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(22) Requires that antiseptics, disinfectants and the like possess a definite germicidal power and fulfill their promises under the indicated conditions of use.
(23) Authorizes control by licensing when public health cannot be protected otherwise. Provides for factory inspection and the procurement of records needed to prove interstate transportation.
(24) Authorizes executive seizure of imminently dangerous products.
(25) Increases the penalties and exempts publishers from a charge of false advertising when they supply information identifying the advertiser.
(26) Authorizes the courts to restrain repetitious offenses by injunction.
S. 2800 affords immeasurably more protection to the public than can be given now. So it is inevitable, it seems to me personally, that the Department and all others who are interested in greater public protection should support this bill. There can be no justifiable fear or concern by honest manufacturers that through zealous administration it will result in the creation of burdensome restrictions on legitimate enterprise, since it vests the district courts with jurisdiction to restrain officials from the enforcement of unreasonable, arbitrary, or capricious regulations and penalizes officials for the disclosure of trade secrets.
The CHAIRMAN. All those who have requested a hearing have been heard. So far as I know, there is no one else present who desires to be heard. If this be so, I shall declare the hearings closed. Any one desiring to do so may file a brief for the printed record provided it is received by us within a few days.
I offer for the record a letter from Mr. Robert Muldrow of San Antonio, Tex., and a brief prepared by Mr. J. F. Schalafly of St. Louis, Mo. (The letter and brief are as follows):
MOUNTAIN VALLEY WATER Co., Hon. HUBERT D. STEPHENS,
San Antonio, Tex., February 26, 1934. United States Senate, Washington, D.C. DEAR SENATOR STEPHENS: I am writing you to vigorously protest against Senate bill 2000, known as the Copeland-Tugwell bill.
This proposed law seems to give entirely too much bureaucratic power to the Agriculture Department, and also seems to restrict the power of the law and the courts. It restricts also the right to decide for yourself what remedy you may buy. There is ample power now in several governmental departments to protect the public against willful violators of the Pure Food and Drugs Act.
In connection with our interest in this matter, will say for your information that we are handling Mountain Valley mineral water from Hot Springs, Ark., and are the sole distributors for this well-known and valuable mineral water in South Texas. You may perhaps know something of the merits and value of the waters of Hot Springs, Ark., and no doubt may have used some of these waters with benefit to yourself and family.
I am informed that if this bill passes and becomes a law as proposed, distributors of Mountain Valley Water throughout the United States would be forced out of business, for we would be prohibited advertising benefits in cases of nephritis, high blood pressure, diabetes, and even arthritis and would be prohibited. On the other hand, it is well known and has been clearly established for more than 50 years that the Mountain Valley Water from Hot Springs, Ark.. is clearly and unmistakably of great benefit to those suffering from these diseases. There is nothing added to or taken from the Mountain Valley mineral water. It is bottled and sealed at the springs and delivered to the patient absolutely as nature made it. Yours very truly,
The Banking Act of 1933, the Securities, the National Recovery Act, the Agricultural Adjustment Act, have applied equally to all subjects within their respective fields. Objections to them have been raised, but not the objection of arbitrary discrimination. The proposed Food and Drug Act is discriminatory. Arbitrary discrimination, which is forbidden by the fifth amendment, may be pro or con. It is both pro and con when it does not directly aid a special group but by crippling a competitive group accomplishes the same result. The proposed act discriminates against those who sell medical preparations by printed or radio advertising and in favor of those who sell medical preparations orally, viz, physicians, peddlers, and door-to-door canvassers.
In listing our specific objections to S. 2800 we confine ourselves to those sections of the act that affect us in our business of wholesaling and retailing mineral water.
“ SEC. 6. A food, drug, or cosmetic shall be deemed to be misbranded-
“(a) If its labeling is false or misleading in any particular. Any representation concerning any effect of a drug shall be deemed to be false under this paragraph if that representation is not supported by substantial medical opinion or by demonstrable scientific facts.
“Seo. 9. (a) An advertisement of a food, drug, or cosmetic shall be deemed to be false if it is false or misleading in any particular relevant to the purposes of this act regarding such food, drug, or cosmetic. Any representation concerning any effect of a drug shall be deemed to be false under this paragraph if that representation is not supported by substantial medical opinion or by demonstrable scientific facts.” BRIEF SUBMITTED BY J. F. SCHLAFLY, 3673 OLIVE STREET, ST. LOUIS, PRESIDENT
OF THE MOUNTAIN VALLEY SPRINGS Co.
