Part 10 — APPENDIX D. (continued 2)
Reading edition
F. I. D. 26 is also amended so that in certain cases importation after relabeling will be permitted. It is difficult to state exactly in what cases these amendments to F. I. D. 12 and F. I. D. 26 will be applied. In general, it may be said that where a food product is misbranded, but no substance deleterious to health has been added, and where neither the importer nor the shipper has had notice of the existence of the law or of its requirements, permission to relabel may be given. A similar permission will be extended to all food products already afloat at the time of receiving the first notice, or which are so advanced in shipment that they can not be countermanded by cable or otherwise. Other miscellaneous requests for permission to relabel will be decided upon the merits of the case presented, and permission to relabel be granted when it is evident that neither negligence nor indifference is responsible for the failure to secure a proper branding of the product. A similar permission will also be granted when it is apparent that the purpose of the law may thereby be fully accomplished. This action is not to be taken in case of food products containing added substances injurious to health or forbidden by the laws of the country from which the substance comes.
In this connection it is suggested to importers that all orders for food products in the United States be given subject to the passing of the inspection at the ports of entry. It will not be considered a sufficient excuse for the importation of improperly branded or otherwise objectionable food products to show that they were paid for before the inspection took place. The law has now been in force long enough to acquaint foreign exporters with its existence and domestic importers with its provisions. It is therefore held that paying for food products before inspection is completed will not be deemed a sufficient excuse for asking for the relabeling, remarking, or admission thereof.
There are certain other cases in which relabeling of an importation of food products may be permitted, but in no case will such a courtesy be extended where it is evident that either importer or exporter has had ample opportunity and notice to comply with the provisions of the law. Such cases include those where evidently honest attempts have been made to comply with the conditions of the law and where failure has been due to ignorance of the exact nature of the conditions required, or some unavoidable cause. These amendments are made to prevent unnecessary annoyance and hardships, and will not be construed in any way to excuse a failure to comply with the conditions of the law where it is evident that these conditions have been fully understood and opportunity afforded for their application.
Approved: James Wilson, Secretary of Agriculture. Washington, D. C., January 16, 1906.
(F. I. D. 36.) SUBSTANCES, ORDINARILY FOOD PRODUCTS, INTENDED FOR TECHNICAL PURPOSES.
The question has been raised on several occasions whether food products which are offered for importation for other purposes than to be used in foods are subject to the inspections of similar products when intended for consumption. It has been held (F. I. D. 32) that it is not the purpose of the law, nor is it possible, to follow the ordinary food product into consumption in order to determine to what use it is finally put. The law levying duty on olive oils specifically provides that when such oil is imported for mechanical purposes it is free from duty as an edible oil, provided it is in a condition of rancidity or other state which renders it unfit for consumption as human food. There is no statute covering a similar condition for other food products. It seems only reasonable, however, to apply this principle of law to other food products when it can be done without complicating the question of the ordinary inspection.
It is therefore held that a substance which ordinarily is considered a food product, when offered for importation for technical purposes may be admitted without inspection on the following conditions:
(1) That in the invoice and accompanying declaration it is specifically stated that the substance in question is to be devoted solely to technical use.
(2) That the substance be so denatured, either by natural or artificial means, as to render it unfit for consumption as human food.
This Department reserves the right to determine in any given case whether or not the denaturing process is of a character which would render it impracticable to recover the article in a form suitable for consumption as human food. When substances ordinarily food products are presented hereafter for import into this country with the invoice and declaration above mentioned and in the denatured condition specified, they will not be detained for inspection by this Department longer than is necessary to ascertain the above facts. A denaturing process will be held to be valid provided it so changes the taste of the food product as to make it impossible for it to be consumed for food purposes, as, for instance, by the addition of an excessive quantity of common salt or other denaturing agent which would impart a taste of such a character as to cause it to be rejected by any one attempting to consume it.
This decision shall not be considered in any way to change the opinion of this Department with reference to food products offered as such for importation and afterwards declared to be intended for technical purposes, as stated in F. I. D. 25, of June 21, 1905.
Approved: James Wilson, Secretary of Agriculture. Washington, D. C., January 18, 1906.
F. I. D. 37-38.
UNITED STATES DEPARTMENT OF AGRICULTURE, BUREAU OF CHEMISTRY, H. W. WILEY, Chief of Bureau.
FOOD INSPECTION DECISIONS 37-38.
(F. I. D. 37.) LABELING OF CHOCOLATES.
The question of the proper marking of plain or bitter chocolates and sweet chocolates has arisen on several occasions in the inspection of imported food products, and, after full investigation of all the facts of the case and the relations of previous decisions thereto, it appears that the following points are established:
1. Chocolate, plain or bitter, is imported for cooking and not for directly edible purposes.
2. Sweet chocolates are imported practically as a candy or confection.
This question is covered to a certain extent in F. I. D. 26, section 8, which reads as follows:
8. The addition of the ordinary condimental substances to a food product, such as sugar, vinegar, salt, spices, and wood smoke, may be practiced without any notice to this effect appearing upon the label.
Section 9 limits the application of section 8. It reads as follows:
9. Food products of any given name are to correspond in quality to the standards established by authority of Congress for such products, and if they vary from this standard a notice to that effect is to appear upon the label.
It appears from the standards adopted by authority of Congress (Circular No. 13, Office of the Secretary) that chocolate, plain or bitter, can not have any substances added to it not noted in the standard and remain a standard product. If, therefore, chocolate, plain or bitter, have any starch or other substance added thereto for any purpose whatever, or sugar in insufficient quantities to make it a sweet chocolate, the addition of these bodies should be indicated by an appropriate statement on the label.
On the other hand, sweet chocolate, being intended for and plainly being a confection, would not require a statement to the effect that sugar had been added or a statement in regard to any of the other substances mentioned in the standard. If, however, any foreign substance other than that mentioned in the standard should be added to a sweet chocolate, a proper statement indicating that fact would be required upon the label.
This decision is given without prejudice to revision in case it should become advisable, as a result of experience, to further distinguish between these two bodies by some appropriate designation.
“Milk chocolate” will be considered as a sweet chocolate to which whole milk (fresh, evaporated, or desiccated) has been added.
Approved: James Wilson, Secretary of Agriculture. Washington, D. C., March 30, 1906.
