BRIEF OF DR. JOHN F. ANDERSON, VICE PRESIDENT OF E. R. SQUIBB & SONS, 745 FIFTH AVENUE, NEW YORK CITY

Mr. Chairman and Members of the Committee on Commerce:

My name is John F. Anderson. I am a physician, vice president of E. R. Squibb & Sons of New York City, and director of the research and biological laboratories of that company. I appeared before the subcommittee of this committee at the time it was holding hearings on S. 1944, and presented a brief approving in general the purpose of that bill and making suggestions which we felt would improve it.

E. R. Squibb & Sons are glad to see that in drafting S. 2800 many suggestions which were made on my first appearance have also appeared advisable to the committee. A few suggestions which we still deem of considerable importance were, however, either not adopted at all, or only partially adopted in S. 2800. We are, therefore, calling these again to the attention of the committee.

At the outset we wish to reemphasize the necessity for Congress to adopt some legislation to counteract the serious abuses which were referred to in my original statement to this committee regarding the dangerous practice of counterfeiting drug, cosmetic, and food products. We are prepared to recede from our original position that these dangerous abuses be covered in the Federal Food and Drugs Act but as a necessary supplement to the present bill we respectfully urge the adoption of legislation in the form of S. 783 introduced by Senator Wagner on behalf of Senator Copeland in the first session of the Seventy-third Congress. The present bill does not purport to cover the counterfeiting evil yet, in our judgment, at least as great, if not greater, dangers lie in this field than in the field covered by the present bill. We speak from experience when we say that some of the most dangerous and vicious elements of racketeers are devoting themselves to the counterfeiting of drugs and nationally advertised products.

They have learned much that is helpful in distributing their wares from their experiences in the liquor bootlegging business. They are experts at false labeling and, of course, the sources from which their products come are subject to no supervision, are very difficult to locate and the dangers to the public health are obvious. Established manufacturers with well-known brands even without the passage of the present bill are subject to the very effective administratiton of the food and drug department and of the Department of Agriculture. They will be even more so, we hope, after the passage of the present bill, and it is quite anomalous that such manufacturers will be subject to the stringent requirements of the present bill and these other elements to which we refer will not. We do not wish, however, to confine our arguments to the public health aspect alone. Although this is, no doubt, the paramount consideration, the Government, we submit, should also be desirous of protecting its citizens in the establishment of honest business and against such patently dishonest practices. We think the Food and Drug Administration will be among the first to acknowledge that many manufacturers have cooperated with them in their attempts to bring about pure food and drug dissemination and to eliminate improper methods of distribution, and it seems only fair that the powerful instruments of the Federal laws be applied to protect such manufacturers from this evil. Many States have adopted laws along the lines of S. 783 but, without the control of interstate commerce of these goods, which only the Federal Government can effect, such laws can only be partially effective.

We are aware of the thought and time which has been given to the preparation of S. 2800 and we know that this Committee is loath to take the time necessary to adjust the proposed legislation to fit the abuses of which we are now speaking, but this is, of course, wholly unnecessary as the other legislation (S. 783) is designed only to cover counterfeiting, is along lines which have already been laid out by State legislation, and if the Committee in its report will likewise urge the adoption of a bill along the lines of S. 783, as a complement to this bill to which we believe no honest objection can be raised, the Committee will, in our judgment, have covered the entire field. In our judgment, it will have rendered a great service to the public and to the cause of honest business.

The following are the specific suggestions which we made at the time of my previous appearance before the subcommittee which have not been incorporated in S. 2800 and which we deem of such importance that they should be

again presented to the committee with the request that it give them its serious consideration in connection with any bill that it recommends to the Senate. Page 6, section 4, paragraph (b), subdivision (2), beginning with line 5, reads as follows:

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"No drug shall be deemed to be adulterated under subdivision (2) of this paragraph if its label bears, in juxtaposition with the name of the drug, a statement indicating wherein its strength, quality, and purity differ from the standard of strength, quality, and purity set forth in the appropriate official compendium, as determined by the tests or methods of assay applicable under this paragraph.

