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36

FOOD, DRUGS, AND COSMETICS

Tho languago employed in the original law is:

In the case of food, first, if any substance has been mixed or packed with it 80 as to reduce or lower or injuriously Allect its quality or strength; secondi, if any substance has been substituted wholly or in part for the article; third, if any valuable constituent of the article has been wholly or in part abstracted.

llow aro you to detormino when the standard of a product has been lowered? When como valuable constituent has been removed; or whon some ingredient has been substitutod, unless you procood from a definito concoption of a standard?

In the enforcoinont of this law now wo are roquired to go into court and show by tostimony of manufacturors, and tho tostimony of housewives, wlint that standard is.

You can onsily appreciate the fact that the standard sot up in such circumstancos is not an exact standard. Manufacturing praoticos and consumer conception of standards of idontity vary. This variation will involvo A sprond of from 5 percent to 10 percent, or snore.

We are now formulating and publishing administrative standards; as a inatter of fact, that was done long before the passage of the presont law. They have no legal stntus under the Federal Inws.

The appropriation bill of 1902, up to and including 1906, carried items covering the expensos of the operations of a standards committeo.

The issuance of administrative standards by a committee was renewed by us after a lapse of several years, for the very dofinite purpose of influencing manufacturing practices. Wo understand that such advisory expressions can do inuich to establish a uniform standard in the preparation of food products. Further we prepare these standards to meet the needs of some 20 States that havo passod Inws making these advisory standards of tho Department of Agriculture legal in those Statos.

The CHAIRMAN. In this section 11, did my bill have practically this samo requirement?

Mr. CAMPBELL. I think your bill indicated in more particularity what the comunittec should be and how it should function.

The CHAIRMAN. That is to say, my bill was a little moro specific as to how these standards should be fixed?

Mr. CAMPBELL. Yos.

Tho Chairman. As a matter of fact, under this provision, as it is included here, how would the department fix the stnndards?

Mr. CAMPBELL. The Department would proceed in substantinlly tho same way thnt it doos now in the detormination of these adminis. trative standards.

Thero is a committee thnt is composed of departmental and State officials, and representntives from scientific associntions.

There is an appearance before this committee, nt periodic bearings, at which time wo take up certnin food products, the nature of which has been announced specifically, in advance, to permit manusncturers and othors to discuss them.

Unfortunately, there has been no general participntion on the part of the public, in spite of the fnct that we have mado these hearings known to the public, and have invited the public to attend.

At that time, there is an attempt by the committro to convnss the oxpoctation of tho buyer of the product nnd the dilliculties involved in the preparation of it so as to meet tnt conception. The standard

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37

authorized by this bill would not be set up on an arbitrary basis hy someone in the Department, but on facts developed through the employment of groups of competent people, in the saine way that the presont stundurils luvo boon arrived at. The standardy committee would operato in the same way that tho present administrativo standards comınittee functions. As a matter of fact if this bill bocomes law, it is my conception that the existing food standards ostablished for administrative purposes would be adopted substantially as they are now.

The Chairman. I assume there would be first a notice of a public meeting, and there would be submitted to this group of experts, to this scientific body, provided for in somo way, and after 30 anys or some other timo, at promulgation by the secretary of the standard 80 set up; thut would becomo the arrangemont. Would that be subject to appeal to the courts?

Mr. CAMPBELL. Yes. Any action we would take would be subject to court review.

Senator McNARY. Does this general statute provide for any right of appenl from the Food and Drugs Act?

Mr. CAMPBELL.. No; possibly the Code provides that.

Sonutor McNally. The right of appeal is not a cominon law right but must be specifically set forth.

Mr. CAMPBELL. Thore could be no objection to that being put in. It would, however, be necessary to establish a special court for the purpose since the establislıment of a standard is a quasi-logislative and not al qunsi-judicial act.

Tho CHAIRMAN. If the committeo decidos that there should be a right of appeal providod, the Department would not objovt?

Mr. CAMPBEL... Not it all. The Department is anxious to have provided somo legislation which would permit udministrativo funcLioning for the protection of the public. This is now impossible because of the lack of legal stundurils, delinite tolerances, and other features covered in this bill.

Turning back to page 8, may I sny that this is an extremely importunt provision, not only from the standpoint of the establishment of identity stundurds us prescribed in D, but also the stundards of quality provided for in (o). There lins born inore public interest in that paragraph and in its companion section in the inisbranding portion of tho act than in any other provision of this bill. The housewiso is giving more consideration to questions of diototies and home economics than ever before. Undor the presont law it is impossible to require labeling of an affirmative character regarding the composition or quality of food products. There is more and more a demand for that type of information. I was agreonble surprised when my uttoption wils callod a low duys ago to tho fuct thut this samo provision wus rocommondod ulso by Dr. Wiloy in the measures that were considered prior to 1906.

