1246. Adulteration and misbranding of Sea-Sol, and misbranding of various other
drugs. V. S. v. 91 Bottles of West's Imported Sea Vegetable Tablets, etc.
Consent decree of condemnation. Products ordered released under bond
for relabeling. (F. D. C. Nos. 9608, 9900. Sample Nos. 13926-F to 13935-F,
incl., 14804-F, 14811-F to 14816-F, incl., 14820-F to 14827-F, incl.)
On March 29 and May 12, 1943, the United States attorney for the Southern
District of California filed libels against the following products, located at Los
Angeles, Calif., and packed in bottles of various sizes: 130 bottles of West's Im-
ported Sea Vegetable Tablets; 223 bottles of Sea Vegecene (Powder); 226 bottles
of Ocean Lax Tablets; 140 bottles of Sodeom Tablets; 63 bottles of Sea-V-Aid
Tablets; 118 bottles of Sea-Vo-Kra tablets; 116 bottles of Imported Sea Vege-
tables Vitaminized with added Vitamin 'A,' in tablet form; 99 bottles of FYA
Tablets; 201 bottles of D-X Tablets; 16 bottles of Sea-Soi; and 78 bottles of
Kalseom Tablets. It was alleged in the libels that the articles had been snipped
between the approximate dates of February 17, 1942, and January 23, 1943, by
Mineralized Foods, Inc., Baltimore, Md.
Examination of West's Imported Sea Vegetable Tablets disclosed that they
contained seaweed; and that they yielded approximately 29.5 percent inorganic
constituents, including, per tablet, 1.2 milligrams of iodine, 43 milligrams of cal-
cium, 6 milligrams of magnesium, 17 milligrams of phosphorus, and 0.3 milli-
gram of iron. The article was alleged to be misbranded because of false and mis-
leading statements on the bottle label and in a circular entitled, "West's Imported
Sea Vegetables," which represented, suggested, and implied that there exists in
the ordinary foods consumed a substantial deficiency in the mineral elements
supplied by the article, which deficiency would result in the various disease condi-
tions named and suggested in the labeling, i. e., arteriosclerosis, apoplexy, high blood
pressure, premature aging, intestinal catarrh or inflammation, constipation, some
forms of eye trouble, skin eruptions, sensitive nerves, irritability, bad temper, a
listless, tired feeling, kidney diseases, rheumatism, arthritis, neuritis, tardy
glandular functioning, slow child growth, goiter, thyroid disturbances, dry skin
and falling hair, anemia, faulty metabolism, poor teeth, delayed coagulation of
blood, rickets, weak bones, stiff joints, hardening of the arteries, acidosis, faulty
elimination, and diuresis; that use of the article would prevent or correct those
disease conditions; and that the article was of nutritional and therapeutic value
because of the presence of sodium, potassium, and magnesium.
Examination of the Sea Vegecene (Powder) disclosed that it consisted essentially
of a mixture of dried and powdered seaweed, containing, in each level teaspoonful
(2.35 grams), approximately 3 milligrams of iodine, 1.5 milligrams of iron, and 4.0
milligrams of phosphorus. It was alleged to be misbranded because of false and
misleading statements on its label which represented and suggested that the article
was of nutritional significance because of the presence of iron, sodium, and phos-
phorus, as well as other unnamed minerals.
Examination of the Ocean-Lax disclosed that it consisted essentially of dried
plant material including rhubarb and seaweed; and that it yielded, per tablet,
approximately 0.3 milligram of iodine. It was alleged to be misbranded because
of false and misleading statements on the jar label and in a circular entitled, "Are
You Occasionally Constipated?", which represented, suggested, and implied that
the article was appropriate for food purposes; that its laxative ingredients were
derived from the ocean; that the alkalinity and amount of minerals supplied by the
article were consequential; and that the use of the article as directed would be
effective in the prevention of simple goiter, arteriosclerosis, apoplexy, and high
blood pressure; that it would cleanse the alimentary canal of poisonous wastes;
that it would alkalize the digestive tract, supply iodine to the system, stimulate
intestinal activity, retard premature aging, and increase the intake of essentia^
food minerals. It was alleged to be misbranded further (1) in that the label railed
to reveal the material fact that the sea plants and peppermint leaves in the article
did not contribute to its laxative effects; and (2) in that the label did not show
that the only active ingredients in the preparation were senna pods, purging cassia,
and rhubarb root.