(F. I. D. 38.) LABELING OF COCOAS.
Cocoas, in the preparation of which alkalis or other substances have been employed in order to increase the apparent solubility of the product, should bear on the label a declaration of such treatment. The phrase “Prepared with Alkali” (or alkalis) or “Manufactured with Alkali” (or alkalis), or some similar treatment, would be a sufficient notification. This declaration should also be in keeping with the provisions of F. I. D. 26. The denomination of such products as “soluble cocoas” will not answer, since the term “soluble,” as used in this connection, is, to a certain extent, misleading. The apparent increased solubility of products treated as above is due rather to the suspension of the particles than to their solubility. The descriptions of the manufacture of these products show that potassium carbonate, sodium carbonate, magnesium carbonate, ammonium carbonate, and ammonium hydroxid are the principal alkaline salts employed. Tartaric acid is also at times used to correct any undue alkalinity produced by these added substances. The subject of the wholesomeness of these added products is reserved for further consideration.
Approved: James Wilson, Secretary of Agriculture. Washington, D. C., March 30, 1906.
F. I. D. 39.
UNITED STATES DEPARTMENT OF AGRICULTURE, BUREAU OF CHEMISTRY, H. W. WILEY, Chief of Bureau.
(F. I. D. 39.) PRESERVATIVES AND ARTIFICIAL COLORS IN MACARONIS.
Inspection of recent importations of macaroni, noodles, and similar products has shown that these goods sometimes contain chemical preservatives, such as fluorids, which are regarded as injurious to health. A small amount of coloring matter is also frequently added to macaroni. It appears that Martius yellow is often used for coloring these products. This substance is held to be injurious to health and is so classed by the laws of several European countries, especially Italy, which has decreed that, among other colors, Martius yellow (dinitro yellow, naphthol yellow, Manchester yellow, saffron yellow, and gold yellow) must not be used in the preparation of foods. In view of this fact no importation of macaroni colored with Martius yellow or other colors forbidden by the Italian law, or preserved with fluorids or other preservatives injurious to health, will be permitted after June 1, 1906, and all importations of macaroni which contain any permissible coloring matter must be labeled with the words “Artificially colored,” in accordance with F. I. D. 26.
Approved: James Wilson, Secretary of Agriculture. Washington, D. C., May 1, 1906.
F. I. D. 40-43.
UNITED STATES DEPARTMENT OF AGRICULTURE, BUREAU OF CHEMISTRY, H. W. WILEY, Chief of Bureau.
FOOD INSPECTION DECISIONS 40-43.
(F. I. D. 40.) FILING GUARANTY.
In order that both the Department and the manufacturer may be protected against fraud it is requested that all guaranties of a general character filed with the Secretary of Agriculture in harmony with Regulation 9, Rules and Regulations for the Enforcement of the Food and Drugs Act, June 30, 1906, be acknowledged before a notary or other official authorized to affix a seal. Attention is called to the fact that when a general guaranty has been thus filed every package of articles of food and drugs put up under the guaranty should bear the legend, “Guaranteed under the Food and Drugs Act, June 30, 1906,” and also the serial number assigned thereto, if the dealer is to receive the protection contemplated by the guaranty. No other word should go upon this legend or accompany it in any way. Particular attention is called to the fact that nothing should be placed upon the label, or in any printed matter accompanying it, indicating that the guaranty is made by the Department of Agriculture. The appearance of the serial number with the phrase above mentioned upon a label does not exempt it from inspection nor its guarantor from prosecution in case the article in question be found in any way to violate the food and drugs act of June 30, 1906.
Approved: James Wilson, Secretary of Agriculture. Washington, D. C., October 25, 1906.
(F. I. D. 41.) APPROVAL OF LABELS.
Numerous requests are referred to this Department for the approval of labels to be used in connection with articles of food and drugs under the food and drugs act of June 30, 1906. This act does not authorize the Secretary of Agriculture nor any agent of the Department to approve labels. The Department therefore will not give its approval to any label. Any printed matter upon the label implying that this Department has approved it will be without warrant. It is believed that with the law and the regulations before him the manufacturer will have no difficulty in arranging his label in harmony with the requirements set forth. If there be questions on which there is doubt respecting the general character of labels, decisions under the food and drugs act will be rendered, of a public character and published from time to time, covering such points.
Approved: James Wilson, Secretary of Agriculture. Washington, D. C., October 25, 1906.
(F. I. D. 42.) MIXING FLOURS.
The following communication has been received respecting the mixing of flours of different cereals:
In conformity with the custom of a century or more, the manufacturers of rye flour, in order to produce a lighter and more easily worked flour, have added a proportion of wheat flour to their rye and branded it “Rye Flour.”
This custom simply conforms to the consumers’ demand for a whiter loaf and from every standpoint is a perfectly legitimate operation.
Under the interpretation of the food and drugs act of June 30, 1906, apparent restrictions are placed upon this compounding, and I would therefore respectfully ask your ruling upon the following points:
1. Under this interpretation will it be necessary to add the word “compound” to the brands?
2. Will it be necessary in accordance with this interpretation to name in the brand the fact that a wheat admixture has been made, in addition to the use of the word “compound,” providing that word is necessary?
3. Referring to paragraph f, Regulation 17, which reads as follows:
“An article containing more than one food product or active medicinal agent is misbranded if named after a single constituent,”
will it be permissible to still name the rye-wheat admixture “rye flour”?
The food and drugs act of June 30, 1906, and the rules and regulations made thereunder, provide for the proper marking of food product and penalties for misbranding.
The act also provides that a food product is not misbranded “in the case of articles labeled, branded, or tagged so as to plainly indicate that they are compounds, imitations, or blends, and the word ‘compound,’ ‘imitation,’ or ‘blend,’ as the case may be, is plainly stated on the package in which it is offered for sale.”
Keeping in view these provisions of the law, and rules and regulations made thereunder, it appears that the mixing of rye flour and wheat flour is not prohibited by the law provided the package is marked “compound” or “mixture,” the word standing alone and without qualification, and also if the label contain the information which shows that it is properly branded. The mixture may also be denominated a “blend” if rye flour and wheat flour be regarded as like substances. It is held that this information in the case mentioned would be a statement of the ingredients used in making the compound. It is further held that the use of an ingredient in small quantity simply for the purpose of naming it in the list of ingredients would be contrary to the intent of the law, and therefore that the ingredients must be used in quantities which would justify the appearance of their names upon the label. The statement made of the constituents used should be of a character to indicate plainly that the article is a compound, mixture, or blend.
