Senator COPELAND. That is what we are arguing now, if he did get into court, whether the whole question would be open, or whether, as you contend, that the findings of the Secretary as to the facts, that that would close that particular phase of the question, but that is not what the language says.

Mr. CAVERS. It calls for a certain amount of construction beyond the language of that single sentence, Senator, but I believe the court would so construe that language if it were to remain in the bill.

Senator HEBERT. There would be an opportunity for the court to examine the record, which would, of course, present facts as presented by both sides, or the many sides presented in a question of this sort at the hearing. The court would not be blinded to that. Senator HEBERT. Then why the language that the findings of fact are going to be conclusive? We come right back to that all the time.

Mr. CAVERS. In that examination, it would look to this whether the evidence in the record supported the findings. I mean whether there was any evidence in the record to support the findings.

Senator HEBERT. Does it make any difference? They are conclusive, they are conclusive once the facts have been found under the language of the bill.

Mr. CAVERS. I am afraid I shall have to refer again to the quotation from Mr. Chief Justice Hughes. Our statement is that they shall be conclusive if in accordance with law. We read in the light of the decisions the phrase: "If in accordance with law ", to read "if supported by evidence." In other words, the court must find in the record evidence to support the conclusions. If, however, the court finds a divergence of evidence, then the court would be precluded from substituting its judgment on those facts, as to what the proper findings should be.

Senator HEBERT. That is the point, that is the difficulty, and in that way you are going to substitute a government of men in place of a government of laws.

Now, let me cite an illustration I have in mind. A and B own automobiles. They have an accident on the highway. The State has made a law creating a commission to investigate automobile accidents and to find who is the guilty party, and their findings are conclusive under the law. What is left for the defendant when he goes into court with that condition?

Mr. CAVERS. Senator, it seems to me there you have a question which differs materially from the one which we have at issue now. In that situation, the statute of which you speak has invested an administrative officer with a quasi-judicial function, a function to determine what has happened in the past, which is now going into a given controversy. That is a function of a court normally, and to an increasing extent we do find a tendency to vest that power in a commission. We have no desire to see questions of that sort vested in the Secretary. The sort of power which this section would place in the Secretary is a quasi-legislative power in which the Secretary would be acting to promulgate regulations for the future, not to find out whether a man has in a given case improperly conducted himself to establish a rule to be a guide to the persons affected by it in their future conduct. That operates as a delegation, and I think

a constitutional delegation-no one has argued to my recollection the contrary-of legislative power, not judicial power.

Senator HEBERT. There is no question about the ability to delegate that much power. That has been held time and again. But in no instance which has come to my knowledge has the finding of one clothed with that power been made conclusive. That is the point. Mr. CAVERS. A moment ago, Senator, you said that we should have a government of laws and not of men. I submit, SenatorSenator HEBERT. I said you were substituting.

Mr. CAVERS. Substituting a government of men for a government of laws?

Senator HEBERT. Yes.

Mr. CAVERS. I submit that a court-particularly a court of the first instance is a single man, it is comprised of a single man. His judgment on such a matter cannot be determined by law, because this is not a question of law. His judgment on that matter is that of an individual who has not made a considerable study of the problem; that is, has not gone into the scientific facts as have the committees of the administrative officers, and therefore it seems to me the problem is whether we shall substitute the judgment of experts for the judgment of a man who is not expert upon a question not of law, but of fact.

Senator HEBERT. No; whether we shall substitute the judgment of experts for the judgment of a jury. That is the great question. Mr. CAVERS. Would the question of the validity of a regulation be placed with a jury, Senator?

Senator HEBERT. It is a question of fact. If the facts are to be disclosed in the proceeding, then it goes to a jury, and the jury determines. That is a right guaranteed by the Constitution, as I understand it.

Mr. CAVERS. A regulation is made which provides that a given dosage shall be administered-or that not over a given dosage should be administered of a given drug, and a provision is made on the label that that statement be placed on the label. A prosecution is brought for a violation of the regulation requiring such dosage. The issue before the criminal court is whether there was a violation or not. The defendant would move that the regulation was unconstitutional. That would be his contention, let us say. Would not that be proper for the court to determine as a matter of law whether that regulation was or was not constitutional?

