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FOOD, DRUGS, AND COSMETICS

"The Government is forced to prove that an added, not a naturally occurring poison (for that does not count), is present in a specific consignment of food in such quantity that the food may be deleterious to health if consumed. It is therefore open to the manufacturer or shipper to prove that this particular lot of food may not be deleterious to health if so consumed. Each court case stands by itself and the consumer is inadequately protected."

The matter of added poisons has always been well understood. The word appears in the present law.

The Supreme Court of the United States in U.S. v. 40 Barrels, 241 U.S. 265, pointed out that the word "added" was used to distinguish between deleterious ingredients that might be found in an article and put there by man, from deleterious ingredients which might be found in nature's products as she produces them.

The difficulties which, in the opinion of Professor Tugwell, apparently result in the insufficiencies of the present law, is disclosed in the following language used by him in the article referred to:

"The Government is forced to prove" and "it is * * * open to the manufacturer or shipper to prove that this particular lot of food may not be deleterious to health if so consumed. Each court case stands by itself and the consumer is inadequately protected."

Why should not the Government be forced to prove the facts it alleges? Why should property be destroyed without such proof? If a particular lot of food does not contain added poisons deleterious to health, why should not the manufacturer be permitted to meet the charge and prove that his article is a wholesome article of food containing no such poisonous or deleterious substances?

I take it that what the good professor desires is that the manufacturer be not permitted to prove his innocence or that his preparation is a good food article. The article contends that the consumer is inadequately protected if any appcal may be made to the courts. That is the sum and substance of it.

Another matter appearing in the Tugwell article to which I wish to advert: "It does not give undue dietatorial powers to so-called Government bureaucrats. While it does grant the Secretary of Agriculture certain new authorities, it is very specific in these grants, and protects legitimate business interests effectually. Any attempt at the abuse of such authority by an arbitrary or capricious exercise of it will not succeed, because the courts, in the long run, refuse to sustain any requirements too far divergent from the ordinary community standards of good conduct and fair practice.'

Notwithstanding that in one paragraph the statement is made that the grants of power to the Secretary of Agriculture are confined within narrow limits, in the very next paragraph appears the statement:

"A law must be sufliciently broad and flexible to effect the conviction of offenders whose conduct has fallen below the standards demanded by both consumers and ethical competitors. But if the language of the statute restricts itself merely to specific antisocial acts that its drafters anticipate, the discovery of loopholes in that law is inevitable, and the difficulties of its enforcement multiply endlessly."

The declaration that the grant is limited to a narrow scope is disposed of in the language which I have last quoted. The law must be so broad and flexible that the language is not restricted to specific violation for fear that loopholes may be discovered and difficulties of enforcement multiplied. Interesting, isn't it? In other words, bureaucracy is not to be limited. It is not to be confined within narrow limits. Powers must be so broad and flexible that these powers may not be challenged in court by an interested party who may feeel his rights have been invaded.

The Congress is now being asked to so rewrite the Food and Drugs Act that commerce in drugs be the subject of edict and decree and that action need not be limited to proper cases nor necessary care be taken in the preparation and trial. NOTE.-Italics supplied.

V

The bills introduced declare among other things that their purpose is "to prevent the false advertisement of foods, drugs, and cosmetics."

There has been a persistent effort to show that there is no regulation of advertising in the field of foods, drugs, and cosmetics. You will see from what follows

that there is both law and efficient enforcement. I quote from the annual roport of the Federal Trade Commission, relensed December 12, 1932, for the fiscal year

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ending June 30, 1932, and addressed to the Senate and House of Representatives of the United States, pages 46 and 47:

"During the fiscal year ending June 30, 1932, the special board concluded the investigation of and reported to the Commission 406 cases. Of these, 341 were against advertisers, 57 against publishers, and 8 against advertising agencies,

"In 45 cases the advertisers discontinued business, 12 more were forced out by post-office fraud orders, 3 discontinued false and misleading advertising before complaints were made, 42 cases were dismissed for lack of evidence or jurisdiction, 18 were referred to other divisions, 233 were disposed of by stipulation and prosecution of formal proceedings was recommended in 9 cases. In 44 cases investigations were completed, reported to the Commission, and await further orders.

"While it is impossible to state accurately the number of false and misleading advertisements that have been discontinued entirely or revised to check fairly with the truth, it is estimated that such number for last year, considered as being directly due to the Commission's activities, exceeds 20,000. The money saved to the purchasing public amounts to many millions of dollars."

You will please note the extraordinary activities of the Federal Trade Commission, together with their estimate that the number of false and misleading advertisements which have been either discontinued entirely or revised to check with the truth and resulting from the Commission's activities, exceeds 20,000. In addition to the above, the so-called "Printer's ink law" prohibiting false advertising has been enacted by the legislatures of all of the States and the District of Columbia, except Arkansas, Delaware, Georgia, Maine, Mississippi, and Texas. The desire for new legislation in this behalf is the wish to extend the new despotism.

