1041. Misbranding of Vitaminerals VM No. 1, VM No. 150, VM 100, VM 120,
and VM No. 204 Pneumatic Dilator. U. S. v. John Francis Gorman (Vita-
minerals Co.). Plea of nolo contendere. Fine, $1,000 on 2 counts, and
?J??ation *?*. i*ye,ar on^3 c?i??*S' (F. D. C. No. 8791. Sample Nos. 81451-E,?81453-E to 81455-E, incl.)
On April 30', 1943, the United States attorney for the Southern District of
California filed an information against John Francis Gorman, trading as the
Vitaminerals Co., Los Angeles, Calif., alleging shipment on or about May 5,
1942, from the State of California into the State of Colorado of a quantity of
the above-named products which were misbranded.
Examination of Vitaminerals VM No. 1 disclosed that this article was in the
form of orange-colored tablets containing a large proportion of rhubarb root
tissues together with Irish moss tissues (Chondrus), okra tissues, cranberry fruit
tissues, parsley leaf tissues, and acid-insoluble material. It was alleged to be
misbranded in that the statements in its labeling which created in the mind
of the reader the impression that the article was a supplement in the dietary
treatment of constipation; that the ingredient rhubarb root was a food; and
that the article derived its physiological activity principally from concentrates
and extracts from common vegetables used for food purposes, and from vitamins,
were misleading since the article was not a supplement in the dietary treatment
of constipation, but was a laxative drug; the ingredient rhubarb root is not a
food but is a drug; and the article did not derive its physiological activity
principally from concentrates and extracts from common vegetables used for
food purposes, and from vitamins, but derived its physiological activity princi-
pally from the plant drug rhubarb. It was alleged to be misbranded further (1)
in that the statements in its labeling which represented and suggested that the
article would be efficacious as a dietary treatment of constipation; that it
possessed anti-infective value; that it would be an efficacious tonic treatment
for the smooth muscle; that it would facilitate the changing of the colonic flora
so as to reduce the colonic bacilli count and the resulting inflammation of the
colonic mucosa; that it would promote peristaltic activity, and act practically
in the treatment of constipation; that it would produce normal elimination; that
it would be efficacious in the primary treatment of hemorrhoids; and that it
would be efficacious in the secondary treatment of arthritis due to excess calcium,
and arthritis due to systemic origin, colds, neuralgia, neurosis, obesity, and
tonsilitis were false and misleading since the article would not be efficacious
for the purposes recommended or accomplish the results claimed; (2) in that
the name "Vitamineral" was misleading since the name suggested and created
the impression in the mind of the reader that the article derived its physiological
activity solely from vitamins and minerals and contained no other physiologi-
cally active ingredient, whereas the article contained rhubarb root, from which
it derived its principal physiological activity; and (3) in that the statements
in its labeling, "Ash (Mineral matters*) 22.20?," and "Mineral Matter includes:
Calcium 2.18? Phorphorus 0.84? Potassium 1.15? Sodium 0.67? Mag-
nesium 0.34? Chlorine 0.03? Sulphur 0.51? Manganese 0.0023? Iron
0.115? Copper 0.0013? Iodine 0.002?," were misleading since those state-
ments suggested and created the impression in the mind of the reader that
the article contained the minerals listed therein in amounts which, when taken
in accordance with directions on the label, "Two to four tablets, one or two
before breakfast and upon retiring," would furnish the minerals in quantities
sufficient to contribute in an important respect to the daily requirements of the
body for those minerals, whereas the article, when taken according to the
directions, would not furnish such quantities of the minerals because the article
contained inconsequential amounts of potassium, sodium, chlorine, magnesium,
sulfur, manganese, and copper; and 4 tablets, the maximum amount recom-
mended in the directions, would furnish less than one-thirtieth the minimum
daily requirement of the body for phosphorus, less than one-tenth the minimum
daily requirement for calcium, less than one-fifth the minimum daily requirement
for iodine, and less than one-third the minimum daily requirement for iron.
Analysis of Vitaminerals VM No. 150 showed that it consisted of a brownish-
yellow, perfumed ointment containing benzocaine. It was alleged to be mis-
branded (1) in that the statements in its labeling, "fortified with 8? Benzocaine
Benzoate and Benzocaine," were false and misleading since the article contained
no benzocaine benzoate and not more than 5.19 percent of benzocaine; (2) in that
the statements in the labeling which represented and suggested that the article
would be efficacious in the treatment of skin conditions, wounds, burns, hemor-
rhoids, ear infections, and tetany were false and misleading since the article
would not be so efficacious; and (3) in that the name "Vitaminerals" was
misleading since that name suggested and created the impression in the mind
of the reader that the article derived its physiological activity solely from
vitamins and minerals, whereas it derived its physiological activity from the
physiologically active drug benzocaine.
