"Provided, however, That any person who violates any of the provisions of subdivisions (4) or (5) of paragraph (a) of this section shall only be liable for and forfeit and pay a civil penalty of not more than $1,000, to be recovered by civil action in the district court within the district where the person resides or carries on business, if (1) the violation does not involve imminent danger to health or gross deception, and (2) the violation is established by opinion evidence only."

This proviso is inoperative. It requires that the violation must be established by opinion evidence only. The violation consists of dissemination (publication) of an advertisement that contains a false representation. The publication is a fact that must be established by factual evidence, and recovery cannot be had unless publication is established. The falsity of the statement might be established by opinion evidence. The violation, consisting of the two elements of publication and falsity, cannot, under any condition, be established by opinion evidence only. This proviso, therefore, is meaningless. It cannot be used to temper the penalty or save the offender from being branded as a criminal.

SUGGESTED AMENDMENTS

The object of this proviso may be attained by striking out the proviso and amending subdivisions 4 and 5 on page 30 by striking the word 'false" in lines 7 and 12 and inserting after "cosmetics", in lines 11 and 14, the following: "That are imminently dangerous to health or person."

THE FEDERAL TRADE COMMISSION QUICK AND EFFECTIVE PROCEDURE

Congress in 1914 created the Federal Trade Commission, declared all unfair methods of competition in interstate commerce to be unlawful, and empowered and directed the Commission to prevent them.

The courts have uniformly held that false or misleading advertising is such an unfair method, and sustain the Commission in preventing false or misleading statements in advertising.

The Commission has acted in over 3,500 cases. Its action in these cases has controlled many times that number.

The procedure of the Commission is quick and effective. Under its present procedure, the advertising is revised and corrected promptly; sometimes immediately upon notice, and usually within a few weeks. This procedure protects the public by preventing misleading advertising in the future.

The Commission has no power to punish past offenses. This bill seeks to punish past offenses. It does not prevent future offenses. For minor offenses, there is no occasion to brand offenders as criminals by imposing prison penalties which indicate felonies, as long as the power to prevent future offenses is vested in another Government agency.

The informal procedure of the Commission is far more rapid and effective than any formal procedure in court can be.

Limiting the imposition of penalties to the dissemination of advertisements of food, drugs, devices, or cosmetics that are imminently dangerous to health or person, will make this section reasonable and enforceable.

COMPOUNDING FELONIES

Page 35, lines 17 to 22, reads:

Nothing in this act shall be construed as requiring the Secretary to report for prosecution, or for the institution of libel, injunction proceedings, or civil penalty actions, minor violations of this act whenever he believes that the purposes of the act can best be accomplished by a suitable written notice or warning."

This is an unusual provision.

The Secretary of Agriculture must, of necessity, act through a multitude of subordinates. The Secretary (through his subordinates) must gather evidence to establish violation of the many provisions of this act. This evidence must be submitted to the district attorney, and the district attorney is required, without option, to prosecute the offender.

To clothe the Secretary (his subordinates) with power to compound felonies. is a very unusual grant of power to administrative officers. This power enables the subordinates of the Secretary to administer this act unfairly by threat of criminal prosecution, unless the apparent offender submits to the

reasonable or unreasonable demands of some field agent of the Secretary. This installs Government by threat and bluff.

Many business men will yield to unjust demands rather than undergo the cost and disgrace of defending criminal charges threatened by the agents of the Secretary. Such a condition should not be established, and there is no occasion for it. The power to prevent minor offenses is vested in some Government agency as it is now vested in th Federal Trade Commission.

A provision permitting the Secretary to report minor offenses to the Federal Trade Commission for action, and major offenses to the district attorney for prosecution, will correct this situation, also avoid the abuse of power by threats and bluffs made by subordinate officials.

Lines 20, 21, 22, page 35:

AMENDMENT SUGGESTED

Strike out "minor violations of this act whenever he believes that the purposes of the act can best be accomplished by suitable written notice or warning."

And insert in lieu thereof "but in minor violations of this act the Secretary is authorized and directed to report the same to the Federal Trade Commission together with all evidence he may have in hand to establish such violations."

See section 712, page 39.

INJUNCTIONS

There is no occasion to vest power in another tribunal to prevent the dissem ination of false advertising when articles introduced into commerce are subject to seizure and libel proceedings. The Department of Agricuture is not authorized to seize all of such articles, and the Federal Trade Commission is authorized to prevent false advertising as an unfair method of competition in interstate commerce.

