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FOOD, DRUGS, AND COSMETICS

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Mr. MUELLER. I would suggest striking out the words "standards of quality."

Senator COPELAND. In section 11, lines 13 and 14, you would strike out "standards of quality"? Is that right?

Mr. MUELLER. Yes, sir.

Third. Section 13. Because the power granted is too broad. While we welcome any inspection of promises, finished or unfinished materials, containers or iabels, we object strenuously to inspection of methods and processes unless there is a definite need for such inspection because of some unusual occurrence where the public welfare demands such action. To empower any Federal inspector, and any local or State health officer working under this proposed law free access to methods and processes at any and all times would be most unfair to the industry and would not serve any public interest. Senator COPELAND. Your idea is that in an emergency where public health is involved that might be done, but in general you would not suggest that.

Mr. MUELLER. Exactly. I also suggest to strike out the words "methods, processes", and to add to line 24, "to inspect methods and processes if sufficient evidence is available to prove such inspection necessary to safeguard public health."

Senator COPELAND. Thank you very much, Mr. Mueller. That will be incorporated into the record. I am going to ask the secretary to take a watch and at the end of 15 minutes to indicate by a stroke of the gavel that that amount of time has been exhausted."

I call now on Mr. Charles Wesley Dunn, general counsel for the Associated Grocery Manufacturers of America, and the American Pharmaceutical Manufacturers Association.

STATEMENT OF CHARLES WESLEY DUNN, GENERAL COUNSEL FOR THE ASSOCIATED GROCERY MANUFACTURERS OF AMERICA, INC., AND AMERICAN PHARMACEUTICAL MANUFACTURERS ASSOCIATION

Mr. DUNN. Mr. Chairman, the Associated Grocery Manufacturers of America, Inc., the leading food manufacturers, and also a representative group of the food manufacturers of this country, is the nearest thing we have in this country to being a national association of food manufacturers.

The American Pharmaceutical Manufacturers Association includes manufacturers of ethical pharmaceutical products which are sold for use under the physician's direction.

I also desire to appear at this time on my own behalf as one who has given specialized professional consideration to this law for approximately a quarter of a century.

Mr. Campbell is undoubtedly right in his major premise upon which this bill is based, that the Federal Food and Drugs Act requires revision to oure serious defects in it which are derogatory to the public interests.

The act when it was passed in 1906 was defective. Its defective form arose out of two facts. The first was that it was a compromise bill. The second was that it was new legislation, broadly speaking, from the Federal standpoint.

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During the consideration of the Federal Food and Drugs Act in Congress and such legislation was considered beginning with 1879 and continuing to 1906-it was very controversial legislation; and then, aside from the controversy as to whether or not there should be such a law, there was a very great controversy as to what the terms of the law should be. This latter controversy involved an indefinite difference of opinion. So when the law was enacted in 1906 it was seriously defective in form, and the seriousness of its enforcement has amply demonstrated that the act contains other defects which require amendment.

So it is not unnatural that in the 27 years of the life of this act it has been amended five times, and numerous other amendments have been proposed to Congress and are now pending before Congress. Hence the legitimate food and drug manufacturing industry of this country must take the sound position that the act does requiro certain constructive revision, and that the only objection that can be properly offered to this bill is to the question of its form, where that form is objectionable. There can be no objection, as I say, to the major provisions against false advertising, filled containers, and so forth. The objection as to form falls into two classes--first, the objection against unduly broad or indefinite language; and, secondly, an objection against provisions which are unsound in principle and public policy as such.

I am not going to undertake to analyze the act at this time extensively because, Mr. Chairman, you have stated that you desire to conclude this hearing today and you prefer to have specific amendments and specific objections filed in written form. Therefore, I will cite two illustrations at this time of the objections that we have in mind. First, as to an objection against the form of this bill upon the ground that it is unduly broad.

I will cite as my illustration section 9 (a) on page 12. That section relates to false advertising and defines it as a duplicate of section 6 (a) in respect to the label. This section and section 6 (a) provide, in effect, that a food or a drug or a cosmotic is misbranded or falsely. advertised if its label or advertisement or ambiguity or inference creates a misleading impression regarding the product.