Senator HEBERT. Yes; when you raise a constitutional question you and I know that is not for the jury, but I am speaking always of the question of fact, and we are directing our attention to the question of fact in this regulation fixed by law, always the question of fact and not the question of law, and if now, in the trial of a case arising under this law the facts can be determined and can be submitted to a jury, there is no question in my mind about that provision. I do not care whether it is in there or whether it is out. It does not make any difference, if it can go to the jury ultimately to determine these facts.

Mr. CAVERS. In that event, Senator, we get back to the situation, it seems to me, which we are faced with at the present time, that the offense becomes as defined in section 5 (a), to take an example

from the cosmetic control provisions, where you have a general provision against the use of a poisonous substance instead of paragraph (b). Furthermore, Senator, I rather doubt if you merely strike out the last sentence in paragraph (h) of section 22, that that result would be effective, that these questions would go to the jury. Judge Goodwin in his argument before this committee the other day pointed out that the validity of the regulation would have a presumptive value. That is, validity in an attack on the lawthe legality of that regulation.

Senator COPELAND. Judge Goodwin took your view. He said that if this language were put in, there would be no appeal to the district court. That was a statement Judge Goodwin made, as I recall it. Senator HEBERT. That was his contention, and I disagree with him. Now I find that I am not in accord with the professor who wrote the provisions.

Mr. CAVERS. I did not write this provision.

The CHAIRMAN. Perhaps I misunderstood you, but I thought you meant by something you said a few minutes ago that when the court came on to review this matter of regulation that the court would read the evidence that was offered before the Secretary and no other?

Mr. CAVERS. That is right. The court would examine the record. The CHAIRMAN. Just take the record and go no further?

Mr. CAVERS. That was, I believe, Judge Goodwin's objection. He did not wish to carry it to the jury. Senator Hebert, I think, wished to carry it to the court.

The CHAIRMAN. You indicated that there were complete hearings and a difference of contention with reference to fact. Suppose no one should appear at all when one of these regulations is being considered, no testimony taken, would no person have a right to attack that regulation?

Mr. CAVERS. I should say, Senator, in answer to that in the first place, we assume that the record does contain evidence which supports it.

The CHAIRMAN. But it might not.

Mr. CAVERS. It would have to contain evidence in support. It might not contain evidence contrary to it. The answer there would be that the failure of anyone to interest himself sufficiently in the hearings of this sort concerning which public notice would be given would preclude, and it seems to me properly so, his further later objecting, waiting until his interest became involved in the case to introduce evidence. It seems to me that we afford in this machinery ample opportunity for all those who wish to be heard.

Senator HEBERT. All right. You assume that he is guilty of laches and that therefore he cannot be heard in court. Supposing when this case comes up involving a particular individual, it involves one who was not in business at all when the regulation was made, knew nothing at all about it, he couldn't be heard, he didn't want to be heard, he had no interest in it, but subsequently he does acquire an interest, then what are you gong to do with him?

Mr. CAVERS. It seems to me, Senator, that that very situation emphasizes the importance of having these findings conclusive at the time. Supposing we have a situation where an industry has

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been consulted at length regarding a regulation that it puts in its views, and a satisfactory result is reached. Then later some other person who, we will say, wishes to conduct his business on a somewhat lower plane, wishes

Senator HEBERT. Not necessarily lower, but different.

Mr. CAVERS. Well, different. Supposing he wishes to upset the regulation which serves as the law to the industry, resulting in a considerable investment perhaps in labels, perhaps in processes, then someone, that has no interest at the time this determination was made, decides to get into the picture, that he, we will say, secures the services of scientists, chemists, and the like, who differ in their views from those appearing in the hearing, and undoubtedly he can build that up, since these problems are always in the realm of opinion, enjoy substantial change, would then be not only in a position to attack the reasonableness of the regulation, but to throw the whole problem open again and possibly upset the work of the past and require that you have the regulation being regarded as in valid-the whole process to go over again. If different view were taken by the Secretary, making different findings under the new regulation, then those that were working under the old one would be in position to open up that again.