Examination of the Sodeom disclosed that it contained dried and powdered sea-
weed, calcium phosphate with small amounts of calcium carbonate, and starch;
and that it yielded approximately 39.6 percent inorganic constituents, including,
per tablet, 0.7 milligram of iodine. The article was alleged to be misbranded be-
cause of false and misleading statements on the jar label and in a circular entitled,
"Introducing 'Sodeom' from the Ocean," which represented, suggested, and im-
plied that the article was of nutritional significance because of the presence of
sodium; and that it was of value in treating and preventing arthritis, neuritis,
rheumatism, acidosis, and other nutritional deficiency conditions, throbbing,
aching pain in the hands, shoulders, legs, and back, nervous, sleepless nights,
kidney stones, rheumatic fever, and premature aging.
Examination of the Sea-V-Aid disclosed that it contained vegetable tissue, in-
cluding seaweed, and yeast; and that it yielded approximately 26 percent in-
organic constituents, including 0.6 milligram of iodine per tablet. It was alleged
to be misbranded because of false and misleading statements on the bottle label
and in a circular entitled, "Are You A Victim of Nerves?," which represented,
suggested, and implied that the article was of nutritional value because of the
presence of minerals; that it would prevent or correct jumpy, snappy nerves, nerv-
ous condition due to dietary deficiency, premature aging, arteriosclerosis, apoplexy,
high blood pressure, and pellagra; and that the principal ingredients of the article
were derived from the sea.
Examination of the Sea-Vo-Kra disclosed that it contained dried, powdered
okra and dried seaweed; and that it yielded approximately 27.1 percent inorganic
constituents, including 0.7 milligram of iodine per tablet. It was alleged to be
misbranded in that the statements on the jar label and in a circular entitled,
"Even Though You Have Ulcers of the Stomach or Intestines," which represented,
suggested, and implied that the article was of value in the prevention or treatment
of ulcers, and that it was of nutritional value as a source of food minerals and
vitamins A, B, C, and D, were false and misleading since the article was not of
value in the prevention or treatment of ulcers, was not of value as a source of
food minerals, with the exception of the extent to which it may have provided a
supplementary source of iodine, and was not a consequential source of vitamins
A, B, C, and D.
Examination of the Imported Sea Vegetables Vitaminized with added Vitamin
'A' disclosed that the article contained dried seaweed; and that it yielded 43 per-
cent inorganic constituents, including 0.6 milligram of iodine per tablet. It was
alleged to be misbranded because of false and misleading statements on the jar
label and in a circular entitled, "Watch Out! Beware of Night Blindness!,"
which .represented, suggested, and implied that there exists in the ordinary foods
consumed a substantial deficiency in the mineral and vitamin elements supplied
by the article, which deficiency would result in the various disease conditions
named and suggested, i. e., sinus conditions, colds, mucus and catarrhal infections,
night blindness, poor vision, arthritis, premature aging, arteriosclerosis, apoplexy
and high blood pressure; and that use of the article would prevent or correct
those disease conditions.
