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 case 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 me 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 The point was never decided and unquestionably our rights were affected until the eighteenth amendment was repealed.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 years 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

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 three 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: We 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 read, 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 are simply at a disadvantage in serving the public. There is one more thing I would like to call to your attention, that is the voluntary in

spection service, section 22, page 29. That, in my opinion, is not a voluntary inspection service, it is a compulsory inspection service and if it is to be enacted in every State, it means that in each State we will also have compulsory-called voluntary-inspection service. Can you imagine, Senator, when one manufacturer says, "I have been approved by the Government", another manufacturer daring to say, "I have not been approved by the Government." I do not like the principle; I do not like the members of the industry being taxed in the way of extra fees that are not designated and not known. It gives every bureau, if this principle is good, opportunity to go to the Congress for their appropriation, and then go to the industry for another appropriation in the way of a tax for services. If we have two sets of fees, one from the State, and one in the form of Federal fees, in addition to the 18 or 20 or 30 more individual State taxes, it is going to amount to a considerable amount of money.

The CHAIRMAN. Would you suggest cutting out that section entirely.

Mr. PHILIP. I would consider, certainly, that you can figure some way for that inspection, if that inspection is of value to the public, the public ought to pay for it.

The CHAIRMAN. It should be universal?

Mr. PHILIP. It should be universal if at all. One other thing I overlooked, Senator. That is the fact that the statement made in any lay publication or in any publication that is not to the physician a scientific publication is false on its face. We have 60 or 70 drug trade journals. These are not scientific publications in the sense that the American Medical Journal is. They are not to the physician or to the pharmacologist, but they go to 60,000 druggists that serve the physicians in the United States, and serve the people. I do not believe under the provisions of S. 1944 drug journals are strictly scientific publications. Mediums for many prescriptions could not be advertised to 60,000 druggists through our drug trade journals.

The CHAIRMAN. I did not understand your last comment...

Mr. PHILIP. I say I do not believe that under the provisions, under the article dealing with the strictly scientific preparations for these prescriptions, under this article, that they could be advertised through our 60,000 trade journals, but the same thing could be brought to the attention of the public through scientific magazines like the Scientific American or maybe Popular Mechanics, if that is considered a scientific publication. I call that to your attention principally for this reason, since the drawing up of this bill is so full of conclusions that must be analyzed and reanalyzed, that I feel as though_our contention is correct and we should amend either the present Pure Food and Drug Act and if it were my privilege to write the great men of America, I certainly would put Dr. Wiley, Dr. Harvey Wiley and his associates, way up in the head of the list, because I regard him as one of the great men of this country.

The CHAIRMAN. You and I are one in our admiration of Dr. Harvey Wiley. He was one of the finest.

Mr. PHILIP. I desire to have inserted in the record at this point a brief which I have prepared. The brief follows:

The National Association of Retail Druggists is an organization over 30 years old. This association has something over eight thousand and odd individual paidup members and by affiliation of 48 State pharmaceutical associations and the

District of Columbia Pharmaceutical Association has an affiliated representation and membership which bring the total number of members above 30,000.

There are approximately 60,000 retail drug stores in the United States, therefore, the National Association of Retail Druggists represents over half of the retail drug stores in the United States.

The disastrous provisions of this bill could wreck the industry of pharmacy. To you who are interested in protecting the consuming public listen please to the position of words, phrases, and clauses of S. 1944 (also including the corresponding H.R. 6110) which would control 60,000 retail druggists besides numerous other people who have the right to live.

I. The druggists feel that if the law does not define adulterated, misbranded, false, etc., with words more definite than opinions how can a manufacturing druggist or a retail druggist know what the law is? He cannot.

II. How can Members of the Senate or House or any committee vote intelligently on any measure that does not tell what it is going to do? This proposed legislation is left to regulations which are not yet made and which may be changed at any time.

III. Is it desirable to have standards for foods, the same as those standards that are subscribed for drug substances? (The same requirement?) No law should demand that they be the same; as, salt, olive oil, etc. (The United States Pharmacopoeia and the National Formulary fixes a standard for many items used both as medicines and foods.)

IV. Druggists must know what is a "devices"? Where does power to control "devices" begin and end? In accordance with the far-reaching scope of this bill (see section on advertising) I cite as an example, surgical instruments used by physicians for operating on "bone diseases", "cancer", and "tumors" which are mentioned in the law. These could not under the proposed bill be mentioned orally or by writing or in drug-journal advertising. All information to industrial establishments regarding these surgical instruments would be prohibited whether legitimate or not.

V. Druggists ask, How can a ruling made by the Secretary, which is wrong, be modified? If industrial experts refute it under regulations when the law limits the word "Secretary" to one person?

VI. Druggists want to know, "What is an opinion?" If a druggist has thousands of dollars invested in accordance with the opinion of one Secretary of Agriculture, and that Secretary changes his opinion, the fact remains the same, or if another Secretary of Agriculture is appointed with another opinion, who refunds the money when the druggist loses his investment?