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While this language has been changed somewhat in detail its meaning is the same as in S. 1944. We still believe that this paragraph will be improved if amended to read as follows:

"No drug shall be deemed to be adulterated under subdivision (2) of this paragraph if (1) its label bears immediately following the principal name of the preparation a plain and conspicuous statement indicating wherein its strength, quality, and purity differ from the standard of strength, quality, and purity set forth in the appropriate official compendium, as determined by the tests or methods of assay applicable under this paragraph or (2) if its label bears immediately following the principal name of the preparation a plain and conspicuous statement indicating wherein the preparation fails to meet the definition, formula, or description, set forth in such compendium, provided that the variation from such official definition, formula, or description does not either materially affect the efficacy of such preparation or substantially alter its identity.'

As stated at the time of my previous appearance, this amendment is designed to cover a very definite need which now exists under the present law, There are many articles which are defined in the United States Pharmacopoeia, Homoeopathic Pharmacopoeia, or National Formulary, which because of their viscosity or unsuitable form require the introduction of some nonactive ingredient to improve their availability for consumption. To introduce such an ingredient is sometimes deemed to alter the identity of the product and thus preclude the use of the designation referring to that product in the official compendium. As we previously pointed out, a very good example of this is the case of castor oil. Castor oil is defined in the United States Pharmacopoeia substantially as extract from the castor bean. Everyone knows that the high viscosity of pure castor oil makes it unpalatable and disagreeable to take. The introduction of certain oils render castor oil much more agreeable to the taste and thus promote its use. The amount of oil which is added is inconsequential so far as the efficacy of the product is concerned. Again, elements are introduced into products to keep them from freezing or dissolving under certain temperatures so that they may be constantly available for consumption. Their introduction does not affect the real identity or efficacy of the product but on the contrary most definitely improves it. As previously pointed out, it is no answer to say that the manufacturer may designate his product by a name other than the official name for the official name is the one the public is used to and readily recognizes. The expenditure of large sums of money in advertising the product under the new name would be necessary to familiarize the product to the public even in the most general way. The provision which we have suggested which would require that the variation does not materially affect the efficacy or substantially alter the identity of the product will, we believe, check abuse of this provision. As previously pointed out, we urge the provision for the further reason that it will permit and encourage the introduction and use of definite pharmaceutical improvements in existing specifications in the United States Pharmacopoeia, Homoeopathic Pharmacopoeia or National Formulary.

Page 10, section 8, line 18, reads as follows:

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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."

This paragraph has also been modified, but our suggestion to amend the paragraph by inserting "or does not constitute specific substitution therapy" after the word "cure" has not been adopted. Medical science has produced and is at this time producing specific glandular extracts containing hormones which are recognized by physicians as specific substitution therapy. These

preparations are capable of replacing deficiencies of such hormones when properly administered to patients. We believe that the peculiar efficacy of these preparations in the treatment of certain diseases warrants their recommendation in the treatment of these conditions without the necessity of explaining in detail how they accomplish palliation of the manifestations of the disease. It is our suggestion, therefore, that this paragraph be amended to read as follows:

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SEO. 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 or does not constitute specific substitution therapy 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."

Pages 13 and 14, section 8, paragraphs (i) and (j) beginning, respectively, at line 18 on page 13 and line 13 on page 14, read as follows:

"SEC. 8. A drug shall be deemed to be misbranded

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‘(i) If it purports to be or is represented as a germicide, bactericide, disinfectant, or antiseptic for any use on or within the body and its labeling fails to bear a plain and conspicuous statement of such use, including the strength or dilution, manner, and duration of application, and when tested by methods simulating as nearly as practicable the conditions of such use, or in the absence of such methods, when tested by a standard method, it does not have the germicidal effect within the duration so prescribed of a one to eighty dilution of phenol used by a standard testing method for ten minutes at thirty-seven degrees centigrade. All testing methods for the purposes of this paragraph shall be prescribed by regulations as provided by section 22: Provided, That no drug shall be deemed to be misbranded under this paragraph by reason of failure of its labeling to bear a statement of any advertised use if such advertising is disseminated to members of the medical and pharmaceutical professions only, or appears in scientific publications of these professions.

