party residing in the United States making the sale of the article or articles covered by it to the dealer, and shall be to the effect that such article or articles are not adulterated or misbranded within the meaning of the Federal Food and Drugs Act.

(e) Each guaranty in respect to any article or articles should be incorporated in or attached to the bill of sale, invoice, bill of lading, or other schedule, giving the names and quantities of the article or articles sold, and should not appear on the labels or packages.

(f) No dealer in food or drug products will be liable to prosecution if he can establish that the articles were sold under a guaranty given in compliance with this regulation.

F. I. D. 154 (May 11, 1914).1

REGULATION OF MARKING THE QUANTITY OF FOOD IN PACKAGE FORM.

Under section 3 of the Food and Drugs Act of June 30, 1906 (34 United States Statutes at Large, pages 768 to 772), as amended by the act of March 3, 1913, entitled "An act to amend section eight of an act entitled 'An act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes,' approved June thirtieth, nineteen hundred and six" (37 United States Statutes at Large, page 732), regulation 29 of the Rules and Regulations for the Enforcement of the Food and Drugs Act is hereby amended so as to read as follows:

STATEMENT OF WEIGHT, MEASURE, OR COUnt.

(Section 8, paragraph 3, under "Food," as amended by act of March 3, 1913.)

(a) Except as otherwise provided by this regulation, the quantity of the contents, in all cases of food, if in package form, must be plainly and conspicuously marked, in terms of weight, measure, or numerical count, on the outside of the covering or container usually delivered to consumers.

(b) The quantity of the contents so marked shall be the amount of food in the package.

(c) The statement of the quantity of the contents shall be plain and conspicuous, shall not be a part of or obscured by any legend or design, and shall be so placed and in such characters as to be readily seen and clearly legible when the size of the package and the circumstances under which it is ordinarily examined by purchasers or consumers are taken into consideration.

(d) If the quantity of the contents be stated by weight or measure, it shall be marked in terms of the largest unit contained in the package; for example, if the package contain a pound, or pounds, and a fraction of a pound, the contents shall be expressed in terms of pounds and fractions thereof; or of pounds and ounces, and not merely in ounces.

(e) Statements of weight shall be in terms of avoirdupois pounds and ounces; statements of liquid measure shall be in terms of the United States gallon of 231 cubic inches and its customary subdivisions, i. e., in gallons, quarts, pints, or fluid ounces, and shall express the volume of the liquid at 68° F. (20° C.); and statements of dry measure shall be in terms of the United States standard bushel of 2,150.42 cubic inches and its customary subdivisions, i. e., in bushels, half bushels, pecks, quarts, pints, or half pints: Provided, That, by like method, such statements may be in terms of metric weight or measure.

(f) The quantity of solids shall be stated in terms of weight and of liquids in terms of measure, except that in case of an article in respect to which there exists a definite trade custom otherwise, the statement may be in terms of weight or measure in accordance with such custom. The quantity of viscous or semisolid foods, or of mixtures of solids and liquids, may be stated either

1 Signed by the Secretary of the Treasury, the Secretary of Agriculture, and the Secretary of Commerce.

40066-14-11

by weight or measure, but the statement shall be definite and shall indicate whether the quantity is expressed in terms of weight or measure, as, for example, "Weight, 12 ounces," or "12 ounces avoirdupois"; "volume, 12 ounces," or "12 fluid ounces."

(g) The quantity of the contents shall be stated in terms of weight or measure unless the package be marked by numerical count and such numerical count gives accurate information as to the quantity of the food in the package. (h) The quantity of the contents may be stated in terms of minimum weight, minimum measure, or minimum count, for example, “minimum weight, 16 ounces "; "minimum volume, 1 gallon," or "not less than 4 ounces"; but in such case the statement must approximate the actual quantity, and there shall be no tolerance below the stated minimum.

(i) The following tolerances and variations from the quantity of the contents marked on the package shall be allowed:

(1) Discrepancies due exclusively to errors in weighing, measuring, or counting which occur in packing conducted in compliance with good commercial practice.

(2) Discrepancies due exclusively to differences in the capacity of bottles and similar containers resulting solely from unavoidable difficulties in manufacturing such bottles or containers so as to be of uniform capacity: Provided, That no greater tolerance shall be allowed in case of bottles or similar containers which, because of their design, can not be made of approximate uniform capacity than is allowed in case of bottles or similar containers which can be manufactured so as to be of approximate uniform capacity.

(3) Discrepancies in weight or measure, due exclusively to differences in atmospheric conditions in various places, and which unavoidably result from the ordinary and customary exposure of the packages to evaporation or to the absorption of water.