My objection, and the objections of the industries that I represent, center around that word "impression." An impression is a state of mind, or a reaction, or a feeling, on the part of the purchaser which may be wholly apart from the facts of the advertisement or the label; any purchaser may have an impression, a misleading impression, regarding A product which arises solely out of his own ignorance or his own stupidity or his own misunderstanding or his own misroading, or whatever the situation may be, wholly apart from the fact as to whether or not the label or advertisement is falso in fact. So that as a result of this bill in its present form, the Government would be empowered to condemn a food label, or a food advertisement, or a drug label, or a drug advertisement, upon the ground that it created a misleading impression in the mind of the consumer and regardless of the fact that the label or the advertisement might be wholly true in fact.

Let me give an illustration. You may got the impression for some reason that I am a thief. Whatever the reason for that impression may be, let us assume that it is an entirely erroneous impression.

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Upon the theory of this bill I could be put in jail because of your impression. Now, it is perfectly obvious that I should not be condemned for violating a law against thieving unless it is proven in fact that I have stolen. That little illustration goes to the point of our objection against this bill.

We believe the provision here as to both the label and the advertisement should be written in somewhat this form: That a label or an advertisement is false if it is false or injuriously misleading in fact in any material particular relating to the purposes of the act. That is a sound public policy and a sound declaration which is entirely equitable, so far as the industry is concerned, and amply answers the public need against false advertising and false labeling.

Senator COPELAND. Turn to section 6 (a), page 6, for a moment, Mr. Dunn. Suppose that line 24 were changed so that the whole subsection (a) would read: "If its labeling is in any particular false, or no unsupported claims are advanced."

Mr. DUNN. I feel, Mr. Chairman, that that is not, perhaps, the best form of a statement of public policy for this law. The present law provides against a false or misleading label in any particular. That law has been in force for some 27 years with satisfaction in that respect.

Senator COPELAND. Then you would be satisfied to use the language of the present act in the light of the decision that the court made regarding it?

Mr. DUNN. I believe, Senator Copeland, that so far as false advertising is concerned, the amendment should run somewhat in this fashion; should condeinn an advertisement as false where it is false or injuriously misleading in a material particular relating to the purposes of the act.

Of course, if this is a material particular it should not be considered. If it is not related to the purposes of the act it should not be considered. But if this touches in fact the consuming public of this country it should be condemned.

Those are sound principles of food and drug law control which have been laid down for years in this country.

Now, I go to the second broad objection against this bill, namely, the insertion of provisions which are unsound in principle and public policy in our view, and I will cite an as illustration of our objection the provision which runs throughout this bill from start to finish giving the Secretary of Agriculture practically unlimited administrative power which has the full force and effect of law.

Now, that provision reverses completely the public policy of the present act and, broadly speaking, reverses the public policy of the food and drugs law of this country as it has existed down to this time. It also is directly contrary to the public policy expressed by the British Food and Drugs Act and the Canadian Food and Drugs Act. For example, the public policy of the present act is substantially this: To set up a general requirement in the act with which the manufacturer must comply; and, on the other hand, to give the Secretary of Agriculture administrative power to enforce that requirement; but when he comes into court the burden of proof is upon the Government to establish that the law has been violated. That is the present public policy of the present act and it is the public policy that has existed

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from the very beginning with respect to the food and drugs law of this country, generally speaking.

The public policy of the proposed bill is just the reverse of that. It is to give the Secretary the power broadly to make administrative findings and decisions in the administration of the act, which findings and decisions shall have the force and effect of law. So that when a manufacturer or other person who is charged with the violation of this law goes to court, instead of the burden of proof being upon the Government to establish that he has violated the statute, according to the rules of evidence, he is faced with the situation where the burden of proof is upon him to establish that the administrative decision or finding of fact is wrong.

Now, the decisions of the United States Supreme Court have very broadly sustained administrative power with respect to decisions and findings of fact; and it is almost impossible, in a practical sense, broadly speaking, to everywhere get those administrative decisions and findings under a broad statutory power.

So that the effect of the whole thing with respect to this provision is to substitute the opinion of the Secretary of Agriculture for the judgment of the court or the jury in the final analysis.

We believe that is a fundamentally unsound public policy; that it is not consistent with the principles of the common law, with the principles of the law as it has been developed in this country, and that it is not a proper provision to write into this act.

