As a result, individual business enterprises have censored advertising copy and will continue to do so. It is generally recognized that all factors in business which deal with advertising should exercise constant and vigilant care to prevent fraudulent and untruthful advertising as a principle of business conduct.

Your committee recommends that Government imposition of censorship in any form upon advertising an attempt at inexcusable intrusion into private business affairs and should be opposed.


Discretionary power8.--In legislative proposals imposing regulation of business for the ostensible purpose of protecting public health, a clear distinction is not always drawn between measures necessary to safeguard public health and measures designed to regulate business practices which have no relation to public health.

In preparing legislation to prevent fraudulent practices which affect the public health, it is often difficult to write specific provisions into the law. It is difficult to anticipate developments in business which may need to be controlled. It is also difficult to foresee the possibilities of evasions of specific provisions of law. For this reason the temptation exists to make laws which are more or less of a framework to be filled in, as occasion may require, by administrative regulations.

Laws are frequently drafted by those who will enforce them, or prosecute cases under them. Guided by the best of intentions these persons can scarcely help having uppermost in their minds flagrant cases that have come to their attention which cannot be reached by present laws. They see only the bad cases which are thrown out of proportion to the great body of fair business prac. tices. It is natural to attempt to write laws which will cover every conceivable case without proper consideration of the effect of the law on legitimate activities. Great care should be exercised to be sure that unwarranted and unneces. sary powers are not granted to officials. Where it is necessary to grant discretionary powers, they should be limited to the obvious necessities to accomplish the purpose of the law, with a clear right to a fair hearing and appeal.

Business men should oppose those features of legislation which needlessly inject the Government into private affairs, and contain a threat, through broad discretionary powers vested in officials, that the Government may step in to regulate business on a wide scale under the guise of protecting the public health. Even though there may be appeal to the courts for protection against improper administrative rulings, great hardship would result before the wrong can be set right.

Laws which place considerable discretionary power in the hands of Government officials create uncertainty in many cases as to what may be unlawful not only at the time the laws are enacted, but as to the future when administrative regulations may be issued. Uncertainty is also caused by vagnie and meaningless terms which cannot be interpreted with any degree of assurance even by the most able men. In the final analysis the interpretation of law rests with the courts, but until the courts have delivered opinions, in many cases, no one can be certain of the law's scope and meaning. In such cases business may be harassed by administrative interpretations until the meaning of the law has been decided by the courts. The language of law should not be so vague as to lend itself readily to widely differing interpretations by the various officials who may administer the law. Those who will be governed by the law should be able to know, from the language of the law itself, within reasonable limits, what actually is unlawful.

Factory permits.--Recent proposals for amending the Food and Drugs Act contemplate a system of “permit” factories. Under these proposals an agency in the Government, or one to be set up, would be authorized, under certain conditions, to prescribe regulations governing the various manufacturing and distributing processes of manufacturers of products where the public health may be involved. Permits would be issued to the factories that would be covered by the regulations, and the manufacturers would be compelled to live up to the regulations under threat of having the permit withdrawn.

The withdrawal or suspension of a permit would mean that the manufacturer's products could not be shipped in interstate commerce, and the practical effect of this action would be to close the factory by administrative decree or to force the manufacturer to conform to the regulations. So wide a power in an administrative agent goes far beyond the degree necessary for the protection of the public health.

Factory inspection.—Other proposals concerning the Food and Drugs Act have to do with factory inspection by Government officials. Under existing State and local laws manufacturing plants are subject to inspection in many cases where the products of the factories may have an injurious effect. To impose a Federal inspection system, in addition to these other inspections, would result in confusion because of the variety of different regulations that might be established and would be an unnecessary burden.

A “ voluntary” factory inspection service has likewise been proposed by means of which any manufacturer of products subject to food and drug laws could secure Government inspection of his products and, if they conform to certain regulations, could have them marked with United States Government approval. Undoubtedly all manufacturers would be coerced into applying for this service in order to meet competition which would come from other manufacturers who would seek the sales advantage of Government approval of their products. The main purpose of this proposal seems to be to enable the Government to impose standards and grades. It is a further attempt at Government interference with business, entirely unnecessary for the protection of public health.

