions, general debility, muscle cramps, infections, poisons, head pains,
sinus infection^ a condition of poisoned blood stream, skin disease, chronic
rheumatism, and scrofula; providing a gland food to enable the glands to
produce testosterone, progesterone, and cortisone; overcoming angina pectoris,
ringworm, psoriasis, and other skin ailments, arthritis, rheumatic fever, pros-
tate gland weakness, menstrual difficulties, menopausal difficulties, nervous
headaches, hot flashes, menstrual cramps, emotional upsets, depression, and
allergic difficulties; preventing softening of the bones, diabetes, high blood
pressure, and heart attacks; and providing good health.
Ardine tablets. 502(a)-the labeling of the article contained false and mis-
leading representations that the article was an adequate and effective treat-
ment for providing good health and happiness; enabling one to retain youth,
beauty, and vigor; providing a complete germicidal power that will kill all
germs and bacteria and remain effective for such purposes for several hours
when placed in the vagina; preventing infection, including gonorrhea; and
overcoming pyorrhea, ringworm, eczema, and leucorrhea.
DISPOSITION : On 6-28-57, after a hearing at which the defendant appeared, the
court entered a preliminary injunction. On 8-8-57, the defendant having
failed to answer or otherwise plead to the complaint, a default decree of per-
manent injunction was entered against the defendant enjoining him against
commission of the acts complained of.