The CHAIRMAN. Every effort will be made to accomodate everyone. The next statement that we have is that by Mr. Huston Thompson.

STATEMENT OF HUSTON THOMPSON

Mr. HUSTON THOMPSON. Gentlemen of the committee, having been before committees a number of times, I think I had better state specifically just whom I represent, so there will be no question as to my position. I am here as the executor and trustee of the estate of Carl H. White. The Carl H. White Co. is vendor of certain products. Carl II. White was the founder of the Health Products Corporation. This corporation produces a number of medicinal articles. Among those articles are what is known as 'White's Concentrate," and a laxative chewing gum called Feenamint. In looking over the bill, it seems to me that there should be an amendment or inclusion or a proviso that will cover articles of this kind; that is, articles such as Feenamint being a laxative chewing gum, and "White's Concentrate.” The bill, as it now stands, has a definition.

The CHAIRMAN. On page 2?

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Mr. THOMPSON. Yes. On page 2 there is a definition of the term "drugs." On page 1 there is a definition of the word "food. Those articles of which I speak, and there are many others, of course, on the markot of a similar nature, which are composed of both food and drug. So that so far as this bill is concerned, they are in a twilight zone, being covered by neither group.

It is my suggestion that we have a proviso by inserting the words, after the word "animals", on the last fine-no, it is on line 11 of page 2-that will cover articles where the article is both a food and a drug. I have a draft of this proviso to follow the word "animals" on line 11 on page 2, in paragraph B.

The CHAIRMAN. Just read it.

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Mr. THOMPSON. This is an amendment offered by Houston Thompson to this bill. I offer the following language as an amendment in the form of a proviso to be placed after the period following the word "animals" on the eleventh line under (3) of paragrapli B," page 2, of the said bill.

Provided, That any substance or preparation which may be a combination of a food and drug shall be deemed and classified only as to food or drug, dependent upon its intended and/or actual use, which shall be clearly expressed on the carton containing the said combination, or on the label marking.

The CHAIRMAN. I do not understand the last part of that. Mr. THOMPSON. That should be "which shall be clearly expressed in or on the carton containing the label marking the said combination." My reason for that is this: This bill merely leaves a great discretion to the author of the bill or its administrator in connection with that, without being at all specific. It does not provide for it as specifically as would be desirable. For instance, if you turn over, for example, to the section covering tolerances, section 10, page 14, at the bottom of the page, you will find the subject of tolerances for poisonous ingredi ents in food and cosmetics and certification of coal-tur colors. Also you give discretion, as I understand this bill, to the Secretary to determine on the question, for example, of poisons and of antideleterious substances. If this were a food in all cases and there wore used this element in there, as, for example, phenolphthalein, the question will arise as to whether there was injected a deleterious substance. You are in a position, if you leave the definition as it is now covering simply the question of food and drugs, that the strict interpretator would have the power over such a combination or such a product that might be a very serious one.

The CHAIRMAN. I see your point, and on page 2, between lines 11 and 12, you wish to have inserted the material which you have given us.

Mr. W. Bruce Philip, of Washington, D.C., counsel for the Association of National Retail Druggists, one of our 5-minute speakers, will now state his views in connection with this matter.

STATEMENT OF W. BRUCE PHILIP

Mr. PHILIP. The National Association of Retail Druggists has for over 25 years represented the interests of 60,000 retail druggists in the United States.

We wish to subscribe to Dr. Beal's analysis of the Tugwell bill. We wish also to subscribe to the suggested amendment to the present Food and Drugs Act that will be presented.

Briefly, the problem of the retail druggist is quite different from the problem of the large manufacturer. On the druggists special subjects I would like to give you a little information and some experiences.

It is easy enough to say that if the laws or regulations are not satisfactory you can go to court. The average retail druggist cannot afford to go to court, in fact, the druggists, I should say, over 59,000 of the 60,000, will be forced to accept the regulation, regardless of whether they are in accordance with the law or in accordanco with their rights. It is almost impossible for the average retail druggist to protect himself against the regulations. This bill, as I read itand I have read it carefully-is a skeleton bill that gives to the

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authorities, the Secretary of Agriculture and his assistants, full power to regulate food, drugs, and cosmetics.

