-3974. Misbranding of Elip tablets.   U. S. v. 216 Boxes, etc.   (F. D. C. No. 33230.
Sample No. 37623-L.)
_LIBEL FILED :    May 8,1952, Eastern District of New York.
ALLEGED SHIPMENT :   On or about February 11,1952, from Newark, N. J.
PRODUCT : 216 boxes, each containing 12 tablets, of Elip tablets, together with
a number of empty boxes labeled, in part, "Elip Tablets" and a number of
leaflets headed "Elip The Only Internal Pile Remedy," at Freeport, N. Y.,
in the possession of the Elip Distributing Corp.
Analysis showed that the product consisted of sulfur, rhubarb, and a
tartrate.
.BEsmyrs OF INVESTIGATION : The product was part of a bulk shipment of 120,000
tablets which had been made from Newark, N. J., to Baldwin, N. Y., from
where a portion of this shipment was transported to Freeport, N. Y., and
was packaged into boxes by the Elip Distributing Corp.
.NATURE OF CHAEGB: Misbranding, Section 502 (a), the statement "Elip Bead
Backward Spells Pile" appearing on the box label was false and misleading
since the statement represented and suggested that the article was an adequate
and effective treatment for piles, whereas such was not the case; Section 502
(e) (2), the label of the article failed to bear the common or usual name of
each active ingredient since its label failed to declare the presence of rhubarb;
and, Section 502 (f) (2), the labeling of the article failed to bear such ade-
quate warnings against unsafe dosage and duration of administration, in such
manner and form, as are necessary for the protection of users since the article
was essentially a laxative and its labeling failed to warn that frequent or con-
tinued use, or use in accordance with the directions "Take 3 tablets with water
the first night then 2 tablets every night thereafter," may result in establish-
ment of dependence upon laxatives to move the bowels.
Further misbranding, Section 502 (a), the following statements in the above-
mentioned leaflets accompanying the article were false and misleading: "The
only internal pile remedy * * * what are piles? Hemorrhoids or piles
are actually coils of dilated veins occuring inside or outside the rectal mucous
membrane. The causes of piles are many and varied but the most common one
is constipation. What does Blip do for pile.s? The astringent action of Elip
gently shrinks the mucous membrane of the rectum which promptly relieves con-
gestion and promotes healing of the affected parts. Elip contains no harmful
ingredients, and as a result is highly recommended by physicians." The state-
ments represented and suggested that the article was an adequate and effective
treatment for piles and that it was harmless. The article was not an adequate
and effective treatment for piles and was capable of causing dependence upon
laxatives to move the bowels and, in case of appendicitis, of causing rupture of
the appendix.
The article was misbranded in the above respects while held for sale after
shipment in interstate commerce.
DISPOSITION: January 28, 1953. Default decree of condemnation and
destruction.