It is evident from the above explanation that the naming of a mixture of this kind “rye flour” would be plainly a violation of the law and the regulations made thereunder.
Attention is called also to the act of Congress approved June 13, 1898, U. S. Revised Statutes, sections 36 to 49, inclusive, imposing special taxes under the supervision of the Commissioner of Internal Revenue on mixed flour.
Approved: W. M. Hays, Acting Secretary. Washington, D. C., October 30, 1906.
(F. I. D. 43.) RELABELING OF GOODS ON HAND.
The following is a type of numerous communications received concerning the operation of the food law:
The retail grocers of our city, as well as some of the jobbers, are very much concerned over stocks of canned goods and other similar goods they might have in stock on January 1, 1907, when the new pure-food act goes into effect.
We are under the impression that where there is nothing deleterious to health contained in such goods so held it is not the Department’s intention to interfere in any way, shape, or form with them.
Where these goods are held by retailers in our own city does this come within the jurisdiction of the National law, or is it controlled only by State laws?
Similar letters have been received relating to drugs, medicines, and other articles affected by the operation of the law. A general answer is deemed advisable, which, it is hoped, wilt cover the cases in question.
Section (i) of Regulation 17 provides that—
The regulation regarding the principal label will not be enforced until October 1, 1907, in the case of labels printed and now on hand, whenever any statement therein contained which is contrary to the food and drugs act, June 30, 1906, as to character of contents, shall be corrected by a supplemental label, stamp, or paster. All other labels now printed and on hand may be used without change until October 1, 1907.
It is held that under this regulation labels which contain statements relating to the name of manufacturer, the place of manufacture, etc., which are not in harmony with the general meaning of the law may be used if on hand on the 1st of January, 1907, the day on which the regulations become effective. Any statement, however, respecting the character of the contents which is false or misleading should be corrected as indicated. The correction should secure the obliteration of the misstatement either by placing the supplemental label or paster over it or obliterating it in some other way. If the goods contain artificial color or preservative other than ordinary condimental substances (salt, sugar, vinegar, wood smoke, spices, and condiments of all kinds), that fact should appear upon the supplemental stamp or paster. If any of the words required to be placed upon drugs and foods in the specific wording of the act do not appear upon the label, such as alcohol, opium, etc., it is held that the correction must include the enumeration of these substances, as provided for in Regulations 28 and 29.
If goods that are packed and sealed in a carton which contains the bottle or other package also sealed and labeled were not in the hands of the manufacturer after January 1, 1907, but had been already delivered to the jobber or dealer, it will be held sufficient to mark the external carton alone, provided the goods are sold only in the unbroken carton. If the container, however, holds a large number of separate packages, it will be necessary that each of the separate packages to be sold as such shall be labeled with the words required specifically by the act.
It must not be forgotten that Regulation 17, section (i), is for the purpose of avoiding the expense of relabeling articles already packed and branded at the time the regulations go into effect and which necessarily could not have been so packed and branded with any intent to evade the provisions of the law, and it is expected that jobbers and dealers will do everything in their power to bring the packages now on hand into as close harmony with the provisions of the act and the regulations made thereunder as possible.
All articles in the hands of manufacturers, jobbers, and dealers on the 1st day of January, 1907, which are sold wholly within the State in which they are found on that date are exempt from the provisions of the act. Thus the use of the supplemental label, stamp, or paster is required only on those articles which on or after the 1st day of January, 1907, enter interstate commerce or are offered for sale in the District of Columbia and the Territories. It is believed that the provisions of Regulation 17, section (i), can be complied with without great annoyance and expense. It will be deemed sufficient if the supplemental pasters and labels are attached at the time the goods are shipped beyond the State line, that is, they need not necessarily be attached to such article on the 1st day of January, but at any time thereafter when prepared for interstate commerce. Thus the labor of meeting this requirement will be distributed according to the exigencies of actual trade. On and after October 1, 1907, the label must be originally properly printed, and no further amendment will be considered.
Approved: W. M. Hays, Acting Secretary. Washington, D. C., November 6, 1906.
F. I. D. 44-45. Issued December 4, 1906.
UNITED STATES DEPARTMENT OF AGRICULTURE, BUREAU OF CHEMISTRY, H. W. WILEY, Chief of Bureau.
FOOD INSPECTION DECISIONS 44 AND 45.
(F. I. D. 44.) SCOPE AND PURPOSE OF FOOD-INSPECTION DECISIONS.
From the tenor of many inquiries received in this Department it appears that many persons suppose that the answers to inquiries addressed to this Department, either in letters or in published decisions, have the force and effect of the rules and regulations for the enforcement of the food and drugs act of June 30, 1906. The following are illustrations of the inquiries received by this Department:
Must we stamp all goods as conforming to the drug and food law, whether they have alcohol and narcotics therein, or not?
On a brand of salad oil, which is a winter-strain cottonseed oil, can it be sold under the brand of salad oil, or must it state that it is cottonseed oil?
It seems highly desirable that an erroneous opinion of this kind should be corrected. The opinions or decisions of this Department do not add anything to the rules and regulations nor take anything away from them. They therefore are not to be considered in the light of rules and regulations. On the other hand, the decisions and opinions referred to express the attitude of this Department in relation to the interpretation of the law and the rules and regulations, and they are published for the information of the officials of the Department who may be charged with the execution of the law and especially to acquaint manufacturers, jobbers, and dealers with the attitude of this Department in these matters. They are therefore issued more in an advisory than in a mandatory spirit. It is clear that if the manufacturers, jobbers, and dealers interpret the rules and regulations in the same manner as they are interpreted by this Department, and follow that interpretation in their business transactions, no prosecution will lie against them. It needs no argument to show that the Secretary of Agriculture must himself come to a decision in every case before a prosecution can be initiated, since it is on his report that the district attorney is to begin a prosecution for the enforcement of the provisions of the act.
In so far as possible it is advisable that the opinions of this Department respecting the questions which arise may be published. It may often occur that the opinion of this Department is not that of the manufacturer, jobber, or dealer. In this case there is no obligation resting upon the manufacturer, jobber, or dealer to follow the line of procedure marked out or indicated by the opinion of this Department. Each one is entitled to his own opinion and interpretation and to assume the responsibility of acting in harmony therewith.
