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Food, drugs, anD COSMETICS

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Senator COPELAND. Let me ask you, Mr. Campbell, if you do not think the public would be sufliciently protected if the manufacturer wore required to file with the Departinent a formula of the remedy to be placed upon the market?

Mr. CAMPBELL. I do not.

Senator COPELAND. Your thought about that is, and you expressed it very well, that a man who indulges in self-medication, who stands in the position of being his own physician, is entitled to know what it is-I think you said "putting it down his gullet".

Mr. CAMPBELL. Prescribing for himself, I think is better language. Senator COPELAND. I went through this war once before when I was commissioner of health of New York City. I assume it must have been a compromise, but it was written into the law that it should be the duty of every manufacturer, and so forth, before offoring any such medicine to be sold in the city to register the same and secure a certificate of registration from the department of health. It was our theory at the time that in that way we would know whether there were any incompatibles in the formula or any poisons in the formula; and, likewise, we would be possessed of information so that when we made seizures we would have on file in the office the material to determine that the contemporary package conformed to the formula as presented. But your view, I take it, is that that is not sufficient?

Mr. CAMPBELL. I think not. There is an advantage unquestionably in a requirement of that sort for enforcement operations, but there is no advantage accruing to the public in such circumstances. The point that I am trying to make is that each individual purchaser of this product who is to use it in the treatment of ills which the individual has diagnosed for himself is entitled to know what is the nature of the product that he or she is prescribing for that disease.

Senator COPELAND. In order that the record may show the answer, What advantage to the public is it to know that a bottle contains such articles as are designated on this bottle here? What would those names mean to the average purchaser of dope, whatever it is?

Mr. CAMPBELL. That question has arisen repeatedly in connection with this particular paragraph. I grant you that at the present time the public, perhaps generally, would not know the significance of such products. They would not know the therapeutic action of a number of ingredients that might be declared on the label; but there is no reason in the world why the public should not be given through governmental agencies the sort of information that would permit them to acquire and apply that knowledge in the course of time. But what I am stressing particularly is the importance to individuals who have hypersensitiveness to certain drug products of avoiding articles which contain such ingredients. That is of immediate importance und benefit.

Senator COPELAND. I notice in connection with "Swamp Root", which is made in my State, that while the package carries a label giving the names of the ingredients it does not give the quantities.

Mr. CAMPBELL. No. I said that was an observance in part of the requirements of this paragraph. That is a qualitative declaration. Our prosposal is to make that a quantitative declaration.

So far as the contention may be advanced that this is a property right on the part of the manufacturer, and that he should not be

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required to disclose it, I think the statement made by the Supreme Court in Corn Products Refining Co. v. Eddy (249 U.S. 427) disposes of that argument once and for all. The Supreme Court said:

It is too plain for argument that a manufacturer or vendor has no constitutional right to sell goods without giving to the purchaser fair information of what it is that is being sold. The right of a manufacturer to maintain secrets as to his compounds and processes must be held subject to the right of the State in the exercise of its police power and in the promotion of fair dealing to require that the nature of the product be fairly set forth.

The concluding portion of this particular paragraph, Mr. Chairman, gives to the Secretary the authority to prescribe by regulation. such further requirements in the way of disclosure of information on the label as may be deemed necessary for the protection of public health.

Without wasting any time in the discussion of that, let me refer to this particular occurrence. The Department brought action under the Food and Drugs Act against a treatment for asthma, known as "Dr. Herman's Asthma and Hayfover Medicine." The Government lost the case. After the presentation of the evidence the jury returned a verdict to the effect that they found for the claimant; but they did the most unusual thing of including a further recommendation for the future conduct of the manufacturer.

It so happens that one of the most important ingredients in the product is potassium iodide. You know what the effect of potassium iodide is. That product is, as the physicians say, contraindicated in cases of active or dormant tuberculosis; and it was shown quito conclusively by the testimony that the use of that particular medicine for an individual suffering from hay fever and who was also suffering from tuberculosis would do immeasurable damage. The jury in connection with its verdict stated:

We recommend that the claimant insert in his literature a warning against its use by persons having tubercular tendencies.

That is merely an illustration of the utter impossibility without provisions similar to those in this bill, to give to the public adequate information and the protection that is requisite for the maintenance of health.