Senator HEBERT. But I can conceive that there will be such a development of the art that it ought to be.

Mr. CAVERS. That is one of the virtues of having rule-making powers, rather than relying solely on statutes, because it is possible then to have a reopening of the case with the administration.

Senator HEBERT. But supposing the administration refuses to review it, what is his remedy? How can he get the facts before the court under your construction of that law? You have got to assume all the conditions now that may arise. I am not in accord as to a regulatory provision which has merit, but I am thinking of the man whose rights may be denied in the application of it. That is the man I am thinking of.

Mr. CAVERS. He would be deprived of no right that he has the enjoyment of now in the case you suggest. It would merely preclude him from the possibility of going forward. It is quite possible that we should embody some of these tolerances, some of these standards in a statute. We have a butter standard now, which is statutory. In that event, the individual who, we will say, wished to take advantage of scientific developments to produce a different grade of butter is hopeless. The statute is unyielding, and yet I do not believe we should feel that he should be in a position to go into court and enjoin the enforcement of that statute as unconstitutional. We have, however, here, where we do not rely on a legislative standard and elastic machinery, a flexible machinery.

The CHAIRMAN. You can raise the constitutional proposition any time, can't you? Do you think they ought not to be allowed to come into court and attack a statute because it is believed to be unconstitutional?

Mr. CAVERS. Would it render the statute unconstitutional if you had a development

The CHAIRMAN. I am not raising that question, but you said they might attempt to raise the constitutionality.

Mr. CAVERS. I am afraid that I am wrong as to the ability to raise. I was trying to solve the question, rather than its raising. I question whether the possibility of injustice, which is always present under any law, is greater in this situation, and I believe that there is a very considerable advantage to the industry in-it seems to me it would be found advantageous to the industry as well as to the public to have this power granted in the law. I have not prepared an elaborate legal argument on this, but I believe I should appreciate the privilege of filing in a very short time a further brief in respect to it.

The CHAIRMAN. You will have that privilege.

STATEMENT OF W. G. CAMPBELL, CHIEF, FOOD AND DRUG ADMINISTRATION-Resumed

Mr. CAMPBELL. Turning to section 8, dealing with misbranding of drugs, much criticism has been launched at paragraph (a), which defines a drug as misbranded if its labeling bears the name of any disease for which it is not a cure but is a palliative, and fails to bear a statement that the drug is a palliative and how the palliation is effected. Much ado has been made about the last phrase, "how the palliation is effected." It is claimed that this is indefinite, ambiguous, and impossible of fulfillment on the part of the drug manufacturer. A consideration of the terms of the present law in its effect on label statements involving names of diseases will reveal the need for a provision of the kind under consideration here if the public is to be given even a modicum of information that will permit the intelligent and safe use of drugs for self-medication. The present law deals merely with false claims of therapeutic effect. Under its provisions we have been unable to maintain a number of cases in court where the label bore such statements as 66 for pneumonia, influenza, and so forth", without further qualification, despite the fact that medical testimony of both Government and defense agreed that the drug possessed no curative effect whatever and its sole value was to render the patient only slightly less uncomfortable. This theory carried through to its logical conclusion could be employed to substantiate a claim "for pneumonia " on ordinary tap water, since water may be used in certain ways to alleviate somewhat the suffering of the patient. Certainly, if the public is to be encouraged in the intelligent use of drugs, if the public is to be prevented from relying too extensively on drugs, when they merely palliate but do not cure, if the resulting postponement of rational methods of treatment until it is too late is to be guarded against, there must be some requirement guaranteeing a reasonable amount of information as to just what can be expected from the drug. Bear in mind that this paragraph applies in those cases only where the name of a disease appears on the label. If the product is not a cure for that disease but is merely a palliative, the public has a right to know that. It furthermore has a right to know just what manifestations of the disease will be alleviated by the use of the preparation. If the drug tends to deaden the sensibilities to pain, or if it tends to reduce the fever, or if it lessens the congestion of the nose or throat, the public has a right to know these facts and will thus