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FOOD, DRUGS, AND COSMETICS

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Senator COPELAND. Let mo ask you, Mr. Campbell, if you do not think the public would be sufliciently protected if the manufacturor wore requi'cıl to filo with the Department a formula of the remody to bo pluced upon tho market?

Mr. CAMPBELL. I do not.

Sonator COPELAND. Your thought about that is, and you exprousod it very well, that a man who indulgos in self-modication, who stands in the position of being his own physician, is entitlod to know what it is-I think you said "putting it down his gullot".

Mr. CAMPBELL. Prescribing for himself, I think is better language.

Senator COPELAND. I wont through this war once before when I wus commissioner of boalth of Now York City. I assuno it must have boon 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 sumo and socure a certificate of rogistration froin the dopartment of hoalth. It was our theory at the time thint in that way wo would know whother thuro woru any incompatibles in the forinula or any poisons in the formulu; and, likewise, we would be possessed of inforination so tbat whon wo mude seizuros we would have on lile in the offico the naterial to determine that the contemporary puckage conformed to tho formulu ns prosonted. But your viow, I take it, is that that is not sufliciont?

Mr. CAMPBELL. I think not. There is an advantago unquestionably in n requiromont of that sort for onforcement operations, but thoro is no advantage accruing to tho public in such circumstances. Tho point that I ain trying to make is that euch individual purchaser of this product who is to use it in the treatinont of illy which the individual lins dirignosed for himself is ontitled to know what is the nature of the product thnt he or she is prescribing for that discuso.

Senator Corrlano). Ju order that the rocord my show the answor, Whut advantage to the public is it to know that a bottlo contuins such articles as are designatod on this bottlo bore? Whut would those namos mean to the avorago purchaser of dopo, whatever it is?

Mr. CAMPBELL. That question aus arisen ropoulodly in connection with this particular paragraph. I grant you that at tho prosent tirno the public, perhaps generally, would not know the significance of such products. They would not know the thorupoutic action of a number of ingro lionts that might bo dochucod on the label; but there is no roasou in the world why the public should not be given through govornmontal agencies the sort of information that would permit thom to acquiro und apply that knowlodyo in the course of timo. But what I ain stressing particularly is the importance to individuals who have lıypersensitiveness to certain drug products of avoiding articles which contain such ingredients. That is of immediate importance und bonolit.

Senator COPELAND. I notice in connection with “Swamp Root" which is made in ny Stuter

, that while the package carries a labul giving the names of tho ingredients it does not give the quantities.

Mr. CAMPBELL. No. I said that wus un observanco in part of the requirenients of this.paragraph. That is a qualitativo dochuration. Our prosposal is to make thuni u quantitutive declaration.

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

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roquired to disclose it, I think the statement made by the Supreme Court in Corn Producis 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 soll goods without giving to the purchaser fair information of what it is that is being soldi. The right of a manufacturer to maintain secrets as to liis 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 bo fairly set forth.

The concluding portion of this particunr paragraphi, Mr. Choirman, gives to the Secretary the authority to prescribo hy regulation such furthor requirements in the wny of disclosure of information on the label as may be deomed necessary for the protection of public benlth.

Without wasting any time in the discussion of that, let me rolor to this particular occurrence. The Department brought nction under the Food and Drugs Act agninst a trentinent for asthunn, known as “Dr. Herman's Asthma and Havsover Medicine." The Govorninent lost the case. Altor the presentation of the evidence the jury returned a verdict to the ellicct that they found for the claimant; but they did the most unusual thing of including a further recommendation for the futuro conduct of the manufncturer.

It so happens that one of the most important ingredients in the product is potassium iodide. You know what the cliect of potassium iodide is. That product is, as the physicians sny, controindicated in cases of active or dormant tuberculosis; and it was shown quito conclusively by the testimony that the use of that particular meclicino for 01 individual suffering from hoy fever and who wns also suffering from tuberculosis would do immeasurable damage. The jury in connoction with its verdict stated:

Wo recoinmond that tho claimnnt insert in his literature a warning against its use by poreons having tubercuiar tendencies.