I am going to confine myself to those two illustrations or objections, and then I ask your permission to file a brief stating specifically our objections with respect to this bill.

I think I expressed the opinion of the legitimate food-manufacturing and drug-manufacturing industries of the country when I say that it is our duty at this time to constructively cooperate with the committee and with the Government to revise this bill, simply to make its form sound, and at the same time to preserve its high purposes of protecting the public health and safeguarding the public health from injurious foods and drugs.

The following resolutions were adopted by the Associated Grocery Manufacturers of America, Inc., and the American Pharmaceutical Manufacturers' Association with reference to this bill:

Resolved, By the Board of Directors of the Associated Grocery Manufacturers of America, Inc., on this 27th day of November 1933, in pursuance of the recommendation by the association's legislative committee, that:

(1) The board approves a sound and constructive revision of the Federal Food and Drugs Act, to correct its defects and to effectually realize its high protective purpose.

(2) The board disapproves S. 1944, because and to the extent it is not drawn in due form to accomplish such a revision of that act.

(3) The board approves action by the association to secure an effective substitute bill, drawn in due form and to be submitted to the board for review.

Resolved, That the American Pharmaceutical Manufacturers' Association in convention assembled on this 10th day of November, 1933, (1) approves a sound, constructive, and early revision of the Federal Food and Drugs Act, to correct its defects and to adequately realize its high intendment of public protection; (2) approves the purpose of the so-called "Tugwell bill", to accomplish such a revision of the act; (3) regretfully disapproves the Tugwell bill, because it is not drawn in due form; (4) pledges its immediate action to suggest an effective substitute bill drawn in due forin and directed to provide a basis for general concurrence in the circumstances.

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Senator COPELAND. Thank you very much, Mr. Dunn. We shall be glad to have your brief. We have some 2-minute speakers. The next speaker will be Mr. Francis L. Whitmarsh, of tho National Wholesalo Grocers' Association.

STATEMENT OF FRANCIS L. WHITMARSH, CHAIRMAN OF THE PURE FOOD AND LEGISLATIVE COMMITTEE OF THE NATIONAL AMERICAN WHOLESALE GROCERS' ASSOCIATION

Mr. WHITMARSH. Mr. Chairman and members of the committee, I am speaking now as the chairman of the Pure Food and Legislativo Committee of the National American Wholesale Grocers' Association. Our association is the result of the union of the old National Wholesale Grocers' Association and the American Wholesale Grocers' Association, brought about, in part, to promote greater cooperation with the Government under the National Industrial Recovery Act.

The first official act of the National Wholesale Grocers' Association, which was organized in 1906, was to communicate to President Theodore Roosevelt and the leaders in Congress its approval of the National Pure Food Law. For more than 20 years we have worked diligently in promoting the enactment of State food laws prohibiting adulteration and misbranding of foods, uniform with the existing Federal Food and Drugs Act.

While we are not here to oppose the underlying principles of this bill, we feel that it would be unfortunate if the present Food and Drugs Act were repealed and an entirely new statute substituted, as is here proposed.

If under the present statute serious abusage exists as respects food products, it is our view that these abuses should be corrected by amending the existing law rather than to discard all that has been accomplished in the way of enforcement and interpretation by the courts during the past quarter of a century.

We are submitting for the record a memorandum indicating our suggestions and requesting various changes in a number of the provisions of the pending measure.

Senator COPELAND. That is, you are recommending changes in the bill that is now before us?

Mr. WHITMARSH. We are recommending that the present existing Pure Food and Drugs Act be amended so as to give sufficient strength rather than an entirely new bill.

Senator COPELAND. Are you making any suggestions as to the amendment of the bill that is now being heard?

Mr. WHITMARSH. In our memorandum we are doing so.

Senator COPELAND. Very well. Thank you.

(The memorandum above referred to is as follows:)

DECEMBER 8, 1933.

MEMORANDUM OF NATIONAL AMERICAN WHOLESALE GROCERS' ASSOCIATION CONCERNING S. 1944

To prevent the manufacture, shipment, and sale of adulterated or misbranded food, drugs, and cosmetics, and to regulate traffic therein; to prevent the false advertisement of food, drugs, and cosmetics, and for other purposes.

30300-84-10

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