VOL. 1 LEGISLATIVE HISTORY OF THE FOOD, DRUG, COSMETIC ACT 86 FOOD, DRUGS, AND COSMETICS When the Federal Food and Drugs Act was enacted, Mr. Chairman, the most glaring defect which we had to meet in those days was the one which dealt with the label on the outside of the carton, and somehow or other those of us interested in the formulation of that law were so impressed by that fact that we lost sight of everything else. Later, when an amendment to this art was passed, we did get fairly good control over the face of the label, whether appearing on the bottle or on the outside of the package, or carton. As I say, we concede certain material defects in the present law, and we are anxious to see them corrected, and we stand ready to assist to the extent of our ability to see that they are corrected. Now, it is all well enough to say that a certain bill has certain admirable general principles. Whether or not those principles will be carefully carried out, so as to accomplish their true purpose, or whether it will fail to accomplish that purpose, and result in possibly greater evils, depends upon the specific provisions by which the principles are attempted to be put in force. Now, Mr. Chairman, on behalf of my association. I wish to call your attention to some provisions which seem to us to be defective. You will be responsible--your committee--for the final text in which this bill is put by the national legislative body—if it should ever get that far. In section 2, dealing with definitions. I wish to call your attention to the effect upon the definition of "drugs" after introducing the word “devices,” and the word “devices" is introduced there without any qualifying or limiting terms. Now, we concede that there are mecical devices which are falsely and fraudulently advertised and sold, and we concede that this abuse should be corrected, but we wish that you would, in finally passing upon the text of this bill, consider the possible effect of this term "devices" es it now stands. Under the new definition, the term “drug” will include such multifarious items as trusses, suspensories and obesity bandages, shoulder braces, fountain syringes and contraceptives, tooth brushes, spectacles and eye glasses, ear trumpets, and artificial aids to hearing, artificial teeth and limbs, gymnasium equipment, and so forth. Now, since this also applies to animals as well as to man, it includes check reins, to make horses hold their heads up, interference pads, to prevent them from interfering, blinkers, to prevent them fron exercising the function of their eyes to the right or left, and dog muzzles laughter)-all of these could, if the definition were not limited by proper qualifying terms, be construed to the mitigation or prevention of disense intended to affect the functions of the body of man or other animals. We come now to section IV, relating to the adulteration of drugs. Senator COPELAND. Are you going to recommend some change of language? Dr. BEAL. I am going to call attention at this time, Mr. Chairman, to what we believe to be improper statements in the bill. At a later date we hope to be able to recommend some language which we believe will cover the question. Senator COPELAND. Do you not think that that would really bo more helpful than the line of attack that you are taking? FOOD, DRUGS, AND COSMETICS 87 Dr. BEAL. If the Senator will concede me the opportunity of continuing so as to get through as quickly as possible, I will attempt to answer any questions later. Paragrapli (a) provides that a drug shull be deemed to be adulterated "if it is or may be dangerous to houlth under the conditions of use prescribed in the labeling thereof." Now, since the phrase "may be dangerous to health" is undefined in the bill, it follows that its limitations must be supplied by regulations, which means that the quality and quantity of danger will be measured by the opinion of those who frame the regulations. Now, it is a matter of common knowledge that there are occasional individuals who are supersensitive to the action of certain drugs and foods to even such ordinarily innocuous substances as the white of an ogg, milk and strawberries, which will set up very serious reactions, and, unfortunately, these cases of hypersusceptibility cannot be determined in advance. We only find out the people who are susceptible when the drug is actually administered or actually applied in practice in daily life. Unfortunately, such cases of hypersusceptibility can be discovered only through the actual use or application of the particular agent. Under the bill as written, if applied literally, almost any known drug could be excluded from interstate commerce. The language should, therefore, be modified either by some limitation of the phrase "may be dangerous to health" or by an express exception showing that occasional cases of allergy and idiosyncrasy are not included within the law. Senator COPELAND. Mr. Campbell, is this new language? Senator COPELAND. And also (V)? Mr. CAMPBELL. (V) is not new language. Senator COPELAND. Go ahead, Doctor. Dr. BEAL. Paragraph (b) of section 4 provides that U.S.P. and N.F. drugs will correspond to U.S.P. and N.F. standards. This is not exactly what it is in the main. An expansion of the corresponding paragraph in the existing law, and down to line 13, is unobjectionable, except perhaps for the inclusion of the indefinite and unlimited word "formula" in