VII. What good to a pharmacist is his United States Pharmacopoeia or National Formulary, if the "limits of tolerance" on food products included in the United States Pharmacopoeia or National Formulary may be changed by the Secretary of Agriculture?

VIII. (c) of section 3 is so carelessly drawn that it would stop the sale of gum because it contains chickle, which is a nonnutritious substance, popsickles, allday-suckers, chocolate bananas, and all confectionery without end, and any that have a stick for a holder.. Does not this show that the Secretary of Agriculture proposed a disastrously worded bill that was supposedly written in his department by his experts? Will not the present Secretary allow regulations to be issued that may destroy a branch of industry? What guaranty have the industries and the druggists that another Secretary will be more far-sighted, and write more clearly worded regulations than this one has in this bill?

IX. How are druggists going to have a standardized definition of "dangerous to health" when human bodies have idiosyncrasies to medicines? Individuals interpret words, directions, labels, and advertisements differently.

X. Druggists want to know, will the word "simulate" prohibit the using, as part of a title to their preparations of any drug which is mentioned in the United States Pharmacopoeia or National Formulary? Example, Browns Cinchona Mixture.

XI. The pharmaceutical profession wants to know why the Secretary of Agriculture can arbitrarily change the "lists or methods of assay" of the United States Pharmacopoeia or the National Formulary.

The bill (S. 1944) gives no guaranty that the Secretary will abide by the decision of, or call in, experts equal to, or superior to those who have already determined the "lists or methods or assay" in the United States Pharmacopoeia or National Formulary.

Will new lists be adopted if the Government loses its case in court whenever there was an honest difference of opinion between the Secretary and industry, thus in fact revising the court's opinion?

If whenever there is an honest difference of opinion between industry and the Secretary, and the Government loses its case, does not S. 1944 permit the Secretary to change the disputed standard which will then revise the decision of the court.

Practically, this means regulations issued by the Secretary must be accepted by industry.

XII. Druggists ask, "When is a cosmetic injurious"? Who is to be the standard, man or woman the Secretary of Agriculture will measure cosmetics by or on? XIII. Druggists want to know, when will the limits of tolerance be stationary? Could not changing tolerance exclude one manufacturer and favor another?

XIV. Druggists ask, why is there not a way to arrive at reasonable variations, and have them prescribed by the law, and not left to one man?

XV. How can a druggist be sure he is not "creating a misleading impression" when numerous sales are made over the telephone.

XVI. With thousands of illiterates as drug-store customers, in the United States, how can a retailer be sure any label is "readily intelligent to the purchasers" of his wares.

XVII. Druggists want to know if the words "misleading the purchaser" would not be a problem between the individual and the manufacturer, and would there not have to be 125 million of such opinion ascertained if the manufacturer wanted to be sure that he was not misleading someone.

XVIII. It is of vital importance for druggists to know what the words "further information" on the label means. Might not this require that full formular disclosure be made on the label?

XIX. This bill is so far reaching that druggists under the terms of it must know exactly the strength of each and every drug, medicine, or food, which they sell in terms of a pallative or a cure. When we come to the section on advertising this law becomes more drastic and far reaching.

As the word "drug" inclues preparations (combinations) this problem becomes highly complex.

No text books, even standard books, now used in colleges can be relied upon for this information.

XX. Suppose a pharmacist wants a medical opinion on a preparation he has made. Could he go to those standing highest in his community or State; or would he have to obtain that opinion through only those designated and approved by the Secretary of Agriculture. Would this not give the Secretary of Agriculture's medical experts a monopoly on all information given out to the public by label? Would not this increase the price of such an opinion?

XXI. Pharmacists are much concerned over the confusion that may arise over the fact that the common names of a drug are required to be placed on labels, because a common name in one part of our vast country may not be applied to the same drug in another part of the country.

XXII. Druggists will want to know if a package of medicine is placed in a peculiar-shaped bottle to give it distinction (and individuality), and contains 4 ounces and is so labeled, must the package be changed if a customer claims it has misled him as to quantity?

XXIII. Manufacturing druggists want to know how they are going to comply with section 8 (j). Is this a laboratory standard, or are human beings to be used as a standard? What factors of application and pathological conditions must be

met?

XXIV. May a druggist put any advertisement in any publication, or say anything or write anything, about a drug when the bill says "an advertisement" "shall be deemed to be false if in any particular" it "creates a misleading impression"?

Under this wording could a pharmacist who was working with a group of scientists, put his name to any article which resulted from the scientists' research and which dealt with any drug, unless the article was approved by physicians chosen by the Secretary of Agriculture who might announce a general agreement of medical opinion? If he did, might he not be liable to fine and imprisonment? XXV. District of Columbia druggists want to know if section 9 (c) does not prevent them giving information over the telephone in the event of emergency or in any other way suggesting emergency use of medicine or application for dis