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FOOD), DRUGS, AND COSMETICS
that, when they are unnecessary, added deloterious substances should be eliminated altogether. We recognizo, at the same timo, that tolerancos must be established for fruit and vegetables, but should be restricted to amounts safe for consumption.
The ChainMAN. It occurs to me that ense of administration would bo materially promoted if you have a small group of poisons now known to the Department is likely to be found in food-Jam roforring now to chemical poisons--that il you actually wrote into your bill tho tolerances and quantitios which would be permitted, you would bove the samo onse of administration that you have with regard to butter.
Mr. CAMPBELL. Quite right, if that could be done. Of course it would be the ideal and proper way, but I doubt whether it can be done. Shall I go abead with section 1?
The CUAIRMAN. You minv proccerl.
Mr. CAMPBELL. Online 3, page 4, under item (3) of this subparagraph, ihe same language is used to delino ndulteration that is now einployed in the present net.
Under iton (1), you will lind the new lanninge. It is: "il it bas been prepared, purkce, or held under insanitary conditions wherely it may have become contaminated with filth;"
Under the present. Inw, the only action that can be taken to require thin observance of sanitary precautions in the handling of food is to be found in section 7, porngruph (, which deems a food product to be adulterated if it is silthy.
The CHAIRMAN. Would that coverat dirt and the escreen of animal?
Mr. CAMPBELL.. Yes; it, wowed mor that and as a matter of fact, those instances where fooi bind beru prepared under objectionable and thoroughly insanitary conditions, even though your could not find, upon an objective examination of the sample, the evidence or definite proof of that filthy condition.
Lot me illustrate: On the Eastern Shore of Maryland oni Virginis, thero is it concentrated industry engaged in the preparation of fresh claub nient. It is a favored orticle of food along the onstern coast, and also in cortnin other sections of the country, at certain timos of
lo some places, it las lucen found trint tie conditions imder which this perishable food product was prepared worn such as to lend thonselves to contamination of this fooi. Such contamination has manifested itself by outbreaks of illness in the principal consuning sections of the country.
Perhaps the very food thout my vr been responsible for the illness lind barn sampled and examined by the Department, but the Jimitations of bacteriological examination and such that allirmative evidence of the filthy condition could not linve been obtained in all CASOS.
The only thing that is required liere is that there be nopted a decent system of cleanliness in oufacture. Particularly is this essential in perishable foods of this type.
This is a requirement that is imposed loyal tot many of the Sites in one form or another. These student which invocopteed refierno Tenis, in some form, comparable or identical will she longiunge suggested here are Maine Maryland, Mississippi, Nevada, New
FOOD, DRUGS, AND COSMETICS
Hampshire, New York, Oregon, Pennsylvanin, South Dakota, Toxas, and Wisconsin.
If there is required to be maintained this standard of ncceptable sanitation, in the production of food products for consumption in thoso States, and if there is no protoction by means of u provision in the terms of a Federal law, and if there is a State which has no legal requirement for the observance of these sanitary conditions, it is uttorly impossible for thoso States just enumeratod to take any legal action for the protoction of consumery in such States.
I do not imagine there will be any objection voiced to this item by anyone, Souutor.
It is obviously an essential requirement.
“If its contniner is composed of any poisonous or deletorious substance which may by contamination render the contents injurious to honlun."
This is not to be found in the present law, but need for it will be definitely rocognized when I rosor to the use of len chests, or loud containors, for the packing of ten. It has beon found that through tho abrusion of the louves the loud content of the contrinor dous bocome, in the course of tiine, and through extensive hunndling, moro or less dissominated through the ten, throughout the package. Ii hils been found in the brew made from such teu.
Thoro are other packing methods that can be adopted that will Avoid this objection.
The elimination of lead foi] by the use of tin soil or of aluminuin foil would do so. There is a delinile remedy, and there is no definito hurdship
, pluced upon the nineturers because of the variety of containers that exist wany. The provision certainly is essential for the protection of the houlth of consumers.
In paragraph (1)) of section 3, the first, the second, the third, and thu fourth items are substantially as they are to be found now in the law.
In some instances these requirements have been made in modified form.
l'aragraph (c). Confuctionery. It retains the existing prohibition against the presence of alcohol. It also prohibits rosinous glazo, or nonnutritive substances excopt. coloring and linvoring--this is new.