It seems to me that this particular paragraph and others represent an improvement over the present law, and they represent those things that the consumer from the standpoint of avoidance of fraud or in the protection of health can expect and demand as his right.

Senator COPELAND. Mr. Campbell, let me ask you another question, for the sake of the record. Would your views be met reasonably well if it were required that the label should carry the names of the substances or the ingredients used in the order of their medicinal or physiological predominance?

Mr. CAMPBELL. Now could you determine the order of their medicinal or physiological predominance? That would not relate, would it, to the proportion in which they would be found in the entire mixture, bearing in mind that some drugs are of great activity physiologically and others only slightly so?

It seemed to us in drafting this bill that adequate information could be conveyed only by the requirement on the label of a quantitative declaration of the ingredients; and in this respect this section differs from the corresponding section under "foods.”

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Shall I proceed to the next paragraph?

The CHAIRMAN. I would like to ask you one question. I think in the oarly part of your statement you said it might be conceded that one manufacturer had a superior method of combining his ingredients of his preparation. Did you say something like that?

Mr. CAMPBELL. I think that is true in a great many instances. The CHAIRMAN. If they were conceded to have that superior method, would it be fair to the man having the superior method for preparation to disclose to the public the ingredients of his package when the maker of the inferior product might curry upon his package the identical ingredients as to quantity and identity found in the first package?

Mr. CAMPBELL. If there is any merit in the contention that there is a definite improvement in the product due to the factory technique of one manufacturer being superior over another, then that will be very definitely recognized and appraised by the public; that will represent good will to the manufacture of the superior goods.

The CHAIRMAN. Are you not giving the public inore acute powers of observation than the public possesses?

Mr. CAMPBELL. If it is not true there is not much to it in any event. If it is true that there is an advantage in the alleged secret processes by which these admixtures are combined and effected, such secret processes of course would not have to be disclosed.

The CHAIRMAN. Under the bill, in its form as proposed, would the maker of this superior article be permitted to call attention to the superiority of his method?

Mr. CAMPBELL. Why, certainly. There could be absolutely no objection to a declaration of any truthful character by a manufacturer which that manufacturer might wish to make.

The CHAIRMAN. I think that is all I wanted to know on that.

Mr. CAMPBELL. It has been frequently alleged that if manufacturers are faced with these requirements and restrictions on drug products it will discourage progress; that no manufacturer will want to spend considerable sums of money on research; for it will avail him nothing if he makes known to his competitors the results of his researches and thereby enables them to reap profits in equal measure. I know very well that our patent laws have protected industrial operations where science and research are the foundations of progress. If there is any new discovery which is developed in the course of such work, is there any reason why adequate protection in the same way cannot be accorded here as it is accorded in other lines?

Paragraph (f). This refers to package and labeling requirements imposed by the text of the United States Pharmacopeia and National Formulary. In the United States Pharmacopoeia there are certain specifications now given as precautionery measures for the preservation of health in storing and using certain products. One of those is in connection with bichloride of mercury tablets. The United States Pharmacopoeia monograph on this product says:

Tablets of an angular shape having the word "poison" and the skull and crossbone design distinctly stamped upon it. The tablets are to be colored blue. They are to be dispensed in securely stoppered glass containers on the exterior of which is placed a red label bearing the word “poison".

And so forth.

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That precaution manifestly is for the preservation of health, and it was to avoid fatalities which too frequently have occurred accidentally through the use of bichloride of mercury tablets. There is no provision in the existing law which can compel the observance of these requirements of the United States Pharmacopoeia. Section (f) is merely an implementing provision, made to put into effect such exactions as the Pharmacopoeia may impose upon the packaging and labeling of official products.

Paragraph (g) refers to deterioration. It authorizes the Secretary, after notice and hearing, to establish regulations which will first indicate such products as may have been determined to be subject to deterioration, and prescribe the circumstances and conditions under which they may be sold.

The CHAIRMAN. Is that new?

Mr. CAMPBELL. Yes, and the foregoing paragraph is.

The CHAIRMAN. It speaks for itself, that particular section?

Mr. CAMPBELL. Yes. You are aware of the fact that no such regulation now exists, and such products as digitalis, aconite, and ergot will soon deteriorate.