The Department of Agriculture has been using a horsetail weed compound which was sold as a cure for diabetes and a depilatory which contained more Larium sulphide than is found in most rat poisons to call attention to the deficiencies in the present food and drugs law and the need for a new law. These samples of the holes in present Pure Food and Drugs Act are useful in pointing out where that act should be amended, but they are only a pretext and not a reason for an entirely new act. All the patent medicine evils pictured in the Chamber of Horrors could be prevented by amending the present law so as to include cosmetics and the advertising of dangerous drugs. Nevertheless Drs. Tugwell and Campbell introduced Senate bill 1944 as the necessary solution of these evils.
This measure was the only “new deal” bill that sought to make one department of the Government the absolute and permanent master of business in its sphere. Under the admirable N.R.A. each industry was asked to write its own code and then these codes and not the Department of Commerce were for 2 years to be the rule of conduct. S. 1944 abounded in grants of arbitrary power—"as he (the Secretary) may deem (deems) necessary” occurred seven times. Other general and irresponsive powers were conferred on the Secretary: “Whenever the Secretary determines" (present twice), “As the Secretary may find ” (present five times).
In redrafting S. 1944 and its successor, S. 2000, Senator Copeland and his committee have eliminated some of the objectionable features, but after all, S. 2800 is only a redraft and not a new bill. It is not what the subcommittee did that we object to, it is what the subcommittee did not do.
No standards of truth and falsity are available. Medicine is not an exact science and the Department of Agriculture has no uniform accepted standards as has the Bureau of Standards. The elements of a drug can be accurately determined and weighed. The medical properties cannot. The proverb : “ One man's me!t is another man's poison " has withstood the test of time. A distinction between chemical constituents and medical properties is plain. As to the truth or falsity of the former there can never be a dispute, as to the truth or falsity of the latter there can seldom be absolute certainty.
Thus, the advertiser or labeler is made to act at his peril. If his statement does not coincide with the Secretary's notion of the true medical properties, he has violated the proposed act. It is not answer to state that he must first be convicted in the courts. Because the Secretary may destroy his business and good will by seizure (sec. 16), or adverse publicity (sec. 21) before securing a conviction.
The effect of the second sentence in each clause is to shift the burden of proof. The prosecution can state that there is no evidence that the label or advertisement is supported by substantial medical opinion or scientific facts, and then rely on the statutory presumption created by “ deemed to be false." The defendant labeler or advertiser must prove that the label or advertisement is so supported or be guilty of a falsehood and forfeit his freedom and his business. Our Anglo-American system of law has always considered the defendant in a criminal suit to be innocent until proved guilty beyond every reasonable doubt.
The proposed Food and Drugs Act has inverted this cherished safeguard. Instead of saying that the labeler or advertiser is to be considered innocent as long as any reasonable doubt remains as to the falsity of the label or ad. vertisement, the act deems the label or advertisement false (until proved to be true) and the labeler or advertiser guilty no matter how many reasonable doubts are present. Under our present criminal law the blackest felon, be he murderer, or kidnaper, can rest in court without putting in any evidence and secure acquittal if the Government does not prove its case beyond every reasonable doubt. Under the proposed act the Government can rest in court and still secure the conviction of an honest and good-intentioned business man if the latter does not affirmatively prove the truth of his statements.
“ SEC. 8. A drug shall be deemed to be misbranded
(a) If its labeling bears the name of any disease for which the drug is not a specific cure but is a palliative and fails to bear a plain and conspicuous statement, so placed as to be readily observable where such name occurs, indicating that the drug is a palliative and how the palliation is effected.
* SEC. 9. (b) An advertisement of a drug shall also be deemed to be false if it contains the name of any disease for which the drug is not a specific but is a palliative and fails to contain a plain and conspicuous statement, so placed as to be readily observable where such name occurs, indicating that the drug is a palliative and how the palliation is effected.
Who is to decide whether a drug is a cure or only a palliative? Drugs cannot be placed in water-tight compartments marked “cure ”, and “palliative." Whether a drug is a cure or merely a palliative will often depend on the constitution of the individual using it, the manner of his use, the stage of the disease at the time treatment was started. Perhaps the general agree. ment of medical opinion is to be the norm. But frequently there is no general agreement of medical opinion. For example, as to the medical merits of common drugs like aspirin and alcohol there are both deniers and affirmers.
Let us assume that the medical profession will band together and form general agreements. To make medical agreement the law's standard is like enacting that the employers' agreement shall be the standard in all wage disputes under the N.R.A. No judge will hear a case in which he has a personal interest. The medical profession should not be asked to judge a proprietary medicine because many doctors believe that the success of such medicines is contrary to the prosperity of their profession.
