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FOOD, DRUGS, AND COSMETICS
V. It is enough to simply point out that this same destruction of the prepared medicine industry would have a most serious effect on most druggists. A large part of their volume of sales consists of sales of prepared medicine. Practically none of them could stand to lose this immense part of their business without being very seriously injured, and many would be pushed to the wall. But as I have shown, that part of their business would necessarily be practically wiped out if this bill should pass with these unreasonable and destructive provisions. Therefore this is one of its "worst features.".
VI. One of the worst and most vicious features of the pending bill has been pointed out before the committee but has not been adequately presented. I refer to its provisions for licensing and inspection. These provisions are contained in sections 12, 13, 15, and 22. Although this bill does not specifically make it mandatory for all manufacturers of food, drug, or cosmetic products to obtain a license from the Secretary if they are to continue in business, it confers upon him such broad power that he can, as a practical matter, require any such manufacturer to go out of business unless the manufacturer accepts a license from him upon almost any conditions he may see fit to fix regarding the operation of the plant. The Secretary need simply "find" that the distribution of any of the products may (not that they necessarily will or reasonably may), by reason of conditions surrounding the manufacture, processing, or packing thereof, be injurious to health and that such injurious nature cannot be adequately" determined after such articles have entered interstate commerce; then he may "after notice and hearing" "make such regulations governing the conditions of manufacture, processing, or packing as he deems necessary to protect the public health" and require the manufacturers, processors, and packers "to hold a permit conditioned on compliance with such regulations." food, drug, or cosmetic product could possibly be injurious through mistakes in preparation or compounding, and since the Secretary could decide that such mistakes could not be "adequately" determined after the product had left the plant, this provision practically gives him an unlimited discretion to license any food, drug, or cosmetic manufacturers (sec. 12 (a)).
Since almost any
The next paragraph (b) of section 12 authorizes him to issue such permits for any such periods of time as he may by regulation prescribe and to make any regulations regarding their issuance and renewal. He is authorized "to suspend immediately upon notice" any permit--that is without any warning, hearing, or opportunity for defense and without going into court; he could do this whenever he "finds" that "any of the conditions of the permit have been violated", regardless of how slight the danger to health might be as a result of the violation of some condition of the permit. No manufacturer could afford to try to question or resist even an unreasonable regulation or condition. If, after his permit has been thus revoked, the manufacturer shipped one package he could be jailed for 1 year and fined $1,000 or both; if he shipped a second package he could be fined $3,000 and put in the penitentiary for 2 years and if the court found that years or fine him not less he did this wilfully or with knowledge that his permit had been revoked the court must imprison him for at least 6 months and up to than $1,000 and up to $10,000 or inflict both the fine and imprisonment (see sec. 17 (b) and (c)) for each shipment.
Under these provisions of section 12 of this bill the Secretary could by regulations and licenses or permits, control just about everything concerning personnel, formulae, methods of manufacture, equipment, plant and of working conditions, because they could all possibly affect health and because no manufacturer could afford to dispute his authority or try to resist.
The last paragraph (c) of section 12 provides that "any officer or employee designated by the Secretary shall have access to" any establishment operating Such access or permission to examine under permit, "for the purpose of ascertaining whether or not the conditions of the permit are being complied with." anything the inspector cares to investigate, had better not be denied because such denial is "ground for suspension of the permit."
It is not only such manufacturers, processors or packers of food, drug or cosmetic products, as have been put under permits or licenses by the Secretary, that are subject to "inspection" by inspectors on the payroll of the Food and Drug Administration or of the Department of Agriculture. The first paragraph (a) of section 13 provides that any officer or employee commissioned by the Secretary, if he first obtains the permission of the management, may enter any plant in which "food, drugs or cosmetics are manufactured, processed, packed or held for The expression "after first shipment" and may inspect it "and all equipment, methods, processes, finished and unfinished materials, containers and labels." obtaining permission" of the management is a "joker" and conceals on casual
FOOD, DRUGS, AND COSMETICS
reading the full import of this provision. Because, to insure that the management will not withhold such permission, the second paragraph (b) provides that whenever such permission is withheld for an inspector to do any of those things the United States district courts can issue an injunction, either temporary (before any hearing) or permanent, to restrain the movement of any products from the plant into interstate commerce, until the permission is given, and to punish summarily for contempt any violation of such injunction.
