27642. Pharma-Caps Prenatal capsules.    (F.D.C. No. 46592.    S. No. 64-795 R.) 
QUANTITY :    1   10,000-capsule  drum,   and  35   100-capsule  btls.,   at  Oakland,
Calif., in possession of Normal Pharmacal Co.
SHIPPED :    1-9-59, from Long Island City, N.Y., by Nysco Laboratories.
LABEL IN PART: (Drum) "20 M Capsules Lot No. 40139 Prenaeap Capsules 
Each Capsule Contains * * * Folic acid 0.1 mgm. * * * The M.D.A.R. for 
the following vitamins has not been established: Niacinamide * * * Nysco 
Laboratories"; and (btl.) "Pharma-Caps Prenatal Each Capsule Contains: 
* * * Folic acid 0.1 mgm. * * * Normal Pharmacal Company—Oakland 7, 
Calif.   Control No. 40139."
RESULTS OF INVESTIGATION: The article in the bottles was repacked by the 
dealer from the bulk stock shipped as described above.
LIBELED :   10-23-61, N. Dist. Calif.   '
CHARGE : 402(a) (2) (C)—when shipped and while held for sale, the article con- 
tained a food additive, namely, folic acid, which is unsafe within the meaning 
of 409 since it and its use or intended use were not in conformity with a regu- 
lation or exemption in effect pursuant to 409; and 403(j)—the article pur- 
ported 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 proportion of the minimum daily require- 
ment for (bulk) niacinamide and (repack) vitamin A, vitamin D, thiamine, 
riboflavin, niacinamide, ascorbic acid, calcium, iron, and iodine supplied by 
such food when consumed in a specified quantity during a period of one day.
DISPOSITION :   11-15-61.   Default—destruction.