5801. Saffocil capsules.   (F.D.C. No. 41883.   S. No. 34-251 P.)
QUANTITY :   2 bulk ctns., each containing 5,000 capsules, and 44   72-capsule btls.,
at Norristown, Pa., in possession of Plymouth Vitamin Products.
SHIPPED :   1-31-58, from Detroit, Mich.
LABEL IN PAET: (Btl.) "Saffocil Formula 537 Unsaturated Fatty Acids with
Pyridoxine HC1 * * * Provides supplemental essential unsaturated fatty acids
to daily diet. Daily ration of three capsules provides: Linoleic Acid 2595
Mg. Oleic Acid 660 Mg. Palmitic Acid 135 Mg. Stearic Acid 60 Mg. Mixed
Tocopherols .828 Mg. (preceding from 3450 Mg. of Safflower Oil) and 9 Mg. of
Vitamin B6. The minimum daily requirements for B8 and the need for un-
saturated fatty acids and mixed tocopherols in human nutrition have not been
established. 72257 Dist. by Plymouth Vitamin Products Plymouth Meeting,
Pa."
ACCOMPANYING LABELING: Leaflets entitled "Plymouth Nutritional Review -
Published for the Information and Knowledge of our Customers" and reprints
of an article appearing in the July 1, 1957 issue of Drug Trade News entitled
"Sees Essential Fatty Acid Lack Causing Degenerative Disease."
RESULTS OF INVESTIGATION: The article in the bottles was repackaged and
labeled by the dealer, and the above-mentioned leaflets and reprints were used
by the dealer in promoting the sale of the article.
LIBELED:   6-24-58, E. Dist. Pa.
CHARGE: 502(a)-the labeling accompanying the article, while held for sate,
contained false and misleading representations that the article, when used as
directed, would prevent, and was an adequate and effective treatment for,
atherosclerosis, heart disease, artery disease, nephrosis, angina pectoris, high
blood pressure, obesity, and glandular dyscrasias; and the following state-
ments on the bottle label, namely, "Provides supplemental-essential un-
saturated fatty acids to daily diet" and "the need in human nutrition for un-
saturated fatty acids * * * have not been established" were false and mis-
leading since the two statements are contradictory.
DISPOSITION :   11-19-58.   Default-destruction.