That particular pluraso "or nonnutritive substanco" was intended to take care of the candy-carrying trinkets of the sort that have been in the rocont past extremely populu. ll you will notico, froin the specijnen of candy in this jur, the individual pieces of candy huvo boen cut apart in order to let you see the location of the trinkets inside. Those that have not been cut contain these trinkets inside. You can Hoe the different types of trinkots, themselves. There is no question abont the risk to children in the consumption of this candy, 110t only because there is a likelihood of breaking teeth, but because of the possibility of swallowing the candy, ud aspirating the trinket, and requiring a surgical operation of a serious character tu romove it.
Ilero is an X-ray photograph showing that this is not merely an imaginative danger or a mere speculation is to possible victims of the consumption of this candy, but it slow's the location in the trachen, of this metallic trinket.
FOOD, DRUGS, AND COSMETICS
Note, please, that this game item involves a specific prohibition against resinous glaze. A great deal of candy of certain types is found to be contor with this glaze. In a groat many instances it is nothing niore or less than shellac.
Undor tho torms of the prosent law we cannot take action against it. Under the torms of the presont Inw we can take no action agninst that specimen containing trinkots.
Wo brought prosecutions but the court held that that practice WAS not violative of the prosent law.
Stroud Jordan, in bis Confoctionory Standards, statos:
Glaze of any kind is not essential is the products are handler properly. Reginous glazes have no place in confoctionery. They can only be classed as unnecessary adulterants.
There is one provision of thnt paragraphi, Mr. Chairman, that we recognize would work a hardship, as it stands now. This was not apparent to us at the timo the bill wus drnsted. There would be, perhaps, à complete prohibition agninst chewing gum, the chiclo in it being a nonnutritivo substance.
Wo would suggest that the wording be modified, and that nitor the phrase "or nonnutritive substance except coloring and lavoring,” the following words be addod "and masticatory substancos used in chowing gum.
The CHAIRMAN. You desire to add these words at the ond of the lino "and masticatory substances used in chewing gum"?
Mr. CAMPBELL. Yos, sir.
Paragrnph (d) of this act inakes it an offense to use a conl-tar color othor than one from a batch that has boon certified by the Socretary in accordnnce with regulntions as horeinaftor provided.
In section 10, to which we referred, on page 14, you will find, in the second paragraph of that section, line 8, page 15, that the Secretary is authorized to make rogulations aftor notice and honring, for the certification of coal-tar colors which he finds to be harmless for use in food.
The CHAIRMAN. That is not in the low now?
Mr. CAMPBELL. By regulation wo bave actually done that. After the oxisting law becamo effective tho thon Bureau of Chemistry, in recognition of the impurities to be extensively found in a great many coal-tar colors and the poisonous character of some of the colors thomselves, issuod rogulations designed to assure the manufacturers and other purchasers that the colors 11900 by them would be nontoxio And froe from doleterious ingredients. These rogulations ostablished the practice of oxnmining and cortisying tho purity and enfoty of coaltar colors as a method for the protection of the public.
It is desirablo that it be continued. In this lnngungo wo are asking for legislative confirmation of a practico which has existed since 1907.
The Chairman. Has that been disputed particularly by the tradothose regulations?
Mr. CAMPBELL. Thore wore somo objections in the early days, of courae; but it Jins not, in recent years, boon disputed or protostöd' by manufacturers of colors themselves.
Tho CHAIRMAN. I suppose that is due to the fnct thero is wider knowlodge of the real monaco of the use of these products othorwise?
FOOD, DRUGS, AVI COSMETICS
Mr. CAMPBELL. Yes.
Parngruph (11) is now. Thero is no provision in the nct at the prosent time to suppress the marketing of dangerous drug products. The necossity for that is vory distinctly und definitely illustratod, Mr. Chairman, in the consequencos from the consumption of Radithor which, us the label states, is a rudim-containing water.
The product has resultod in death, despite repented warnings by the Dopartinent. There is no provision in the law that will enable is to ronovo it from tho narkot. It has been claimed that this provision may affect all types of medicine because all medicines which are potent are capable of producing injury, but this particular paragraplı, is you will noto, is one that condemns such drug products ir dangerous to lionlth under the conditions of use prescribed on the labeling thereof.
And, in a later section it will be made a requirement that the conditions of uso shall be stated on the container of the drug.