Examination of the Pneumatic Dilator disclosed that this device was com-
posed of 2 red rubber bulbs connected to each other through a one-way valve,
and then through a foot of black rubber tubing to a steel tube partly covered
with soft white rubber. This steel tube was equipped with a protective hard
rubber or plastic cap at one end and a hard rubber or plastic, flanged shield
near the other end in such a manner that the intervening portion of steel
tubing was completely covered with the soft white rubber. This rubber covering
could be inflated to a diameter of at least 2 inches by squeezing the first rubber
bulb several times. The second rubber bulb produced a further inflation when
compressed and was equipped with a release valve allowing for complete
deflation when desired. The device was packed in a box containing 1 dozen
white rubber finger cots and 1 jar of VM No. 150. The device was. alleged to
be misbranded because of the false and misleading statements in its labeling
which represented and suggested that the device would be an efficacious and
appropriate treatment for external and Internal hemorrhoids, thrombotic type
of simple varicosities with or without ulceration, prolapsed varicosities, benign
anal strictures, post-operative or post-injection strictures, spastic anal sphincters
associated with inflammatory conditions of the intestinal tract, and with
fissures, cryptitis, anal ulcers, anal excoriations, anal dermatosis, neurological
conditions, genito-urinary conditions (prostatitis, uterine retroflexion, cervicitis,
endometritis), pruritis and associated conditions, spastic constipation, also
vaginismus, vaginodynia, prostatic disorders, spastic sphincters, proctitis, and
other pathologies of the anorectal region; that the device was rapidly sup-
planting manual dilation, divulsion, and the use of solid or semi-solid dilators
and digital prostatic massage; that the device would eliminate many unsatis-
factory operations which are painful and injurious to inflamed tissues; that it
would be efficacious to increase local metabolism and neuromuscular function;
that it would bring about rapid healing, and would help progressively to
re-establish normal physiological action in the rectum, anus, and contiguous
structures; and that it would be an efficacious and appropriate treatment or
prevention of nervous headaches, spastic colitis, low back pain or lumbago,
biliousness, indigestion, dysmenorrhea, sciatica, lumbo-sacral soreness, nervous-
ness, and neurasthenia.
Analysis of Vitaminerals VM 100 Vaginal Suppositories disclosed that the
article consisted of plain gelatin capsules containing a mineral substance com-
posed largely of sulfate, aluminum, acid-insoluble matter, and ferric iron, along
with a small amount of ferrous iron and a possible trace of phosphate. It
was alleged to be misbranded in that the statement in its labeling, "containing
ferric sulfate, ferrous sulfate, and ferric phosphate," was false and misleading
since it represented and suggested that the article contained significant amounts
of ferric sulfate, ferrous sulfate, and ferric phosphate, and that it contained no
aluminum sulfate, whereas the article contained no ferric sulfate or ferrous
sulfate, and an insignificant proportion of ferric phosphate, and did contain a
material amount of aluminmn sulfate. It was alleged to be misbranded further
because of false and misleading statements in its labeling which represented
and suggested that the article would be efficacious to produce toning and
granulation of new tissues; that it would cause pathological tissue to slough
with every indication of a natural reaction, leaving no scar tissue; that it was
an efficacious and appropriate treatment for endocervicitis, endometritis, vagi-
nitis, polypus-vaginal and uterine, cysts, leucorrhea, dysmenorrhea, and ame-
norrhea ; that it would be efficacious in the treatment of abnormal tissue
growths; that it would be an efficacious and appropriate treatment in cases of
hemorrhage; and that it was an efficacious and appropriate primary treatment
for uterine cramps, dementia, and deficient menstruation.