It may be proper to add that in reaching opinions and decisions on these cases the Department keeps constantly in view the two great purposes of the food and drugs act, namely, to prevent misbranding and to prohibit adulteration. From the tenor of the correspondence received at this Department and from the oral hearings which have been held, it is evident that an overwhelming majority of the manufacturers, jobbers, and dealers of this country are determined to do their utmost to conform to the provisions of the act, to support it in every particular, and to accede to the opinions of this Department respecting its construction. It is hoped, therefore, that the publication of the opinions and decisions of the Department will lead to the avoidance of litigation which might arise due to decisions which may be reached by this Department indicating violations of the act, violations which would not have occurred had the opinions and decisions of the Department been brought to the attention of the offender.
James Wilson, Secretary of Agriculture.
Washington, D. C., December 1, 1906.
(F. I. D. 45.) BLENDED WHISKIES.
Many letters are received by the Department making inquiries concerning the proper method of labeling blended whisky. Manufacturers are anxious to know the construction placed by the Department upon this particular part of the food and drugs act of June 30, 1906, and to ascertain under what conditions the words “blended whisky” or “whiskies” may be used. The following quotation from one of these letters presents a particular case of a definite character:
On account of the uncertainty prevailing in our trade at the present time as to how to proceed under the pure-food law and regulations regarding what will be considered a blend of whiskies, I am taking the liberty of expressing to you to-day two samples of whisky made up as follows:
Sample A contains 51 percent of Bourbon whisky and 49 percent of neutral spirits. In this sample a small amount of burnt sugar is used for coloring, and a small amount of prune juice is used for flavoring, neither of which increases the volume to any great extent.
Sample B contains 51 percent of neutral spirits and 49 percent of Bourbon whisky. Burnt sugar is used for coloring, and prune juice is used for flavoring, neither of which increases the volume to any great extent.
I have marked these packages “blended whiskies” and want your ruling as to whether it is proper to thus brand and label such goods.
My inquiry is for the purpose of guiding the large manufacturing interests in the trade that I represent.
In a subsequent letter from the same writer the following additional statement is made:
The reason for wanting your decision or ruling in this matter is just this: No house in the trade can afford to put out goods and run the risk of seizure and later litigation by the Government on account of the odium that would be attached to fighting the food and drugs act.
The question presented is whether neutral spirits may be added to Bourbon whisky in varying quantities, colored and flavored, and the resulting mixture be labeled “blended whiskies.” To permit the use of the word “whiskies” in the described mixture is to admit that flavor and color can be added to neutral spirits and the resulting mixture be labeled “whisky.” The Department is of opinion that the mixtures presented can not legally be labeled either “blended whiskies” or “blended whisky.” The use of the plural of the word “whisky” in the first case is evidently improper for the reason that there is only one whisky in the mixture. If neutral spirit, also known as cologne spirit, silent spirit, or alcohol, be diluted with water to a proper proof for consumption and artificially colored and artificially flavored, it does not become a whisky, but a “spurious imitation” thereof, not entirely unlike that defined in section 3244, Revised Statutes. The mixture of such an imitation with a genuine article can not be regarded as a mixture of like substances within the letter and intent of the law.
James Wilson, Secretary of Agriculture.
Washington, D. C., December 1, 1906.
F. I. D. 46, as amended. Issued March 22, 1907.
UNITED STATES DEPARTMENT OF AGRICULTURE, BUREAU OF CHEMISTRY, H. W. WILEY, Chief of Bureau.
FOOD INSPECTION DECISION 46, AS AMENDED. Fictitious Firm Names.
F. I. D. 46, Issued on December 13, 1906, on the Subject of Fictitious Firm Names, is Hereby Amended to Read as Follows, for the Purpose of Obviating Any Ambiguity That May Have Existed in the Original Decision. The Amended Portion is Set in Italics.
The following extract from a letter is typical of a question frequently asked:
In connection with our manufacture of flavoring extracts, we produce an article containing a certain percentage of artificial coumarin and vanillin. This product has been placed on the market under the name of ———— and Company, a fictitious firm, although dealers have always understood that it was our product. Is there any objection to our continuing to brand the product as manufactured by ———— and Company?
The same question has frequently been asked by importers who state that they desire to assume the responsibility for particular brands.
It has been held by the Attorney-General (F. I. D. 2) that—
the words “... Daisy Sugar Corn, ———— ———— Company, Milwaukee, Wis.,” clearly imply that the goods referred to are manufactured or prepared by that company in Wisconsin. The general public, unfamiliar with trade practices, would inevitably reach that conclusion.
Regulation 18 provides that if the name of the manufacturer and the place of manufacture be given, they must be the true name and the true place. If would appear, therefore, that the use of a fictitious name in such a manner that it would be understood to be the name of the manufacturer would be clearly a violation of Regulation 18. It is apparent that the provisions of Regulation 18 will not be fulfilled by the nominal incorporation of a fictitious firm. The regulations require that goods must be actually manufactured by the firm represented on the label as the manufacturer.
When a proper name, other than that of the manufacturer, is placed upon a label it must not be used in the possessive. For instance,
CHARLES GASTON’S OLIVE OIL BORDEAUX
can only be properly used on an oil manufactured by Charles Gaston at Bordeaux. The same is true if the designation
GASTON’S OLIVE OIL BORDEAUX
be employed.
On the other hand, the word “Gaston” might be used in an adjective sense, and not in the possessive case as qualifying the words “olive oil,” in a manner that would indicate that it represented a brand and not a manufacturer, as
GASTON OLIVE OIL.
Or,
OLIVE OIL, GASTON BRAND.
In such case, however, neither given name nor initials should be employed. The word “Gaston” should be in the same type as “olive oil” and in equal prominence, thus forming a part of the label.
The phrase “Olive Oil, Charles Gaston Brand,” may be used, in which case the name of the actual manufacturer should appear, in order that no false indication of the name of the person or firm manufacturing the product may be given.
James Wilson, Secretary of Agriculture.
Washington, D. C., February 21, 1907.
(F. I. D. 47.) FLAVORING EXTRACTS.
