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it would be extremely unlikely that any harm would result from its use?

Mr. DILLINGHAM. I never knew that any harm resulted from its

The CHAIRMAN. Have there been any complaints in your industry about your association. Have you had any complaints from the departments here or from any State health official about the ingredients contained in spices?

Mr. DILLINGHAM. We have not, so far as I know.

The CHAIRMAN. You are just fearful that something might happen to you?

Mr. DILLINGHAM. That something might happen so we would have to disclose formulas. You see, very many spice manufacturers make up seasonings, for example, under their own formulas for meat packers, etc., and if the man has a formula of his own which is better than somebody else's, it does not seem fair that he should have to disclose it.

Senator McNary. Where is your principal office?
Mr. DILLINGHAM. The American Spice Trade Association?
Senator McNARY. Yes.
Mr. DILLINGHAM. 82 Wall Street.

The CHAIRMAN. I suppose your organization has been beset by manufacturers of food products who make use of spices? I have the feeling that so far as you are concerned you do not have much to worry about?

Mr. DILLINGHAM. Of course the spice industry, in so far as it is a component part of the food industry, as a whole, is a comparatively small item, but, naturally, it is of tremendous importance to those who are in it.

May I go on from there, sir? The CHAIRMAN. Oh, yes. Mr. DILLINGHAM. Referring now to section 9 (a), on page 12, which has to do with false advertisements, it appears to us that insofar as this article affects food in general and spice in particular this provision is too broad in its terms. This is simply in line with what others have said, and there is no need of our going into it.

The CHAIRMAN. You would prefer to take the law as it is nw witho the interpretation of the Supreme Court regarding it than to have new language?

Mr. DILLINGHAM. Insofar as it affects our industry, yes.

Section 12 (b). Line 24: Substitute the word "shall” for "may," in that sentence beginning “The Secretary may reinstate.”

Section 13 (a). Line 24: Substitute a comma for the period after the word "stored” and add "provided, however, nothing herein contained shall be construed as requiring a manufacturer to disclose any formula or formulae."

Section 15 (a),—that is on page 19, line 15: Insert a period after the word "Agriculture" and delete the balance of the paragraph. Our reason for that is that this gives the employees of the Department of Agriculture the sole right to conduct investigations and takes it out of the hands of State and municipal employees, as we do not think it belongs there.

The CHAIRMAN. Would not that proposal, if adopted, throw a tremendous expense upon the Department of Agriculture which is unnecessary because health officials elsewhere are competent to pass judgment?

Mr. DILLINGHAM. In discussing that paragraph it seemed to us that the knowledge and ability of whatever men the Department appoints as investigators will probably be of a higher type than we would be likely to get in the underemployees of the various cities and municipal health boards.

The CHAIRMAN. Is it not entirely probable that the oustide officials would give consideration to that fact?

Mr. DILLINGHAM. It would be probable, yes, if such men were available.

Senator McNARY. Go ahead.
Mr. DILLINGHAM. Section 15 (b)

The CHAIRMAN. Before you pass that, let me call attention to the present law, Section 5, where a provision is made for the employment of these outside officials. In other words, this is already in the law.

Mr. DILLINGHAM. I agree with you, sir.

Our next suggestion in regard to Section 15 (b), in lines 21 and 22, is that we delete from that paragraph the phrase "or to whom any health, food, or drug officer of any State or territory, or political subdivision thereof."

The CHAIRMAN. The same suggestion as the other?

Mr. DILLINGHAM. Exactly the same. Simply covers that same point.

The dictatorial powers conferred upon the Secretary of Agriculture, in our opinion, deny business its constitutional guarantees. They place the Secretary in the position of a judge and jury, with no adequate right of appeal for the accused.

We are of the opinion that it is most unfair to ask business to appeal to the official who himself makes the ruling and decision, from which appeal is taken. We should have a court of appeals fashioned somewhat along the lines of our United States Customs Court of Appeals.

The CHAIRMAN. We are much obliged to you, Mr. Dillingham.

The next speaker is Clinton Robb, counsel for the United Medicine Manufacturers of America.