Discrepancies under classes (1) and (2) of this paragraph shall be as often above as below the marked quantity. The reasonableness of discrepancies under class (3) of this paragraph will be determined on the facts in each case. (j) A package containing two avoirdupois ounces of food or less is "small" and shall be exempt from marking in terms of weight.

(k) A package containing one fluid ounce of food or less is "small" and shall be exempt from marking in terms of measure.

(1) When a package is not required by paragraph (g) to be marked in terms of either weight or measure, and the units of food therein are six or less, it shall, for the purpose of this regulation, be deemed "small" and shall be exempt from marking in terms of numerical count.

F. I. D. 155 (May 29, 1914).1

CHANGING EFFECTIVE DATE OF FOOD INSPECTION DECISION NO. 153, WHICH AMENDS REGULATION 9, RELATING TO GUARANTIES BY WHOLESALERS, JOBBERS, MANUFACTURERS, AND OTHER PARTIES RESIDING IN THE UNITED STATES TO PROTECT DEALERS FROM PROSECUTION.

The effective date of Food Inspection Decision No. 153, issued May 5, 1914, is hereby postponed until May 1, 1916: Provided, That as to products packed and labeled prior to May 1, 1916, in accordance with law and with the regulations in force prior to May 5, 1914, it shall become effective November 1, 1916: And provided further, That compliance with the terms of regulation 9 of the Rules and Regulations for the Enforcement of the Food and Drugs Act as amended by Food Inspection Decision No. 153 will be permitted at any time after the date of this decision.

1 Signed by the Secretary of the Treasury, the Secretary of Agriculture, and the Secre tary of Commerce.

DECISIONS OF COURTS.

UNITED STATES v. HARPER.

(Police court, District of Columbia, March 12, 1908.)

Notice of Judgment No. 25.1

held

A drug product labeled "Harper's Cuforhedake Brane-Fude misbranded on account of false and misleading statements borne on the label and inclosed in the package.

Information alleging violation of sections 1 and 2 of the Food and Drugs Act. Jury trial. Verdict of guilty.

[2] IVORY G. KIMBALL, Judge (charge to the jury). I want to congratulate you upon your arrival at the last stage of this very long, but very interesting and important case. As was stated by Mr. Baker, the United States district attorney, it is the first case under the pure food [3] law in any court in the country, and it is one that may, in its final results, test many questions that are raised by the law and necessary to its proper administration, which questions must be finally settled by the courts.

The act known as the pure food law was passed on the 30th of June, 1906, but did not go into effect, as far as this case is concerned, until the 1st of January, 1907, thus giving to manufacturers a chance of changing their labels and packages, if they found it necessary to do so, and giving opportunity to dealers to get rid of any drug that might come under the purview of the law. So that in this case, as you have noticed in the prayers, the date is given to you as from January 1, 1907, up to the date of the filing of this information.

The information as originally filed had four counts, but the Gov ernment has abandoned the second and third; and, therefore, in your deliberations you will take no account of the second and third counts, but will confine yourselves to the first and fourth.

The first count relates to the manufacture of a misbranded drug; the fourth count relates to the sale of such a misbranded drug.

There was no law on this subject before the passage of this act. So that up to the 1st day of January, 1907, this drug might have been legally branded as the Government claims it was branded after that date; but from the 1st day of January, 1907, the law of June 30, 1906, went into effect, and is effective upon all manufacturers coming within its purview.

The first section of this information charges that the defendantį Robert N. Harper, manufactured a drug which was misbranded; and to fully inform you as to what is meant by the law by "misbranded," I will state what the law requires, because the law uses the word

1 Notices of Judgment will hereinafter be referred to by the initial letters, N. J. * Numbers in brackets refer to pages in Notice of Judgment.

163

"misbranding" and then defines it, and the court and jury are bound by the definition of misbranding as laid down in the law. The term applies to all drugs or articles of food, or articles which enter into the composition of food, "the package or label of which shall bear any statement, design, or device regarding such article or the ingredients or substances contained therein which shall be false or misleading in any particular."

You will notice how broad the law is in its definition. If it is found from the evidence that in any particular this drug known as "Harper's Cuforhedake" misstates or states falsely, then the law has been violated. It is not necessary that each one and all of them have been broken, but the law says "in any particular." So that if you find from the evidence that in any one point there has been a misbranding under the definition which I have read to you then you shall find a verdict of guilty.

I might say here that there are several items in this first count which, before entering upon the trial, Mr. Baker, on behalf of the Government, abandoned. So, in considering this, you will only take into account the items that I shall name, they being the only items on account of which Mr. Baker says the law was violated.