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

It seonis to me that this particular paragraph and others represent an iniprovoment over the present Inw, nnd they represent those things that the cousumer from the standpoint of avoidinco of fraud or in the protoction of health can expect and demand as his right.

Sonator COPELAND. Mr. Campbell, let me ask you another question, for the enke of the record. Would your viows bo met roasonably well if it woro roquired that the label should cnity tho namos of the substances or the ingredients usod in the order of their medicinal or physiological predominance?

Mr. CAMPBELL. Now could you doterinino tho order of thoir 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 scomed to us in drafting this bill that adequate information could be conveyed only by the requirement on the label of a quantitntivo doclarntion of the ingredients; and in this respoct this section differs from tho corresponding section under "foods."

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Shall I proceed to tho next paragraph?

Tho Chairman. I would liko to ask you one question. I think in the ourly part of your statemont you said it might be conceded that ono manufucturer bud a superior inethod of combining his ingredients of his preparation. Did you say something like that?

Mr. CAMPBELL. I think that is truo in a great many instances.

The CHAIRMAN. If they were concoded to have thut superior method, would it be fair to the man having the superior method for proparation to disclose to the public the ingredients of his package whon the maker of the inferior product might curry upon his package the idontical ingredients as to quantity and identity found in the first puckare?

Mi. CampuELL. If there is any marit in the contention that thero is a definito improvement in the product due to tio factory tochnique of one manufucturer being superior over another, then that will be very definitely recognized and appraised by thé public; that will ropresont good will to tho inanufacture of the superior goods.

Tho CHAIRMAN. Are you not giving the public inore acute powers of observation than the public possosses?

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

Tho CHAIRMAN. Under the bill, in its form is proposed, would the inaker of this superior article bo permitted to call utteution to the superiority of his method?

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

The ChamMAN. I think that is all I wanted to know on thail.

Mr. CAMPBELL. It has been frequently alleged that is manufacturers are suced with these requirements and restrictions on drug products it will discourage progress; that no manufacturer will want to spend considerable sus of money on resourch; for it will avuil him nothing is ho makes known to his competitors the results of his resourches and thereby enables them to reap profits in equal measure. I know very well that our putent laws huvo protected industrial operrtions where scienco and resourch are the foundutions of progress. If thero is any new discovery which is developed in the course of such work, is there any reason why udequate protection in the same way cannot be accordod hero is it is accorded in other lines?

Parugruph (f). This refers to package and labeling requirements imposed by the text of the United States Pharmacopæia and National Formulary. In the United States Pharmacopæia there are curtain spocifications now given ns precautionery measuroy for the presorvation of houlth in storing and using cortuin products. One of those is in connection with bichloride of mercury tablets. The United States Pharmacopoeia monograph on this product ynys:

Tablets of an angular shinde having the word "poison" am the skull and drugs. bone design distinctly stiumped upon it. The tablets are to be colored blue. They aru lulic dispensed in securely stoppered glites containers on the exterior of which is placed u red lubel bearing the worl"poison".

And so forth.

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That procation manifestly is for the prescrvation of honlth, and it was to avoid fatalities which too frequently have occurred accidentally through tho use of hichloride of mercury tablots. There is no provision in the existing Inw w ich can compel the observance of these requirements of the United Stntes Pharmacopain. Section (f) is merely nu implementing provision, made to put into effoct such exactions as the Pharmacopain may imposo upon the packaging and labeling of official products.

Paragraph (8) refers to deterioration. It authorizes the Secretary, after notice and hoaring, to establish regulations which will first indicate gurl products as may havo been determined to be subject to doterioration, and proscribe the circumstances and conditions under which they may be sold.

Thic (RMAN. Is that now?
Mr. CAMPBELL. Yes, and the foregoing paragraplı is.
The Chuman. It speaks for itsell, that particular section?

Mr. CAMPBELL. Yry. You are aware of the fact that no such regnIntion now exists, and such products as digitalis, aconito, and orgot will soon deteriorate.

Paragraph (h) is the slack-pack requirement applied to drugs, as a previous section applied to food. There is a container of castor oil. We have substituted, of course, this colored liguici so the deceptive nature or bor bottle can be soen. Castor oil heightens the rioception because of its colorless repperurance. When you look from this angle unul see low thick the two siers of this bottle are, and the sinall space jost

. between them la carry the oil, you can got some appreciation of the scope of liber deception.

l'aragraph (i) likewise is new. It refers to drug specialties which perhaps have been more extensively expleviter than any other line of drug products, gerinicidos, bactericides, disinfectants, and antiseptics.

