'28302. Adulteration and misbranding1 of solution of citrate of magnesia. IT. S. 
v. Roma Extract Co. and Joseph Graceffa. Plea of nolo contendere. 
Fine, $10 each.     (F. & D. No. 39455.    Sample Nos. 12131-C, 12132-C.)
This product differed from the standard laid down in the United States 
Pharmacopoeia since it contained materially less magnesium citrate than pre- 
scribed therein and contained magnesium sulphate (Epson salt), an ingredient 
not specified therein.
On May 17, 1937, the United States attorney for the District of Massachusetts, 
acting upon a report by the Secretary of Agriculture, filed in the district court 
-an information against the Roma Extract Co., Boston, Mass., and Joseph Graceffa, 
an officer of the corporation, alleging shipment by the said defendants in viola- 
tion of the Food and Drugs Act on or about August 13 and October 17, 1936, 
from the State of Massachusetts into the State of Rhode Island of quantities of
83647—38 1 
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solution of citrate of magnesia which was adulterated and' misbranded. The 
article was labeled in part: "Roma Brand * * * Roma Extract Co. Inc. 
Boston, Mass."
It was alleged to be adulterated in that it was sold under a name recognized 
in the United States Pharmacopoeia and differed from the standard of strength, 
quality, and purity as determined by the test laid down therein since 100 cubic 
centimeters of the article contained magnesium citrate corresponding to less than 
1.6 grams, namely, 0.14 gram of magnesium oxide, and 10 cubic centimeters of 
the solution  after precipitation  and  conversion of the citric  acid  into  ash, 
required less than 26 cubic centimeters, namely, not more than 3.3 cubic centi- 
meters, of half-normal hydrochloric acid to neutralize the alkalinity of the ash, 
and 100 cub:'c centimeters of the articles contained 5.0 grams in the case of 
one lot, and 5.2 grams in the case of the other, of magnesium sulphate; whereas 
the pharmacopoeia provides that solution of magnesium citrate shall contain 
in each 100 cubic centimeters an amount of magnesium citrate' corresponding 
to not less than 1.6 grams of magnesium oxide, that 10 cubic centimeters of the- 
solution after precipitation and conversion of the citric acid into ash, shall require- 
not less than 26 cubic centimeters of half-normal hydrochloric acid to neutralize 
the alkalinity of the ash, and magnesium sulphate is not mentioned in the- 
pharmacopoeia in the formula for the product, and the standard of strength, 
quality, and purity of the article was not declared on the container.
It was alleged to be misbranded in that the statements, "Solution of Citrate 
of Magnesia with Magnesia Sulphate," borne on the wrappers, "Solution Citrate- 
Magnesia," blown in the bottles, and "Citrate of Magnesia Solution," borne on; 
the bottle caps, were false and misleading. The article was alleged to be mis- 
branded further in that it was a product composed in large part of magnesium 
sulphate prepared in imitation of and offered for sale under the name of another 
article, solution citrate magnesia and citrate of magnesia solution.
On October 13, 1937, pleas of nolo contendere were entered by the defendants,, 
and they were sentenced to pay fines in the total amount of $20.
HAERT L. BROWN, Acting Secretary of Agriculture.