Mountain Valley Water has many friends in the medical profession. Thousands of physicians have prescribed the water to their patients. We are sincere believers in professional diagnosis and treatment; we also believe that the medical profession is not the best judge of its alleged competitors. And if the medical profession is not a competent judge, we see no reason for permitting a minor official in the Department of Agriculture to make the decision, or for permitting one of the Department's many chemists to pass on the subtle physiological differences between palliation and cure. Hairline distinctions of this sort should not be a basis for criminal liability.
“ Sec. 9. (c) To discourage the public advertisement for sale in interstate commerce of drugs for diseases wherein self-medication may be especially dangerous, or patently contrary to the interests of public health, any advertisement of a drug representing it to have any effect in the treatment of any of the following diseases shall be deemed to be false : Albuminuria, appendicitis, arteriosclerosis, blood poison, bone diseases, cancer, carbuncle, cataract, cholecystitis, dental caries or erosion, diabetes, diphtheria, dropsy, encephalitis, epilepsy, erysipelas, gallstones, goiter, heart diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, hephritis, otitis, media, paralysis, pericdantal diseases, pneumonia, poliomyelitis, prostate-gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infections, smallpox, tuberculosis, tumors, typhoid, uremia, venereal diseases, and whooping cough; except that no advertisement not in violation of paragraph (a) or (b) of this section shall be deemed to be false under this paragraph if it is disseminated to members of the medical and pharmaceutical professions only or appears in the scientific periodicals
of these professions, or if it is disseminated for the purpose of public health education by persons not commercially interested, directly or indirectly, in the sale of such drugs; provided, that whenever the Secretary determines that an advance in medical science has made any type of self-inedication safe as to any of the diseases enumerated above, he shall promulgate regulations, as provided by section 22, exempting the advertisement of drugs having curative or therapeutic effect for such disease from the operation of this paragraph, subject to such conditions and restrictions as may be necessary in the interests of public health."
Herein the right to self-medication is explicitly denied. The proponents of S. 2800 have flattered the prohibition advocates by imitation. Because liquor was unsafe in the hands of some, it was forbidden to all. Because a few yullible people have subscribed to dangerous or preposterous remedies for these diseases, self-medication is forbidden to all. The patient must see a physician or do without medication.
We submit that self-medication for some of the aforesaid diseases through the drinking of Mountain Valley water is not only not dangerous but is decidedly beneficial. Mountain Valley water has been used by sufferers from diseases of the kidneys, stomach, and bladder for 75 years. It has been prescribed by physicians as an aid in the treatment of albuminuria, arteriosclerosis, cholecysetitis, diabetes, dropsy, high blood pressure, nephritis, pyelitis, and uremia, for over 50 years. We have in our files the names and addresses of 1,112 physicians who are prescribing Mountain Valley water for these and other diseases.
The fifth amendment forbids depriving any person of property save by due process of law. The effect of section 9 (c) is to render valueless private property, viz, the Mountain Valley spring, not by judicial decree, but by fiat order from which there is no appeal.
SEC. 17. (b) Any person who violates or causes to be violated any of the provisions of paragraph (a) of this section shall be guilty of a misdemeanor and shall on conviction thereof be subject to imprisonment for not more than 1 year, or a fine of not less than $100 nor more than $1,000, or both such imprisonment and fine; and for a second or subsequent offense imprisonment for not more than 2 years, or a fine of not less than $100 nor more than $3,000, or both such imprisonment and fine.
We object to this section because it provides criminal punishment for acts which may have been done without criminal intent by reputable business men in the course of conducting legitimate businesses.
SEC. 16. (a) Any article of food, drug, or cosmetic in interstate commerce that is adulterated or misbranded or that has been manufactured, processed, or packed in a factory or establishment, the operator of which did not, at the time of manufacture, processing, or packing, hold a valid permit, if so required by regulations under section 12, shall be liable to be proceeded against while in interstate commerce or at any time thereafter on libel of information and condemned in any district court of the United States within the jurisdiction of which the article is found. The article shall be liable to seizure (1) by process pursuant to the libel, or (2) if a chief of station or other officer of the Food and Drug Administration, duly designated by the Secretary, has probable cause to believe that the article is so adulterated as to be imminently dangerous to health, then, and in such case only, by order of such officer, issued under his oath of office, particularly describing the article to be seized, the place where located, and the officer or employee to make the seizure. In case of seizure pursuant to any such order, the jurisdiction of the court shall attach upon such seizure. Any article seized pursuant to any such order shall there. upon be promptly placed in the custody of the court and a libel of information shall be promptly filed for condemnation thereof.