One experience that we had under a law that was wiped out this month (the eighteenth amendment), was a caso in point where undoubtedly not only our constitutional rights, but the services to a large group of people were affected. We raised $4,000 to carry the case to the United States Supreme Court. We did the best we could. The Government informed ine that they were very happy to have the point involved decided by the Supreme Court. When the case came to the Supreme Court, the Government's attorney found that we had failed to join the Collector of Internal Revenue and therefore we lost our case. The point was never decided and unquestionably our rights were affected until the eighteenth amendment was repealed. The enthusiasm that people get in the Government employ often carries them beyond the point of necessity. Inasmuch as this is a bill depending upon regulation rather than the wording of the bill we cannot understand what it means. Let me tell you of an instance that occurred showing how important regulations are. Some of you may be familiar with this regulation. This regulation existed for vears after it was written.

I think you, Dr. Copeland, may have had some personal experience in connection with this regulation. Inasmuch as I am a pharmacist. At that time I was in my own drug store, and we were filling prescriptions for a great many tuberculosis patients. I, personally, was working at the prescription counter and I was familiar with the regulation I will tell you about. It was a narcotic regulation. Let me, before I go further, say this. Our association is behind the narcotic regulations; we will go to almost any degree to support any officer in the enforcement of narcotic regulations, and they will so tell you. This regulation required that when a narcotic was prescribed for a person with an incurable disease the name of the disease had to be written on the prescription. It was undoubtedly a good intention. They wanted to protect the public from receiving lots of narcotic prescriptions or to prevent a few physicians or a few pharmacists abusing the law. But actually what did this regulation do? The doctor handed the patient a piece of paper and the patient could read his own death warrant. The regulation made the prescription the patient's death warrant. I, personally, have seen people dejected and in despair with their narcotic prescription in their hands which said to them, "You must die." It was not the law; it was a regulation. It took 2 or 3 years to have that regulation changed. That is a long time.

We could have gone into court, but we had no money to go into court. Instead, we protested, and we had to protest time and time again. Finally, the regulation was changed.

Our members have to deal not with men like Mr. Campbell, not with the people here in Washington, but with the hundreds of people that are lesser employees in the Government service. Many are inexperienced. We have untold problems with these inspectors and enforcing officers. The first time we had an insecticide law in California, we had tooth paste and hair preparations tied up in one district for a week or two until we could get our committee together and go to Sacramento and have the regulations changed and new instructions given to the inspectors. That is the way regulations

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were carried out in an insecticide law. We had to have inspectors told how regulations were to be carried out under an insecticide law. If this law is to be effective, and our idea is to have laws effective we must have a similar Tugwell bill in every State. To pass an entirely new law that is different from 48 similar State laws, must mean the repeal of 48 present State food and drug acts and the passing of a bill like the Tugwell bill in every State. This is a very difficult proposition. It is far better to take the present law and amend it and then have State laws which are now following the present Food and Drug Act, amended. As I said, S. 1944 is a skeleton bill with full power in the Secretary of Agriculture. Are we going to have 48 States laws with the power in each State in the State secretary of agriculture? Are we going to have any uniformity? Under these conditions, are we going to have anything that is a protection to the public and that is satisfactory to the public? I doubt it.

We have here in the S. 1944 an example of the Department's enthusiasm, and I do not blame Mr. Campbell for his enthusiasm; I do not blame anyone working for a law like this, being enthusiastic, but in the definition of confection, in his desire to punish those putting metallic substances in candy he has written S. 1944 so that it would destroy the entire chewing gum industry. It was not the intention of Mr. Campbell or Mr. Tugwell to do that, and I am sure the law will be modified. But, in their enthusiasm to reach one or two or threo problems they have written provisions that have a very far-reaching effect. In their effort to reach these cases which are asserted to be dangerous, the bill has been written without regard to how far many provisions will go. I mean by that, that in trying to enforce this law aginst such things as these metallic trinkets that do not represent the average condition, but are more or less far fetched, that the farreaching effect of the regulations and the laws will be difficult to be lived up to in ordinary practice.

The CHAIRMAN. You will remember that Mr. Campbell suggested an amendment to that particular section.

Mr. PHILIP. He did, and that is the point, Senator Copeland. Laws are prepared so that we may come here and protest and have the law rewritten, but a regulation is issued over night. We do not see the regulations until they are handed to us and they have the force of law. If the definition of a confection was a regulation it would wipe out the industry of chewing gum until we could go into court or reach the proper person here in Washington and have the regulation changed. What we want, Senator, is this: Wo want a law we can understand. We think we are right in wanting it, and we think we are earnest in our intentions in coming here, to ask for a law that we can understand, that we can road, understand, and follow as a part of our business. We have the difficult problem of serving the public and we must know exactly what we should do.

I object, both as a citizen and in the name of the association, to placing a great deal of power in the hands of any Government bureau. Congress meets every year. We will go with you or with Mr. Campbell or anyone else in an endeavor each year to have laws strengthened and modified, but if the law is so written that we have regulation after regulation, and it takes 2 or 3 years to change that regulation, we aro simply at a disadvantage in serving the public. There is one moro thing I would like to call to your attention, that is the voluntary in

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