Analysis of Vitaminerals VM 120 disclosed that it consisted of an acidic, aque-
ous solution containing sulfate, aluminum, glycerin, ferric iron, and a trace of
ferrous iron. It was alleged to be misbranded in that the statements in its
labeling, "An Astringent and detergent liquid concentrate containing Ferric Sul-
phate derived from natural sources," and "Ferric Sulphate, Ferrous Sulphate and
Ferric Phosphate," were false and misleading, since those statements repre-
sented and suggested and created the impression in the mind of the reader that
the article contained ferric phosphate and derived its astringent properties solely
from ferric sulfate, ferrous sulfate and ferric phosphate, whereas the article con-
tained little, if any, ferric phosphate, and did not derive its astringent properties
solely from ferric sulfate, ferrous sulfate and ferric phosphate, but did contain a
large amount of aluminum sulfate, from which its astringent properties were
largely derived. It was alleged to be misbranded further because of false and
misleading statements in its labeling which represented and suggested that the
article would be efficacious to build tone and resistance to infection; that it would
produce results in various colon disorders, and would combat colitis and other
complicated diseases; that it would be efficacious in the treatment of stomatitis,
tonsilitis, and kindred infections of the throat, pyorrhea and trench mouth; that
it would be efficacious as a nasal douche in the treatment of nasal congestion,
head colds, sinus, and like infections; that it would be efficacious as an eye
wash to produce a soothing and healing action on the delicate membrane of the
eye; that it would be efficacious in the prophylaxis of pterygium and in the
treatment of local infections of the ear canal, cuts, sores, open wounds, ulcers,
burns, and similar conditions, indicated by the abbreviation "etc."; that it
would be efficacious in .relieving inflammation, reducing pain, and restoring
normal tissues in hemorrhoid cases, and would bring prompt relief and promote
rapid healing in gastric ulcers; that the article would serve as a general body
tonic; that it would be efficacious when administered orally in the primary
treatment of albuminuria, anemia, cramps, diarrhea, enteritis, excessive men-
struation, gastritis, uterine hemorrhage, influenza, intestinal disorders, kidney
disorders, kidney inflammation, disorders of the liver, such as catarrhal gall
ducts, cirrhosis (alcoholic) and enlargement, malaria, nausea and vomiting,
orchitis, lack of resistance, tentany, duodenal, gastric, stomach, and peptic ulcers,
intestinal ulcers, and tape and helminth worms; that it would be efficacious when
used topically in the primary treatment of acne, boils, exzema, empyema, and
hives; that the article would be efficacious in the primary treatment by pack
method of hemorrhages, including uterine hemorrhages; that it would be
efficacious, when used as directed, in the primary treatment of ameba, amenorrhea,
calcium in lenses, catarrh, corneal ulceration, uterine cramps, cystitis, dysmenor-
rhea, ear infections, endocervicitis, endometritis, eye infections, fistula, hemer-
alopia, impetigo, keratomalacia, laryngitis, leg ulcers, leukorrhea, excessive,
deficient and painful mentruation, miscarriage, opthalmia, vaginal and uterine
polypus, rectal polypus, prostatitis, proctitis, psoriasis, respiratory infections,
shingles, skin disorders, sty, loose teeth, uterine prolapse, vaginitis, varicose
ulcers, varicose veins, and xerophthalmia; and that it would be efficacious, when
used orally, in the secondary treatment of acidosis, alcoholic neuritis, ameba,
angina pectoris, asthenia, asthma, boils, Bright's disease, calculi of the bladder
and kidneys, faulty digestion, eczema, gall bladder inflammation, gallstones,
gastro-intestinal disturbances, hay fever, hemophilia, biliary stasis of the
liver, engorgement and jaundice of the liver, lymph infections, mal-petit-grand,
malnutrition, nausea and vomiting of pregnancy, neurasthenia, old age, septi-
cemia, and tuberculosis.
All of the articles were alleged to be misbranded further in that the state-
ment in their labeling, "We hereby guarantee that all Vitamineral products
listed herein are not adulterated or misbranded within the meaning of the
Federal Food, Drug, and Cosmetic Act of June 25, 1938," was false and mislead-
ing, since the articles were misbranded within the meaning of that Act.
The information alleged in count 1 that the product "Vitaminerals VM No. 1"
was also misbranded under the provisions of the law applicable to foods, re-
ported in notices of judgment on foods.
On September 27, 1943, the defendant having entered a plea on nolo con-
tendere, the court imposed fines of $500 on count 1 of the information, which
involved charges against the Vitaminerals VM No. 1 both as a food and a drug,
and $500 on count 3, which involved the drug Vitaminerals VM No. 150, and
placed the defendant on probation with respect to the remaining 3 counts which
involved the other products.