3191. Adulteration of Creme-A-Tone and adulteration and misbranding of Vex-
trin capsules, Trestilon tablets, Elgyn capsules, Folitrin tabsules, Slix
tablets, and Estra-Beta capsules. U. S. v. Oxford Products, Inc. Plea
of guilty. Fine of $1,300, plus costs. (F. D. C. No. 28112. Sample Nos.
353-K, 354-K, 358-K, 2252-K to 2254-K, incl., 3130-K, 21365-K, 21366-K,
30739-K, 30740-K, 42129-K, 43432-K, 43433-K.)
INFORMATION FILED: June 14, 1950, Northern District of Ohio, against Oxford
Products, Inc., Cleveland, Ohio.
ALLEGED SHIPMENT: Between the approximate dates of March 15, 1948, and
March 14, 1949, from the State of Ohio into the States of Georgia, West "Vir-
ginia, Virginia, Missouri, California, Illinois, and Michigan.
NATURE OF CHARGE: Creme-A-Tone. Adulteration, Section 501 (b), the article
purported to be and was represented as aluminum hydroxide gel, a drug the
name of which is recognized in the United States Pharmacopoeia, an official
compendium, and its strength differed from the official standard; and the
difference in the strength of the article from the standard was not plainly
stated, or stated at all, on its label. The standard provides that aluminum
hydroxide gel contains the equivalent of not less than 3.6 percent of aluminum
oxide, and that the volume of tenth-normal acid required to neutralize one
gram of aluminum hydroxide gel shall be not less than 12.50 cc. All shipments
of the article contained the equivalent of less than 3.6 percent of aluminum
oxide, and_in one of the shipments the volume of tenth-normal acid required
to neutralize one gram of the article was less than 12.50 cc.
Vextrin capsules, Trestilon tablets, Elgyn capsules, Folitrin tabsules, Slix
tablets, and Estra-Beta capsules. Adulteration, Section 501 (c), the strength
of the articles differed from that which they purported and were represented
to possess.    Misbranding, Section 502 (a), certain statements in the labeling
of these products relating to their declared strength were false and misleading.
The statements represented and suggested:
That each Vextrin capsule contained 20 milligrams of iron and would supply
2 times the minimum adult daily requirement for iron;
That 4 Trestilon tablets would furnish 2,000 percent of the daily minimum
requirement of iron for adults and 50 percent of the daily minimum require-
ment of calcium for adults;
That each Elgyn capsule contained 20 milligrams of iron and would supply
2 times the minimum adult daily requirement for iron;
That two Folitrin tabsules would provide the minimum adult daily require-
ment for iron;
That 9 of the Slice tablets contained 460 milligrams of calcium and 360 milli-
grams of phosphorus, and that 9 such tablets contained 50 percent of the mini-
mum daily requirements for calcium and phosphorus;
That each Estra-Beta capsule contained 30 milligrams of niacinamide and
20 milligrams of iron and would supply 2 times the minimum adult daily re-
quirement for iron.
The Vextrin capsules, Trestilon tablets, Elgyn capsules, Folitrin tabsules,
and Slix tablets were deficient in the above named ingredients; and one ship-
ment of the Estra-Beta capsules contained less than 30 milligrams of niacin-
amide, and the other shipment contained less than 20 milligrams of iron and
would supply less than 2 times the minimum adult daily requirement for iron.
DISPOSITION :   June 14, 1950.   A plea of guilty having been entered, the court
imposed a fine of $1,300, plus costs.