2516. Adulteration and misbranding of Millard's Triple Prescription Formula
Tablets No. 1 and misbranding: of Millard's Triple Prescription Formula
Tablets No. 2 and No. 3. U. S. v. The Millard Go. and Millard H. Krasne.
Pleas of guilty. Fines of $120 against the company and $80 against the
individual, together with costs. (F. D. C. No. 24260. Sample Nos. 68556-H,
99645-H.)
INFORMATION FILED: July 9, 1948, Southern District of Iowa, against the
Millard Co., a partnership, Council Bluffs, Iowa, and Millard H. Krasne, a
member of the partnership.
ALLEGED SHIPMENT : On or about May 21 and June 25, 1947, from the State of
Iowa into the States of Missouri and Nebraska.
PRODUCT: Analyses disclosed that the Tablets No. 1 in the May 21 shipment
were compressed white tablets consisting essentially of acetylsalicylic acid;
that the Tablets No. 2 in that shipment were brown-coated tablets consisting
chiefly of phenolphthalein and aloin; that the Tablets No. 1 in the June 25
shipment were white compressed tablets containing much less than the de-
clared amounts of caffeine and aspirin and more than the declared amount of
acetophenetidin; and that the Tablets No. 2 in the latter shipment consisted
of brown-coated tablets containing chiefly phenolphthalein, aloin, podophyllin,
and calcium carbonate. The composition of the Tablets No. 3 agreed substan-
tially with the label declaration.
LABEL, IN PART : "Tablets No. 1 * * * Contains: 5 Gr. Acetosalicylic Acid,
2 Gr. Caffeine, 1? Gr. Acetophenitidin," "Tablets No. 2 * * * Contains:
Aloin, Podophyllin, Sodium Salicylate, Ginger extract of Belladonna," and
"Tablets No. 3 * * * Contains: Carotene, Thiamin Hydrochloride, As-
corbic Acid, Riboflavin, Calcium Pantothenate, Nicotinamide, and Pyroxidine."
NATURE OF CHARGE: Tablets No. 1. Adulteration, Section 501 (c), the strength
of the tablets differered from that which they purported and were represented
to possess. The tablets purported and were represented to contain 5 grains
of acetylsalicylic acid, 2 grains of caffeine, and 1? grains of acetophenetidin,
whereas the tablets in the May 21 shipment contained less than 2 grains of
caffeine and less than iy2 grains of acetophenetidin and the tablefs in the
June 25 shipment contained less than 5 grains of acetylsalicylic acid, less
than 2 grains of caffeine, and more than l1^ grains of acetophenetidin. Mis-
branding, Section 502 (a), certain statements in the labeling of the article
which represented and suggested that each tablet contained 5 grains of acetyl-
salicylic acid, 2 grains of caffeine, and 1? grains of acetophenetidin, were
false and misleading. Further misbranding, Section 502 (a), certain state-
ments in the labeling of the article, which included an enclosed booklet
entitled "I Hope Sincerely That My Medicines Relieve Your Pains Promptly,"
were false and misleading. Such statements represented and suggested that
the article would be effective to relieve congestion; that when used in con-
junction with Tablets No. 2 and Tablets No. 3, it would be effective to
eliminate pain caused by rhematism, arthritis, neuritis, sciatica, and leg
cramp, and to improve health, vigor, and endurance; and that when used
in conjunction with Tablets No. 2, it would be effective to activate the liver,
to produce more bile, and to improve assimilation. The article would not be
effective for such purposes.
Tablets No. 2.   Misbranding, Section 502 (a), a statement in the labeling
that the article contained sodium salicylate was false and misleading, since
the article contained no sodium salicylate; and certain statements in the
labeling, which included the enclosed booklet referred to above, were false
and misleading,  since the statements  represented  and  suggested that the
' article when used in conjunction with Tablets No. 1 and Tablets No. 8 would
be effective to eliminate pain caused by rheumatism, arthritis, neuritis,
sciatica, and leg cramp, and to improve health, vigor, and endurance; that when
used alone and in conjunction with Tablets No. 1, it would be effective to
activate the liver, to produce more bile, and to improve assimilation; and
that when used with Tablets No. 8, it would be effective to maintain normal
health. The article would not be effective for such purposes. Further mis-
branding, Section 502 (e) (2), the article was not designated solely by a name
recognized in an official compendium and was fabricated from two or more
ingredients; its label failed to. bear the common or usual name of each active
ingredient since the article contained as one of its active ingredients, phenol-
phthalein, and the label failed to declare the presence of phenolphthalein;
and the article contained the alkaloids of atropine, hyoscine, and hyoscyamine,
as constituents of belladonna, and its label did not bear the name and
quantity or proportion of the said alkaloids, nor did the label bear, in lieu
thereof, the quantity or proportion of the total alkaloids contained as con-
stituents of belladonna.
Tablets No. 8. Misbranding, Section 502 (a), certain statements in the
labeling of the article, which included the above-mentioned booklet, were
false and misleading. Such statements represented and suggested that the
article when used in conjunction with Tablets No. 1 and Tablets No. 2, would
be effective to eliminate pains caused by rheumatism, arthritis, neuritis,
sciatica, and leg cramp; that when used alone and in conjunction with the
other tablets, the article would be effective to improve health, vigor, and en-
durance ; and that when used in conjunction with Tablets No. 2, it would be
effective to maintain normal health. The article would not be effective for
such purposes.
DISPOSITION: September 24, 1948. Pleas of guilty having been entered, the
court imposed a fine of $120 against the partnership and $80 against the indi-
vidual, together with costs.