It is all very well for Mr. Campbell to tell the committee that neither he, the Secretary, nor any of the officials of the Food and Drug Administration intend to missuse, or use harshly, any of the broad and unlimited powers which would be conferred upon them if this bill, in its present form, were enacted. But this bill is not proposed as temporary or emergency legislation; it is presented to become the permanent law. The time will come when neither Secretary Wallace nor Mr. Campbell will be in office and when the law will be administered by others who may not be so fair minded or practical. And it should be remembered that most of the powers would be exercised necessarily by a horde of inspectors. No powers so unlimited, arbitrary, bureaucratic and despotic should be permanently vested in any public officials, powers of life and death over three giant industries. Note that the Food and Drug Administration would have to provide out of its appropriations for the salaries of inspectors and expense of inspections under section 12 and section 13. Such inspections, conditions for licensing and cancelation of licenses or permits could be carried out in a most galling and oppressive fashion. Unless I entirely misunderstand human nature and the desire to extend the operation of bureaucratic activities further than Congressional appropriations will usually permit, the powers under these two sections are very likely to be exercised in such a way that the average manufacturer will elect to "voluntarily" apply for the "voluntary inspection service" cleverly provided for in section 22. This will relieve the Administration of all expense in the matter of managing or "regulating" business, so that it can, without increasing its expenses or need for heavy appropriations, enlarge its force of supervisory inspectors just as far as politics and bureaucratic policy or ambitions may dictate. (See sec. 22.)
Section 22 provides for the voluntary inspection service. Under its provisions the Secretary may, upon “voluntary" application of any manufacturer or packer of foods, drugs or cosmetics, appoint "supervisory inspectors" to examine and inspect all premises, equipment, methods, materials, containers and labels used by the manufacturer or packer. Here, then, is the bait to induce manufacturers to be hooked; if, and so long as, everything is found to conform to the provisions of this bill and to all "regulations", a manufacturer may be authorized to attach some kind of seal of approval of the Department on his product.
Under the practical operations of the law it probably will become advisable for every manufacturer of food, drug or cosmetic products "voluntarily" to apply for this "service.”
Of course, it will require thousands of supervisory inspectors to inspect and regulate all of the plants; the Department could not hope to get sufficient appropriations to enable it to support such a host of tax eaters. So point number one (of the two-pointed hook) is that the manufacturer shall pay fees to be fixed by regulations in such amount as to cover the cost of the supervisory inspection and examination, together with the reasonable costs of administration. The other point of the hook is that the concern will practically pass under the management of the Food and Drug Administration regarding all matters of plant, personnel, equipment, formulae, methods, and operation.
I don't think there is any doubt but that, if the bill becomes law, the Department will push the expense of inspection off on the manufacturers by making it very advisable that they voluntarily apply for this service. They will get inspection anyhow, under the licensing provision (sec. 12) or under the factory inspection provision (sec. 13), and the supervisory inspectors under the voluntary inspection service will probably be much more reasonable fellows and much easier to satisfy than the inspectors sent out to noncooperating manufacturers, under those other two sections and at the expense of the Food and Drug Administration.
Under these sections the Administration can put over a gigantic plan for the management and control of those concerns and at the manufacturers' expense.
If this bill becomes law the chief of the food, drug, and cosmetic control will become a powerful man with an army of underlings and will be czar of the food, drug, and cosmetic industrics. He will be treated with deference and regarded with fear and trembling by them and by all publications that carry food, drug, or cosmetic advertising and by the radio industry. Managing, supervising, or regulating concerns that now do a business running into the billions of dollars
FOOD, DRUGS, AND COSMETICS
annually, he should then be entitled to a big salary. He will be able to pass out lots of patronage for the political party in power. Probably the concerns that exist only at his will, or which he could effectively put out of business, will be willing to make voluntary and substantial contributions to the campaign fund of the political party represented by him or by his Secretary of Agriculture; it will take only the tactful suggestion of the supervisory inspector in charge of the particular plant that it has been put down for $1,000 or $10,000 as the case may be.
I think that this section 22 is one of the cleverest in the whole bill. Officials of the Food and Drug Administration realize that it would be impossible to get sufficient appropriations from Congress to support the whole army of inspectors that they would like to have under them and that would be necessary in order to control and manage all the food, drug, and cosmetic plants of the country as they want to manage and control them. So this plan to get the effective management of the plants and at the same time make the manufacturers pay the entire load was devised.
It is common knowledge among those familiar with the workings of the Food and Drug Administration that officials of that Administration have desired, for years, to obtain such power to regulate or control the food and drug plants of the country by supervisory or managing inspectors. But heretofore the impossibility of procuring the necessary congressional appropriations has stood in the way. There is no reason to believe that this power, if granted by enacting those provisions of the pending bill, would not be exercised. It has been estimated that there are in the country 40,000 plants in which the Department could put its inspectors under these provisions. It would be a most dangerous and impolitic thing to authorize the creation of this immense political army living like parasites on the three industries which they would control and regulate, and for all practical purposes manage, if not destroy.