Senator McNARY. Wus not thut samo recominondation made luter on?

Mr. Campbell. Yos. For standards and definitions, yes. This bill provides for definitions of identity, and standards of quality or grados. This section dividos itself into grudes und into standards of identity.

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F001, DRUGS, AND) COSMETICS

So far as E is concerned, lis is actunliy being put into elect now, Mr. Chairinan, by the Depurtment of Agriculture, under an item in the approprintion bill, with reference to perishablo form products. What wo are asking is legislntion to extend the standard snaking authority to take care of the consumer interest in fabricatod proda ucts as well as perishable for products which are now being laken care of, as I said, through tho grading operations of such products. Wo dosire to oxtond this, from the standpoint of consumer intorest, to fabricated products to which the items in the appropriation bill do not apply.

The Chairman. Is subsection F practically the same ns tho present law?

Mr. CAMPBELL. No; it is now, entirely.
Tho CHAINMAN. Ilavo you renched it now?

Mr. CAMPBELL. Yes. That is the section that roquires a declnrntion of ingredients in food products in the order of their prodominance by weight. It is to give to the consumer information that ho cannot get at tho present time. Lot me tell you that more than a year ago, in order to counteract soine of the vicious advertising practices that provniled, the Department, at the invitation of the broadcasting companies went on the air with a series of broadcasts on the subject of "Read the Label.” Tho rear ion was instantaneous and extensive. But, in rouding the labels, under thio requirements of the present law, it was impossible for consumers to acquire much, if any, information. The only thing sought here is to requiro the manufacturer to givo consumo's the information seressary to make in intolligent purchase. This idon is not something new. Most of the States require such inforination to be placed on packages of feed for livestock. Il secris w mo with that interest, which is being inanifosted in nutritional questions, the housewife is entitled to comparable inforination when it comes to the selection of food for horfamily.

Tho Cirman. Would it bo required in a caso of self-rising llour that there shoulil bo i declaration on the inbol of the flour as to the soda and the other contents of the flour, whatovor those articlos might be? Is thint correct?

Mr. CampbeLL. Yes; is it is an article or a product for which no definition or standard lias been declared. What this paragraph doos is to subject food products to the same supervision that drug products Havo.

The Chairman. Tint is to say, to uso my samo exainpin, is you lind ostablished a standard of self-rising flour, thoro would be no occasion to put it on tho label?

Nr. CAMPBELL. Yes. We havo a number of exhibits bore. I regrot to take up so much time bocause I know liow anxious you nro to experlito this honring, but I think I havo hore someting that should be brought to your attention, Mr. Chairman. Thoso aro samples of a mixture of clickon und noodles. Notice the variation in the amount of the mont, the exponsive part of it. You sce it ranges froin 9 percent to 1534 percent.

The Chairman. That is the percentage of mont?

Mr. CAMPBELL. Yos. You can in whint this means to the consumor from the economic standpoint and nlso to the manufacturer who wants to maintain a clinito standaril. This shows exactly what competitive pressure will causo manufacturers to do. Thero

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is no way by which we can require a definite standaril now. There is no way by which the buyer can purchulso understandingly or intelligently in the absence of informative lubels. In the event that stune dards woro promulgated for akticles of this sort, they would bo required to comply with such standards. Otherwise they would fall squarely within the provisions of paragraph (1). Notice the continuing portion of paragraph (f) which suys thut the Secretary is authorized to proscribe by regulations, requirenients for such further informntion on the label cloroof us he may douin necessary to protect the public from decoption. The Secretary would be authorized to require manufacturers to disclose the percentago of ment or to givo to the buyer that information in some other forn.

That particular authorization to the Socretary is extremely important in niore than just nettors of economy. For instance, we know thnt tomuto juico burs been popularizod Locause of its vitamin contunt. 16 :30 druppens that it contains one of the very important vitamins, but und ihnt is csily destroyed. Suppose a munufacturer wore to preparo a product in wrich tomto juico is an ingredient, and in my selectivo purchusing I buy it because of that fuct. If it hud been found that the vitamin content of that tomato juice hud been destroyed by processing operations it would be extrentely inportant for my protection that soine further information bo givon than that tomato juico is one of the ingrodionts.

