34

FOODS, DRUGS, AND COSMETICS

STATEMENT BY CONGRESSMAN ARTHUR P. LAMNECK,
COLUMBUS, OHIO

Mr. LAMNECK. Mr. Chairman and gentlemen of the committee. I am a Representative in Congress from Columbus, Ohio. I am here to oppose the passage of this bill. I do not know which one you are considering now, whether it is 1944, 2000, or 2800.

The CHAIRMAN. S. 2800 is the bill.

Mr. LAMNECK. The people that I represent are opposed to all three of them. Now, in my district I have large wholesale houses, I have many manufacturers engaged in the manufacture of drugs, foods, and cosmetics, and if I reflect their sentiments, I believe I am safe in saying that there is no public demand for this bill. They seem to feel that the present bill should be amended, if there is anything wrong with the way the Drug Act or this Pure Food Act is being handled. They oppose very strongly the passage of this bill, because it gives an executive of a department autocratic powers and, expressing my personal opinion, I believe that Congress, in the last few years, is delegating powers to executives which they should not do, and as far as I am concerned, I expect to oppose that tendency in legislation, and I think I could say that you gentlemen know that many bills that we have passed during this session and in the previous session, have delegated powers to executives, which I do not think we should do.

Now, if there is anything wrong with the old Pure Food Act, that was passed in 1906, why not amend it, and put the amendments in that bill, to make it a good law? I think it is a good law now, except that it does not include some of the things that have developed since the original act was passed.

Another thing I want to call your attention to is that 46 cities in the Union have passed laws based upon the old act, and if that old act is repealed, I am not so sure that you will seriously affect the laws that are now in effect in the various States. It will affect many court decisions, and I am told that one of the reasons for the passage of this act is that the department which has been trying to enforce the old law, has found many judicial cases decided against them, and that they are trying to pass a law which will make their decisions effective.

Now, I don't know whether that is true or not, but if it is, it seems to me it is a very poor plan to follow.

Now, you take some of your definitions, take your definition of advertisement; it includes "all representations of facts or opinions disseminated in any manner, by any means other than by labeling or label."

Now, it seems to me that is a very poor decision, and is going to get us into a lot of trouble. Take your definition of a drug. A drug is deemed misbranded if a disease is mentioned for which the drug is not a specific cure. Now, I am told that there are only four specific cures known to medicine, and I believe that a man that thinks aspirin is a good thing for a headache, as I do, if he wants to call it a cure for headache, that is all right, and if they advertise it as a cure for headache, it is to me in many cases; it cures my headache; maybe not permanently, but it cures it temporarily anyway. Now,

FOODS, DRUGS, AND COSMETICS

35

it seems to me that one of the things that is back of this movement— I do not know where it originated-is probably to prevent the public from going to a drug store and buying some patent medicine that they think is good for the thing that ails them. This bill, in our judgment, is too drastic. It puts autocratic powers in the hands of executives. We do not think the bill is necessary, and if there is anything wrong with the present Drug Act, we ought to amend the act and cure some of the effects that we are complaining about.

Now, that is our position, and that is all I have to say, and I represent manufacturers of foods, drugs, and cosmetics, and the only expressions that I have had favoring this bill come from the university professors at the Ohio State University, and some of the students that they have asked to write letters supporting the original bill.

That is all I have to say, gentlemen.
The CHAIRMAN. Thank you, sir.
Mr. Dunn, we will hear you.

STATEMENT OF CHARLES WESLEY DUNN, NEW YORK CITY, REPRESENTING THE ASSOCIATED GROCERY MANUFACTURERS OF AMERICA, AMERICAN PHARMACEUTICAL MANUFACTURERS' ASSOCIATION, NATIONAL DRUG TRADE CONFERENCE, AND OTHER ORGANIZATIONS

Mr. DUNN. Mr. Chairman, and gentlemen. I represent at this hearing the following organizations: First, the Associated Grocery Manufacturers of America. That organization is, in fact, the National Association of Food Manufacturers in this country, and includes the representative food manufacturers throughout the country, to a very large extent. They are all advertisers, and many of them are among the larger advertisers in this country. I also represent the American Pharmaceutical Manufacturers Association, which includes the representative pharmaceutical manufacturers who serve the medical profession. Of both of these associations I have the honor of being the general counsel. I should state, at this point, that while I am chairman of a special committee of the National Drug Trade Conference, which largely represents the organized drug trade of this country upon this legislation, that Dr. James H. Beal, who will follow me, will speak for the conference at this hearing.