The public has bocn Ind to believe, by the type of advertising similar to that I am now submitting to you, thist these allegood gormicidos constituto affectivo trentmont for every imaginable disease. The ono that I nin looking at gives a display of a cross section of a hunon foco, thront, clown through the trachen, into the lung cavity. The advertisement says nothing whatovor about the import of this design, but gives an extensive dissortation on the causes of various disonsos and the importance of avoiding or destroying germs by the use of this particular product.

The statements in very fow instances, considered independently of other statements in the advertising, can be alleged to be false. I slowed yoll an advertisement al moment ago in which the word "Huberculosi," uppenreed scross the top of the pain. The only con cussion that could be rouched by one uninitinted and ronding that statement is thini that particular antiseptic and germicidio wns of importance in the treatment of luiserculosis or in preventing tuberculosis. The villue of it, Mr. Chairinon, 118 ? plysicinn, you know is extreinely limited in such instances. T'ho inference, no doubt., will crente a confidence in, and inspire a reliance upon, this product. Perhaps this miny be responsible for the neglect or disuso of those conventional methods, particularly sterilization, whicle arro now (1110 pogod for prevention of infection. C'rrlarinin a large number of thin iliscasos from which we sull'er 1. Whoe present, limo sur'n due to culleront types of bacterial inloction. In this jourticular advertisement libo list

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of diseases mentioned includes: Influenza, measlos, pneumonia, smallpox, tuberculosis, chickon pox, diphtheriu, and erysipelas.

Tho scopo of the advertisement in its entirety, and it is true of the othorn, is to crento a buliol on the part of tho rendor's of it that troutment for such diseases can be ollectively undertaken by the purchaser of such products without further regard for medicul or sunitary care.

We have found in our attempt at the regulation of such products, that sonis of thein which claimed to be gerinicidal actually liud gerins living in them. Thoro is no legal standard by which we can dotermine the gorniicidal strength a product should possess before it cau be sold as a gernicide. There is no provision that gives us power to establish standards for gorinicides or antiseptics. We have tukon the oxtremely tenuous position und tried to maintain it, thut no product which does not possess the power of destroying such organisms als staphylocus aureus should bo perunitted to be sold us germicidal. This is one of the pus fomning organising us you know. We have found and we do know that there are a number of gerinicidos which will be effoctive in the dostruction of that particular organisin but will not have the offect of sutisfuctorily destroying or proventing the growth of organisms less resistant. In other words, what might be found to be a good gerinicido for ono particular kind of germ would not, necessarily, be a good germicide for another. All thut we are asking in this particular paragraph of the act is that something fairly dolinite 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 deterinination and it should be expected of him to do so, thut the product is buclericidal or germicidal toward a certain organisnı only, then let him sell it under il label which declares it to be that und which indicatos the conditions of uso, the length of time, and the necessary concentrations. If he clocs not wish to do that and insists upon Inboling it as a gerinicide unquulilied then place upon him the obligation of making a germicide for all types of vegetable microorganisins and justify the confidence which he desires, and which will be placod in it under such circuinstances--namely, that it is an effoctivo general gerinicide.

Tho CHAIRMAN. llave 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 low for inuking that determination are those of tho laboratory. But if we were to find thnt a germicide which cluimod to be such for some type of micro-organism would not in fact kill that organism in any period of timo, in any concentration, certainly we would have adequate reason to say in ihnt case that the sale of that product as a germicido wus deceiving and defranding the public. It is granted that there is a dislorence between the determination of a gormicide in vivo und in vitreo. There is a differenco belween laboratory detormination and effect on the human being. The fact that these products cannot be used offectively in combating diseases, particularly when the pering thenisolves have lodged in thut portion of the anatomy where they cannot be renched, and where, il a successful permicide were employed, destruction of the body tissue would result, ought to be a suiliciont argument against them. Perhaps this paragraph should be made even more stringent. The

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