1566. Misbranding of Pso-Ridisal. IT. S. v. 1,233 Dozen Bottles of Pso-Ridisal
(and 2 other seizure actions agrainst Pso-Ridisal). Consent decree of
condemnation.    Product   ordered   released  under   bond.     (F.   D.   C.   Nos.
13314, 13415, 13627.    Sample Nos. 81350-F, 81385-F, 81399-F.)
LIBELS FILED : Between the approximate dates of August 11 and September 11,
1944, Western District of Missouri; amended libels filed on or about September
12,1944.
ALLEGED SHIPMENT : Between the approximate dates of April 19 and August 29,
1944, by the Nu-Basic Product Co., from Royal Oak, Mich.
PRODUCT :   1,302? dozen bottles of Pso-Ridisal at Kansas City, Mo.   Analyses of
?   samples disclosed that the product consisted essentially of sulfanilamide,
carbolic acid, mineral oil, and water.
NATURE OF CHARGE: Misbranding, Section 502 (a). The legend "A Sulfa Drug
Compound" and the designation "Pso-Ridisal," appearing on the label of the
article, were false and misleading since they implied that the article would be
effective for ridding the user of psoriasis, by reason of its content of sulfanila-
mide, whereas it would not be so effective. The label statement, "This prepa-
ration is intended * * * to soothe the * * * irritation and discom-
fort resulting from such skin diseases as Psoriasis, Dermatitis, Eczema, * * *
Athlete's Foot and Dandruff, and to assist in removing * * * unsightly
lesions, was false' and misleading because the article would not be effective
to soothe the irritation and discomfort resulting from psoriasis, dermatitis,
eczema, athlete's foot, and dandruff, or to assist in removing unsightly lesions.
The label statement, "Warning Initial application should be confined to a
small area of the body to permit comparison between treated and untreated
parts. Should undesirable reaction occur, discontinue use immediately and
consult your physician. Use only as directed," created the misleading impres-
sion that the only potentially harmful effect the article might have was the
causing of a visible or otherwise recognizable reaction on the small area of the
body treated, and it failed to reveal the fact, material in the light of such repre-
sentation, that use of the article might sensitize the user to sulfonamides so
as to preclude their subsequent use, including their use in serious disease
The legend appearing on the label, "A Sulfa Drug Compound," was misleading
since it created the impression that sulfanilamide was the only pharmacologi-
cally active component of the preparation, whereas the preparation also con-
tained carbolic acid and mineral oil, which are pharmacologically active.
Further misbranding, Section 502 (e) (2), the label of the article failed to
bear the common or usual name of the active ingredient, carbolic acid; Section
502 (f) (1), its labeling failed to bear adequate directions for use in the
treatment of impetigo, for which purpose the article was offered, since the label
statement,   "Directions   This  preparation   is   intended   *    *    *   to   soothe
*?*   *   irritation   and   discomfort  resulting  from   such  skin  diseases   as
*?* * Impetigo * * * Shake well before using and then apply locally
by a gentle finger massaging of affected parts," did not constitute adequate
directions for use of the article in the treatment of impetigo; and, Section 502
(f) (2), the article contained sulfanilamide and its labeling failed to bear a
warning that its use should be discontinued if the skin condition under treat-
ment became worse, if a new rash appeared, or if the patient developed a fever
or any other indication of illness, and that the article might sensitize the user
of sulfonamides so as to preclude their subsequent use, including their use in
serious disease conditions.
DISPOSITION : The Nu-Basic Product Co. appeared as claimant and filed a motion
to dismiss on the ground that a libel proceeding was pending in another district
based upon the same misbranding as alleged in the instant actions, and that
there had been no prior judgment in favor of the Government which would .
authorize multiple seizures of the product. The motion was subsequently
overruled with the filing of amended libels which incorporated the allegations
that the labeling had been found by the Commissioner of the Food and Drug
Administration to be in a material respect misleading to the injury or damage
of the purchaser or consumer of the product, and that an article of like com-
position and substance to the product, and labeled and branded almost exactly,
had been previously the subject of a libel action which resulted in the con-
demnation of the article for having been misbranded. Thereafter, the cases
were consolidated and removed for trial-to the Northern District of Illinois,
and on May 28, 1945, the claimant having admitted the facts in the libels,
judgment of condemnation was entered and the product was ordered released
under bond for relabeling under the supervision of the Food and Drug
Administration.
DRUGS ACTIONABLE BECAUSE OF CONTAMINATION WITH FILTH