2. The rules of the Council require that the name of a pharmaceutical mixture shall indicate the potent ingredients. The name of this mixture does not indicate the presence of the nitrites, the potassium nitrate, the bicarbonate or the extract of hawthorne and the nondescriptive name is likely to lead physicians to use the tablets without fully realizing what they are giving.
3. No evidence was submitted that the tablets, as found on the market, contained the amount of sodium nitrite and nitroglycerin claimed. That is, it does not appear that the manufacturer checks the sodium nitrite and nitroglycerin content by analysis. The Council did not determine the nitrite content of the tablets. It maintains that when a manufacturer places a product on the market the burden of proof is on that manufacturer to show that the facts are in accordance with his claims for his product. Further, the examination by the Council of one or several specimens of any commercial product (particularly in the case of nitroglycerin preparations) would not be a guarantee of the constancy of its composition so long as the manufacturer does not himself control the composition by analysis. The necessity of such control of tablets containing nitroglycerin is evident from the report[102] of L. F. Kebler of the U. S. Bureau of Chemistry. Dr. Kebler said:
“... nitroglycerin tablets have in a majority of cases been found deficient in the nitroglycerin content declared.”
“... these commodities are manufactured largely by rule of thumb. Little checking obtains in their manufacture and generally no analyst is employed.”
A further proof that nitroglycerin tablets are likely to be deficient in strength is contained in the convictions under the Food and Drugs Act of manufacturers who sold tablets below the declared strength, recorded from time to time (Notices of Judgments Nos. 3405, 2059, 1843, 1799).
4. There is no good evidence, experimental or clinical, to justify the simultaneous administration in fixed proportion of two vasodilators like sodium nitrite and glyceryl trinitrate (nitroglycerin). Also there is no rational excuse for combining extract of hawthorne, which is said to have a tonic effect on the heart muscle, with nitrites, which cause relaxation of the vascular system, or for the combination with these constituents of potassium nitrate or of sodium bicarbonate.
In the absence of evidence for the combination, Pulvoids Natrium Compound must be considered an irrational mixture, the use of which is a detriment to sound drug therapy and, hence, not admissible to New and Nonofficial Remedies.—(From Reports of Council on Pharmacy and Chemistry, 1916, p. 69.)