Mr. Robb?

STATEMENT OF CLINTON ROBB ON BEHALF OF THE UNITED

MEDICINE MANUFACTURERS OF AMERICA

Mr. ROBB. Mr. Chairman and Senators, while I am authorized to speak on behalf of the United Medicine Manufacturers of America, I shall try to reflect very briefly in a few observations that are the result of my specialization for the past several years in the laws and regulations pertaining to foods and drugs, and to some extent cosmetics. I shall try to be fair, constructive, and helpful, instead of merely critical. My whole object is one of cooperation with this committee. Let me say at the outset that for Mr. Campbell, Dr, Cullen, and"

, the others who are seeing to enforcing the Food and Drug Act, I } only the highest respect, and that anything I might say here intended or to be construed as reflecting upon them in any w

May I also say that what I may have to say regarding self-medication, it is not to be understood as expressing any want of appreciation or respect for that high profession which the chairman of this Committee so honors and adorns.

My first observation is that a reading of this bill and a consideration of the statements made by the proponents of it might lead one to the belief that the public now is largely at the mercy of the unscrupulous, willful violator, for whom, of course, neither my organization nor the industry as a whole has any use whatever.

Nothing could be farther from the fact; the truth is that at this moment there are functioning three thoroughly organized and thoroughly coordinated Federal agencies that are dealing very effectively, as I have good reason to know, with the willful violators.

Those three agencies are, first, the Post Office Department. It does not seem to be generally known that under the postal laws and regulations it is possible for the Government in a case where the manufacturer is using the mails to sell direct to a consumer, as any large manufacturer often may have to do, it is possible for the Government to reach and punish and stop the business of a manufacturer who is merely sending a package to another point in the same State; in other words, one who is doing a clearly intrastate business, which could not be reached under the Foods and Drugs Act.

Senator McNARY. What do you think about this bill?
Mr. ROBB. I am coming to that very briefly.
Senator McNARY. Let us have it now.

Mr. ROBB. Turning to section 8, the requirement is in effect that a product is to be considered as misbranded unless the manufacturer states that the product is not a cure. It is a well known fact that even physicians are not able to cure, that nature alone can cure, and that the physician cannot do any more than assist nature.

If the drug had to bear a label that it was not a cure, I submit that the manufacturer would have no better chance of selling that product than the physician would have of selling his services if he had to place over the door of his office, "I do not cure." That is with all due respect to the Chairman.

Now, if this industry is to be liquidated, let us do it expeditiously and directly instead of through what I may describe as an added poisonous or deleterious ingredient in this statute.

The CHAIRMAN. Now, Mr. Robb, I know you want to be perfectly fair

Mr. Robb. I certainly do, Senator.

The CHAIRMAN. The department has in mind that there should not be the privilege on the part of manufacturers or advertisers to set out to cure incurable ailments.

Mr. ROBB. Neither do I. I haven't any use for the man who does.

The CHAIRMAN. All right. Then you suggest how we can formulate the bill in a way to accomplish what you have in mind without invading the field of common decency.

Mr. ROBB. I was attempting to develop that, and I rather have interrupted the argument I expected to make. If I may be indulged I shall be glad to try to do it and very quickly.

Now, under the present Food and Drugs Act, and particularly since the decision of the Supreme Court of the United States through the then justice, now chief justice, Hughes, Congress deliberately excluded

a

the field of honest differences of opinion between schools of practitioners.

Now, theoretically, a manufacturer may rely upon the opinion of a minority of the profession. It is conceivable, theoretically, that the views of only 10 percent of the medical profession, if backed by outstanding figures in the profession, might warrant the manufacturer in putting out his product based upon those views.

Now, what is the practical situation? I think it is a situation which you might be interested in a typical case. The manufacturer has a preparation which represents the prescription of a practicing physician. He employs a competent chemist to help him perfect the development of that product. He in turn submits that formula to other physicians and improvements are made.

He is summoned by the Government and informed that his claims are regarded as extravagant and untrue. He employs counsel and counsel advises him after careful consideration of the case that he is warranted in making these claims. Now, what happens?