In addition, I have the privilege of representing a large organization of manufacturers of animal foods, subject to this bill, known as the "National Association of Manufacturers of Dog Food."

Moreover, I represent at this hearing a prominent manufacturer of cosmetics, the Armand Co., which is engaged in the manufacture and advertisement of cosmetics throughout the country.

I perhaps may further be privileged to speak in my own personal capacity at this time, for the reason that for more than a quarter of a century I have been giving special professional consideration to the food and drug law that we have here in this country. Now, as I stated, Mr. Chairman, after the December 7 and 8 hearing upon Senate bill 1944, the food, pharmaceutical, and cosmetic interests, I have the honor to represent, endorse, and approve the public

36

FOODS, DRUGS, AND COSMETICS

purpose of this legislation. That purpose is this: To revise the Federal Food and Drugs Act, to cure serious defects in it, and to strengthen the protection of the Act in the interests of the consuming public.

Now, the bill is designed to accomplish this public purpose by doing these things, principally: First, to prohibit the false advertising of foods and drugs and to extend the act accordingly. Secondly, to extend the act to also include cosmetics, therapeutic and remedial devices and substances and preparations other than food, which are directed to affect the structure or any function of the body, in order to prevent the adulteration, misbranding, and false advertising of these products; and thirdly, to strengthen the definitive and the administrative and the procedural provisions of the act, especially to the extent, for example, of increasing the penalties, by adding a new enforcement procedure, by injunction, and of increasing the power of publicity of the Government under the act.

Because we approve the stated public purpose of this legislation, our objection to it is confined to its form, and its form presents serious questions of policy, provision, and omission. To constructively indicate our views of an appropriate bill upon this subject and to assist Congress in drafting such a bill, we have prepared and caused to be introduced S. 2858, by Mr. McCarran, and H.R. 7964, by Mrs. Jenckes, which I will hereafter call the McCarran-Jenckes bill; and in discussing S. 2800, which is before you, I will comparatively review the two bills to note important differences between them. As the situation_now stands, we are opposed to S. 2800 as drawn, and we support S. 2858, but we hope that, as a result of this hearing and after the committee has considered all of the pertinent bills before it, the committee will report a sound, just, and effective bill to revise the Federal Food and Drugs Act. Such a bill is in the public interest, and we approve of it.

Before stating our specific and principal objections to S. 2800, I desire to make two general comments upon S. 2800. The first comment is that it should be revised in the interest of a more logical order and a clearer statement of its provisions. For example, the

Senator CLARK. Are you speaking of S. 2800?

Mr. DUNN. I am speaking of S. 2800. For example, the definitions relating to food are scattered through six and more different and separated headings, with the result that the bill is difficult for even one who is fairly familiar with this subject to conveniently read and to readily understand. This has been done in the case of the McCarran-Jenckes bill. That is to say, the definitive provisions as to food, drugs, and cosmetics, respectively, have been consolidated under a single product heading for immediate reference.

The second comment I have to make is this, that the official name of the revised act, which is prescribed by section 1 of S. 2800, is inaccurate and misleading. That name is "the Federal Food and Drugs Act", which is the present name of the existing act, whereas the fact is that the revised act applies also to cosmetics. Therefore, the correct name for the revised act is manifestly the "Federal Food, Drugs, and Cosmetics Act." Section 1 of the McCarran bill so provides.

FOODS, DRUGS, AND COSMETICS

37

Now, before dealing with the definitive provisions as to food, I am going to discuss two principal objections to the administrative part of this bill, which are a basis for any intelligent discussion of the definitive sections of the bill.

First, we respectfully object to the omission from S. 2800 of a provision for an administrative board of review; that is, a board to which a manufacturer, advertiser, or importer may appeal for a review of administrative decision that he has violated the act, which decision he believes to be warranted, and prior to his criminal prosecution upon the basis of the decision.

Senator COPELAND. You have that right under the present law? Mr. DUNN. We do not have the right under the present law. I will discuss the reason.

Senator COPELAND. What you are proposing is that all administrative acts of the Secretary shall be subject to review by the board which you propose!