The percentage of alcohol is not required to be stated in the case of extracts sold for the preparation of foods only. It is held, however, that extracts which are sold or used for any medicinal purpose whatever should have the percentage of alcohol stated on the label.
Numerous inquiries are received regarding the proper designation of products made in imitation of flavoring extracts or in imitation of flavors. Such products include “Imitation vanilla flavor,” which is made from such products as tonka extract, coumarin, and vanillin, with or without vanilla extract. They may also include numerous preparations made from synthetic fruit ethers intended to imitate strawberry, banana, pineapple, etc. Such products should not be so designated as to convey the impression that they have any relation to the flavor prepared from the fruit. Even when it is not practicable to prepare the flavor directly from the fruit, “imitation” is a better term than “artificial.”
These imitation products should not be designated by terms which indicate in any way by similarity of name that they are prepared from a natural fruit or from a standard flavor. The term “venallos,” for instance, would not be a proper descriptive name for a preparation intended to imitate vanilla extract. Such products should either be designated by their true names, such as “vanilla and vanillin flavor,” “vanillin and coumarin flavor,” or by such terms as “imitation vanilla flavor” or “vanilla substitute.”
Articles in the preparation of which such substitutes are employed should not be labeled as if they were prepared from standard flavors or from the fruits themselves. For instance, ice cream flavored with imitation strawberry flavor should not be designated as “strawberry ice cream.” If sold as strawberry ice cream without a label the product would appear to be in violation of Regulation 22.
Artificial colors should be declared whenever present.
James Wilson, Secretary of Agriculture.
Washington, D. C., December 13, 1906.
(F. I. D. 48.) SUBSTANCES USED IN THE PREPARATION OF FOODS.
The following letter was recently received at the Department of Agriculture:
We import a preparation of gelatin preserved with sulfurous acid for the purpose of fining wine. This gelatin is not used as a food and does not remain in the wine, although a small amount of the sulfurous acid may be left in the wine. Please inform us if the sale of this product is a violation of the food law.
It is held that the products commonly added to foods in their preparation are properly classed as foods and come within the scope of the food and drugs act. The Department can not follow a food product into consumption in order to determine the use to which it is put. Pending a decision on the wholesomeness of sulfurous acid as provided in Regulation 15 (b), its presence should be declared.
James Wilson, Secretary of Agriculture.
Washington, D. C., December 13, 1906.
F. I. D. 49-53. Issued February 18, 1907.
UNITED STATES DEPARTMENT OF AGRICULTURE, BUREAU OF CHEMISTRY, H. W. Wiley, Chief of Bureau.
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.
(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.
FOOD INSPECTION DECISIONS 54-59.
54. Declaration of the quantity or proportion of alcohol present in drug products. 55. Method of stating quantity or proportion of preparations (containing opium, morphin, etc.) used in manufacturing other preparations. 56. Names to be employed in declaring the amount of the ingredients as required by the law. 57. Physicians’ prescriptions: The status of packages compounded according to physicians’ prescriptions and entering into interstate commerce. 58. The labeling of products used as food and drugs as well as for technical and other purposes. 59. National Formulary appendix.
(F. I. D. 54.) DECLARATION OF THE QUANTITY OR PROPORTION OF ALCOHOL PRESENT IN DRUG PRODUCTS.
The question of stating the percentage of alcohol present in drug products has caused a multitude of inquiries. The following questions along this line serve as examples:
Is it necessary to give the amount of alcohol present in U. S. Pharmacopœial or National Formulary products? It seems to me that such a requirement is absurd, and not contemplated within the spirit of the act. None of them are patent medicines. Will I be compelled to tell how much alcohol is present in such goods?
If we apply for and obtain a serial number, must we in addition to putting this number on our labels state the percent of alcohol?
Will it be necessary to give the percent of alcohol present in such products as ether, chloroform, collodion, spirit of nitrous ether, and similar preparations?
The law is specific on the subject of declaring the amount of alcohol present in medicinal agents, as can readily be seen from the following language: “An article shall also be deemed misbranded ... if the package fail to bear a statement on the label of the quantity or proportion of any alcohol ... contained therein. No medicinal preparations are exempt, whether they are made according to formulæ given in the U. S. Pharmacopœia or National Formulary or formulæ taken from any other source. The serial number, with or without the guarantee legend, does not exempt a preparation from this requirement. The law does not make any statement as to the amount of alcohol that may or may not be employed. It requires, however, that whatever amount be present shall be set forth on the label. The percentage of alcohol given on the label should be the percentage of absolute alcohol by volume contained in the finished product. The manner in which it should be printed is shown in F. I. D. 52.
James Wilson, Secretary of Agriculture.
Washington, D. C., March 13, 1907.
(F. I. D. 55.) METHOD OF STATING QUANTITY OR PROPORTION OF PREPARATIONS (CONTAINING OPIUM, MORPHIN, ETC.) USED IN MANUFACTURING OTHER PREPARATIONS.
Many inquiries are received as to the method of stating the quantity or proportion of preparations (containing opium, morphin, etc.) used in the manufacture of other preparations. Of these the following are typical:
If the label on the bottle were to bear the words “Tincture of Opium,” I reason that as this is a definite preparation, constituting a preparation of opium, and so definite as to its composition that to any intelligent person it expresses definitely all that it is desirable to express, the use of this title alone should be sufficient. I feel that as a preparation it is distinct from opium, and if this particular tincture is used in the manufacture of a preparation the mention of it alone should be sufficient.
Where extract or tincture of cannabis indica, or extract of opium, is employed in making other drug products, would it not be complying with the law if the use of such articles be clearly indicated on the label as prescribed by the law, or is it necessary to give the actual amounts of the drugs themselves represented by these preparations?
Names of drug products bearing any of the names of the ingredients enumerated in the act are construed as representing “preparations” within the meaning of the act; and if the same are clearly declared upon the label as required by Regulations 17 and 30, it will not be necessary to give the actual amount of the primary drugs used or represented by such article. It is desirable, however, that the word or words used in the law shall constitute the first part of the name of the product. For example: “Opium, Tincture of;” “Cannabis Indica, Extract of,” followed by the amount of tincture or extract used.
James Wilson, Secretary of Agriculture.
Washington, D. C., March 13, 1907.
(F. I. D. 56.) NAMES TO BE EMPLOYED IN DECLARING THE AMOUNT OF THE INGREDIENTS AS REQUIRED BY THE LAW.
