LABELING OF BITTERS. In Section 6 of the Food and Drugs Act of June 30, 1906, the term "drug," as defined in the act, includes "all medicinal preparations recognized in the United States Pharmacopoeia or National Formulary for internal or external use and any substance or mixture of substances intended to be used for the cure, mitigation, or prevention of disease in either man or other animals." Notwithstanding this comprehensive definition, it appears from a large correspondence on this subject that there is still some uncertainty as to whether or not certain commodities should be classed as drug products, and of this type are the alcoholic products known as "bitters. It is necessary to determine definitely whether or not "bitters, for example, are to be classed as drugs. This is necessary for the reason that under Section 8 of the Food and Drugs Act a drug is deemed misbranded "if the package fails to bear a statement on the label of the quantity or proportion of any alcohol contained therein." * * * On investigation of labels that are found on "bitters" it has been discovered that in most cases they are recommended for various ailments. For example, they are said to "aid digestion," "allay irritation of the nerves," "excite the appetite to a marvelous degree," "prolong life.” Again, labels bear the statements "is not only a delicious beverage, but also a wonderful tonic, "valuable in intermittent fever, illness due to the spleen, stomach catarrh, diarrhea, colic, cramps, vomiting, hypochondria, etc." These are examples of common phrases found on labels. "Bitters" are frequently prescribed in the same manner as medicines in general. For example, "to be taken in tablespoonful every hour, "increase the dose if the effect is not immediate," etc. It is well known that certain substances may be used both as foods and as drugs. It is claimed by some that certain products advertised as medicinal products are not sold and consumed on account of their medicinal properties, but merely as alcoholic beverages. This, however, does not seem to be consistent with the information found on some of the labels. In a case of this kind the classification will be made from a study of the literature published in connection with the article and by ascertaining the uses to which it is put. When a "bitters" is described on the carton or label attached to the bottle, or any advertising matter accompanying the package, as possessing any medicinal or tonic properties, or if in fact it does possess such value, it must of necessity be classed as a drug product and, in consequence of this classification, bear a statement of the quantity or proportion of any alcohol contained therein. The method of stating the proportion of alcohol is that of per cent by volume, as suggested in regulation 28 of Circular 21 of the Office of the Secretary. In Food Inspection decision 52 is the suggested order in which the statements required by law should occur on a label. This food inspection decision is promulgated so that those interested in the importation of "bitters" may understand how the department is obliged to rule in such cases, the decision as to whether a product be a food or a drug depending not only upon what claims are made for it. but also upon the uses to which it is put. This same principle must guide the Department in its interpretation of the law governing similar products which have the dual function of serving as both foods and drugs. United States Food Inspection Decision 86 concerning the definition of "Original Unbroken Package" is too long to reprint in full in this bulletin. The following excerpts are given herewith as being of special interest to manufacturers and dealers in this State. Complete copies of this decision can be obtained upon application to the Director of the State Food and Drug Laboratory, Berkeley. Regulation 2 of the Rules and Regulations for the Enforcement of the Food and Drugs Act (Circular No. 21, Office of the Secretary, United States Department of Agriculture) declares: The term "original unbroken package" as used in this act is the original package, carton, case, can, box, barrel, bottle, phial, or other receptacle put up by the manufacturer, to which the label is attached, or which may be suitable for the attachment of a label, making one complete package of the food or drug article. The original package contemplated includes both the wholesale and the retail package. This definition of original unbroken package was inserted in the regulations for the purpose of facilitating the administration of the act. It was intended to be, or at all events is, a guide to the inspectors