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It will be observed that the term “ advertisement” as used in the bill is also to include representations of opinion. The word “ opinion” is defined in the dictionary to mean "A conclusion or judgment held with confidence but falling short of positive knowledge.' It is proposed that a criminal statute shall be written, crimes de
, fined, property seized, fines assessed and imprisonment imposed, not upon the basis of positive knowledge but upon the theory that they are not in accord with conclusions held by some of the medical profession.
I know the committee will pardon me if at this point I call attention to the sixth amendment to the Constitution of the United States, which, among other things, provides That an accused shall enjoy the right
to be informed of the nature and cause of the accusation.
Any law that does not define a crime, other than one already defined under the common law, with definiteness and certainty, is void.
In Twelfth Cyclopedia, 141, under the heading of Criminal Law", we find the following:
In the absence of provision to the contrary, a statute may punish an offense by giving it a name known to the common law, without further defining it, and the common law of definition will be applied. In creating an offense which was not a crime at common law, a statute must of course be sufficiently certain to show what the legislature intended to prohibit and punish, otherwise, it will be void for uncertainty.
In United States v. Wiltberger (5 Wheaton 76), Mr. Chief Justice Marshall declared
It is the legislature and not the court which is to define the crime, and ordain its punishment.
In Louisville & Nashville Ry. Co. v. Commonwealth (99 Ky. 123), decided by the Supreme Court of Kentucky and approved by the Supreme Court of the United States in McChord v. Louisviile & Nashville R.R. (183 U.S. 483), it was declared
It seems to be clear to us to be utterly repugnant to our system of laws to punish a person for an act, the criminality of which depends, not on any standard erected by the law, which may be known in advance, but on one erected by a jury. And especially so, as that standard must be as variable and uncertain as the views of different juries may suggest, and as to which nothing can be known until after the commission of the crime.
As it is disclosed later in this bill, it is proposed that the Congress, in defining a crime shall be indifferent to this rule of law and shall make a criminal offense, as well as a quasi-criminal offense, based upon opinions which cannot, like allegations of fact, be proved to be false.
There is no way in which a defendant may be informed of the charge which he must meet. Violation cannot be established by ordinary criminal evidence, when such charge, in and of itself, is based upon conclusions or judgments short of positive knowledge.
The Supreme Court of the United States has recognized this situation in a line of cases. In American School of Magnetic Healing v. McAnnulty (187 U.S. 90), the court said, among other things:
The claim of the ability to cure may be vastly greater than most men would be ready to admit. Yet those who might deny the existence or virtue of the remedy would only differ in opinion from those who asserted. There is no exact standard of absolute truth by which to prove the assertion false and a
We may not believe in the efficacy of the treatment to the extent claimed by complaints, and we may have no sympathy with them in such claims. Yet their effectiveness is but a matter of opinion in any court.
Again, the same court, speaking through Mr. Justice Holmes, in the case of United States v. Johnson (221 U.S. 485), in part said:
We shall say nothing as to the limitation of constitutional power, and but a word as to what Congress was likely to attempt. It was much more likely to regulate commerce in food and drugs with reference to plain matters of fact, so that food and drugs should be what they profess to be when the kind was stated, than to distort the users of its constitutional power to establish criteria in regions where opinions are far apart.
The Congress of the United States, in the enactment of the Sherley amendment, so-called, to the present Food and Drugs Act, recognized that there are differences of opinion. In order that no doubt should be left upon the point, the Congress deliberately excluded that field (see Seven Cases v. U.S., 239 U.S. 509).
I will later refer to this matter of opinion, but have discussed it here in order that the full implications of the bill may be understood.
Will the committee please turn now to paragraph (a) section 4, on page 5! I discuss this provision only in the interest of clarity. The phrase “ dangerous to health " leaves something to the imagination, which I again submit ought not to be found in a criminal and quasicriminal statute. The apparent purpose. of this prohibition is to protect the public against a drug which is likely to be injurious when used according to directions. With this no fault is found.
There is a phrase somewhat similar found in the reference to foods in the fifth paragraph, “ In case of foods”, section 7 of the present law. It reads:
Fifth. If it contain any added poisonous or other added deleterious ingredient which may render such article injurious to health.