The first claim that he made is that said drug was not a cure for headache, nor a food for the brain, and I want to read in that connection, because the words "Cure" and "Brain Food" have been referred to by each one of the counsel who has appeared before you, the prayer that I have granted as to the meaning of those words:

The jury are instructed that in determining the meaning of the words “brainfood," " cure," "poisonous," and " harmless," the definition of which has been called into question by this inquiry, they are to give such words their ordinary and customary meaning as understood by the general public and not a technical meaning as given by any expert witness.

This law was passed not to protect experts especially, not to protect scientific men who know the meaning and the value of drugs, but for the purpose of protecting ordinary citizens, like the jury and like counsel and others, who have learned during the hearing of this trial a great deal more about these things than they ever knew before in all their life.

[4] In determining the meaning of the words used upon these cartons, bottles, and circulars, they are to be taken in the way that an ordinary, plain, common citizen, without scientific knowledge, would understand them if they were put before him.

And so with regard to this "Cuforhedake," you can take it to mean what an ordinary man would take it to mean-the meaning which it conveys to an ordinary person when he gets a remedy said to be a cure for headache. The first prayer as presented to me on the part of the Government touches that subject. I do not know that it is necessary for me to read it to you again. It has been read three times. If that word, spelled in the two different ways that it is spelled, would convey to the ordinary citizen the idea that it was a food for the brain as contradistinguished from the idea of a food for the whole body, then it is-and I so charge you in this first prayermisleading, and therefore a violation of the law; and if you find that such a definition is what the ordinary citizen would apply to it, then you, under that first prayer, would be compelled to bring in a verdict of guilty, and you have the right, in considering that question, to

take it in the connection in which it is placed. You have the right to consider that it is on a medicine which it is claimed is a cure for headache, an ache which is supposed by most citizens to be from the brain, and the words brain food spelled in the two different ways you have had demonstrated to you so many times are used in connection with a cure which is said to cure the headache-an ache that is seated in the head. You have a right to consider all that. How would an ordinary citizen, in taking that up and seeing these words, understand it? What would he understand by the use of those words?

I have granted some other prayers where the subject of brain food is referred to.

Mr. BAKER. If your Honor please, when you read the other ones, will you spell out the words?

The COURT. The jury are further instructed that if they find from the evidence that the use by the defendant of the name "branefude " as a part of the name of the defendant's preparation was not reasonably or fairly calculated to deceive or lead to the belief that the preparation was a food for the brain, then they shall find that the use by the defendant of the word "branefude was not false or misleading. That is the question that I suggested to you a moment ago. How would the ordinary citizen, upon reading that, understand it? If it would mislead him or have a tendency to mislead him, then the case is made out. If there is nothing in the term in the way in which it is used that would mislead an ordinary citizen, then, of course, that, under the prayers that I have granted, is to be taken into con sideration by you.

Mr. BAKER. Would your Honor read that first prayer now? The COURT. I will read, at the request of counsel, the first prayer: If the jury find from the evidence beyond a reasonable doubt (and you gentle men are old jurors and understand perfectly well what is meant by a reasonable doubt. I need not again charge you on that point, because you have had that charge over and over again. The doubt must be a reasonable one-one that à reasonable man would entertain from the evidence), that the defendant Robert N. Harper, on the fifth day of August, 1907, or at any time between the first day of January, 1907, and the date of the filing of this information, in the District of Columbia, did manufacture a certain liquid medicine or preparation, styled and designated "Harper's Cuforhedake Brain Food," or "Harper's Cuforhedake Brane Fude," and did place on the bottle, box, or circular thereof the following statements, designs, and devices, or any of them, viz, “Cuforhedake Brain Food" or "Cuforhedake Brane Fude," unless you further find from the evidence that there is a known and distinct kind of food that feeds and nourishe the brain as distinguished from a food that feeds and nourishes the whole body, and that the said drug or preparation is a food, and that it feeds and nourishes the brain particularly, as distinguished from a food that nourishes all parts of the body, then the jury are instructed as a matter of law that the words [5] "Brain Food" and "Brane Fude”—if you find that "Brane Fude" means brain food-are false and misleading, and your verdict shall be guilty on the first count of the information; and if the jury further find that the defendant did sell or offer for sale to the said Stone & Poole, on the date or within the time mentioned and in the District of Columbia, the said drug in this prayer described, they shall find the defendant guilty on the fourth count of the information.

The next objection that is made in this information is "nor did said drug contain any poisonous ingredients of any kinds."

Gentlemen, the question raised is not whether it is a poison in the doses prescribed in the preparation. That is not the question before you as jurors. You have nothing to do with the question of whether it is poisonous in the doses prescribed or in larger doses. The sole