Vol. V SEP 201915 AUGUST-SEPTEMBER, 1915 LIBRARY MONTHLY BULLETIN OF THE Nos. 8-9 Public health is purchaseable. Within natural limitations a community can determine its own death rate. PATENT MEDICINE LEGISLATION OF THE UNITED STATES AND FOREIGN COUNTRIES. PUBLISHED MONTHLY BY THE DEPARTMENT OF HEALTH NEW YORK, N. Y. 149 CENTRE STREET OF THE Department of Health of the City of New York All communications relating to the publications of the Department of Health should be addressed to the Commissioner of Health, 149 Centre St., N. Y. Entered as second class matter May 7, 1913, at the post office at New York, N. Y., under the Act of August 24, 1912. Vol. V. NEW YORK, AUGUST-SEPTEMBER, 1915. Nos. 8 and 9 PATENT MEDICINE LEGISLATION OF THE UNITED STATES AND FOREIGN COUNTRIES. BY DR. HORACE GREELEY, Bureau of Public Health Education. The effect of the extensive use of patent medicines upon the public health having recently engaged the attention of the Department, it became desirable to ascertain what had been done elsewhere in the premises for purposes of information and guidance and, also, in order that all interested might learn that the patent medicine menace was beginning to be understood and attacked in many parts of the world. For the purpose, a circular letter of inquiry was sent to the secretary of state and to the health commissioner of each state of the Union, and to the health officer of each city of over 30,000 inhabitants in the country. Also a similar inquiry was sent to the chief health official of each foreign country. Besides information from the replies received, publications of the Federal government were consulted, as well as statutes of various states on file in the law libraries. As a result, it is believed that there is printed herewith a fairly complete, up-to-date and accurate presentation of patent medicine legislation which, it is thought, will be helpful to many interested in this phase of public health. Furthermore, it is hoped that the attention which this pamphlet will attract will bring home to many the great need of special legislation in the many localities where no protection has as yet been afforded the public from a fraud which, while from its very nature one that all are naturally most susceptible to, is capable of most serious injury to health. In some communities so little attention has been paid to the question that the health officers of several of the stat、s actually wrote that they had no law on the subject, while, upon consultation of the statutes of their states, a full equivalent of the Federal law was found operative. United States. FEDERAL LAWS. The National Food and Drugs Act, regulating interstate commerce, that went into effect January 1st, 1907, provides: Section 8. That the term "misbranded," as used herein, shall apply to all drugs, or articles of food, or articles which enter into the composition of food, the package or label of which shall bear any statement, design, or device regard ing such article, or the ingredients or substances contained therein which shall be false or misleading in any particular, and to any food or drug product which is falsely branded as to the State, Territory, or country in which it is manufactered or produced. That for the purposes of this Act an article shall also be deemed to be misbranded: In case of drugs: First. If it be an imitation of or offered for sale under the name of another article. Second. If the contents of the package as originally put up shall have been removed, in whole or in part, and other contents shall have been placed in such package, or if the package fail to bear a statement on the label of the quantity or proportion of any alcohol, morphine, opium, cocaine, heroin, alpha or beta eucaine, chloroform, cannabis india, chloral hydrate, or acetanilide, or any derivative or preparation of any such substance contained therein. Third. (The Sherley Amendment). If its package or label shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein, which is false and fraudulent. Regulation 17. (Established under the Act.) (e) "An article containing more than one food product or active medicinal agent is misbranded if named after a single constituent. In the case of drugs, the nomenclature employed by the United States Pharmacopoeia and the National Formulary shall obtain. (f) The use of any false or misleading statement, design, or device appearing on any part of the label shall not be justified by any statement given as the opinion of any expert or other person, nor by any descriptive matter explaining the use of the false or misleading statement, design or device. The Bureau of Chemistry of the National Department of Agriculture recently, (November, 1914), issued the following: Suggestions for Labeling Medicines Under the Sherley Amendment to the Food and Drugs Act, June 30, 1906. The bureau has received many inquiries relative to the proper labeling of medicinal preparations in compliance with the requirements of the Food and Drugs Act, as amended by the act of August 23, 1912, commonly known as the Sherley amendment. The following suggestions are offered to manufacturers or proprietors of such preparations to serve as a guide in the preparation of labels: 1. Claims of therapeutic effects.-A preparation can not be properly designated as a specific, cure, remedy, or recommended as infallible, sure, certain, reliable or invaluable, or bear other promises of benefit, unless the product can as a matter of fact be depended upon to produce the results claimed for it. Before making any such claim the responsible party should carefully consider whether the proposed representations are strictly in harmony with the facts; in other words, whether the medicine in the light of its composition is actually capable of fulfilling the promises made for it. For instance, if the broad representation that the product is a remedy for certain diseases is made, as for example, by the use of the word "remedy" in the name of the preparation, the article should actually be a remedy for the affections named upon the label under all conditions, irrespective of kind and cause. 2. Indirect statements-Not only are direct statements and representations of a misleading character objectionable, but any suggestion, hint, or insinuation, direct or indirect, or design or device that may tend to convey a misleading impression should be avoided. This applies, for example, to such statements as "has been widely recommended for," followed by unwarranted therapeutic claims. 3. Indefinite and sweeping terms.-Representations that are unwarranted on account of indefiniteness of a general sweeping character should be avoided. For example, the statement that a preparation is "for kidney troubles" conveys the impression that the product is useful in the treatment of kidney affections generally. Such a representation is misleading and deceptive unless the medicine in question is actually useful in all of these affections. For this reason it is usually best to avoid terms covering a number of ailments, such as "skin diseases, kidney, liver, and bladder affections,” etc. Rheumatism, dyspepsia, eczema, and the names of many other affections, are more or less comprehensive, and their use under some circumstances would be objectionable. For example, a medicine should not be recommended for rheumatism unless it is capable of fulfilling the claims and representations made for it in all kinds of rheumatism. To represent that a medicine is useful for rheumatism, when as a matter of fact it is useful in only one form of rheumatism, would be misleading; such statements as "for some diseases of the kidney and liver,” “for many forms of rheumatism," are objectionable, on account of indefiniteness. Names like "heart remedy," "kidney pills," "blood purifier," "nerve tonic," "bone liniment," "lung balm," and other terms involving the names of parts of the body are objectionable for similar reasons. 4. Testimonials:-Testimonials, aside from the personal aspect given them by their letter form, hold out a general representation to the public for which the party doing the labeling is held to be responsible. The fact that a testimonial is genuine and honestly represents the opinion of the person writing it does not justify its use if it creates a misleading impression with regard to the results which the medicine will produce. No statement relative to the therapeutic effects of medicinal products should be made in the form of a "testimonial" which would be regarded as unwarranted if made as a direct statement of the manufacturer. 5. Refund guarantee.-Statements on the labels of drugs guaranteeing them to cure certain diseases or money refunded may be so worded as to be false and fraudulent and to constitute misbranding. Misrepresentations of this kind are not justified by the fact that the purchase price of the article is actually refunded as promised. The history of federal effort against the fraudulent pretensions of the patent medicine trade is well given in the Fourth Annual Report of the Department of Health of the progressive state of Oklahoma. "The Federal Board of Food and Drug Inspection* (after the Food and Drugs Act became a law) believing that it had jurisdiction to pass upon the merits of such preparations to determine whether or not the products were mislabeled, 'in *Of the Bureau of Chemistry, Department of Agriculture. |