The importance of protecting public health is fully recognized. Obvious shortcomings in the present Food and Drugs Act which permit evasions that may endanger health should be corrected, but it should be done without imposition of Federal systems of inspection upon existing State and local systems.

Your committee recommends that discretionary powers to impose conditions upon manufacture and distribution should be granted to administrative agencies only where and to the extent clearly necessary for the effective enforcement of proper Federal laws.

Punitive features.—Some bills which have been introduced in Congress with respect to food, drugs, and cosmetics contain unusual penalties, including penalties for violation of administrative decisions. There is an obvious question which should interest all persons concerned with the proper enforcement of the laws, about the possibility of enforcing such penalties, for they include imprisonment for a first offense even though it is not willful, and seek to fix the minimum amounts of fines which courts may impose.

There are other provisions that would undertake to give a Federal right to action for damages to any person as a result of injury or death caused by violation of the laws, although all such rights in proper cases now exist in States.

Proposals for legislation contain attempts to impose the same conditions of manufacture and sale upon all foods, drugs, and cosmetics. Conditions surrounding the manufacture and sale of foods may be very different from those surrounding manufacture and sale of drugs. The problem of regulation and the necessity for regulation are somewhat different. These differences should be recognized in legislation and in administrative regulations.

Your committee recommends that legislative and administrative provisions in food and drug laws, as well as penalties for their violation, should bear a definite relationship to the protection needed in the public interest.


For the stated purpose of protecting the consumer, for the elimination of waste in industry, or for a variety of other purposes, a wide assortment of proposals are being made. Broad powers would be given under these proposals to an existing or a new Federal agency with a sizable budget to achieve these purposes. They propose to set up “standards” for everything the consumer buys; would require manufacturers to produce their goods according to Government specifications, and would impose specific and detailed requirements respecting the designation of quality, durability, usefulness, size, strength, grade, quantity, composition, origin, date and process of production, weight, and measure of all the objects of commerce.

Some of these proposals would require, by law, that manufacturers produce consumers' goods according to specifications. Others would depend on education and propaganda to persuade consumers to buy goods made in conformity with the standards established by the Government.

Some of the proposals for marking or labeling all commodities in commerce are very sweeping in scope. The amount of information required would be so great as to be impracticable for the labels of most goods as they reach the hands of consumers. Further than that, the information, in many instances, would be of no practical value. Carried out literally, they would add improperly to the cost of merchandise and would create an impossible problem of enforcement and administration. The premium of evasion by dishonest persons would be large.

It is generally recognized that in the case of some commodities, particularly primary products, the establishments of standards has facilitated trade and been helpful to producers and distributors. Other standards, such as standards for drugs, are well established and recognized in existing law. The advantages and benefits from such standards, however, must not be assumed to apply to every conceivable kind of article that the public will buy.

Such an extension of standards would inevitably hamper the initiative which leads to improvement and to new articles. The idea of standardization carried out on any general scale would undoubtedly destroy the value of brand names and the good will which manufacturers and distributors have built up over long periods of time. It would eliminate the incentive manufacturers have to improve their products continually. It would impair methods of distributing goods which are necessary to support large-scale operations. Such operations, admittedly, have been responsible for economies in manufacturing and distribution, and have benefited the public.

Efforts to develop standards for goods of general categories should be undertaken by manufacturers and distributors themselves. In developing standards care should be taken not to limit the proper opportunities of the public for choice and selection.

Your committee recommends that industry itself should continue its progress in arriving at standards of quality for articles to which such standards can properly be applied.




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S. 2800 is entitled “A bill to prevent the manufacture, shipment, and sale of adulterated or misbranded food, drink, drugs, and cosmetics, and to regulate traffic therein; to prevent the false advertisement of food, drink, drugs, and cosmetics; and for other purposes."