In this case the possible injury to health is due to the fact that there have been poisonous or deleterious ingredients added to it by man.
Permit me to digress for a moment to say that that was the distinction made by Mr. Justice Hughes in the Coca Cola case by the significance of the words “ poisons added by man ” as distinguished from poisons in the food added by nature.
The existence of such poisonous or added ingredients must not only be shown but their presence in such quantities as are reasonably likely to injure, and in such event such likelihood should be general and not confined to cases of sensitiveness, allergy, or idiosyncrasy.
Does this provision mean that a drug is adulterated if it is of such character as to be reasonably likely to be dangerous to community health, or does it mean that it may be dangerous to the health of a single individual.
That this section may be clarified, I respectfully suggest to the committee that the following or similar language be added :
But in construing this section reasonable allowance shall be made for allergy or an abnormal individual reaction by the consumer.
It is well known that there are such abnormal reactions to practically every food or drug. If a preparation is reasonably safe, is being used by thousands of citizens without untoward effect it should not be condemned as adulterated because some individual abnormally reacted to its use.
Your attention is now invited to section 6, paragraph (a), on page 7, and a similar provision appearing in paragraph (a) of section 9, page 15.
What I have to say concerning paragraph (a), section 6, is equally applicable to the paragraph in the advertising provision and need not be repeated.
A drug is deemed to be misbranded if its label is false or misleading in any particular. This prohibition of necessity is confined to such statements as may disclose that an article of drugs is not what it professes to be when the kind is stated. It does not extend, in my opinion, to claims of therapeutic or curative value, and if it is intended so to the extent its constitutionality is subject to challenge.
Similar language is found in the first paragraph of section 8 of the present Food and Drugs Act, which reads:
The term “misbranded ”, as used herein, shall apply to all drugs, or articles of food, or articles which enter into the composition of food, the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular.
This language has been declared by the Supreme Court of the United States not to include claims concerning the curative or therapeutic effect (United States v. Johnson, 221 U.S. 488).
That the first sentence in this paragraph is not intended to cover claims of therapeutic value is apparent from a reading of the second sentence, which deals with the claimed effect of the drug, which of course means its value as a curative agent. In this sentence it is provided that any representation concerning the effect of the drug shall be deemed to be false if that representation is not supported by substantial medical opinion or by demonstrable scientific fact.
The language used herein recognizes the correctness of what I have already said, that opinion is a mere conclusion or judgment short of positive knowledge, because it has been modified by the use of the word " substantial whatever that means.
Again the question arises of the definiteness and certainty and the constitutional right to be informed of the nature of the charge. The fact is that what might be accepted as sufficient proof in one court and jury might not satisfy a court and jury in another jurisdiction.
An attempt is made to overcome the dilemma by introducing the phrase“ demonstrable scientific facts.” These terms sound good, but what do they mean? The medical profession has been practicing its art for some thousands of years. During all of that time, with very few exceptions, it has only been learned that certain reactions follow the administration of certain drugs. The effect is noted, but how and why the effect has been produced has not, except in few instances, been scientifically demonstrated.
I quote a sentence from an editorial appearing in the September 9, 1933, issue of the Journal of the American Medical Association,
When pathogenesis is not well understood, therapy also is a field for conflict and dispute.
If the pathogenesis of a disease is not known, what are the demonstrable facts upon which a claim of value can be made? If therapy
is a field for conflict and dispute, should property be destroyed and manufacturers and others sent to the penitentiary because some doctors have in their own minds an opinion on it, or because the impossible is required?
It is unfortunate that this is a state in which medical knowledge of therapy finds itself. The difficulty is in the fact that it is in such a state. The Supreme Court of the United States has recognized this situation. A former Congress of the United States, after more than a year of consideration, recognized it. They deliberately excluded the matter of medical opinion from the act and enacted the so-called “Sherley amendment to that act, which reads:
Third. If its package or label shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein, which is false and fraudulent.
I suggest, therefore, that the language used in the second sentence of paragraph (a) be deleted and the language of the Sherley amendment, which has stood the test of more than 20 years, be substituted therefor.