Many inquiries are coming to this Department relative to the names that may be employed in declaring the quantity or proportion of the ingredients, as required by Congress.
The following are representative:
The word “alcohol” has received so much unfavorable notoriety during the last few years that we hesitate to place it upon our labels. Could we not employ some other words in place of it, such as “cologne spirits,” “spirits of wine,” “pure grain alcohol,” etc.?
Would it be satisfactory for us to use “Phenylacetamid,” or the following formula, C6H5(CH3CO), for the chemical acetanilid?
One of our preparations contains trichlorethidene ethyl alcoholate, which would undoubtedly under the law be considered a derivative of chloral hydrate. Will it be satisfactory for us to use this name on our trade packages in giving the amount of this chemical present in the product?
In the manufacture of some of our products we use opium. It would, however, be a financial loss to state this fact on the label. Could we not say this preparation contains 20 grains of the concentrated extract of the Papaver somniferum to the fluid ounce?
Dover’s powder is mentioned in the regulations as one of the preparations of opium. It would seem sufficient at first glance that Dover’s powder as a preparation, if mentioned on the label, would be all that could be required as to opium.
One of the objects of the law is to inform the consumer of the presence of certain drugs in medicines, and the above terms do not give the average person any idea as to the presence or absence of such drugs. In enumerating the ingredients, the quantity or proportion of which is required to be given upon the principal label of any medicinal preparation in which such ingredients may be present, the act uses only common names, and the permission to use any but such common names for any ingredients required to be declared upon the label is neither expressed nor implied in any part of the law.
The term used for acetanilid is “acetanilid” and not phenylacetamid. No reference is made to the use of the chemical formula in designating the presence of chemicals. The words “chloral hydrate” appear in the act, but not the chemical name trichlorethidene glycol. It can readily be seen that if the act were not closely adhered to in this connection there would soon be such a confusion and multiplicity of names and phrases that one of the objects of the act would be defeated.
The names to be employed in stating the quantity or proportion of the ingredients required by the act to appear on the label of all medicinal preparations containing same are—
First. Those used in the law for the articles enumerated; example, “alcohol,” not “spiritus rectificatus.”
Second. In the case of derivatives: (a) The name of the parent substance used in the act should constitute part of the name; example, “chloral acetone,” not “trichlorethidene dimethyl ketone.” (b) The trade-name, accompanied in parentheses by the name of the parent substance; example, “dionin (morphin derivative).”
Third. Names of preparations containing the name of some ingredient used in the act. In such cases the name used in the act should constitute the first portion of the name of the preparation. (See F. I. D. 55.)
Fourth. Common names (such as laudanum, Dover’s powder, etc.) of preparations containing an ingredient enumerated in the law, provided such name or names are accompanied in parentheses by some such phrase as “preparation of opium” or “opium preparation,” followed by the number of minims or grains, as specified in the regulations; for instance, “laudanum (preparation of opium), 40 minims per ounce.”
James Wilson, Secretary of Agriculture.
Washington, D. C., March 13, 1907.
(F. I. D. 57.) PHYSICIANS’ PRESCRIPTIONS. The Status of Packages Compounded According to Physicians’ Prescriptions and Entering into Interstate Commerce.
Packages resulting from the compounding of physicians’ prescriptions under the food and drugs act are the subject of many queries, of which the following are representative:
If a druggist compounds a physician’s prescription and sends it into an adjoining State, will it be necessary to state upon the label the amount of alcohol, morphin, etc., that may be present?
Supposing a regularly licensed practicing physician has patients located in various States of the Union and supplies medicines to them through the mails, by express, and otherwise, do such packages come under the provisions of the law, and, if so, can the required information be given in pen and ink on the label?
We treat drug addictions on a very gradual tonic treatment reduction plan. For instance, if John Doe writes for information as to the home treatment for his addiction, I send him a symptom blank which contains, among other questions, an inquiry as to the kind of drug he uses, how he uses it, the length of time he has used it, etc. In addition to giving me a complete history of his case, he states he is using 10 grains of sulf. of morphin (each twenty-four hours), hypodermically or internally, as the case may be. In prescribing in his case I immediately put him on just one-half of the amount he reports as his daily allowance, combining same with a bitter tonic.
It is necessary for the reduction in drug cases to be made without the patient’s knowledge. It is, of course, understood by all physicians that you can not trust a drug habitué to properly make his own reductions, for, as a matter of fact, if he knew to what extent I was reducing his daily allowance of opiates, he would imagine the reduction too rapid, he would get frightened, and would take to his former drug for relief. Treatment prepared in this way I do not think would come under the head of a proprietary preparation or a patent medicine, as I prescribe the contents of each bottle to meet the requirements of each individual patient. All instructions as to the conduct of treatment and the use of auxiliary remedies are given by letter; consequently there are no printed labels or cartons containing any claims concerning the efficacy of this treatment.
I would be pleased to have you inform me whether in your opinion I would be violating the pure-food law in any manner, shape, or form should I continue to label my preparations as I am now doing, and in having them prepared in ———— and forwarded direct to my patients in this and other States.
If a package compounded according to a physician’s prescription be shipped, sent, or transported from any State or Territory or the District of Columbia to another State or Territory or the District of Columbia by a compounder, druggist, physician, or their agents, by mail, express, freight, or otherwise, the label upon such package is required to bear the information called for by Congress. If, however, the patient himself, or a member of his household, or the physician himself carries such package across a State line, and such package is not subject to sale, it is held that such package need not be marked so as to conform with the law, because such a transaction is not considered one of interstate commerce.
The package may be marked so as to comply with the act by either stamp, pen and ink, or typewriter, provided all such written matter is distinctly legible and on the principal label, as prescribed in Regulation 17.
James Wilson, Secretary of Agriculture.
Washington, D. C., March 13, 1907.
(F. I. D. 58.) THE LABELING OF PRODUCTS USED AS FOODS AND DRUGS AS WELL AS FOR TECHNICAL AND OTHER PURPOSES.
Frequent requests for information relative to the proper labeling of products bearing the names of foods and drugs, but used also for technical and other purposes, are received. The following are typical:
We will kindly ask you to advise us in regard to the new law that governs the line of oils. We manufacture a compound product, so-called “turpentine,” which contains pure turpentine and a very fine petroleum product. It is used in most branches where pure turpentine is used, with the exception of medicinal purposes, for which we do not sell it.