A perusal of this bill discloses that its intent to regulate the activities referred to in the title of the bill applies entirely to substances or products destined for use on or within the body. Yet the definition of the term “ drug as given in section 2, paragraph (b) (2) is such as to extend the scope of the bill to comprise industrial activities now regulated under different laws, and more specifically, under the Insecticide Act of 1910. That part of the definition with which the National Association of Insecticide and Disinfectant Manufacturers, Inc., is concerned (and on whose behalf this brief is being filed) reads as follows: "The term ‘drug' includes all substances, preparations, and devices intended for use in the cure, mitigation, treatment, or prevention of disease in man or other animals.”

Prevention of infection may concern itself with the destruction of microorganisms on and within the human body, or with their elimination from inanimate objects with which the body or its parts may come in contact, for example, utensils, furniture, etc., handled by persons affected with contagious diseases. Insofar as germicidal substances are concerned, destined for use on or within the human body, they may conceivably be regarded as drugs in the true sense of this term, and their manufacture, sale, and advertisement would represent activities which it is the intent of S. 2800 to regulate. On the other hand, there exists a group of products such as insecticides and disinfectants, the use of which in some or all instances, may be interpreted as aiming at a mitigation or prevention of disease in man or other animals. The industrial activities in regard to this group of substances are regulated at the present time under the Insecticide Act of 1910, and to date this arrangement seems to have worked out very satisfactorily from the standpoint of the enforcing officials, the manufacturer, and the consumer.

The definition of the term “drug" referred to above, by including the activities with regard to insecticides and disinfectants within the scope of S. 2800. would thus make the regulation of these activities subject to two different laws and by two different departments which are entrusted with the enforce ment of these laws, viz, the insecticide division on one hand and drug control on the other.

It need not be emphasized that such a state of affairs is liable to cause considerable hardship to the manufacturers of insecticides and disinfectants not intended for use on or within the body. Aside from the fact that such manu. facturers would have to deal with two departments with regard to regulatory procedure, they might conceivably be exposed to further difficulties in the case of conflicting rules by the two departments.

Accordingly, the National Association of Insecticide and Disinfectant Manufacturers, Inc., feels that the provisions of S. 2800 should not extend to those branches of the industry, represented in this association, which are concerned with the manufacture, sale, and advertisement of insecticides and disinfectants not recommended for use on or within the bodies of man or animals; this, incidentally, the association assumes to be the intent of the framers of S. 2800.

However, in order to eliminate the possibility of an erroneous application of the provisions of S. 2800, the National Association of Insecticide and Disinfectant Manufacturers, Inc., respectfully requests that the following proviso be added to section 2, paragraph (b):

Provided, That the requirements of this paragraph shall not apply to a preparation or product represented as an insecticide, or to a preparation or product represented as a germicide, bactericide, or disinfectant for inanimate objects only, and not for any use on or within the body, such preparations or products being subject to the provisions of the Insecticide Act of 1910."

So that the entire paragraph (b) of section 2 should read as follows: “(b) The term “drug' includes (1) all substances and preparations recognized in the United States Pharmacopoeia, Homeopathic Pharmacopoeia of the United States, or National Formulary or supplements thereto; and (2) all substances, preparations, and devices intended for use in the cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) all substances and preparations, other than food, and all devices intended to affect the structure or any function of the body : Provided, That the requirements of this paragraph shall not apply to a preparation or product represented as an insecticide, or to a preparation or product represented as a germicide, bactericide, or disinfectant for inanimate objects only, and not for any use on or within the body, such preparations or products being subject to the provisions of the Insecticide Act of 1910.".




Pursuant to public notice of hearing on Senate bill 2800, we appear today as representatives of the Manufacturing Chemists' Association of the United States, an organization established in 1872, and comprising the leading chemical manufacturers of this country.

