3329. Misbranding of Vit-Ra-Tox Osmotic Baths.   U. S. v. 30 Cans, etc.   (F. D. C.
No. 30240.    Sample Nos. 79696-K, 79697-K.)
LIBEL FILED :   November 14,1950, District of Massachusetts.
ALLEGED SHIPMENT:    On or about September 15, 1950, from Newark, N. J.
PRODUCT : Yit-Ra-Tox Osmotic Baths. 30 cans, each containing 4? pounds, at
Franklin, Mass., and 58 cans, each containing 4? pounds, together with a
number of pamphlets entitled "I M Vit-Ra-Tox Osmotic Baths," at Boston,
Mass.
RESULTS OP INVESTIGATION : The drugs had been shipped in interstate com-
merce at the behest of Irons & Moore, from Garden City, N. Y., in unlabeled
drums, to Franklin, Mass., to be repacked into 4?-pound cans, labeled as set
forth below. At the time of the investigation, 58 cans had been delivered to
Irons & Moore at Boston and were accompanied by a number of the pamphlets
referred to above.   30 cans were seized in possession of the repackager.
LABEL, IN PART: (Can) "I M "Vit-Ra-Tox '18' Osmotic Baths National Dis-
tributors Iron & Moore, Boston, Mass. Active Ingredients Vitratox Os-
motic Baths contain a new extract of the myroxylon tree from one particular
tropical environment. This extract also contains eucalyptol, nerolidol and
cinnamein (used as extractors) and is combined with laurel sodium sulfonate
(foaming and wetting agent) and sodium carbonate (water softener). Net
Weight Four Lbs. 8 Ounces   $13.95."
NATURE OF CHARGE: Misbranding, Section 502 (a), (58-can lot) certain state-
ments in the accompanying pamphlet were false and misleading. The state-
ments represented and suggested that the article was an adequate and effec-
tive treatment for arthritis, bursitis, sciatica, sinusitis, colds, infections; in-
fections in the bones, tissues, and muscles; tissue swellings, sore throat, rheu-
matic fever, asthma secondary to paranasal sinusitis, and neuritis; that the
article would prevent colds and effect reabsorption of calcium deposits; and
that the Food and Drug Administration had been furnished reports evidencing
effectiveness of the article in relieving arthritis, bursitis, sciatica, and sinus-
itis, which did not recur after the lapse of months. The article would not
fulfill the promises of benefit mentioned, and the Food and Drug Administra-
tion had not been furnished with the reports indicated.
Misbranding, Section 502 (f) (1), (30-can lot) the labeling failed to bear
adequate directions for use since the labeling failed to indicate the diseases
or conditions for which the article was intended to be used.
The article in the 30-can lot and in the 58-can lot was misbranded in the
above respects while held for sale after shipment in interstate commerce.
DISPOSITION: December 18, 1950. Default decree of condemnation and
destruction.
DRUGS AND DEVICES ACTIONABLE BECAUSE OF DEVIATION FROM   <
OFFICIAL OR OWN STANDARDS*