2634. Misbranding of Estromone.  U. S. v. 42 Vials   *   *   *   (and 1 other seizure
action).    (F. D. C. Nos. 16027, 16378.    Sample Nos. 16233-H, 31429-H,
31442-H, 31443-H.)
LIBELS FILED:   May 23 and June 16, 1945, Northern District of Illinois and
Southern District of California.
ALLEGED SHIPMENT : Between the approximate dates of January 1 and May 10,
1945, by Endo Products, Inc., from Richmond Hill, N. Y.
PBODTJCT : Estromone. 42 vials at Chicago, 111., and 128 vials at Los Angeles,
Calif. The product was contained in 10-cc. and 25-cc. vials. Examination
snowed that it was an oil solution containing estrogenic substances consisting
essentially of estradiol, with an insignificant amount, if any, of estrone.
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements in the
labeling of the article "Estrogenic Substance Derived from Equine Urine,"
"Estrogenic Substance derived from pregnant mares' and stallions' urine,"
and "from natural sources" were false and misleading since the estrogenic
material present in the article did not consist of estrogenic substances as de-
rived from pregnant mares' and stallions' urine or from equine urine.
Further misbranding, Section 502 (e) (2), the article in the California lot
was fabricated from two or more ingredients, and its label failed to bear the
common or usual name of each active ingredient since the designation "Estro-
gens" appearing on some of the packages is not the specific name of any par-
ticular substance but is a generic name for a class of substances; and the state-
ment "Estrogenic Substance derived from pregnant mares' and stallions' urine,"
or "Estrogenic Substance Derived from Equine Urine," appearing on the re-
mainder of the packages, is not the common or usual name of the active ingre-
dients of the article.
DISPOSITION : Endo Products, Inc., appeared as claimant, and in accordance
with its request, the cases were consolidated and transferred to the Southern
District of New York. On October 19, 1948, the claimant having admitted
the allegations of the libels, judgment of condemnation was entered and the
product was ordered released under bond for relabeling, under the supervision
of the Federal Security Agency.