We understand that if we were to sell any cottonseed oil so branded as to indicate that it was intended to be used as a food, as, for example, under the brand “Blank Salad Oil,” it would be necessary to observe the requirements of the law referred to; but we are in doubt and would be glad to have your opinion as to whether a sale or shipment of this oil (for lubricating purposes) under the ordinary trade-brand of cottonseed oil, and without anything to indicate that it was of a quality suitable for use as a salad oil, would subject us to the provisions of the act.
During personal interviews the question of marking chemical reagents has also been discussed.
Products used in the arts and for technical purposes are not subject to the food and drugs act. It is, however, a well-recognized fact that many articles are used indiscriminately for food, medicinal, and technical purposes. It is also well known that some products employed for technical purposes are adulterated or misbranded within the meaning of this act. Inasmuch as it is impossible to follow such products into consumption in order to determine to what use they are finally put, it is desirable that an article sold under a name commonly applied to such article for food, drug, and technical purposes be so labeled as to avoid possible mistakes. The ordinary name of a pure and normal product, whether sold for food, drug, technical, or other purposes, is all that is necessary. Pure cottonseed oil or turpentine may be sold without any restrictions whatever, whether such article is sold for food, medicinal, or technical purposes, but it is suggested that a cottonseed oil intended for lubricating purposes, or a so-called turpentine consisting of a mixture of turpentine and petroleum oils, used by the paint trade, be plainly marked so as to indicate that they are not to be employed for food or medicinal purposes. Such phrases as the following may be used: “Not for Food Purposes,” “Not for Medicinal Use,” or for “Technical Purposes Only,” or “For Lubricating Purposes,” etc.
In order to avoid complication it is suggested that chemical reagents sold as such be marked with such phrases as the following: “For Analytical Purposes,” or “Chemical Reagent,” etc.
James Wilson, Secretary of Agriculture.
Washington, D. C., March 13, 1907.
(F. I. D. 59.) NATIONAL FORMULARY APPENDIX.
The National Formulary is one of the standards recognized under the law. The question has been asked a number of times whether the appendix of this authority would be construed as part and parcel of the book itself. On page iv of the preface it is distinctly stated that the formulæ collected in the appendix of the National Formulary are “no longer designated as ‘N. F.’ preparations.” This shows that these formulæ are not integral parts of the book under the law, which covers only those products of the National Formulary recognized as such by this authority. By this it is understood that if a drug product is sold under a name contained in the appendix of the National Formulary, it will not be necessary for such product either to conform to the standard indicated by the formula or to declare upon the label its own standard strength, quality, and purity if a different formula is employed in its manufacture. Such articles are, however, subject to the law in every other respect, as is the case of other medicinal products not recognized by the U. S. Pharmacopœia or National Formulary.
James Wilson, Secretary of Agriculture.
Washington, D. C., March 13, 1907.
(F. I. D. 60.) MINOR BORDER IMPORTATIONS.
Inquiry has frequently been made regarding the application of Regulation 33 (requiring a declaration to be attached to the invoice) to foods and drugs brought into the United States in small quantities by farmers living near the border. One correspondent says:
Farmers along the border are in the habit of occasionally bringing in, in their own teams, maple sugar in small quantities, also butter and like articles of food products of their own raising, and offering the same for entry at the different offices on the frontier.... The main question is as to whether or not the affidavits and other proof required by the pure-food law shall be required in these instances of minor importations of this class of articles.
Considering the nature of these importations it is held that Regulation 33 does not apply to them and that they may be imported without the declaration. Such products are subject to inspection, however, and if found to be in violation of the law will be excluded.
James Wilson, Secretary of Agriculture.
Washington, D. C., March 25, 1907.
(F. I. D. 61.) COCOA BUTTER SUBSTITUTES.
A manufacturer writes:
We use in the preparation of chocolate sticks a guaranteed pure production of cocoanut oil. May this product be sold merely as confectionery, and not as chocolate sticks? If not, would it be satisfactory for us to mark the product as “Chocolate sticks prepared with substitute butter”?
Regulation 22 prohibits the sale, or offer for sale, in interstate or foreign commerce or in the District of Columbia or in any Territory of the United States, of a food or drug product which bears no label whatever if said product be an imitation of or offered for sale under the name of another article. It would clearly be a violation of the law to sell an article which was made in imitation of chocolate, even though it be sold under the general name of a confection. Such an article should be labeled in such a manner as to correctly represent its true nature.
Regulation 25 (a) provides:
When a substance of a recognized quality commonly used in the preparation of a food or drug product is replaced by another substance not injurious or deleterious to health, the name of the substituted substance shall appear upon the label.
It is held that cocoa butter is the only fat that can be used in chocolate. The declaration of foreign fats merely as “substitute butter” is apparently not sufficient; the nature of the fat employed should be stated.
James Wilson, Secretary of Agriculture.
Washington, D. C., March 25, 1907.
(F. I. D. 62.) GUARANTY ON IMPORTED PRODUCTS.
Many inquiries of the following type have been received by the Department:
We will take it as a favor if you will advise us if (since our goods are all imported and so must pass the custom-house before being sold) the fact of their having passed the customs authorities and the Department of Agriculture examination is not in itself a guaranty that they conform with the pure-food laws as defined by the act of Congress approved June 30, 1906, entitled “An act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, liquors,” etc.
The Department makes a systematic inspection of imported foods and drugs when they arrive at the custom-houses; and while such inspection does not include an examination of samples taken from every package of the aforesaid articles, it is sufficient to indicate that the article is suitable to enter the country and be sent into interstate commerce as long as it retains its identity in the unbroken package. If imported foods and drugs are taken from the original packages and repacked, they become subject to inspection as if of domestic origin, and the persons handling and selling said articles are not immune from prosecution in the event that a subsequent inspection discloses that all or any portion of said foods or drugs are adulterated or misbranded according to the provisions of said statute or the regulations made thereunder.
Only a wholesaler, jobber, manufacturer, or other party residing in the United States can give a guaranty within the meaning of said act. A foreign manufacturer or other foreign dealer can not give the guaranty prescribed in said law, nor can the agent of such foreign manufacturer or dealer give said guaranty unless such agent be a resident of the United States and unless he actually sells the goods covered by the guaranty.
