FOOD INSPECTION DECISIONS 49-53.
[49]. Time Required to Reach Decisions on Different Problems Connected with the Food and Drugs Act, June 30, 1906. [50]. Imitation Coffee. [51]. Coloring of Butter and Cheese. [52]. Form of Label. [53]. Formula on the Label of Drugs.
(F. I. D. 49.)
TIME REQUIRED TO REACH DECISIONS ON DIFFERENT PROBLEMS CONNECTED WITH THE FOOD AND DRUGS ACT, JUNE 30, 1906.
Many letters have reached the Department asking for action on very important questions connected with the food and drugs act which require much study and time to secure all the facts necessary to the rendering of a just decision. It is quite impossible to answer all such letters in detail. The following general statement shows the attitude of the Department on questions of this kind:
All manufacturers and dealers have copies of the law and regulations or can secure them and study them carefully. Each manufacturer and dealer should conduct his business as nearly as possible in harmony with the law as he interprets it. When each particular problem involved reaches a solution in this Department, it is hoped it will be found that the manufacturers and jobbers have come also to a similar decision in the matter. Public notice will be given of each decision as it is issued, that the manufacturers and dealers may be informed and be able at once to place themselves in line with the decisions of the Department. In this way it is hoped that all injustice will be avoided in the execution of the law and everyone be given an opportunity to put himself right and to have due notice of decisions which may be made.
The Department will use every endeavor to reach prompt decisions, but must take time to collect the facts and subject them to a proper study; otherwise the decisions would not have the value which should attach to them in important matters affecting the execution of the law.
James Wilson,
Secretary of Agriculture.
Washington, D. C., January 8, 1907.
(F. I. D. 50.)
IMITATION COFFEE.
A manufacturer writes as follows:
We beg to ask for your opinion as regards the hyphenated word “Cereal-Coffee,” and whether or not we are entitled to its use for a cereal substitute for coffee.... In our opinion the term “Cereal-Coffee” would come under the so-called trade-name and distinctive name.
It is held that since the product mentioned is not a coffee it can not properly be called by the term mentioned. [Regulation 20] (d) provides that a distinctive name shall give no false indication of character. The use of the name “cereal-coffee” might be taken to indicate that the product is coffee or has the properties of coffee, and hence the use of this term does not comply with the definition of distinctive name. Even if the product consist in part of coffee, the name would not be correct. It is suggested that products of this nature be designated as “imitation coffee,” as provided in [Regulation 21] (f). In such case the word “imitation” should be in uniform type, on uniform background, and should be given equal prominence with the word “coffee.”
James Wilson,
Secretary of Agriculture.
Washington, D. C., January 18, 1907.
(F. I. D. 51.)
COLORING OF BUTTER AND CHEESE.
Numerous inquiries, of which the following is an illustration, have been received by the Department:
Will you kindly inform me concerning the coloring of butter and cheese under the pure-food law? Would it be unlawful to color butter and cheese as now practiced?
The coloring of butter is specifically permitted in the law of August 2, 1886 (24 Stat., 209), and the coloring of cheese in the law of June 6, 1896 (29 Stat., 253). It is held by the Department that the food and drugs act does not repeal the provisions of the acts referred to above and the addition of harmless color to these substances may be practiced as therein provided, and that the presence of coloring matter specifically recognized by acts of Congress as a constituent is not required to be declared on the label.
James Wilson,
Secretary of Agriculture.
Washington, D. C., January 18, 1907.
(F. I. D. 52.)
FORM OF LABEL.
The following is an extract from a letter recently received.
We do not understand the requirements of the regulations respecting the arrangement of labels; that is, the order in which the various features of the label should be arranged.
To meet the requests for the opinion of the Department regarding the proper arrangement of a label, the following order is suggested:
1. Name of substance or product.
2. In case of foods, words which indicate that the articles are compounds, mixtures, or blends, and the word “Imitation,” “Compound,” or “Blend,” as the case may be.
3. Statements designating the quantity or proportion of the ingredients enumerated in the law, or derivatives and preparations of same,[51] as mentioned under [Regulation 28]; also statements of other extraneous substances whose presence should be declared, such as harmless coloring matter, or any necessary statement regarding grade or quality.
[51] Attention is called to the fact that the declaration of alcohol and its derivatives is not required in foods.
(The statements specified in paragraphs 1, 2, and 3, should appear together without any intervening descriptive or explanatory matter.)
4. Name of manufacturer (if given).
5. Place of manufacture (if given, or when required in case of food mixtures or compounds bearing a distinctive name).
It is stated in [Regulation 17] that if the name of the manufacturer and place of manufacture be given they should appear upon the principal label. Although the law does not require that the name of the manufacturer be given, or the place of manufacture, except in case of food mixtures and compounds having a distinctive name, it is held that if they are given they must be true, and should be placed with the required information on the principal label. The arrangement of the label is the same for both food and drug products and an example of each is given.
| Sample label for food product. | |
|---|---|
| [Name of product.] | KETCHUP. |
| [Declaration required by paragraphs 2 and 3.] | ARTIFICIALLY COLORED. |
| [Descriptive matter, if desired, but preferably at bottom of label.] | |
| [Name of manufacturer, if given.] | BLANK & CO., |
| [Place of manufacture, if given.] | PORTLAND, ME. |
| [Descriptive matter, if desired.] | |
| Sample label for drug product. | |
|---|---|
| [Name of product.] | COUGH SYRUP. |
| [Declarations required by paragraphs 2 and 3.] | ALCOHOL, 10 PERCENT. |
| MORPHIN, 1⁄2 GRAIN PER OUNCE. | |
| CHLOROFORM, 40 MINIMS PER OUNCE. | |
| [Descriptive matter, if desired, but preferably at bottom of label.] | |
| [Name of manufacturer, if given.] | JOHN JONES & CO., |
| [Place of manufacture, if given.] | WASHINGTON, D. C. |
| [Descriptive matter, if desired.] | |
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.
James Wilson,
Secretary of Agriculture.
Washington, D. C., January 28, 1907.
F. I. D. 54-59. Issued March 23, 1907.
UNITED STATES DEPARTMENT OF AGRICULTURE,
BUREAU OF CHEMISTRY,
H. W. Wiley, Chief of Bureau.