These provisions would create stupendous, almost unlimited opportunities for graft. Such supervisory inspectors could decide to junk equipment and compel manufacturers to install other machines according to specifications fixed by them and which would necessitate the purchase of equipment from particular manufacturers. Also a supervisory inspector in a particular plant, having access to all formulas and processes, would be bound to learn important trade secrets. When he went to a competing plant there would be serious danger of his unintentionally divulging such secrets and venal men could be induced to do so for a proper consideration. No matter how high-minded the Secretary and Chief of the Food, Drug, and Cosmetic Control might be, they could not always make wise appointments and among the 40,000 supervisory inspectors it is reasonable to presume there would be many unfitted by natural ability, training, and experience to exercise such vast responsibilities. It would be like the army of prohibition agents or inspectors who have so frequently disgraced their country.
If Congress should decide to properly amend and revise the pending bill and then pass it, sections 12, 13, 15, and 22 should be entirely expunged and nothing enacted regarding inspection or licensing.
VII. Another of the worst features of the pending bill as drafted is a feature of the present law, but in the pending bill it is greatly increased or aggravated. I refer to the provisions authorizing the Department to publish, without any limitation or restrictions, any information deemed advisable and which might seriously hurt manufacturers who have been given no opportunity to defend themselves.
Section 21 authorizes the existing legal blackmail by which the Department distributes at public expense and all over the country reports (before any trial, opportunity for defense, or judicial finding) which are frequently very damaging to the manufacturers whose names and products are mentioned or referred to. Worse, under the provisions of this section the Secretary can publish any such information regarding any food, drug, or cosmetic as he deems necessary in the interests of public health and for the protection of the consumer against fraud. This can be done without any conviction, hearing, or opportunity for defense and only the Secretary is the judge regarding what information shall be distributed and the frequency and extent of such distributions at public expense. There would be nothing to prevent him from deeming information to be in the interests of public health or for the protection of consumers against fraud although it would be of little or no interest except to discourage self-medication or to otherwise educate the public up to calling in their physicians and veterinarians more frequently, to point out the dangers in the use of package medicines, to educate the people to demand the Department's seal of approval on products or to otherwise injure the package medicine industry.
FOOD, DRUGS, AND COSMETICS
The Government propaganda or publicity which has been broadcast to work upon the emotionalism of the women of this country and to move them to blindly demand passage of the pending bill without any intelligent understanding of its bureaucratic and destructive provisions, by press releases, talks by representatives of the Department before women's clubs all over the country, by radio, and on motion picture screens throughout the country, including the widespread exhibitions of Professor Tugwell's so-called "chamber of horrors"-all designed to create prejudice against food, drug, and cosmetic manufacturers-suggests what kind of publicity could be expected under the provisions of section 21 of the pending bill, even when the administration of the law would be in such capable hands as those of Secretary Wallace, Professor Tugwell, and Mr. Campbell. There is no way to anticipate what the publicity might be if men less fair-minded, high-minded, broad-minded, and conservative might some day be placed in the administration of the law.
If Congress should decide to properly amend the present bill and pass it, section 21 should be entirely deleted and nothing enacted in its stead except a proper provision, which I shall suggest, to prevent all harmful publicity with identifying reference to the manufacturer, advertiser, or individual concerned until he should have had an opportunity to defend himself and there had been a legal adjudication of guilt, except in criminal cases or where notices or warnings might be reasonably necessary to prevent imminent and serious injury to health or death. VIII. Another of the "worst features" is section 23 vesting in the Secretary (Food and Drug Administration) unlimited power to enact any regulations "he may deem necessary for the efficient enforcement of the functions vested in him by the provisions of" this bill, "including regulations with the force and effect of law" vesting in him and his subordinates all of the stupendous powers created by sections 9 and 10 of the Federal Trade Commission Act.
Paragraph (a) of section 15 should be read in connection with section 23. Together they provide that the Secretary through any employees of his Department or through any food, drug, or health officer of any State, Territory, or county duly commissioned by him, may conduct examinations and investigations, like the Federal Trade Commission, anywhere in the United States and may compel the attendance of any witnesses and production of any documents just like that Commission and that, as in the case of the Federal Trade Commission, "The findings of fact by the Secretary shall be conclusive if in accordance with law", so as to make it impossible for the courts to reverse the decision of the Secretary or his underlings if there is any evidence by which their findings could be sustained. For the full effect of section 23, sections 9 and 10 of the Federal Trade Commission Act must be consulted. Among other things it provides that if anyone neglects or refuses to attend and to testify or to produce any documentary evidence in his power in obedience to the subpena he shall be punished by a fine of from $1,000 to $5,000 or imprisoned for not more than 1 year or both.
If the Congress should decide to properly amend the pending bill and pass it, all of section 15 and all of section 23 should be stricken. The Secretary should be given "reasonable" discretion and powers to establish regulations within limited fields and if any provision is enacted to give any special effect to his findings, it should provide that they should be, not conclusive, but prima facie if in accordance with law. I shall suggest amendments on these points.