Examination of the F Y A Tablets disclosed that they contained dried seaweed,
small quantities of calcium carbonate, starch, powdered cinnamon, sucrose, and
coloring; and that they yeilded approximately 43.7 percent inorganic constituents,
including 0.6 milligram of iodine per tablet. The article was alleged to be mis-
branded because of false and misleading statements on the jar label and in a
circular entitled, "Invitation to the Waltz * F Y A For Men and Women past
40," which represented, suggested, and implied that there exists in the ordinary
foods consumed a substantial deficiency in the mineral elements supplied by the
article, which deficiency would result in premature aging, weakness of the glandu-
lar system, arteriosclerosis, apoplexy, high blood pressure, and physical slow-
down; and that use of the article would prevent or correct those disease cond"'
tions.
Examination of the D-X Tablets disclosed that they contained seaweed and
other plant material; and that they yielded approximately 23.7 percent inorganic
:onstituents. The article was alleged to be misbranded in that the statements
n the bottle label and in a circular entitled "Diabetes?," which represented,
ggested, and implied that inadequacies in the mineral content of foods ordinarily
:onsumed are responsible for the development of diabetes, and that use of the
irticle would prevent or cure this disease, were false and misleading since diabetes
s not a deficiency disease resulting from inadequacies in mineral intake, and con-
lumption of the article would not effect the results stated or implied in the labeling.
Examination of the Sea-Soi disclosed that it contained soy beans, dried sea-
veed, and sugar, and that it yielded approximately 3.6 percent of inorganic
;onstituents containing, per 2 ounces, 170 milligrams of phosphorus, 3.5 milli-
grams of iron, and 5 milligrams of iodine. It was alleged to be adulterated in
;hat its strength differed from that which it was represented to possess, "18 milli-
grams food iron-more than the full minimum daily adult requirement," per 2
ounces. The article was alleged to be misbranded because of false and mislead-
ng statements on the bottle label and in a circular entitled, "Nervous . . .
Anemic? Sea-Soi?," which represented, suggested, and implied that use of the
irticle in accordance with the directions for use would prevent or correct short-
ness of breath, rapid heart palpitation, flabby flesh, pale skin, a tired feeling,
sxcessive weight, irritability and supersensitivity, disturbance in the stomach,
gastric secretions, lack of aggressiveness and ambition, chlorosis in adolescent
girls, lassitude, capricious appetite, indigestion and constipation, a general run-
down condition, underweight, iron deficiency, sinus conditions, colds, mucus and
catarrhal conditions, rheumatoid arthritis, beriberi, loss of appetite, general
debility, premature graying, scurvy, anemia, pyorrhea, rheumatoid fever, rickets,
bone deficiencies, calcium deficiency, metabolism, arteriosclerosis, apoplexy, and
high blood pressure; and that the pincipal ingredients of the article were derived
from the sea and soy beans.
The article known as Kalseom Tablets was labeled in part: "Kalseom * * *
Consists of Imported variety of Sea Vegetables * * * carefully blended
with Bone Calcium Phosphate fortified with Vitamin 'C (Ascorbic Acid) and
Vitamin D (Ergosterol)." The article was alleged to be misbranded because of
false and misleading statements on the bottle label and in a circular entitled "Can
This Be True?," which represented, suggested, and implied that there exists in
the ordinary foods consumed a substantial deficiency in the mineral elements
supplied by the article, which deficiency would result in tuberculosis, asthma,
hay fever, allergy, headaches, skin eruptions, gastric, muscular, and nervous
disturbances, weak pulse, poor digestion, poor teeth, and brittle fingernails; and
that use of the article would prevent or correct those conditions.
Misbranding of all of the articles and adulteration of the Ocean-Lax and Sea-
Soi were also alleged under the provisions of the law applicable to foods, as reported
in the notices of judgment on foods.
On August 10, 1943, Mineralized Foods, Inc., claimant, was granted its motion
for the removal of the libel proceedings to a district of reasonable proximity to
the city of Baltimore, Md. On October 7, 1943, the cases having been transferred
to the District of Columbia, an order having been entered for their consolidation,
and the claimant having consented to the entry of a decree, judgment of condem-
nation was entered and the products were ordered released under bond for relabel-
ing under the supervision of the Food and Drug Administration.