2454. Misbranding of Formalon Cream.    TJ. S. v. Daniel Piatt   (Fonnalon Com
pany).    Plea of guilty.    Defendant fined $3,000,  given suspended sen-
tence of 3 years in jail, and placed on probation for 3 years.     <F. D. C.
No. 21466.    Sample Nos. 70802-H, 12947-K, 12948-K.)
INFORMATION FILED : January 23, 1948, Southern District of New York, against
Daniel Piatt, trading as the Formalon Co., New York, N. Y.
ALLEGED SHIPMENT : From the State of New York into the States of Delaware,
California, Pennsylvania, Massachusetts, and New Jersey. The product was
shipped during March and April 1946, and January and March 1947, and a
circular letter was shipped during March, April, and November 1946, and
January and March 1947.
PRODUCT: Analysis disclosed that the product consisted of a pale-yellow
semisolid containing 27.2 mg. diethylstilbestrol in each 2 ounces. Examina-
tion showed that the circular letter contained a number of statements relating
to the efficacy of the product for the development of the breasts and pictures
of women purportedly before and after the use of the product.
LABEL, IN PAST: "Directions Apply ? teaspoon of Formalon daily to each
breast and massage gently at bedtime, or as otherwise directed by physician.
Formalon Cream."
NATURE OF CHARGE: Misbranding, Section 502 (a), certain statements and
pictures appearing in the circular letter were false and misleading. The state-
ments and pictures represented and suggested that the article would be
effective to develop the breasts of women, whereas it would not be effective for
such purposes.
Further misbranding, Section 502 (a), the before and after pictures desig-
nated "Case 5469" and the statement underneath "showing breast growth
produced after using Formalon 8 weeks" and the before and after pictures
designated "Case 1721" and the statement underneath "showing breast growth
produced after 12 weeks of applying Formalon Cream," appearing in the
circular letter, were false and misleading. The pictures and statements
represented and suggested that the pictures were pictures of women which
had been taken before and after treatment with the article, whereas the pic-
tures were pictures of women which had been taken before and after treatment
with another drug.
Further misbranding, Section 502 (f) (1), the labeling of the article failed
to bear adequate directions for use, since the directions which appeared on
the label failed to reveal the conditions for which the article was to be used.
DISPOSITION : August 4, 1948. A plea of guilty having been entered, the court
fined the defendant $3,000 and sentenced him to serve 3 years in jail. The
jail sentence was suspended and the defendant was placed on probation for
3 years, conditioned that he should not directly or indirectly engage in the
sale of drugs or food preparations of any kind, nature, or description.