line 10. This word "formula" is one which has more than one significance in the Pharmacopoeia and pharmacy generally. Do we understand that the word "formula" as here used applies to the symbolic or graphic formula of a drug of definite chemical constitution, or does it refer to the working formula or process by which the article is produced? That should be made clear here. Senator COPELAND. Do you suggest the language? Dr. BEAL. No, sir. My suggestion would be to strike it out. Dr. BEAL. I would strike it out as unnecessary, as adding nothing whatsoever to the merits of the bill. Senator COPELAND. If I understand you, you would strike out the word "formula" altogether? Dr. BEAL. Yes, for this reason, that the working formulas or processes of the Pharmacopoeia are constructed for the purpose of being operated upon the small scale, the making of 1, 2, 3, or 4 88 FOOD, DRUGS, AND COSMETICS pints of a mixture at a time, and these small formulas which work so well in these small scales will in many cases not work at all in the large scale, in the large manufacturing laboratory, such as we have in Philadelphia or Baltimore. They cannot use those formulas. Senator COPELAND. Why is that? Because you cannot mix up a big batch as well as a smaller one? Dr. BEAL. That is one of the reasons. Take in the case of percolation, where you might get a very satisfactory percolation in a percolator holding two litres, It would not work at all if you had to use the same method of packing and the same period of maceration and other corresponding manipulations where you percolated 5,000 or 10,000 pounds. What we contend is that what is important is not the particular working process by which the product is produced, but the product in its finished state, ready for dissemination in interstate commerce. So that word "formula" should either be stricken from line 10, or clarified by definition to show that it does not refer to the working formula or process of manufacture. The exception introduced in lines 14 to 18, authorizing a departure from the tests or methods of assay of the l'harmacopoeia and National Formulary and the substitution of quite different tests, appears to be a dangerous innovation. Under the bill as written the manufacturer is compelled to conform to the tests prescribed by the U.S.P. and N.F. or be subject to prosecution for shipment of adulterated drugs in interstate commerce. But, having complied with the official tests and methods of assay, and having shipped his goods into every State in the Union, they may all be made illegal by reason of the fact that an administrative officer chooses to discard the officially prescribed tests and to substitute others of his own. As I say, by regulation, the Secretary of Agriculture can set aside the U.S.P. and prescribe an entirely different set of tests. Senator COPELAND. If I remember correctly, Mr. Campbell said that now there are continual sessions of the Pharmacopœia Committee, and that a subcommitteo is permitted to set up new standards, which are accepted by him, and become a part of the Pharmacoparia. Dr. BEAL. Usually what we call supplements. Senator COPELAND. Yes, but in case that system should be done away with, it might happen that in the 10-year period that there should be a considerable change by reason of scientific advance. Is that what you had in mind, Mr. Campbell? Mr. CAMPBELL. It was. I stated to you at the time it was under consideration that I thought there would be only infrequent occasions in which this particular authority would be invoked, that there was at the present time authority granted to the revision committee to effect nd interim revisions of the Pharmacopain, a grant which had not characterized certain of the other Pharmacoperis editions, and since the Pharmacopain meets only once in 10 years, it is important at least from a regulatory control standpoint, that the methods of assay which undertake to establish the integrity of the drug be sufficiently accurate to do that. From time to time methods become obsolete, ns we nequire more information about more preciso methods which will disclose some form of sophistication. FOOD, DRUGS, AND COSMETICS 89 So it is of the utmost importance, not only to the consuming public, and the user of the drugs, but to the honest manufacturer of drugs, that the integrity of these products may be established in an efficient and up-to-date manner. The only thing that we want to do is to make more effective the control of drugs where there has been found to be a deficiency in the methods that exist at the moment. We assume that there will be cooperation between the revision committee of the Pharmacopoeia Association and the Food and Drug Administration, or any other Federal or State organization that may be concerned in this matter. I think that in most instances it will be sufficient to call to the attention of the revision committee the fact that improved methods have been worked out and that they should be employed for the more effective guaranty of the purity of the product. Senator COPELAND. Excuse my having broken in, Doctor, but that is the way I understood it. That is what the Department had in mind in using this particular language. Dr. BEAL. That undoubtedly was the intention of the regulation. Nevertheless, Mr. Chairman, as it stands, it constitutes what seems to be a potent danger to the interests of the legitimate manufacturing