2541. Misbranding: of Valens Ano-Perineal Support, ointment, and suppositories.
U. S. v. (Dr.) George Starr White. Plea of nolo contendere. Defendant
placed on probation for 4 years.    (F. D. C. No. 15496.   Sample No. 50318-F.)
INFORMATION FILED: April 24, 1945, Southern District of California, against
(Dr.) George Starr White, Los Angeles, Calif.
ALLEGED SHIPMENT : On or about January 4, 1944, from the State of California
into the State of Pennsylvania. Shipped with the drugs and device was a
circular entitled "Directions for the use of Valens Ano-Perineal Support" and
- a booklet entitled "Points in Anatomy Physiology Hygiene."
PRODUCT: The Valens Ano-Perineal Support consisted of a hard, smooth ellip-
soid suspended on a braided cord, with a belt to be worn about the waist. The
braided cord w?& designed to be attached to the belt, so that the ellipsoid would
be held in place. Its purpose was to support the anal region. The ointment
consisted essentially of zinc oxide, small proportions of a bismuth compound,
a sulfide, and volatile oils, in an oily base. The suppositories consisted essen-
tially of extracts of plant drugs in a cocoa butter base.
NATURE OF CHARGE: Valens Ano-Perineal Support. Misbranding, Section 502
(a), certain statements in the circular and booklet were false and misleading.
These statements represented and suggested that the device, when used alone
or in conjunction with the ointment and suppositories, would be efficacious in
the treatment and prevention of piles or itching anus, in preventing congestion
in the lowest-down part of the pelvis or the ano-perineal region, in the treat-
ment and prevention of fistulas and the form of neuritis known as "sciatica,"
in the treatment and prevention of severe headaches, stomach sickness, "all-
gone feeling," bloating after meals or "at any time," dizziness, forgetfulness,
lack of power to concentrate, itching of the skin on any part of the body, itching
of the pelvic parts, itching about the anus, itching about the sexual organs,
fear, melancholia, weariness after the slightest exertion, shooting pains through
the abdomen as well as through the pelvis, pains in the knees and general
feeling of fatigue, and the similar conditions indicated by the expression etc.;
that the device, when used alone or in conjunction with the ointment and
suppositories, would be efficacious in the cure, mitigation, treatment, and pre-
vention of bleeding hemorrhoids (piles), protruding piles, blind piles (piles
within the rectum), external piles, little cracks or fissures about the anus,
itching about the anus or genitals, irritability about the anus or external
genitals, constipation with a "dry stool," constipation with a mucous stool,
partial paralysis of the lower bowel, irritability of the urinary bladder, irri-
tability in the urethra with a "burning sensation" when urinating, frequent
desire to urinate, "never-get-thru" feeling after bowel movement or after urina-
tion, "crawling sensation" about the anus, buttocks, or external genitals, pains
in the pelvic nerves, especially the sciatic nerve, pains in the knees and calves
of the legs, "cold sensation" in the lower limbs, especially in the feet, varicose
veins in the lower limbs, sexual weakness and general feeling of being "all
tired out," "crotch pains" that seem to be "deep down in the bones," and pros-
tatic trouble in males and female troubles in women; that the device would
exert a helpful and natural influence on the entire alimentary tract; that it
would be an effective treatment for all troubles in the pelvis or in the sexual
organs; and that tobacco smoking and nicotine are largely responsible for
piles. The device, when used alone or in conjunction with the ointment and
suppositories, would not be efficacious for the purposes represented and sug-
gested ; furthermore, tobacco smoking and nicotine are not largely responsible
for piles.
Ointment and suppositories. Misbranding, Section 502 (b) (1), the products
were in package form and failed to bear labels containing the name and place
of business of the manufacturer, packer,.or distributor; Section 502 (b) (2),
the products failed to bear an accurate statement of the quantity of the con-
tents', since the containers bore no labels containing a statement of a quantity
of the contents; and, Section 502 (e), the products were not designated solely
by names recognized in an official compendium and were fabricated from two
or more ingredients, and they failed to bear a label containing the common or
usual name of each active ingredient.
imposition of sentence was suspended for 4 years and the defendant was placed
on probation for that period of time.