The courts have uniformly held that false advertising is such an unfair method, and has sustained the Federal Trade Commission in preventing such advertising.

The language of this section is uncertain.

It reads:

"In order to avoid multiplicity of criminal prosecutions, etc.", the United States district courts are vested with jurisdiction for cause shown to enjoin "the repetition, etc."

Can the courts issue an injunction in such a case before or after at least one criminal prosecution has been terminated by conviction? Ordinarily, there can be no multiplicity without at least one factor to be multiplied. Possibly injunction could be issued after one prosecution has been started.

Who will prejudice the truth or falsity of an advertisement before the charges are established?

In such a case, who can say the advertiser will repeat the same advertisement? Unless he does repeat the same misrepresentations, what cause can be shown for the issuance of an injunction?

Such injunctions are only to be issued to prevent the repetitious dissemination. The repetition must be exactly the same. It cannot vary.

In criminal cases, the charges must be exact and limited to the identical offense. They cannot be extended to all offenses of like import.

The Federal Trade Commission has power and does prevent, by cease and desist orders, or by stipulation with the advertiser, specific false advertising, and all representations of like import.

The Federal Trade Commission may proceed to restrain the advertiser, regardless of the seizure of his product by the Department of Agriculture; prosecution in any court for past offenses; multiplicity of proceedings; or repetitious advertisements.

The power of the Commission is far broader than the power it is proposed to vest in the district courts of the United States by this bill.

Why should the situation be complicated by throwing a multitude of such cases in the district courts of the United States that are already overcrowded and calling for help, when the Federal Trade Commission is available with its trained staff and long line of judicial precedents to guide it in proceeding promptly and effectively to prevent such offenses, and all others of like import?

AMENDMENT SUGGESTED

Strike out all of section 712 on pages 39 and 40, insofar as it refers to false advertising.

Let the Secretary be authorized by law, if necessary, to do what he is now doing in fact, viz, report such cases to the Federal Trade Commission.

We are prepared to assure you of the enthusiastic support of S. 5 if it is amended as we have suggested. We merely wish a bill which is workable; one which protects legitimate interests; and one which is capable of protecting public health.

STATEMENT OF CLINTON ROBB,

CONSULTING COUNSEL FOR

UNITED MEDICINE MANUFACTURERS OF AMERICA, INC.

Mr. ROBB. Mr. Chairman, may I file a prepared statement on behalf of the United Medicine Manufacturers of America?

Mr. CHAPMAN. Yes. Give your name and identification.
Mr. ROBB. I am unable to be here tomorrow.

My name is Clinton Robb, and I appear here as consulting counsel for the United Medicine Manufacturers of America, Inc., one of the large trade associations in this field, as well as in behalf of numerous manufacturers of and dealers in proprietary preparations throughout the United States.

Those whom I represent are not opposed to reasonable revision of the existing Food and Drugs Act, and I shall try to make my observations constructive rather than merely critical, in an effort to be of all possible service to this committee and to the Congress.

As passed by the Senate the so-called "Copeland bill ", or S. 5, is a great improvement over that bill as originally introduced. However, I believe that bill should be further revised to prevent injustice to those whom it would seriously affect.

When considering proposed legislation dealing with proprietary medicines and proprietary preparations it should be kept in mind that the medical viewpoint is that practically all drugs are dangerous unless administered under the supervision of a physician and hence that, except in a few instances involving comparatively trivial ailments, self-medication is dangerous and should be suppressed; and that public statements by the Department of Agriculture, whose views on drug questions are those of its medical advisors, reflect that position.

For these reasons and since it is self-evident that no man should sit in judgment of a case or issue in which he has even an indirect interest, I submit that decision as to the rights of those who make and self proprietary preparations should not be committed by the Congress to the medical profession. Let it be clearly understood that I am not reflecting upon the integrity of medical men but that I am referring to the unconscious prejudice which the physician reasonably may be expected to have against self-diagnosis and self-treatment which tend to cut down the revenues of professional men. Indeed, the medical profession ought not to be placed in a position where its motives and actions may be subjected to criticism and suspicion.

As passed by the Senate, S. 5 provides:

SEC. 402. A drug or device shall be deemed to be misbranded

(g) If its labeling fails to bear plainly and conspicuously (1) complete and adequate directions for use, and (2) such warnings in such manner and form as may be adequate directions against use in such pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application: Provided, That where any requirement of subdivision (1) of this paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Secretary shall promulgate regulations, as provided by sections 701 and 703 exempting such drug from such requirement.