Mr. Duxx. If you will permit me to develop my argument, I will answer that question very fully. The McCarran-Jenckes bill contains this provision for a board of review.

Section 19 (1) (b) of that bill creates such a board and gives the respondent to an administrative proceeding under the act the right of a review of an administrative decision of violation, provided he promptly applies for the review and the board grants his application. This proviso empowers the board to deny an application without merit. The board consists of five members appointed by the President for terms and subject to regulations prescribed by him and its judgment is by a majority vote. These conditions reasonably assure a proper personnel and a due procedure. The board is a quasijudicial body created and acting independently of the Secretary of Agriculture and its judgment of reversal is binding upon the Secretary. Such a board is not effective to prevent the due criminal prosecution of actual violators of the act. For if the evidence sustains the adverse administrative decision under review the board must affirm it. Such a board is only effective to prevent an unwarranted and therefore unjust criminal prosecution of a manufacturer, advertiser, or importer. The extension of the act to prohibit false or deceptive advertising makes the provision for such a board a reasonable, just, and necessary part of the revised act. This because a board law against false or deceptive advertising written in general terms, presents an infinite number of questions of close and borderline construction, questions which are highly technical in character and difficult and puzzling of answer, questions which involve honest divergence of opinion and are subject to honest opposite answer.

Consequently in plain justice and because of the essential place of advertising in the modern merchandising of food, drugs, and cosmetics, and because of the practical difficulty and expense involved in changing settled plans of advertisement there ought to be some provision in this revised act for a competent and impartial administrative review of an adverse administrative answer to such a question. which answer the advertiser sincerely believes is unreasonable and not sanctioned by law, before he is compelled to face a criminal prosecution and is publicly branded as a false advertiser upon the basis of that answer.

38

FOODS, DRUGS, AND COSMETICS

The danger of an erroneous administrative answer to such a question is very real, because the administrative approach to the question is more academic and governed by a strict construction of the act and a literal interpretation of the advertisement and may be influenced by personal disposition or by an unduly narrow point of view. The very existence of this board of review would be a strong influence against a wrong administrative answer to such a question. And it would operate to protect the Secretary of Agriculture from his misadministration of the act, unintentional, of course, as much as it would operate to protect the advertiser. It is an indisputable fact that Senate 2800 as now drawn, contains no provision whatever against an unjust and unwarranted criminal prosecution, based upon an erroneous administrative decision of violation with respect of an advertisement, unless this provision for a board of review or a similar provision is inserted. It is no answer against such a board to say that the present act does not provide for it. And for two reasons: The first is that the present act ought to include such a board, in principle and public policy. The second is that whatever question there may be about including this board in the present act there can be no reasonable question, in our view, that the board ought to be included in the revised act, because of its extension to the broad and infinite field of advertising. Likewise it is no answer against this board to say that the manufacturer or advertiser has his day in court upon his criminal prosecution. For the reason that the very purpose of the board is to prevent an unjust criminal prosecution with its resulting injury. Furthermore it is no answer to this board to say that S. 2800 provides injunctive protection against the misadministration of the act, because that protection, in section 23, is limited to and against invalid formal regulations, which do not deal with the administrative construction of advertisements here principally referred to. I have heard three objections to this board which deserve consideration. The first objection is that the board may not be right in personnel. Our reply is that a right personnel is most reasonably assured by the fact of selection by the President. It may well be provided that not more than three members of the board shall be of the same political party. And it may be better to expressly prescribe the terms of office in the act. The second objection is that the board plan operates to delay the enforcement of the act. Our reply is that the ensuing delay is reasonably necessary to assure a due and just administration of the act. The third objection is that this board plan contains no provision for a court review of a judgment of reversal by the board. Our reply is that we have no objection whatever to such a provision, if the committee desires it. It is undoubtedly in the public interest.

Now, that is all I have to say upon the problem of a board of review, and before passing to another question, I will be glad to answer any questions on that one subject.

Senator COPELAND. Mr. Dunn, may I ask you, would you have this board review advertising, but in addition to that, as I understand it, all the administrative acts of the Secretary!

Mr. DUNN. The board would be empowered broadly to review any decision of violation, but the board is empowered to deny an application for review, if such a review is in its opinion unnecessary or unwarranted.