The ChairMAN. Is there anything unusual in the lunguuge contuined here that the Secrotary is authorized to proscribe by rogulution? Is this guite a common thing in the practice of the Department?

Mr. CAMPBELL. Under certain statutes it is not only a common practice in this Departmont but in other departments.

The Chairman. Proceed.

Mr. CAMPBELL. Wo now come to the misbranding of drugs. . Parugraph 8 (n) (1) states that u drug is misbranded if its labeling benrs the name of any disease for which the drug is not a specific curo but is a palliativo, and fuils to bear in juxtaposition with such namo and in lettors of the same size and prominence u statement that the drug is not a cure for such dise:lse; or if its labeling beurs any l'eprosentation, directly or by ambiguity or inforence, concerning the effect of such drug which is contrary to tlo goneral ugrocment of medical opinion.

I have read items (1) and (2). The particular significance here is in the word "cure." The form of stutement is not prescribed. It inay be expressed properly in any language which conveys the idea.

Senator McNalli. Thut is not in the present luw? Mr. CAMPBELL, Thut is entirely new. The CHAIRMAN. The wholo soction is now? Mr. CAMPBELL. Not tho entire section, but this paragraph of it. This is new. That entire paragraph (u) is new.

Sonator McNany. Who woud decide whether the particular drug is a specific or cure or pullintivo?

Mr. CAMPBEL). The court.
Senator McNally. This goes to court?
Mr. CAMPBELL. Yes; everything we do will go to court.

Sunator McNary. This is very sutisfying. Is it a very difficult mutter for the medical exports to determino whether a drug is a cure or not?

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FOOD, DRUGS, AND COSMETICS

Mr. CAMPBELL. No.

Tho CHAIRMAN. It is the requirement for an agreement of medical opinion. Do you regard that as possible? Mr. CAMPULL. Gonorally, yes I am dealing with the first para

. graph, I have not renched that portion of it to which you reser, Mr. Chairman. There aro only a fow spocifics, but the public does not know that. The modical fraternity knows it and inost manufrcturers of incdicines know it. The public, hy the charncter of labels which prevailed prior to 1906, and the nature of advertising that has boon extensively 11sed since that time, has boon led to believe that almost any concoction which manufacturers produce may be utilized to cure sone disenso. Whore disenscs are mentioned on Inbols tho public thinks of tho medicine usually in terms of n curo. Contrary to what has been assortod, in this paragraph we are not advancing the cause of the medical practitioners.

Senator McNary. I am not quarreling with you on that. This mny havo an angelical forin and be a very angelical statement, but if you go into the drug store nnd buy a bottle of medicine that reprosents itsolf to be effective for n certain disease, who is to determine as to whether it would be a cure or a palliativo? There is the difficulty I would experience in getting this medicino, in going into a drug store and purchasing a bottle of medicino.

Mr. CAMPBELL. I do not think that would be n difficulty.

Senator McNary. I might find it as a curo, and a member of my family might find it ns n pollintive, nnd someone else it would not do any good nt nil. ) confoss I nm perplexed about that. Who would decide whether it was a curo?

Mr. CAMPBELL. If the munufucturers stated on the label thnt it was n cure for malarin and it did contain the amount of quinino and directions for the proper use of that specific, there could be no quarrel with it. On the other hand, if the package contained only thioso ingredients which would merely give relief from pain, and contninod nothing really curative; if it contnined substances used by tho phyxicinns for this purpose, or products employed in the homens pain relievers, and the labol gavo informintion as to its very dolinito pain. relieving value, there would be no objection. If it is not a curo of any disease but does contnin the drugs which nre recognized as being palliatives, it should be labeled as a palliative. The specifics are few and well known.

Senator McNary. Who is going to make for me decision ns to the eflectiveness of various drugs that I might tako?

Tho Cuanman. I think you have got to tako thint snction nlong with the pocond subsection. It seems to mo that you havo to con. sider this under pulsection (n) to answor wlint the Senntor snya.

Mr. CAMPBELL.. This paragraph does not roquire, in this language, that tho product be Inboled a "pollintivo"; it does not require that it be labeled “Not a cure. The paragraph snys in effoct, this: In those diseases such as innuenza--and I think that medical science will adinit that there is no specific cure for it; I think the chairman will bear me out that--the most the medical fraternity can do in influenza is to give you niedicines which will relieve thin distress until the disease lins run its course. They give you pallintivos, anodynes to enso tho pain or discomfort while the disease runs its course.

Senator McNally. What was that?

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