IX. The last thing about the pending bill that I shall refer to, is one of the worst. It gives the bill its bureaucratic character. But I shall not enlarge upon that characteristic because it has been emphasized by other and is patent upon a most cursory reading of the bill. It is the frequent grant of unlimited power, in nearly every section, with no words of limitation or restriction. I don't think the word "reasonable" or "reasonably" can be found in the entire bill. The Secretary would be authorized to make just about any regulation or do anything as he might deem advisable.
It is suggested by the Department that even in the absence of any words of limitation, the courts would construe any grant of authority to be a grant which could be exercised only within reasonable bounds. There is something to this suggestion but it is misleading and the more so because there is some element of fact to it. Without any words of limitation in a particular grant of authority the courts could enjoin or set aside official action clearly so arbitrary, despotic, and capricious as to amount to a taking of property without due process of law. But where, as everywhere in the pending bill, discretion or authority is deliberately conferred without any restriction or words of limitation, the absence of any limitation is not without significance.
FOOD, DRUGS, AND COSMETICS
The courts must recognize the legislative intent to vest the fullest discretion and broadest possible power in the official and to make him the sole judge regarding its exercise wherever reasonable minds could possibly differ. It would be much more difficult for the courts to reverse or nullify his particular action in a given case, than if the grant of power were to "reasonably find" or make "reasonable regulations" or regulations "reasonably necessary for the protection of the public.' With such words of limitation, the courts could not set aside any reasonable action but would always be able to pass upon the reasonableness of the action.
If, as is suggested, the words "reasonable" or "reasonably" would be read into the act by the courts, what is the objection, when the law is being written, to writing those words into it in order to avoid any question, instead of taking chances on the courts reading into the act something which the Congress refused to write into it?
My observations are similar regarding the last sentence in section 23 of the pending bill: "The findings of fact by the Secretary shall be conclusive if in accordance with law." This does not mean that the courts could not set aside any finding of fact regardless of how frivolous or contrary to evidence it might be. But it is not without significance and was inserted in the bill intelligently and advisedly. Its effect would be to make it much more difficult and unlikely for a court to reverse a finding of fact by the Secretary. It would prevent a court from setting aside a finding even where the evidence was such that the court would certainly have found otherwise, but where it could not say that reasonable minds could not possibly differ.
Like the deliberate omission of all words of limitation or restriction in all provisions granting discretionary powers, this provision that the Secretary's findings shall be conclusive would have the effect of making his findings, as his discretionaries, acts would be, just as free from reversal by the courts of the land as it is possible, under our Constitution, to make them. It is impossible absolutely to oust the courts of jurisdiction to interpret the Constitution and laws, but this bill is designed to restrict their action as far as is possible.
The pending bill, besides having the bad features which I have discussed and others which are specifically pointed out, section by section, in my analysis above referred to, is deficient in several of the respects pointed out in the first part of this brief regarding the existing law, especially in failing to provide a simple, direct, expeditious, and remedial procedure for compelling compliance with the law and in failing to include criminal intent in definitions of crimes; also in failing to limit seizure actions to cases where products are imminently and seriously dangerous to human life and in failing to forbid unnecessary and harmful publications before legal determination of violation of the law.
Regardless of its bad features and deficiencies, the pending bill offers a comprehensive, orderly plan for a reasonable, workable law. By proper deletions, amendments, and additions it can be made into a splendid statute that will do in a practical way all that should be done, one which will insure adequate protection to the public without injustice to any citizens, without unduly hampering legitimate business or setting back economic recovery. To so improve it will require considerable amending, but the results would well justify the work involved. As a supplement to this brief and as a part of it I am filing with the committee my suggestions for the specific amendments to the pending bill, S. 1944, which would accomplish all of my recommendations, and I urge that the pending bill be reported out with recommendation for amendment in those respects and passage.
DONALD J. BURKE.
ANALYSIS OF COPELAND BILL, S. 1944, and OBSERVATIONS
Section 2: This section defines the principal terms as used in the bill. "Food" is defined to include "all substances and preparations used for, or entering into the composition of, food, drink, confectionery, or condiments for man or other animals."' The definition is unscientific because it makes use of the term "food" in defining that very term. Note that it includes in the cate gory food all substances or products that are confectioneries and that it does not exclude medicated "foods", such as laxative breakfast foods, medicated fruits, candies, and gums. Such medicated foods or confectioneries are really medicines put up, to be more palatable, in the form of food, gum or candy, and in fairness to the manufacturers thereof and for the protection of the public should be classed as drugs and subject to all of the provisions governing the manufacture, labeling,