SEC. 21. The Secretary shall cause to be published periodically a report summarizing all judgments, decrees, and court orders which have been rendered, including the nature of the charge and the disposition thereof. The Secretary sball also cause to be disseminated such information regarding food, drugs, or cosmetics as may be necessary to protect against danger to public health or fraud upon the consumer: Provided, That no such information shall be so disseminated regarding any brand of food, drug, or cosmetic before rendition of final judgment in proceedings against it except in cases involving imminent danger to health or gross deception of the consumer.
We object to these sections because taken together they give the Secretary ample power to stop commerce in a drug without proceeding to judgment in court. As detective the Secretary spys on the defendant labeler or advertiser, as sheriff the Secretary serves the defendant with notice to appear for a hearing (sec. 22 (h)), as prosecutor the Secretary pleads his case against the defendant's merchandise to seizure, Nation-wide adverse publicity, and presents evidence to the district attorney for the defendant's indictment.
To give a concrete illustration why section 21, even in its modified form gives its authors such full and final power over the very existence of the proprietary drug industry as to arouse widespread alarm and distrust, we call your attention to the fact that the authors of this proposed act have been enforcing the original section 21, as though it were already law. Last summer exhibits were placed by the Department of Agriculture in 12 key cities, and in the Federal building at the Century of Progress Exhibition, which had all the force of governmental condemnation. In this exhibit involving Mountain Valley Water the facts are, that 19 years ago the Department of Agriculture objected to the claims made on the bottle labels by an overzealous Philadelphia retailer. The labels were revised to the Department's satisfaction. There has been no subsequent violation of the law. But the impression given to the public was that Mountain Valley Water had recently been mislabelled and was today being falsely advertised.
Mountain Valley Water is a natural mineral water that flows from a spring located near Hot Springs, Ark., and has helped to make famous that nationally celebrated resort. Every chemist who has ever analyzed Mountain Valley Water has reported it to be pure and wholesome. Yet in these exhibits our product was pilloried alongside of Marmola, Banbar, Lash, Lure, and so forth. To the average visitor, his Government, the greatest Government in the world. was sounding a warning. He did realize that the Department of Agriculture was only lobbying, that it was spending the taxpayers' money in propaganda for S. 2800.
If those officials in the Department of Agriculture who drafted this proposed act in its original form had the effrontery to enforce a part of the bill (the publicity clause) before its enactment, can we safely assume that the same men will be fair and careful in their exercise of these great powers after its passage, We cannot believe that the men who arbitrarily assumed these powers and capriciously enforced them will become just and cautious once these vast powers are legally theirs.
It is true that as section 21 now stands the Secretary cannot disseminate adverse publicity before final judgment is had against a product or concern, except in cases involving imminent danger to health or gross deception of the consumer. On its face this section appears fair and unobjectionable. The catch is that the Secretary (in practice a subordinate official) is to be the judge of what constitutes gross deception of the consumer. Section 23, which gives the courts power to review the Secretary's regulations, if “unreasonable, arbitrary, capricious ", does not apply to section 21. The Secretary may stay within the ordinary understanding of “ gross deception.” But if he does not, the drugs vender has no effective recourse. He cannot compete for public goodwill against the millions of taxpayers' dollars that will be at the disposal of the Secretary.
We respectfully submit that the proposed Food and Drugs Act is discriminatory, deprives the people of the right to self-medication, and concentrates an arbitrary and excessive power in the Secretary of Agriculture, a power that is not necessary for the correction of current evils, and which is foreign to our democratic form of Government.
We therefore earnestly petition this committee that this proposed act be withdrawn or that the herein cited passages be stricken out.
BRIEF SUBMITTED BY HENRY A. BELLOWS, CHAIRMAN OF THE LEGISLATIVE COM
MITTEE OF THE NATIONAL ASSOCIATION OF BROADCASTERS, NATIONAL PRESS BUILDING, WASHINGTON, D.C.
To the Committee on Commerce of the United States Senate:
GENTLEMEN: The National Association of Broadcasters on Thursday, December 7, 1933, filed with your committee a statement regarding S. 1944. That statement, together with the lists of members and officers of this association, appears on pages 120–132 of the printed report of the hearings on S. 1944, and consequently the lists are not here repeated.
While S. 2800 represents, from the standpoint of the radio broadcasting industry, a material improvement over S. 1944, there remain certain specific