Member companies have made careful analyses of the proposed legislatiou and notwithstanding recognition of the purposes of Senate bill 2800, we respectfully submit the following:

We object to power granted the Secretary of Agriculture to decide questions of fact appertaining to the therapeuti: effects of preparations falling within the scope of the bill and the physiological reactions thereto. We believe the Secretary is not qualified to decide such questions nor is it proper for him to do so. This function should more properly repose in the Committee on Public Health as provided in section 22 (b). (Sec. 4 (a) and sec, 5 (a).)

We object to the lack of clarity in the provision regarding misbranding of drugs in that no definition is provided as to what shall be considered substan. tial medical opinion or demonstrable scientific facts. It is common experience that there is a wide difference of opinion even among leading members of the medical profession as to the therapeutic value of many drugs and very few drugs are recognized by all as having undisputed remedial values. This pro

vision would tend to deprive the public of the benefit of many drugs and preparations which are being used with success by a large portion of the medical profession. We believe that this function might properly be placed in the Committee on Public Health, as provided in section 22 (b). (Sec. 6 (a).)

We object to the provision regarding misbranding of drugs, as we feel the requirement of giving on the label the description of “how the palliation is effected” is most impractical. In many instances the underlying pharmacologic reasons for the reactions of a drug on the human body are unknown, and where they are known the explanation of how the result is produced would be so technical and so complicated as to entirely confuse the user. (Sec. 8 (a).)

We strenuously object to the provisions of section 8 (e) (1). Many drugs have more than one medicinal use. Therefore, to comply with regulations requiring “ complete and explicit directions for use" would necessitate directions for each such use and would in many cases be practically impossible to comply with.

We object to the provisions of section 8 (i) and (j), regarding misbranding of drugs in respect to germicides, batericides, disinfectants, and antiseptics. This paragraph establishes that antiseptics must be germicidal having the power of killing existing microorganisms. This is contrary to the established meaning in the medical and bacteriologic professions of the term antiseptic”, wherein this term is applied to the function of inhibiting or preventing the growth of microorganisms. This meaning has been established for many years and has recently been substantiated by exhaustive researches in medicinal and scientific literature.

We object that the provision regarding false advertisements will have the effect of reacting adversely to and effectually impeding the progress of scientific research in chemistry and chemotherapy. (Sec. 2 (j) and sec. 8 (a) and (b).)

We object to the provisions for permit factories in the absence of statement of the specific conditions under which such provisions will become effective. These provisions tend to deprive manufacturers of adequate safeguards for manufacturing processes, formulas, methods of operation. (Sec. 12 (a).)



FEBRUARY 21, 1934. Senator H. D. STEPHENS, Chairman Senate Commerce Committee,

Washington, D.C. DEAR MR. CHAIRMAN AND MEMBERS OF THE COMMITTEE : We wish to go on record as being opposed to Senate bill 2800, by Dr. Copeland, and to all of the other Tugwell-Copeland bills now pending before your committee.

We have no objection to the inclusion of cosmetics under the present Food and Drugs Act, nor to the reasonable regulation of advertising, and we favor adequate protection to the consumer, but we most strenuously object to an attack on the industries affected which goes beyond the necessities of adequate consumer protection.

The original bills introduced at this Congress on this subject evidence an intent to harm, particularly the prepared-medicine business, and the writing of the same were apparently based upon a prejudice against prepared medicine and self-medication.

The great bulk of practicing physicians throughout the United States pay little or no attention to the prepared-medicine business. There is ar active minority of physicians, in most cases prominently connected with medical or. ganizations, whose chief aim seems to be to destroy the prepared-medicine business.

We have often heard of professional men giving important consideration to the dollar in connection with their professions, yet sponsors of this bill would have it believed that no commercial motives are involved and that it is purely a matter of public health.

The impression is given out that persons opposing this legislation are doing so in order to safely prey upon the gullible public.

At the present time there is no more closely regulated field of commerce than that of food and drugs, and with the exception of one or two minor things, the present laws are entirely adequate for public protection.

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