It is true that he has a right to go to court, but before he can get a judicial determination of this difference of opinion that may exist between him and the department, his business may be absolutely destroyed through the seizure of his product.

Now, we maintain that that is unfair and it is un-American.

Where there are honest differences of opinion between the manufacturer and the Government there ought to be an independent tribunal that would give a summary decision that would be binding unless that decision was reversed by a court.

I propose to show very briefly that under the terms of the statute even the rights that he now has would be taken away from him.

I will turn back, if you please, to section 8: “A drug shall be deemed to be misbranded"

The CHAIRMAN. What section is this?

Mr. ROBB. Section 8, Mr. Chairman, line 22: A drug shall be deemed to be misbranded if it is contrary to the general agreement of the medical profession.

Now, I feel sure that the observation and experience of this committee has been the same as mine, that the adoption of the new and the improved usually, and almost always, is by the minority. The Chairman. Pardon me, Mr. Robb. Were you here yesterday?

CHAIRMAN
Mr. ROBB. Yes, sir.

The CHAIRMAN. You will remember that the last witness last night went into that very extensively.

Mr. ROBB. Johnson Beale?

The CHAIRMAN. Yes. For your comfort let me say, if it is any comfort, that I share this view that you have about the impossibility of any unanimity of medical opinion, contemporary or ancient.

Mr. ROBB. Thank you very much, Mr. Chairman. Then the industry will hope that when this bill is given final form it will be so revised that it will not be necessary for the manufacturer to risk his business and his liberty by being found out of harmony with the general agreement of the medical profession.

The CHAIRMAN. Do you feel if the bill were enacted as it were written here it would ruin the industry?

Mr. Robb. I certainly do. I think it would absolutely ruin the industry. I think it would be a practical impossibility for a manufacturer to continue in business.

The CHAIRMAN. Are there no restrictions now upon what you can do and how far you can go?

Mr. ROBB. There are restrictions.
The CHAIRMAN. When they were imposed did the business suffer?

Mr. ROBB. Business did not suffer from the imposition of reasonable requirements. I am not here to maintain for a moment that everything is exactly as it should be in the industry and that no act is necessary. That is not my attitude at all.

The CHAIRMAN. You remember the old lady who had stock in the undertaking concern and found fault because the returns were not good? Have we got to take off the safeguards? Is not this bill in the interests of the public? Are we not here to guard the interests of the public?

Mr. Robb. Let me say frankly and directly, Senator, that we are unwilling that the proponents of this bill should claim all of the available credit for being in favor of the protection of the public health. So are we.

That is the very reason why we are offering our remedies to the public.

(There was a short pause.)

Mr. ROBB. It is like the preacher who preached the sermon on sin; we are against it but we are a little concerned with the definition of what is sinful and with the question of who is going to decide.

The CHAIRMAN. All right, Mr. Robb, very good. Have you finished your statement? Mr. Robb. On that section 8, I have; yes. The CHAIRMAN. What is the next point? Mr. Robs. If you will turn, Senator, to page 13, section (c):

To discourage the public advertisement for sale in interstate commerce for drugs for diseases wherein self-medication may be especially dangerous or patently contrary to the interests of public health

Now, I ask the committee with all frankness and sincerity what the plain implication of that language is? Is there any escape from the conclusion that the framers of this section think that every patent medicine is dangerous but that some are especially or patently so? There is no escape from the conclusion.

Now, we ask the committee

The CHAIRMAN. We go further and we actually put it in the bill on the next page.

Mr. ROBB. Then follows a long list of diseases. Now, let me say right here that up to this moment the course followed considering the permissible scope of self-medication have always made a distinction between ailments which are infectious or contagious and those which are noncontagious and I challenge the opposition to produce a single case in which a court has ever held self-medication is inherently or otherwise dangerous with respect to any ailment not of a communicable nature.

Yet, the provisions of this act would sweep away all that the courts have found for a quarter of century and we would have to start all over again. During the last 25 years the best legal minds in the country, represented by the judges of our Federal courts have given careful, thoughtful consideration to the numerous questions that have arisen

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