Explanation of Rule 2: Identification
In order to avoid errors in the case of chemical compounds, and to guard against adulterations, lack of potency or strength, and the mistaking of one chemical for another, it is necessary to have at hand suitable tests.
Tests, etc.—If these facts have appeared in the literature, or in standard textbooks, reference to them will be sufficient; but with new chemicals, especially synthetics, the manufacturer or his representatives will be required to supply such tests for publication, as will assure an intelligent opinion of these products.
Physiologic Standardization.—In cases in which chemical methods of identification are unknown or unreliable, physiologic standardization should be employed. The Council considers the phrase “physiologically standardized” or “assayed” as misleading unless the standard and method are published in sufficient detail to permit of their control by independent investigators. It is evident that when no standard is published, it is impossible to know whether the quality is high or low, and the conscientious manufacturer who sets for himself a high standard is placed on a level with the dishonest or careless one who adopts a low standard. Again, if the process of standardization is not published, it is impossible to learn, without actual trial, the relative value of one preparation as compared with that of another manufacturer, or to confirm or disprove the statements of the manufacturer as to the quality of his product.
Standardization of Disinfectants and Germicides.—No disinfectant or germicide of the phenol type will be accepted for New and Nonofficial Remedies whose phenol coefficient, determined according to the method of the Hygienic Laboratory, U. S. P. H. S., is not stated on the label of the preparation.
Explanation of Rule 3: Direct Advertising
Lay Advertising.—The impossibility of controlling the irresponsible claims which are usually made in advertisements to the public, the well-known dangers of suggesting by descriptions of symptoms to the minds of the people that they are suffering from the many diseases described, the dangers of the unconscious and innocent formation of a drug habit, and the evils of harmful self-medication, including the dangers of the spread of many infectious and contagious diseases when hidden from the physician, and similar well-known considerations, are the reasons for discouraging, in the interest, and for the safety, of the public, this reprehensible form of exploitation. Advertising in medical journals, etc., distributed solely to physicians, does not come within the scope of this rule.
Exceptions.—In the case of subjects on which the public should be instructed, as the use of disinfectants, germicides, antiseptics and foods, advertisements to the public, if not in objectionable forms, are considered admissible. In no case shall such advertisements include recommendations for use as curative agents, nor shall the names of any diseases be mentioned in exploitation. If the preparation is sufficiently toxic to require caution in its use to prevent poisoning, this fact shall be stated on the label. On account of the deplorable results which would follow any abuse of this privilege, the conscientious cooperation of manufacturers and their agents in adhering strictly to the limitations laid down is asked; and for the same reason the acceptance of an article which is so advertised as to infringe on these limitations in any essential way (as by naming diseases or by making false and exaggerated claims) shall be summarily rescinded, and the reasons for such action may be published without notice to manufacturer or agent. A disinfectant, germicide or antiseptic will be accepted for description in New and Nonofficial Remedies, and an article of this class which has already been accepted will continue to be included in New and Nonofficial Remedies only on the explicit understanding by the manufacturer and agent that such infringements of the rule will be followed by deletion of the article and by publication of the facts as described.
Foods.—We may divide the foods into three groups. The first group contains the ordinary foods, including the well-known breakfast foods. These do not come under the supervision of the Council in any way. The second group includes a large and important class of manufactured products, such as invalid and infant foods, which in a sense stand between the first and third groups. The public has the same interest in these foods that the physician has, and usually is supplied with full information concerning them. While the primary recommendation of these articles should naturally come from the physician, it cannot be expected that their continued use should depend on repeated prescriptions. Information concerning this group of foods would come naturally and properly from a physician, and the collection and dissemination of this information may very properly be included in the work of this Council. As the products in this class are used extensively, it is not proper to limit their advertising to medical journals, but the advertising should be permitted in the lay press so long as it is conducted in a manner compatible with the rules of the Council. The third group includes medicinal foods proper, such as predigested foods. These have a relatively low food value and are characterized by a high alcohol or preservative content. They frequently contain strictly medicinal substances, or food substances for which distinct therapeutic properties are claimed. These products should be used only on the advice of the physician, and the advertisements should be restricted as in the case of ordinary medicines.
Advertisements in Foreign Countries.—The Council deals primarily, in the interest of the public and of the medical profession, with articles proposed for admission to New and Nonofficial Remedies, and, in determining the status of any article, must take into consideration any statements made regarding it or any method of advertising it employed by the manufacturer or his authorized agents or representatives, whether in this country or abroad. The Council will not regard as within its scope, however, questions concerning the marketing of articles (except the matter of direct advertising to the laity and unwarranted claims or misrepresentations) in any country which has a public body corresponding to this Council.