24652. Adulteration and misbranding of solution citrate magnesia. U. S. v. 
Roma Extract Co. and Joseph Graceffia. Pleas of nolo contendere. 
Fines, ?10.    (F. & D. no. 33924.    Sample no. 58074-A.)
This case was based on an interstate shipment of solution citrate of magnesia 
which did not conform to the requirements of the United States Pharmacopoeia, 
and which was not labeled to indicate its own standard of strength, quality, 
and purity.
On March 29, 1935, the United States attorney for the District of Massachu- 
setts, acting upon a report by the Secretary of Agriculture, filed in the district 
court an information against the Roma Extract Co., a corporation, and Joseph 
Graceffa, Boston, Mass., alleging shipment by said defendant in violation of 
the Food and Drugs Act on or about March 21, 1934, from the State of Massa- 
chusetts into the State of Rhode Island, of a quantity of solution citrate of 
magnesia which was adulterated and misbranded. The article was labeled in 
part: (Bottle) "Solution Citrate Magnesia"; (wrapper) "Effervescing Solution 
Citrate of Magnesia * * * (Not U. S. P. * * * Roma Extract Company 
Boston Mass."
The article 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 in that 
authority, since it contained less than 1.5 grams, namely, not more than 0.93 
gram of magnesium oxide per 100 cubic centimeters; less than 9.5 cubic centi- 
meters, namely, not more than 1.3 cubic centimeters of half-normal sodium 
hydroxide was required to neutralize the acid in 10 cubic centimeters of the 
article; less than 28 cubic centimeters, namely, not more than 3.55 cubic centi- 
meters of half-normal sulphuric acid was required to neutralize the ash ob- 
tained from 10 cubic centimeters of the article, and it contained magnesium sul- 
phate, whereas the pharmacopoeia provides that solution of magnesium citrate 
shall contain in each 100 cubic centimeters magnesium citrate corresponding 
to not less than 1.5 gram of magnesium oxide; that 10 cubic centimeters of the 
solution shall require not less than 9.5 cubic centimeters of half-normal sodium 
hydroxide for neutralization of the free acid; that not less than 28 cubic 
centimeters of half-normal sulphuric acid shall be required to neutralize the 
ash obtained from 10 cubic centimeters of the solution, and precludes magne- 
sium sulphate as a normal constituent of solution citrate of magnesia, and the 
standard of strength, quality, and purity of the article was not declared on the 
container. Adulteration was alleged for the further reason that the strength 
and purity of the article fell below the professed standard and quality under 
which it was sold, since it was represented to be solution citrate of magnesia; 
whereas it contained magnesium sulphate which is not found in solution citrate 
of magnesia.
Misbranding was alleged for the reason that the statements, (label) "Solu- 
tion Citrate of Magnesia" and (bottle) "Solution Citrate Magnesia", were false 
and misleading, since the said statements represented that the article was 
solution citrate of magnesia; whereas it was not, but was a mixture composed 
in part of magnesium sulphate. Misbranding was alleged for the further rea- 
son that the article was a mixture composed in part of magnesium sulphate 
prepared In imitation of solution citrate of magnesia, and was offered for sale 
and sold under the name of another article, namely, solution citrate of 
magnesia.
On April 15, 1935, pleas of nolo contendere were entered on behalf of the 
defendants and the court imposed fines in the total amount of $10.
W. R. GREGG, Acting Secretary of Agriculture.