I wish to rush along with this as rapidly na possible. If thore is any question you care to ask, I shall be glud in that ovent to discuss that itoin more fully with you. I wish to givo concreto reasons for some of those provisions.
Provision (b) deals with ollicial products, that is, thoso recognized by the United States Pharmacopocio or National l'ormulary. The Chairman. Is there anything new in regard to that?
Mr. CAMPBELL. The phrase " or simulates" in line 5, on page 5, is now. The other language is substantially the same as the present low Jown to line ! "and when it fails to moet the definition, formula, und description set fortli therein.” That is new.
The present law requires ollicial drugs to comply only with the standards of strength, quality, and purity as determuned by the tests prescribed by the United States Pharmacopocia and National Formu
T'he CHAIRMAN. Let me ask you about line 15. Do you now havo thut arrangement ill present, thiut power given to the Secretary?
Mr. CAMPBELL. No. All of this longunge from line 13 down to and including "standards" is new lunguage.
T1:0 purpose of that is to make it possil le for tho Socretary of Agriculture, in cases of emergency which will arise from time to time, to provido methods for the determination of the standards of quality, strength, and purity of drug products which miny supplement those alrendy found in these authorities. Its only purpose is to maintain thointegrity of the ollicial standards.
The CHAIRMAN. I assume you are to linvo somo support of scientilic assistance there but you spoke of, professional assistance to help yon in such it cilso?
Mr. CAMPBELL.. Yes, there is no question about that. There is no question but what some of tho methods from time to timo become obsolete. The United States l'harmacopoeia Association mooty once in 10 yours. Tho l'harmacopoeia is issued unco in every 10 years. Under present circumstances tho revision committee has been empoworod by that orgunization to olleet ad interim revisions. If that iluthority were revukod and tho l'burunucopocial method wero found insuflicient to establish the identity, purity, quality or strength of a
FOOD, DRUGS, AND COSMETICS
drug or drug product, there could be no relief until the Pharmacopocial Association mot ngnin.
The Chairman. I assume you would not use thnt system provided the United States Pharmacopoeia Associntion pornitted the coinmittee to nct, ad interim; you would have no occasion to have it?
Mr. CAMPBELL. I doubt whether it will ever be found necessary to invoke this authority nt any time. As we find new incthods that reflect, more accurntely, the character of the prodnct, our purpose would be to report them to the revision committee and expect that modification of the ullicinl test would be made in the conventional way.
To other words, as we sind new methods that reflect with greater accurncy the exact characteristics of some product it would be our idea to report them innmedintely to the revision committee, and we would oxpect an ad-interim modification to be made promptly and in the conventional wny.
The CHAIRMAN. The rest of the subscrtion is the same?
At the present time a product, sold under a pharmacopocial name, which declivres its own standard of strength, quality, or purity meots the requirements of the low, even though its label vloes not indicate wherein it differs from the United States Pharmacopoein.
The purpose of the wording used thera is to make it possible for a buyer to know how the product differs from the United States l'hora mremporia standard without having to rosor w the official book to ascertain thint information.
Paragraphi C is substantially what is in the art at the present tine, with tho exception that in line 5, the worol:, “n.nd its identity or strength differs from", involve il now requiremen.
At the present time the Inw states that if a drug product falls below its own declared standard of strength, it shoil be adulternted.
Perhaps the most serious danger to purchasers of drugs is to be found in those drug products which are of excessive potency rather than those that are below the declared standard of strengun. If such products are relied pon by physicinns and exrced the expected stane dard of strength, and the physician is usir.g them under the impression that they are of the standard of strengti set forth, you can seo what the result might be in a case of serious illness and delicacy.
This langunge here roads, "if it is not subject to the provisions of paragraph B of this section, and its identity or strength differs from, or its purity or quality falls below, thout which it purports or is represented to possess." in the present Inw it rounds, "if its strength or purity full below the professed stindard of quality under which it is solid.is
So, it will be observed that the langunge is the same in substance, with the nddition which I started.
Paragraph D is now, but its purpose is merely to preserve or guaranter the integrity of the product.
The next is cosmetics. This is, of course, without counterpart in the existing law. I do not know much about conditions to be found in the general rum of cosmetics tony. The reflects of the list of core tain articles live come to our attention in some few instances where we have made investigations of a superficial nature.