28296. Coldene vitamin tonic with iron.   (F.D.C. No. 45764.   S. No. 82-805 R.) 
QUANTITY :    400 cases, each containing 2 display ctn., each of which contained
6 individually ctnd. btls., at New York, N.Y.
SHIPPED :   Prior to September 1960, from Cranbury, N.J., by Pharma-Craft Corp.
LABEL IN PART: (Btl. & btl. ctn.) "Coldene Vitamin Tonic with Iron * * * 
giving therapeutic amounts of vitamins important to supplement the diet of 
those in run-down conditions.   Especially indicated for use in convalescence
from colds, flu and similar illness. Each fluid oz. (2 Tablespoonfuls) con- 
tains: * * * Riboflavin (B2) 4 mg. * * * Pharma-Oraft Corporation, Distrs. 
Cranbury, N.J."
ACCOMPANYING LABELING:    Leaflet entitled "Coldene Liquid Cold Medicine."
RESULTS OE INVESTIGATION : Analysis showed that the article contained approxi- 
mately 68 percent of the declared amount of riboflavin.
LIBELED:   5-8-61, S. Dist. N.Y.
CHARGE: 402(b) (1)—when shipped and while held for sale, the valuable con- 
stituent, riboflavin, had been in part omitted or abstracted from the article; 
403(a)—the label statement "Each fluid oz. contains: * * * Riboflavin (B2) 
4 mg." was false and misleading as applied to an article which contained less 
than the declared amount of riboflavin; the statements "M.D.R. for Niacin- 
amide * * * not established," and "Need in human nutrition for * * * Me- 
thionine is not established," were false and misleading since they were contrary 
to fact; and 403(j)—the article purported to be and was represented as a 
food for special dietary use by reason of its vitamin and mineral content and 
its label failed to bear, as required by regulations, a statement of the propor- 
tion of the minimum daily requirement for vitamins Bi and B2, and niacin- 
amide and for iron supplied by such food when consumed in a specified quan- 
tity during the period of one day.
The libel alleged also that the article was misbranded under the provi- 
sions of the Act relating to drugs as reported in notices of judgment on drugs 
and devices, No. 6806.
DISPOSITION :    7-6-61.   Default—destruction.