In section 703 (a) it is provided that "To aid and advise the Secretary in promulgating regulations for the protection of public health as contemplated by " certain sections, including the foregoing paragraph (g) of section 402

a committee on public health is hereby provided, which shall consist of five members designated by the President with a view to their distinguished scientific attainment and interest in public health with respect to food drugs, and/or cosmetics and without regard to their political affiliations.

Obviously this section 703 (a) contemplates a board of outstanding physicians and public-health officers who would be committed in advance to the idea that all proprietary preparations intended for self-medication are inherently more or less dangerous and should be removed from the market. It seems only reasonable to expect that under such a board self-medication could not and would not long survive. My objections are not to those requirements of the bill, but as to the committee that would construe and apply them.

Since the interests of the medical profession necessarily conflict in some degree with those of manufacturers of proprietary medicines, no committee or board that is to assist the Secretary of Agriculture or pass upon administrative acts should be composed exclusively of physicians. The public interest can be fully protected and the right of self-medication preserved at the same time by provisions for limiting the number of physicians on such committee or board or requiring the assignment of some nonmedical members who shall be disinterested.

I also feel, after long experience and observation in this field, that in whatever changes it may see fit to make in the present Food and Drugs Act the Congress should do more than merely provide a day in court for a manufacturer or distributor of proprietary preparations who honestly may differ with the Government as to the truth or accuracy of his claims and representations after consulting with those having medical and legal training. Though he may be convinced of the truth of his labeling and advised that his claims and representations do not violate the law, he may be in no position to keep alive the commercial spark while he is fighting for his rights or be without means to wage a long legal battle against the Government, so that he must choose between the short end of a hard bargain with the Department and the destruction of a business which, though of small volume, may represent substantially all his worldly possessions.

I submit that the Congress should prevent such an unnecessary hardship by providing a day in court for those who dispute administrative rulings; by making it possible for a manufacturer or distributor to obtain a summary and informal review of administrative

acts that shall be binding and preserve the status quo pending any review that may be sought in the courts. For reasons already advanced, I suggest the creation by the Congress of a disinterested board of review empowered and directed to give summary consideration not only to threatened prosecutions under the Food and Drugs Act but to threatened administrative acts of the Food and Drug Administration. My position is that if a board of review is created by the Congress, that board should be free from control by the medical profession and should have power to review all administrative acts that do not involve protection of the public from imminent danger to health.

In my humble opinion this matter of a board of review to pass upon threatened prosecutions and administrative acts is one of the most important questions with which the Congress has to deal in connection with this proposed legislation, if a great industry is not to be confiscated and the public deprived of its inherent right to treat its own minor ailments in its own way and with medicines of its own choosing.

Another suggestion is that the Congress leave with the Federal Trade Commission the censorship and control of advertising which does not accompany the package in interstate commerce, rather than commit such censorship and control to the Food and Drug Administration, as contemplated by S. 5. Except in a relatively small number of cases which involve protection of the public from imminent peril to health, and as to which cases the Food and Drug Administration is given ample authority under other provisions of this bill, the censorship of advertising used independently of the package presents questions of fact and fair dealing that properly call for consideration by a board or agency not only familiar with the technique of advertising but with the principles and rules by which the fairness of trade policies and practices in general are to be measured. Not only is the Federal Trade Commission doing very effective work in cleaning up advertising used independently of the package, but the Commission has developed adequate machinery to that end. Moreover, while the viewpoint of the Food and Drug Administration is that of physicians or officials primarily concerned with technical and scientific questions, in which it is bound to reflect the unconscious prejudice of the medical profession against self-diagnosis and self-treatment, the Federal Trade Commission does not have this exclusively medical viewpoint, but accords to medical testimony and evidence only such weight as seems proper in the circumstances. Those whom I represent ask only that the jury before whom they argue their rights be not chosen from those who might be advantaged by a suppression or curtailment of the right of self-medication.

My failure to specify other objections to S. 5 in its present form is not to be construed as an admission that this bill is not subject to revision in other particulars. However, it is my understanding that other witnesses are to cover various other objectionable features of the bill, and I do not feel warranted in consuming the time of this committee by mere repetition.

(The chairman ordered the following communication inserted in the record :)