Any descriptive or explanatory matter that may appear on the principal label, therefore, should be placed at the bottom of the label, or between No. 3 and No. 4, and should be clearly separated from other features of the label by means of a suitable line or space. Statements regarding the reason for using alcohol, artificial coloring matter, and other extraneous substances, come under the head of descriptive or explanatory matter, and should not be interspersed with the declarations required under Nos. 2 and 3.
The information called for under No. 3 should be so worded as to give only the required information, as, for example, “alcohol 17 percent” or “artificially colored.” All numbers used in expressing quantity or proportion of substances required to be stated (see [Regulation 28]) should be expressed in the Arabic notation.
Each substance required to be declared under No. 3 should be printed on a separate line and in type specified in [Regulation 17] (c).
James Wilson,
Secretary of Agriculture.
Washington, D. C., January 18, 1907.
(F. I. D. 53.)
FORMULA ON THE LABEL OF DRUGS.
Many inquiries are received relative to the necessity of giving the formula of medicinal remedies on the label. The following is typical:
I should like to know if it will be necessary for me to state on a label the name of the products from which I prepare my proprietary medicine in order to conform with the pure food and drugs act. If I do this, it will prohibit me from manufacturing and selling a remedy which is a secret of my own; and anyone buying it could, from the label, tell what ingredients were used in its preparation and make his own supply of this medicine. How does the United States Government expect to protect those who have secret medicinal preparations they wish to sell at a profit? If the Pure Food Commission desires, I will send them a sample bottle of my medicine for their inspection and approval.
The food and drugs act, June 30, 1906, does not require the formula of drug products to be given on the label, but requires only that the quantity or proportion of the ingredients enumerated in the law, and derivatives and preparation of same ([Regulation 28]), shall be clearly set forth on the label or labels of all preparations used for the treatment or prevention of disease, either internally or externally, for man or other animals. This includes sample packages as well as regular trade packages.
The question is also frequently asked whether a medicinal preparation would be exempt from the operation of the law if the formula were given on the label. The formula on the label is very desirable, but this information is not required by the law. The act forbids the use of any statement, design, or device in connection with any drug product which is false or misleading in any particular. A defect of this kind would not be corrected by giving the formula on the label. If the formula is given, it must be the correct and complete formula. It is held that, in addition to those substances required by the act to be named, if only a part of the active medicinal agents used in the manufacture of a drug product are set forth on the label, such a procedure is misleading and therefore forbidden by the law. All drug products and their labels must conform to the act, whether the formula is or is not given on the label.