who purchase the samples throughout the United States, as to the nature of an unbroken package. Upon the basis of this regulation the inspectors have collected a large number of samples, but when an examination of some of the cases has been made, with prosecutions in view, it has been found that no action could be taken because the package bought was not an original package, though apparently so upon a reasonable interpretation of the regulation. Furthermore, the department is advised that the food commissioners of some of the states, guided by a literal interpretation of the regulation, have refrained from enforcement of their laws upon all packages apparently embraced within its terms. It is believed that the discussion of the question and the cases cited will prove helpful to those United States attorneys to whom cases are reported for seizure in original packages under Section 10 of the Food and Drugs Act. To prevent the further misconception of the scope of the regulation, and for the information of those concerned, it is the purpose of this decision to set out the interpretation the Department has made of it, and the authorities therefor. Construed in the light of judicial determinations of the question, the terms "original unbroken packages" (as set out in the regulation and as used in Sections 2 and 10 of the act) and "unbroken packages" (as used in Section 3 of the act) will be restricted to such a package containing the food and drug product as has been prepared for shipment or transportation and shipped' or transported, as an entirety or unit, from a state, territory, or the District of Columbia, and delivered to the consignee, remaining his property in the identical form and condition in which it was shipped or transported. After arrival in a state and delivery to the consignee, if any part of the contents of the package be removed, or if the package be transferred by the consignee, it is no longer an original package. The retail package is not an original package unless it bears the characteristics set forth above. It is not practicable to frame a universally accurate and satisfactory definition of an "original package." No statute has done so, and the department disclaims any attempt to do so in its construction of the terms. The question must be determined largely upon each case as it arises, with the guidance of the authoritative decisions of the courts, which for the sake of elucidating and explaining the subject are presented in this decision. United States Food Inspection Decision 87, "Labeling of Corn Sirup, answers several communications received by the Secretary of the State Board of Health, it is therefore quoted in full. "We have each given careful consideration to the labeling, under the pure-food law, of the thick, viscous sirup obtained by the incomplete hydrolysis of the starch of corn, and composed essentially of dextrose, maltose, and dextrine. "In our opinion it is lawful to label this sirup as 'Corn Sirup,' and if to the corn sirup there is added a small percentage of refiner's sirup, a product of the cane, the mixture, in our judgment, is not misbranded if labeled 'Corn Sirup with Cane Flavor.' "It must be remembered, however, that the label 'Corn Sirup' can only be applied to the sirup manufactured from starch of corn; the sirup obtained from starch of potatoes or any grain could not be so labeled." In view of the many inquiries concerning the use of sulphur dioxid and benzoate of soda in foods and food products, United States Food Inspection Decision 89 is herewith presented. Amendment to Food Inspection Decision 76, Relating to the Use in Foods of Benzoate of Soda and Sulphur Dioxid. The question of the addition to food of minute quantities of benzoate of soda and of sulphur dioxid will be certified immediately by the Secretary of Agriculture to the referee board of consulting scientific experts. Pending determination by the referee board of the wholesomeness or unwholesomeness of these substances, their use will be allowed under the following restrictions: Benzoate of soda, in quantities not exceeding one tenth of one per cent, may be added to those foods in which generally heretofore it has been so used. The addition of benzoate of soda shall be plainly stated upon the label of each package of such food. No objection will be made to foods which contain the ordinary quantities of sulphur dioxid if the fact that such foods have been so prepared is plainly stated upon the label of each package. An abnormal quantity of sulphur dioxid placed in food for the purpose of marketing an excessive moisture content will be regarded as fraudulent