"(j) If it purports to be or is represented as an inhibitory antiseptic for any use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body and its labeling fails to bear a plain and conspicuous statement of such use, including strength or dilution and manner of application, and when tested by methods simulating as nearly as practicable the duration of application and other conditions of such use, or in the absence of such methods when tested by a standard method, it fails to prevent the growth of micro-organisms within the entire time of such duration. All testing methods for the purposes of this paragraph shall be prescribed by regulations as provided by section 22: Provided, That no drug shall be deemed to be misbranded under this paragraph by reason of failure of its labeling to bear a statement of any advertised use, if such advertising is disseminated to members of the medical and pharmaceutical professions only, or appears in scientific publications of these professions."

Paragraph (j) which has been added takes care of one of our objections to section 8 (i) in S. 1944. However, as more closely meeting the situation than the modifications which appear in S. 2800 and in the interest of accurate scientific evaluation of the properties of germicides, bactericides, disinfectants, and antiseptics, we wish to repeat the amendment suggested at the previous hearing and urge its adoption in lieu of the above paragraphs (i) and (j) in S. 2800. That amendment is as follows:

"(i) If it purports to be or is represented as a germicide, bactericide, disinfectant, or antiseptic for any use on or within the human or animal body and its labeling fails to bear a statement clearly indicating its phenol coefficiency and the dilutions in relation to time of exposure in which it kills recognized test micro-organisms; provided that any preparation may be labeled as an antiseptic if its directions for use provide for continuous contact with the part treated and in the strength used and in such contact and strength it is capable of preventing the growth of recognized test micro-organisms with which it comes in contact. The Secretary may establish after notice and hearing bacteriological tests, including the various types of test micro-organisms, to be used in determining phenol coefficiency, the strength of killing dilution in relation to time and growth inhibition."

Page 19, section 13, line 8:

This section provides for factory inspection with the exception of methods and processes. We object to this provision on the ground that we do not see

how it is possible to provide for an equitable, fair factory inspection service on a scale sufficiently extensive to cover the food, drug, and cosmetic industries. As stated at the previous hearing before the subcommittee, it is our belief that the Government should be very reluctant to enter upon the broad field of factory inspection except in the specific cases covered by section 12. Section 13 would in effect give agents or employees of the Secretary the right to enter into any factory and inspect all equipment, methods, processes, materials, containers, and labels on pain of restraint of their goods in interstate commerce. Most of the manufacturers of drugs, as well as of foods, have many secret processes which they would be perfectly willing to disclose to the Government if they got no further. However, Government inspectors frequently find their way into commercial establishments, and it is no exaggeration to say that eventually what is in the hands of the Government is in the hands of the competitor. As we have previously stated, in view of the powers contained in section 12, we believe that factory inspection is, furthermore, wholly unnecessary to the true regulation of interstate commerce. With the broad powers already given to the Secretary to check and seize goods in interstate commerce by injunction and libel, we believe that it is quite superfluous to include the inspection provisions contained in section 13. We therefore again urge the deletion of the entire section.

Page 27, section 17, paragraph (e), line 24, reads as follows:

"No dealer shall be prosecuted under paragraph (b) of this section (1) because of commerce in any article he has purchased or received in good faith if he furnishes on request of an officer or employee duly designated by the Secretary the name and address of the person from whom he purchased or received such article, or (2)

This provision is entirely new. We believe it to be quite unnecessary, and ample protection is given to the dealer under the guaranty clause in subdivision 2 of this paragraph. On the other hand, we can readily see how this provision might, under certain conditions, be taken advantage of so as to obstruct and hamper the accomplishment and purpose of the Federal Food and Drug Act.

There are certain other suggestions made by us at the previous hearing before the subcommittee which have not been adopted in S. 2800. However, we have not considered it advisable to further urge the adoption of these suggestions at this time because they are of relatively minor importance. The suggestions which we have mentioned, however, are of such importance, we believe, that their adoption should be given very serious consideration by the committee.

BRIEF OF THE CALIFORNIA COSMETIC ASSOCIATION, INC.

California Cosmetic Association, Inc., on behalf of its directors and members. submits herewith its argument in opposition to certain provisions of Senate bills 1944, 2000, 2800, 2355, and 2508, and other similar legislation, otherwise known and referred to as the proposed Tugwell legislation, and respectfully requests that the facts and matters hereinafter set forth will be read before your committee at its hearing to be held at the hour of 10 o'clock a.m., Tuesday, February 27, 1934:

California Cosmetic Association, Inc., representing a large number of substantial cosmetic manufacturers and distributors on the Pacific coast, is unalterably opposed to Government control and regulation of its industry as set forth in the several bills hereinbefore referred to, in the matter of inclusion of the word "cosmetics" therein. This opposition is based mainly on the ground that such control and regulation is unnecessary. It is impossible for any legislative body to truthfully claim that the manufacture of cosmetic preparations is so fixed in the public interest as to require Government control and regulation.