Your attention is now called to paragraph (d) of section 8. I don't know whether this paragraph is astutely and cleverly drawn or otherwise. If cleverly drawn its real meaning and effect is hidden. It provides that an article is misbranded if any word, statement, or other information required on the label to avoid adulteration is misbranding under any provision of the act is not prominently placed thereon in such a manner as to be easily seen, and in such terms as to be readily intelligible.
The bill contains provisions which specifically require certain statements to appear. I can understand these, and, insofar as the provision relates to definite requirements, it would be unobjectionable. Such statements, which the Congress in its wisdom requires to be disclosed, should be stated in a plain and conspicuous manner.
This provision, however, must be read in connection with section 22, which grants authority to the Secretary to make regulations for the efficient enforcement of the act. Except as this grant is modified by the provisions relating to the power to be exercised by a committee of public health, the Secretary is without limit. This is particularly true where the language used is ambiguous or not clear. Under the terms of paragraph (a) he may require a world of information that is wholly unnecessary for the protection of the public, upon the theory that, in his opinion, such information is necessary to avoid adulteration or misbranding.
I submit that this provision should be deleted, and that if a law is enacted, it state in clear, unmistakable terms the requirements as to such matters as in the opinion of Congress should be declared.
The language used in section 8, paragraph (a), page 10, relating to misbranding of drugs, and section 9, paragraph (b) relating to advertising, are the same, and therefore can be treated together.
This is a requirement that when a drug is not offered as a specific cure but is a palliative, it must declare first that the drug is a palliative, and again, how the palliative, and again, how the palliation is effected.
I am informed that there are but few diseases for which it is even claimed that specific cures have been found. There are thousands
of drugs found in materia medica. Doctors prescribe hundreds of different drugs. With the exception of the very few, practically all drugs are palliatives, and to require such a statement upon all but a few of the drugs used does not appeal to me as being particularly wise. The statement would soon become so common that it would either be meaningless or attain a secondary significance.
It would be wiser if, instead of requiring a statement that a drug is a palliative, the Congress would name the list of diseases for which specific cures have been found, and require a statement that drugs offered for their treatment are in fact specific cures. In the event it would be proven that they are not such specific cures, then the statement would be a misbranding:
Of course the Congress should, if it should so provide, protect the manufacturer or distributor of the drug who does make the statement if tomorrow medical opinion would be changed upon the subject.
The serious situation presented, however, is found in the requirement that there shall be a declaration of how the palliation is effected. It would be interesting to note exactly what is in the mind of the author of the bill in making this statement. Certainly it does no mean that the label requirement will be satisfied if it is stated that the palliation is effected by the taking of so many doses of the drug: If it means that the label must carry a statement concerning the physiological and pharmacological effect of the drug upon the pathological conditions, it is impossible of performance. If this information could be obtained from the medical and pharmacological professions it would be a different thing, but it cannot be so obtained, because they don't know, except in very few instances.
How can a manufacturer know how palliation is affected if the doctors can't tell him? It can neither be declared upon the basis of substantial medical opinion nor by demonstrable scientific fact, first, because there is no substantial medical agreement as to the great majority of diseases, which are palliated, and no facts by which they can be appropriately demonstrated.
When the doctors can tell us just why the stomach does not digest itself; when they have come to an agreement as to the cause common cold, whether it is based upon the hypothesis that it is due to a filterable virus, or, as is claimed by another group, due to a mild form of acidosis.
Permit me to refer to just a few: Take the analgesics—aspirin, amid opyrine, quinine, salicylates. Here are a few of the theories as to how they act to relieve pain.
United States dispensary: “We are entirely ignorant."
Sollman: “ Mechanism obscure—may consist in change of meningeal,” those around the brain.
Cushny: “May be assumed to be an action on a synapse on the path conveying pain.”
Bastedo: “Action on synapse or result of action in regulating balance between heat production and heat lost.”
Solis Cohen: “Partly central, partly peripheral.” Now, where are we when we get a demonstrable scientific fact? That is the medical opinion as to how aspirin is going to relieve pain. Now take the theories regarding how antipyretics reduce