adulteration, under the Food and Drugs Act of June 30, 1906, and will be proceeded against accordingly. Food Inspection Decision No. 76, issued July 13, 1907, is hereby amended accordingly. Vol. 3. MONTHLY BULLETIN. Entered as second-class matter August 15, 1905, at the post office at SACRAMENTO, MARCH, 1908. No. 10 STATE BOARD OF HEALTH. MARTIN REGENSBURGER, M.D., President, HON, J. E. GARDNER, Attorney San Francisco Los Angeles F. K. AINSWORTH, M.D. Watsonville STATE BUREAU OF VITAL STATISTICS. N. K. FOSTER, M.D., State Registrar..Sacramento | GEORGE D. LESLIE, Statistician....... ARCHIBALD R. WARD, D.V.M., Director........... Sacramento STATE HYGIENIC LABORATORY. University of California, Berkeley STATE FOOD AND DRUG LABORATORY. M. E. JAFFA, M. S., Director University of California, Berkeley NOTICE TO COUNTY RECORDERS. Registration of Marriages.-The attention of County Recorders is directed to the statistics on Increase of Marriages in this month's Bulletin. If the decreases or small increases shown for some counties are due to incomplete registration, the Recorders concerned must exert themselves to compel ministers and justices to properly register all marriages performed by them. Recorders can readily keep track of these matters by co-operating with the County Clerks who issue the necessary marriage licenses. DEPARTMENT OF VITAL STATISTICS. GEORGE D. LESLIE, STATISTICIAN. INCREASE OF MARRIAGES: 1906 TO 1907. Summary. The marriages registered in California totaled 23,005 for 1907 against 21,317 for 1906, a gain of 1,688, or 7.9 per cent. The per cent of increase was 9.7 for Northern California and 7.0 for Central California, or 7.4 for both together, against 9.2 for Southern California. The high rate of gain for San Francisco, 17.5 per cent, in contrast with a slight decrease for the transbay counties, indicates the return of population to the peninsula. Other high rates of gain were 12.4 per cent for the counties south of Tehachapi except Los Angeles, and 11.6 for the coast counties of Northern California. Of the individual counties, thirty-eight showed increases in marriages, one no change, and eighteen showed slight decreases. Marriages increased by at least one-fifth, 20.0 per cent, in the following eleven counties: Inyo, Tehama, Kern, Butte, Napa, Calaveras, Mono, Orange, Madera, Humboldt, and Kings. The increases were also above the State average, 7.9 per cent, in fourteen other counties, as follows: San Francisco, Yuba, Santa Barbara, Modoc, Fresno, Sacramento, San Bernardino, Monterey, Tulare, Nevada, Glenn, Santa Cruz, Mendocino, and San Diego. Comparison of the ranking of the leading counties in marriages registered shows notable rises in rank for the following counties: Orange, Humboldt, Santa Barbara, Butte, Napa, Kern, Kings, and Tehama. Geographic Divisions. Altogether 23,005 marriages were reported by County Recorders to the California State Bureau of Vital Statistics for 1907 as compared with 21,317 for 1906, these being the first calendar years covered by the operations of the present registration law enacted in 1905. The increase of marraiges for 1907 over 1906 was 1,688, a gain of 7.9 per cent. In the counties north of Tehachapi the marraiges reported for 1907 totaled 15,728 against 14,650 for 1906, an increase of 1,078 or 7.4 per cent. For Southern California the totals were 7,277 in 1907 and 6,667 in 1906, a gain of 610, or 9.2 per cent. The per cent of increase for San Francisco was no less than 17.5. This high rate of gain indicates that the inhabitants who were driven elsewhere by the great fire in April, 1906, were re-establishing themselves in homes in the new San Francisco throughout 1907. Confirmation appears from the fact that the group of other bay counties, instead of showing the usual increase of marriages, suffered a slight decrease for 1907 as compared with 1906. The net gain for the entire metropolitan area was thus 7.4 per cent, or the same as for the rural counties north of Tehachapi. In Southern California, Los Angeles shows an increase in marriages of 7.6 per cent, against no less than 12.4 per cent for the surrounding counties. The rate of gain for Northern California alone was 9.7, being as much as 11.6 for the coast counties and 7.8 for the interior counties. The corresponding rate for Central California alone was 7.0, the per cent of increase for the coast counties other than the metropolitan area being 3.3 and that for the interior counties being 7.9, or the same as for the entire State. The following table shows the number and per cent of increase in marriages for the several geographic divisions of the State, in 1906 to 1907: |