By no stretch of the imagination may it be argued that a cosmetic preparation is a drug intended for use in cure, mitigation, treatment, or prevention of disease, nor is a cosmetic preparation manufactured or sold for internal consumption. Cosmetics are manufactured and sold primarily for the beautification of women, and among the varied types of cosmetics are included face creams, face powder, lip rouge, mascara, and substitutes for soap and water. Purchasers of cosmetics choose for themselves, and use, the type and brand

of cosmetic preparations most suitable to their complexion or ideas of beautification. Food consumption and drug consumption is entirely another matter, in that one seeking health or one consuming food may be at the mercy of the purveyor thereof, regardless of choice. It is well established in the minds of all citizens that food and drugs must, of necessity, be manufactured and processed so that there shall be no resultant injury. It is evident, therefore. that cosmetic preparations do not come within that category of merchandise, food and drugs, which affect the public health. Present Federal, State, municipal, and county statutes are ample to enforce regulatory measures affecting the public health.

In recent months the Government of the United States, through its distinguished leader, the President, has called upon industry, large and small alike, to regulate itself. At the suggestion of the Government and with its assistance and cooperation the manufacturers and distributors of cosmetics have prepared a code of fair competition, and have submitted this code to the code Administrator for approval. This code contains not only provisions which will tend to increase employment, lessen hours of employment, increase wages, but also will purge the industry of any small or other abuses which may have heretofore existed, and adopts sanitary regulations, and measures to restrain fraudulent, misleading, and unethical advertising. The members of the California cosmetic industry have diligently and earnestly pursued a course of faithful assistance in the preparation of this code of fair competition, in which the industry will be self-regulating, and in nowise place upon the Government the duty of regulation. The Government on the one hand, through emergency legislation sponsored by the President of the United States, says, "Regulate yourselves and we will help you", and now the Congress of the United States, on the other hand, is considering legislation in direct opposition thereto.

At the annual meeting in May of 1919, the Chamber of Commerce of the United States adopted a resolution on the subject of government and business, reading as follows:

"The very essence of civilization is that there be placed upon the individual only that degree of restraint which shall prevent his encroachment upon the rights of others, thus releasing to the utmost individual initiative in every proper direction. Our form of government most effectively expresses and maintains this principle. Within our basic law exists ample provision for such changes as may from time to time be necessary to safeguard our people. It is therefore essential that our Government should scrupulously refrain from entering any of the fields of transportation, communication, industry and commerce, or any phase of business when it can be successfully undertaken and conducted by private enterprise. Any tendency of Government to enter such fields should be carefully weighed in the light of its possible effect upon the very genius of our institutions."

The California Cosmetic Association, Inc., and its membership, is vitally concerned over the proposed legislation affecting its industry. The enactment by Congress of the legislation containing provisions hereinabove referred to. in the opinion of our manufacturer members, means restriction and disruption for their business. The members of our association engaged in the manufacture of cosmetics on the Pacific coast, are upright, conscientious, and active citizens and believe in true American ideals and principles. In this belief we cannot, without injury to ourselves, endanger our whole future by the encouragement or toleration of a deviation from that which is of the very essence of the foundation of our Government.

BRIEF OF CHESTER H. GRAY, WASHINGTON REPRESENTATIVE OF THE AMERICAN FARM BUREAU FEDERATION

A proper approach to the provisions in S. 2800 cannot be made on the part of the representative of the American Farm Bureau Federation, except in relation to the most recent statement, or resolution, of the federation, in regard to the Food and Drug Act. This statement was made by the voting delegates at the fifteenth annual convention in Chicago, Ill., held on December 13, 1933, and reads as follows:

"Fraudulent advertising in print and by radio, the sale of harmful drugs and cosmetics, and similar practices should be prevented by proper amendments to the present Food and Drug Act.

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