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.

BRIEF OF JOHN H. WRIGHT ON BEHALF OF THE NATIONAL ASSOCIATION OF INSECTICIDE AND DISINFECTANT MANUFACTURERS, INC., CHRYSLER BUILDING, NEW YORK CITY

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 activi ties 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 enforcement 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 manufacturers 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."

BRIEF SUBMITTED BY WARREN N. WATSON, 608 WOODWARD BUILDING, WASHINGTON, D.C.. ON BEHALF OF THE MANUFACTURING CHEMISTS' ASSOCIATION OF THE UNITED STATES, JOINTLY SUBSCRIBED TO BY THE SYNTHETIC ORGANIC CHEMICAL MANUFACTURERS ASSOCIATION

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 legislation 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 therapeutic 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 substantial 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).)

LETTER OF J. M. GEORGE, SECRETARY OF THE INTERSTATE MANUFACTURERS ASSOCIATION, WINONA, MINN.

Senator H. D. STEPHENS,

FEBRUARY 21, 1934.

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 an 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.

We, as an important part of the packaged-medicine industry and the cos metic and toilet-article industry, feel that under these bills the future of these industries would be insecure irrespective of any public health question. We feel that we should have as much to say about the regulation of our own business as the doctor has. We frankly admit that the commercial interests of the medical profession are to a certain extent opposed to our interests, yet under these Tugwell bills, prepared without consulting the industries affected and with the assistance of doctors and introduced by doctors in Congress, we would be placed largely under the supervision of the medical profession.

Under the proposed legislation there is no regulation whatsoever of the prescriptions of physicians which are nothing more or less than formulae. There is nothing to require the doctor to tell his patient in what way palliation resulting, if any, from prescriptions is effected. Subsections (i) and (j) of section 8 in the closing clause of each such section expressly exempt advertising disseminated to the members of the medical and pharmaceutical professions from restrictive features which are imposed on all other advertising. Why should such an exception be made?

One of the chief effects of this proposed legislation would be to cast suspicion upon all prepared medicines in a manner which is entirely unnecessary, and which has nothing whatsoever to do with the public interest.

Legitimate manufacturers for years have completely omitted the word "cure" from their literature, labels, and advertising. As a matter of fact, the food and drug administration has for years under the present law prohibited the use of the word "cure."

There is no general impression in the public mind that either a medicine, a prescription, or a physician can effect a cure. Medicines and therapeutics are not exact sciences. Trial and error are outstanding elements in the search by the ailing for health.

The mere statement that a preparation is for use in connection with named ailments does not raise a presumption of claim of cure. It is stretching and expanding the imagination to say that when the public reads a label containing therapeutic claims that the reader assumes that the fact that the claim is made constitutes a claim upon the part of the manufacturers that the preparation is a cure.

Yet this legislation, in spite of these circumstances, requires that the manufacturer must say that his preparation is a palliative. If the law prohibits the use of the word cure" the public is sufficiently protected and the industry is not harmed or embarrassed.

The provision in the present Tugwell bill that the manufacturer must state on his label how palliation is effected has absolutely no application to public welfare or protection. It is patently included in this legislation to embarrass the industry and is clear evidence of an attack against the same. It would be a practical impossibility to comply with this requirement on the label of a large percentage of prepared medicines.

The public is only interested in results-not how they are achieved. Subsection (b) of section 8 of Senate bill 2800 and the other Tugwell bills provides that if any prepared medicine contains a narcotic or hypnotic substance which is habit-forming, the label must bear a statement that the preparation may be habit-forming. This is an unreasonable regulation going beyond the necessities of public protection and is further evidence of prejudice against the industry. This habit-forming warning should be required only on prepared medicines containing narcotics or hypnotics in sufficient amount to raise a question as to habit-forming qualities in the finished product.

The method of establishing the advisory committees provided in this legislation for the regulation of foods and of public health should be such that these committees could not be “packed " against the interests of the industry sought to be regulated. The method relating to the public health committee is particularly susceptible of being taken over by the medical profession.

Attention is invited to the fact that since the introduction of the first Tugwell bill few, if any, important revisions down to the present bill have been made to remove objectionable features in connection with medicines. Many objections, however, have been removed in connection with food regulation. This clearly shows the way the wind blows and is clear evidence of an attack on the medicine industry rather than a revision of the present food and drug laws to bring about adequate protection for the public.

Members of Congress may feel that the medicine industry is too apprehensive of the effect of this kind of legislation. This apprehension is well grounded for under the present doctrine of consensus of medical opinion we are put into a position where it is practically impossible for us to know what is required under the present food and drug act in matters of therapeutics. Under the present law we are limited to a very marked degree and are not permitted to make therapeutic claims for prepared medicines which claims are being made as a common practice for prescriptions containing the same ingredients. Probably the outstanding illustration of this statement is in the case of aspirin which is put up and sold to consumers under that name. In making claims for aspirin we are prevented by the food and drug administration from making claims for use in connection with la grippe or influenza. Since aspirin was discovered and became of common use, there probably has been no case of influenza treated by a physician where he failed to prescribe aspirin as the principal medicinal agent. We are at a loss to understand why there should be any such discrimination.

There is a prepared medicine on the market for sinus trouble which is frequently prescribed by physicians yet this trouble is listed in this legislation as an ailment for which self-medication must be discouraged.

If there are no prepared medicines for the ailments listed under subparagraph (b) of section 9, then there are no prescriptions which can rightfully be issued for the same diseases.

Why should this discrimination be made?

We agree that there is a list of diseases properly considered incurable at the present time and we mention this section of the bill here not by way of objection to the section so much as by way of showing an unfair and prejudiced attitude. Furthermore, in raising some of these questions we realize that Congress has no power under the Constitution to regulate prescriptions.

This industry is entitled however, in spite of this fact, to receive fair consideration and to be subject to legislation and regulations going no further than necessary to protect the public health and interest and it is entitled to be free from the use of the powers of Congress under the commerce clause to put the industry into a position of commercial embarrassment.

We anticipate that this committee will not permit itself to be swayed by prejudice or propaganda or permit itself to be used to further the interests of one group or class against another.

The members of this association are those concerns which have for many years been engaged in the manufacture of a line of packaged foods, toilet articles, medicines and similar articles the distribution of which merchandise to the consumer has been through house to house sales principally in rural communities.

This particular branch of the industry affected by this legislation has many million dollars in invested capital, many employees and approximately 25,000 exclusive dealers which dealers handle nothing else but these lines of merchandise.

Every agricultural community in the United States has one or more of these dealers and such dealers several times per year call upon every farm family in the United States.

Hon. ROYAL S. COPELAND,

HOUSE OF REPRESENTATIVES, Washington, D.C., February 26, 1934.

United States Senate, Washington, D.C.

MY DEAR SENATOR: I am enclosing herewith two letters received from the Arner Co. and the J. R. Watkins Co., of Buffalo, N.Y., containing protests against certain provisions in the revised food and drug bill.

I understand a hearing will be held on this legislation tomorrow and I shall appreciate it if you will have these letters read into the record and give them your consideration.

Yours very sincerely,

ALFRED F. BETTER.

P.S.-I am also enclosing two telegrams sent to Congressman James Mead protesting against the bill. I trust you will have them included in the records. A. F. B.