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other than in which his main office is located, the name of the State in which they were actually manufactured or packed. It is clear from paragraph (b) of Regulation 1865 that such requirement may be made if deemed necessary by the Secretary of Agriculture to prevent deception. The enforcement of such a requirement generally is probably unnecessary and it is not likely to be enforced, unless its nonenforcement is taken advantage of to actually deceive the public.

43. MISBRANDING GENERAL Requirements as to Label -ARTICLES WITHOUT A LABEL:

There is nothing in the Act which requires food or drug products to be branded or labeled unless they contain certain specified substances or are otherwise of a character which would render them liable to be prohibited as adulterated without some statement of character or quality. But the omission of a label or brand will not avoid liability under the Act if the article without a label sold or offered for sale is an imitation of or is offered for sale under the name of another article. Regulation 22, which expressly prohibits selling or offering for sale an unlabeled article of food or drug, if an imitation of or sold under the name of another article, is clearly warranted by the provisions of Section 8.67

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There is nothing in the Act which requires the name of the article to be placed on the label or on the package, but if a name is used it must be the true name. If a drug which is recognized by name in the U. S. Pharmacopoeia or National Formulary it must, if it bear any name, bear the name thus recognized. The common English name may be used if preferred. For instance, Magnesium Sulphate may be labeled Epsom Salts. A food product if it is commonly known to the trade must, if it bear any name, bear the name by which it is commonly known.

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The label need not bear the name of the manufacturer or the name of the locality in which it was produced except in certain cases specifically provided for in the Act, but if either is used it must be the correct name.

44. MISBRANDING-FORM OF LABEL:

With regard to the form or character and appearance of the label upon food and drug products not specifically provided for in the Act no requirement is made. So far as paragraph (b) of Regulation 1768 seems to require a particular arrangement of the matter on the label on food and drug products not specifically provided for in subsequent paragraphs of this Section, it is to be taken, in view of decisions of the Secretary of Agriculture, F. I. D. 52,0 January 18, 1907, as suggestive rather than directory.

The labels now in use on canned goods and most other food products which are put up in packages may continue to be used without change provided they contain no false or misleading statement, design or device. The same is true of the labels now in use on the drugs which are sold under names recognized in the Pharmacopoeia or National Formulary. Such articles, both of foods and drugs, are generally free from adulteration and contain no objectionable color or preservative and do not bear any false statement as to who manufactured them or where they were manufactured.

45. MISBRANDING DRUGS.

The first paragraph under "drugs" in Section 870 provides that an article shall be deemed misbranded if it be an imitation of another article or offered for sale under the name of another article. The prohibition is clear and definite.

No drug which is labeled as being other than it really is will be permitted to be passed off upon the public so far as the Government has the constitutional power to pre

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vent. It does not appear that an imitation of a drug is permitted even if plainly stated to be an imitation. So far as drugs, in the ordinary sense, that is simple or compounded drugs, are concerned there can be no such thing as an imitation. An article either is or is not the drug which it purports to be. As regards medicines in the ordinary sense, that is compounded drugs, there would seem to be no reason for permitting imitations even if plainly stated to be such.

The name applied to a drug must be the name under which it is recognized in the Pharmacopoeia or National Formulary, or if recognized under two names as for instance -Epsom Salts and Magesium Sulphate-either may be used. If not recognized in the Pharmacopoeia or National Formulary the name must be the trade designation applied to the article. A drug or an article purporting to be a drug will not be permitted to be passed off upon the public as being a drug named in the Pharmacopoeia or National Formulary when it is not, or as a drug known in the trade under a certain name or trade description when it is not what it purports to be.

It would seem also that a preparation purporting to be a medicinal preparation known to the trade under a distinctive trademark should be deemed to be misbranded if the package or label bears any imitation of such distinctive trademark.

46. MISBRANDING-DRUGS-REFILLING.

The first part of the second paragraph under "drugs" in Section 81 prohibits the refilling of packages from which the original contents have been removed either wholly or in part. This is, of course, to be understood as meaning refilling for purposes of sale and not to prohibit any use to which a bottle or carton might be put after its original contents have been removed and the label or brand removed or destroyed.

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Substances Required to be Named.

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So far as concerns the District of Columbia and the Territories it is not material whether a refilled package is to be considered an original unbroken package or not, as in either case the refilling is a violation of the provisions of the Act. So far as concerns the States it is doubtful whether the refilling of an original package and delivering it or offering to deliver it to another person, within the State in which the package was refilled, can be punished under the Act. It would seem that in such case the refilling would be a matter to be dealt with under the laws of the State in which the package was refilled. If the refilled package is shipped out of the State in which it was refilled, it may probably be treated as an original unbroken package.

47. MISBRANDING-DRUGS-SUBSTANCES REQUIRED TO BE

NAMED.

In the requirement contained in the second paragraph under "drugs" in Section 872 that the quantity or proportion of alcohol or other substances named in this paragraph or any derivative or preparation of any such substances, contained in any drug shall be stated on the label, the term "drug" is used in the broad sense to include all medicines and drug preparations whether recognized by name in the Pharmacopoeia or National Formulary or not. The requirement is undoubtedly intended to apply particularly to the so-called "Patent" medicines or proprietary remedies.

The requirement applies to veterinary medicines and stock foods as well as to all preparations having or purporting to have medicinal properties for either external or internal use for the treatment or prevention of disease in man or any living creature.

The requirement applies to physicians' prescriptions if compounded in the District of Columbia or in a Territory whether shipped out of the District or Territory or not, and also to physicians' prescriptions compounded in a State and shipped out of the State.73

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The requirement, so far as concerns alcohol, does not apply to flavoring extracts, these being classed as foods."

The substances required to be mentioned on the label are named in the second paragraph" of this Section of the Act. The derivatives or preparations of the substances named in the Act are stated in paragraph (f) of Regulation 28.7

48. MISBRANDING-Drugs-StateMENT OF QUANTITY OR

PROPORTION.

The quantity or proportion of the substances required to be named on the label is the quantity or proportion contained in the finished product. Any substance used in the preparation of a drug or medicine which is eliminated in the process of preparation need not be mentioned on the label." It is the finished product only from which samples or specimens can be taken for analysis by the Department of Agriculture, and the proceedings under the Act can be based only upon the analysis or examination of such samples or specimens.

If a substance named in the Act or a derivative of such substance is present in the finished product only as a mere trace, it probably need not be mentioned on the label. If present in any material proportion or any quantity sufficient to enable its presence to be determined with certainty by analysis or examination, it must be mentioned on the label.

Under Regulation 30,78 the quantity or proportion in case of alcohol must be stated by percentage of volume in the finished product, while in case of any of the other substances required to be named the quantity or proportion must be stated in grains or minims per fluid ounce or miligrams per gram or per cubic centimeter or grams or cubic centimeters per kilogram or per liter. The Regulation seems to require, even in case of medicines put up in tablets, powders, or capsules, that the quantity or proportion be stated in grains or minims per ounce (or as specified if the metric system

74F. I. D. 47, Page 113. 7 Page 88

75 Page 78.

TS Page 98.

Page 97.

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