pharmacists. We further believe it to be unnecessary. While it is true that in the United States the Pharmacopoeia meets as a whole only once in 10 years, the revision committee is in session 365 days in the year throughout the entire 10 years, and the board of trustees is active every day and every week of the year. The revision committee has authority to prepare these supplements as rapidly as new developments in pharmacy and chemistry are created or come into existence, and as rapidly as those supplements are prepared they can be published and are published by the board of trustees. Senator COPELAND. Is it not your judgment that it would be unlikely that the Department of Agriculture would at any time assume to go over the action of the Pharmacopoeia committee? Dr. BEAL. All of the abuses that have been introduced into the law have been introduced either under the excuse that they had a beneficent purpose or would not be abused, and we are simply pointing that out here as a provision which delegates power that can be improperly exercised-not that I have the slightest feeling that my good friend Campbell would intentionally ever exercise power unlawfully or arbitrarily, but since we are called upon to state our ideas on the text of this bill we think it our duty to present these facts. Now, we think some of these things in the bill were introduced through inadvertence. Others were introduced because of the fact that those who were responsible for the particular language did not possess the practical and technical information necessary to express themselves properly. Nobody need tell me that this is not a professor's bill; I can tell that by reading it. I have been a university professor myself for 40 years or more, and I know the breed. I know how they express themselves. Senator COPELAND. I have been a professor, too, and I want to say that I did not write this particular language. I would be willing to have it omitted from the bill, and I an auxious to be shown at the proper time why it should be left in. VOL. 1 LEGISLATIVE HISTORY OF THE FOOD, DRUG, COSMETIC ACT 90 FOOD, DRUGS, AND COSMETICS Dr. BEAL. Thank you. Under paragraph (d) of section 4 a drug will be deemed to be adulterated "if any substance has been mixed or packed therewith so as to reduce its quality or strength or when (2) if any substance has been substituted wholly or in part therefor." Now, here is a fault which I think is purely inadvertent, merely an oversight on the part of the framers of the bill--and I may say that we chased these people all over Washington for a period of weeks trying to get into contact with them to assist them in the preparation of the text of this measure, and we never succeeded in catching up with them or in establishing a practical contact, and as they did not give us the opportunity, we are expressing what we have to say about it now. Now, nature rarely or never produces alkaloidal vegetable drugs of the exact strength prescribed in the Pharmacopoeia. Sometimes they are deficient in the percentage of active or potent constituent; and sometimes they contain an excessive quantity. Take, for example, the standard strength of opium. There the only thing that we can do in order to secure accuracy of dosage is to try to assay the opium, and if it is too weak, to add stronger, or if it is too concentrated, to add some weaker opium, until we ultimately get what we should, a final drug of exactly 10 percent. Pharmacopoeia making has three models which are fundamental. The first is accuracy, the second more accuracy, and third the most complete or possibly complete degree of accuracy, and that is why we have to modify these drugs from time to time, so as to get just one particular strength, no other. So our suggestion, Senator, is that the word "injuriously" should be inserted before the word "reduce" so as to make the line read: "injuriously reduce its quality or strength." Senator COPELAND. Just a ininute before you leave that, Dr. Beal. I do not get quite the same meaning out of that paragraph that you do. If any substance has been mixed or packed with it so as to reduce injuriously or injuriously reduce its quality or strength, that does not mean that you are going to put the same substance in it. I have in mind putting sawdust in, or something or other cheaper than the regular product. Dr. BEAL. That would not make any difference, because while we would not use sawdust, there are better things than sawdust, such as sugar of milk. That paragraph, as I rend it, meats this, if it were applied literally and unintelligently, and it can be shown that we had reduced the strength of opium from 14 to 10 percent by the addition of sugar of cream, or, not opium, but take some other preparation, it would be illegal under this phrase, as it now stands, in the bill; its percentage strength must be reduced in order to make it a proper Pharmacopoeia substance, and therefore we are asking for the legal authority to reduce its crude natural strength to the requisite standard. Section 5 deals with the adulteration of cosmetics. That has only a very indirect, interest to our organization, or the organizations now represented in the National Drug Trade Conference, although the apothecary inventor first introduced perfumes and cosmetics, and wo have Holy Writ as our authority, for you will recall the formula for the manufacture of an aromatic substance or perfume which was to |