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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
eases enumerated. (Read the word "Advertisement" according to its definition. (Sec. 2 (1), p. 3, lines 15-17.)
XXVI. Druggists want to know: What is the standard for the word health? Is health the same for each individual?
XXVII. Pharmacists want to know if an inspection of methods, processes, finished and unfinished materials does not mean letting inspectors know all the details of manufacture which have been perfected after years of study, experience, and research.
XXVIII. Druggists want to know if a crook cannot avoid section 14 by having a continual change of sales agents within the State.
XXIX. Druggists want to know if compulsatory destruction of merchandise under section 16 (d) (last sentence) would be enforced against merchandise innocently purchased if they could be reconditioned.
XXX. Perchance a druggist should write to some member of his family or to another druggist in another State, something contrary to the Secretary of Agriculture experts medical opinion. Then, under section 17 (3), would he not be criminally liable?
XXXI. Often druggists are directors for corporations. Should a board of such directors pass an appropriation for advertising, and part of this money which is paid for an advertisement be declared later on to be misleading (by the Secretary of Agriculture), would not each and every director be criminally liable and subject to fine and imprisonment?
XXXII. Druggists want to know if section 19 is not really substituting for the former plan of multiple seizure, the closing of a factory by injunction, by the Secretary of Agriculture. Multiple seizure is unfair in many instances, and the Secretary of Agriculture seems determined to put out of business those with whom he differs, when he so desires.
XXXIII. What redress will a druggist have against the Secretary of Agriculture if his name or business is ruined, should the Secretary of Agriculture under mistaken fact issue unfavorable publicity under the last sentence of section 21?
XXXIV. The amount of tax for service under section 22 must be stated in the bill. Over half of the sixty thousand druggists are to be found in the red today. If they are to contribute to the support of a bureau of the Department of Agriculture, how much in dollars will this cost?
XXXV. Druggists want to know, will the Secretary of Agriculture expect 48 States to also have a voluntary inspection service? If so, how will conflict of service be avoided? Can a druggist avoid paying for Federal and State revenue a double tax for one purpose?
XXXVI. Pharmacists want to know why the finding of fact by the Secretary should not depend on substantial evidence before it is conclusive?
XXXVII. How much greater will a druggist's liability be under section 24 than under the common law, and how much less will a Government official liabilities be under section 16 (b) than under the common law?
The word "Regulations" appears in S. 1944 33 times, and gives thereby power to the Secretary of Agriculture and this power is not limited by the bill. This power given to the Secretary of Agriculture is more far reaching than the known provision of the bill.
Druggists as well as Senators and Members of the House cannot possibly know the scope of this bill. Under S.1944, an act one day may be legal. The next day, the same act may be a crime. The reason for this might be an "inference" an "ambiguity.”
Many criticisms made by Dr. J. W. Beal, of S. 1944, to be found in the minutes of the hearing before the subcommittee, have been purposely omitted from this brief. Dr. Beal's brief is concurred in.
The retail druggists are not trying to split hairs. Years of experience with Federal Government officials has given us many sad experiences. We could cite incident after incident when the hair splitting has been on the Government inspector's side, especially when they are young and inexperienced. These often desire to make a record.
New laws make much trouble through misinterpretations of their wordings and through interruption of business, pending court decisions, which decisions often take years of litigation.
An amended food and drug law has been suggested instead of S. 1944. It is not only possible to amend the present law, but is the thing to do at this time if any changes are to be made. As the attorney for the National Association of Retail Druggists, I recommend an amended food and drug act, instead of S. 1944.
The CHAIRMAN. I will now call on Mr. Charles M. Cox, of Boston.
STATEMENT OF CHARLES M. COX, BOSTON, MASS.
CHARLES M. Cox. My name is Charles M. Cox, and I am president of the New England Grain Products Co. I am representing the American Feed Manufacturers' Association. We are coming here to ask for a word in regard to the food we furnish for animals and poultry. Ours is a very large industry, sir; probably larger than people appreciate. For example, about 300 carloads a day of feed roll into New England from other States. My own concern handles 50 cars per day. That does not include anything for food for human consumption. It is entirely food for animals and poultry. I might say that, with certain exceptions, we are in sympathy with this bill as it is being introduced. I might say that we might cause some enlivenment in this meeting by introducing some samples of our chicken feed, but I feel it would not meet with the response or receive the welcome accorded other products introduced here today.
The CHAIRMAN. If you will come down to Broadway, you will find plenty of candidates.
Mr. Cox. We are accustomed to Government control of our busi
ness; definitely so. We are controlled possibly more than any other industry, and we are controlled by the State experiment stations; we are controlled very closely. Our own concern manufactures many specialties, and many more are placed on the market in our line by competitors. Our concern employs five specialists who are studying all the time how to improve our products so that we may improve the general line of goods that are sold by us. We are working with experiment-station men at all times. We look for you to produce a bill which we can favor. We have very little opposition to your bill, sir. I might state three instances, very briefly.
Page 4, lines 16 and 17, we would like to add the words "in a deceptive manner." That particular phraseology regarding the increasing of bulk of food-it is very often necessary for us to increase the bulk of our foods for cattle. We do it largely with bran, but we would like to have the words introduced "in a deceptive manner." On page 9, line 6. I am trying to say what I have to say just as rapidly as I possibly can so as to finish within my time.
The CHAIRMAN. You will be given time.
Mr. Cox. I am trying to go pretty fast so as to get done. Page 9, line 6. "In the order of predominance by weight", would lead toward an open formula. I do not think it is called for and we do not think it is necessary in our line of business. There are reasons why in certain periods of certain years some kinds of grains or byproducts are low in price and it is good business both for manufacturer and farmer to vary slightly our formulas in accordance with the prices. We do this in accordance with the experiment station opinions. We think if this clause were allowed to remain in, it might be an injury to people like ourselves where we have been operating 30 years to build up a reputation for our formulas which are successful. It opens up all of these avenues of information which gives anyone the very knowledge that we have taken years to acquire. The CHAIRMAN. Just a minute, Mr. Cox.
Mr. Cox. I am taking all the time you will let me.
The CHAIRMAN. This is not coming out of your time. It is coming out of the audience's time. Predominance by weight; would you