The person who owns and sells imported goods can make a guaranty for the purpose aforesaid, though the goods may be shipped directly by the firm of whom the guarantor buys them to the customer of the guarantor.
James Wilson, Secretary of Agriculture.
Washington, D. C., March 25, 1907.
(F. I. D. 63.) USE OF THE WORD “COMPOUND” IN NAMES OF DRUG PRODUCTS.
Many inquiries are received concerning the use of the word “compound” in names of drug products. There seems to be a general impression that this word can be applied as a corrective to many misbranded products. The following extracts serve as examples:
You have on file our formula (active agents—croton oil and cascara), and we would ask if it is possible to call the same “castor pill compound” and comply with the regulations?
This liniment has been in use for forty years. The ingredients, each separately and collectively, are sanitary and highly curative. The one ingredient after which it was named happens to be present in the least proportion. Can not the compound be called by the name “Compound Sassafras Cream”?
An eminent jurist writes:
I shall be glad to know the views entertained by your Department as to when a druggist has satisfied this act by a label or printed matter which he puts on the package or bottle in relation to a compound. Take, for example, the product put on the market as Cascarin Compound, or Aloin Compound. I am impressed with the fact that such label must have added a statement as to what the other ingredients of the compound are. This may not mean, and probably does not mean, that the formula must be given or the exact proportions, but a purchaser has the right to know what is in the compound in order to determine for himself, or to receive proper advice, as to whether it is safe to be used.
In no case can a preparation be named after an ingredient or drug which is not present. The word “compound” should not be used in connection with a name which in itself, or together with representations and designs accompanying same, would be construed as a form of misbranding under the act.
It is held that if a mixture of drugs is named after one or more but not all of the active medicinal constituents (not vehicle) present in a preparation, the word “compound” can be used in connection with the name, (a) provided the active constituent after which the product is named is present in an amount at least equal to that of any other active medicinal agent present. Example: If it is desired Lo make a mixture consisting of oil of sandalwood, balsam copaiba, and castor oil, and call this product “Oil of Sandalwood Compound,” the oil of sandalwood should constitute at least 331⁄3 percent of the entire mixture. Or (b) provided the potent active constituent after which the product is named is present in sufficient amount to impart the preponderating medicinal effect. Example: If a product is named after the active constituent, strychnine, the strychnine or one of its salts should be present in sufficient amount to produce the preponderating medicinal effect of the preparation. Or (c) provided the complete quantitative formula, as outlined in the United States Pharmacopœia and National Formulary, be given on the principal label. A declaration of the complete quantitative formula, however, does not exempt the manufacturer or dealer from giving the information required by the act in the manner prescribed by the regulations. The ounce shall be the unit. The amounts of the ingredients present (excepting alcohol, which is to be stated in percent) shall be given in grains or minims, and if it is desired the metric equivalent may be given in addition.
James Wilson, Secretary of Agriculture.
Washington, D. C., March 23, 1907.
(F. I. D. 64.) LABELING OF SARDINES.
Many inquiries have been made of this Department respecting the extent to which the term “sardine” can be used in food products entering into foreign or interstate commerce. The question of the proper labeling of fish of this kind was submitted by the Department to the Department of Commerce and Labor, Bureau of Fisheries. After reviewing the nomenclature and trade practices the Department of Commerce and Labor reached the following conclusion:
Commercially the name sardine has come to signify any small, canned, clupeoid fish; and the methods of preparation are so various that it is impossible to establish any absolute standard of quality. It appears to this Department that the purposes of the pure-food law will be carried out and the public fully protected if all sardines bear labels showing the place where produced and the nature of the ingredients used in preserving or flavoring the fish.
In harmony with the opinion of the experts of the Bureau of Fisheries, the Department of Agriculture holds that the term “sardine” may be applied to any small fish described above, and that the name “sardine” should be accompanied with the name of the country or State in which the fish are taken and prepared, and with a statement of the nature of the ingredients used in preserving or flavoring the fish.
It is held that a small fish of the clupeoid family, caught upon or near the shores of and packed in oil in Norway, or smoked and packed in oil, is properly labeled with the phrase “Norwegian Sardines in Oil,” or “Norwegian Smoked Sardines in Oil,” the nature of the oil being designated. In like manner a small fish of the clupeoid family caught upon or near the shores of and packed in France may be called “French Sardines in Oil,” the nature of the oil being specified. Following the same practice, a fish of the clupeoid family caught on or near the shores of and packed in the United States may be labeled “American Sardines Packed in Oil,” or “Maine Sardines Packed in Oil,” or be given some similar appellation, the nature of the oil being stated. It is suggested that the name of the particular fish to which the term sardine is to be applied should also be placed upon the label—for example, “Pilchard,” “Herring,” etc.
James Wilson, Secretary of Agriculture.
Washington, D. C., March 29, 1907.
LIST OF FOOD INSPECTION DECISIONS.
F. I. D. 1-39 practically concern imported foods only and were not issued under the food and drugs act, June 30, 1906.
F. I. D. - 40. Filing Guaranty.
41. Approval of Labels.
42. Mixing Flours.
43. Relabeling of Goods on Hand.
F. I. D. - 44. Scope and Purpose of Food Inspection Decisions.
45. Blended Whiskies.
F. I. D. - 46. Fictitious Firm Names; also F. I. D. 46, as amended.
47. Flavoring Extracts.
48. Substances Used in the Preparation of Foods.
F. I. D. - 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. - 54. Declaration of the Quantity or Proportion of Alcohol Present in Drug Products.
55. Method of Stating Quantity or Proportion of Preparations (Containing Opium, Morphin, etc.) Used in Manufacturing Other Preparations.
56. Names to be Employed in Declaring the Amount of the Ingredients as Required by the Law.
57. Physicians’ Prescriptions: The Status of Packages Compounded According to Physicians’ Prescriptions and Entering into Interstate Commerce.
58. The Labeling of Products Used as Food and Drugs as well as for Technical and Other Purposes.
59. National Formulary Appendix.
F. I. D. - 60. Minor Border Importations.
61. Cocoa Butter Substitutes.
62. Guaranty on Imported Products.
63. Use of the Word “Compound” in Names of Drug Products.
64. Labeling of Sardines.