Paragraph (b) is the slack-pack requirement applied to drugs, as a previous section applied to food. Here is a container of castor oil. We have substituted, of course, this colored liquid so the deceptive nature of the bottle can be seen. Castor oil heightens the deception because of its colorless appearance. When you look from this angle and see how thick the two sides of this bottle are, and the small space jeft between them to carry the oil, you can get some appreciation of the scope of the deception.

Paragraph (1) likewise is new. It refers to drug specialties which perhaps have been more extensively exploited than any other line of drug products, gerinicides, bactericides, disinfectants, and antiseptics.

The public has been led to believe, by the type of advertising similar to that I am now submitting to you, that these alleged germicidos constituto effective treatment for every imaginable disease. The one that I am looking at gives a display of a cross section of a human face, throat, down through the trachea, into the lung cavity. The advertisement says nothing whatever about the import of this design, but gives an extensive dissertation on the causes of various discasos and the importance of avoiding or destroying germs by the use of this particular product.

The statements in very few instances, considered independently of other statements in the advertising, can be alleged to be false. I showed you an advertisement a moment ago in which the word "tuberculosis" appenred across the top of the page. The only conclusion that could be reached by one uninitiated and reading that statement is that that particular nutiseptic and germicide was of importance in the treatment of tuberculosis or in preventing tuberculosis. The value of it, Mr. Chairman, as a physician, you know is extremely limited in such instances. The inference, no doubt, will create a confidence in, and inspire a reliance upon, this product. Perhaps this may be responsible for the neglect or disuse of those conventional methods, particularly sterilization, which are now cmployed for prevention of infection. Certainly a large number of the diseases from which we suffer at the present time are due to different types of bacterial infection. In this particular advertisement. the list

FOOD, DRUGS, AND COSMETICS

of diseases mentioned includes: Influenza, measles, pneumonia, smallpox, tuberculosis, chicken pox, diphtheria, and erysipelas.

The scope of the advertisement in its entirety, and it is true of the others, is to create a belief on the part of tho renders of it that treatment for such diseases can be effectively undertaken by the purchaser of such products without further regard for medical or sanitary care.

We have found in our attempt at the regulation of such products, that some of them which claimed to be germicidal actually had germs living in them. There is no legal standard by which we can determine the germicidal strength a product should possess before it can be sold as a germicide. There is no provision that gives us power to establish standards for germicides or antiseptics. We have taken the extremely tenuous position and tried to maintain it, that no product which does not possess the power of destroying such organisms as staphylocus aureus should be permitted to be sold as gormicidal. This is one of the pus forming organisms as you know. Wo have found and we do know that there are a number of germicides which will be effective in the destruction of that particular organism but will not have the effect of satisfactorily destroying or preventing the growth of organisms less resistant. In other words, what might be found to be a good germicide for one particular kind of germ would not, necessarily, be a good germicide for another. All that we are asking in this particular paragraph of the act is that something fairly definite be given to the prospective buyer in the way of information. If it is found, and certainly the manufacturer has the possibility of making that determination and it should be expected of him to do so, that the product is bactericidal or germicidal toward a certain organism only, then let him sell it under a label which declares it to be that and which indicates the conditions of use, the length of time, and the necessary concentrations. If he does not wish to do that and insists upon labeling it as a germicide unqualified then place upon him the obligation of making a germicide for all types of vegetable microorganisms and justify the confidence which he desires, and which will be placed in it under such circumstances-namely, that it is an effective general germicide.

The CHAIRMAN. Have you the facilities of enforcing this particular provision? How would you do it?

Mr. CAMPBELL. There would be a difficulty always in determining what would be the effect of a product in a human body. The only facilities which exist now for making that determination are those of the laboratory. But if we were to find that a germicide which claimed to be such for some type of micro-organism would not in fact kill that organism in any period of time, in any concentration, certainly we would have adequate reason to say in that case that the sale of that product as a germicide was deceiving and defrauding the public. It is granted that there is a difference between the determination of a germicide in vivo and in vitreo. There is a difference between laboratory determination and effect on the human being. The fact that these products cannot be used offectively in combating diseases, particularly when the germs themselves have lodged in that portion of the anatomy where they cannot be reached, and where, if a successful germicide were employed, destruction of the body tissue would result, ought to be a suflicient argument against them. Perhaps this paragraph should be made even more stringent. The

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