To whom it may concern:

MARCUS W. NEWCOMB, M. D., Browns Mills-in-the-Pines, N. J., July 19, 1935.

I hereby appoint Dr. Norman W. Burritt to represent me and the Medical Society of the State of New Jersey at the hearings of a subcommittee of the Interstate and Foreign Commerce Committee on Senate bill no. 5.

MARCUS W. NEWCOMB, M. D.,

President of the Medical Society of New Jersey.

Dr. BURRITT. For about 22 years the Medical Society of New Jersey has been thinking about the various food and drug legislation, digesting the court records of some 28,000 published proceedings, and the various annual reports of the Department of Agriculture and the Food and Drug Administration. Not lightly does the Medical Society of New Jersey adopt the resolution, practically verbatim, 2 years in succession, which has already been published, but which I prefer to read into the record of the hearings, if I may [reading]:

Whereas the attention of the members of the Medical Society of New Jersey has already been called to the lack of proper enforcement of the present pure food and drug law, under its present administrator; and

Whereas physicians, being compelled to depend upon uniformity of drugs in all their missions of mercy, are vitally interested in the purity and uniformity of drugs prescribed; and

Whereas the physicians of New Jersey, believing that legislation to control advertising should not be confused with legislation to control the purity and uniformity of drugs and foods; and

Whereas it has been demonstrated that the Federal Trade Commission already has power to prevent the false advertising of foods and drugs or any other product, if they be persuaded to do so; and

Whereas the series of offenses which have on occasion been successfully punished under the present mandatory Wiley Act demonstrates that it has sufficient powers for enforcement if properly administered; and

Whereas some of the interested parties have already been accused of, and have admitted, allowing certain food and drug producers to repeatedly violate the law without punishment, while other producers, for even lesser offenses, are criminally prosecuted for a first offense; and

Whereas the same individuals charged with the administration of the law, who have allowed repeated violations of the law, which is a mandatory law and provides only criminal prosecution for every offender, have now sought to have a new law which will legally give them discretionary power in its enforcement; and

Whereas this new bill, Senate bill no. 5, the Copeland bill, in its own words has made an unenforceable law, sponsored by one who sets himself up as against false advertising of drugs and proprietary medicines, while he is himself at the same time lending his voice to radio programs advertising proprietary medicines; and

Whereas the committee on foods, the council on pharmacy and chemistry, and the investigation bureaus of the American Medical Association have exercised selections unwarrantable in the notices of judgments that they have published, and have permitted the licensee to use their seal on the advertisements of products that are even at the same time being successfully prosecuted by libel actions under the food and drug law; and

Whereas it is our duty as physicians to assume a leadership in promoting free and open discussion of a condition of which we should have expert knowledge if we had honest information: Therefore be it

Resolved, That the New Jersey Medical Society does hereby urge and, as representatives of the ethical physicians of the United States, does hereby demand a complete congressional investigation of the enforcement of the present pure food and drug laws, the investigating committee to have full power to call individuals and records, under oath, before any new pure food and drug legislation shall be enacted by Congress.

As I say, not lightly was that resolution passed through the Medical Society, the data accumulated on which the resolution was writ

30598-35- 5

ten being examined by the welfare committee of the State Medical Society, by the board of trustees of the Medical Society, and by the reference committee of the Medical Society in convention.

Mr. KENNEY. Is your reference to the State of New Jersey, Doctor, or does it apply throughout the country?

Dr. BURRITT. It does not apply throughout the United States, for the reason that, although this resolution was taken to the American Medical Association at its last convention at Atlantic City, the resolution was passed to a committee and was not reported back to the floor of the house of delegates for discussion.

Mr. CHAPMAN. Doctor, how many members are there of the Medical Society of New Jersey?

Dr. BURRITT. Three thousand seven hundred.

Mr. CHAPMAN. What proportion of the medical profession in that State does it represent?

Dr. BURRITT. It represents about 92 percent of the medical men in New Jersey.

Mr. KENNEY. When you refer to an "unenforceable law ", Doctor, do you mean in the State of New Jersey?

Dr. BURRITT. No; I am sorry, but I am not a lexicographer. On the other hand, I do understand that the word "authorized" does not mean that a man is commanded to do anything. Section 701, paragraph (a), on page 22, reads:

The authority to promulgate regulations for the efficient enforcement of this act, except as otherwise provided in this section, is hereby vested in the Secretary.

Meaning the Secretary of Agriculture-meaning, of course, the Federal Food and Drug Administrator.

The enforcement clause, on page 27, section 705, reads:

The Secretary is authorized to conduct examinations and investigations for the purposes of this act through officers and employees

In section 710, the latter part of the paragraph, beginning on line 17, the middle of the line, there is a very nice illustration of what is meant by using certo or any such form of pectin in a jelly or jam, which I believe most housewives use in preparing their own jam in their own homes. We did in our household when we prepared jams for ourselves, incorporating therewith, therefore, considerably more water than we would have had if my great-grandmother had prepared them; however, getting a very much better product for keeping qualities. [Continues reading:]

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 action, minor violations of this Act whenever he believes that the purposes of this Act can best be accomplished by a suitable written notice or warning.

Mr. COLE. What is the meaning of that language?

Dr. BURRITT. That is a carte blanche to enforce if the officials care to, or not if they do not care to. There is no mandatory provision in this act. They can prevent the use of pectin or certo in jams or they cannot. They can do it in this case, or they cannot in others. They are not told to do it in every single case.

In the present law, the Wiley Act, section 4, a little more than halfway through the paragraph, reads:

And if it appear that any of the provisions of this Act have been violated by such party, then the Secretary of Agriculture shall at once certify the facts to the proper United States district attorney.

Section 5 [continues reading]:

That it shall be the duty of each district attorney to whom the Secretary of Agriculture shall report any violation of this Act to cause appropriate proceedings

I skip a little there—

To cause appropriate proceedings to be commenced and prosecuted.

Gentlemen, there is no question in the minds of enlightened men who have to do with preparations for the preservation, or possibly the bringing back to life, of those whom we are called to treat, that the former act, commanding the enforcement officials to enforce the act as it is written, has no comparison with the proposed bill, with merely authority given to do this or do that-labeling or looking after the contents of foods or drugs. The definition of a minor offense against the law, instead of being a single case out of 35,000 cases of a jam put out by a certain manufacturer, might be a single bottle containing 16 ounces-a pint of tincture of digitalis or tincture of aconite or any such remedy, which we have to use when we go to the bedside of an individual to treat that particular individual for some condition which is liable to terminate fatally within a few hours. One pint might be a minor offense; 35,000 cases might be a major offense.

Mr. COLE. Doctor, in this resolution adopted by the New Jersey Medical Society you ask for an investigation of the administration of the Food and Drugs Act. In the same resolution you have a direct reference to the author of this bill in the Senate. Do you attach any significance to those two statements being in the same resolution?

Dr. BURRITT. I do not think you need to attach any significance to it at all.

Mr. COLE. The resolution reads very much as though one prompted the other.

Dr. BURRITT. No. It is in the same resolution, but the two subjects are covered by the same resolution. You might unite any two facts in the resolution and say that they are conjoined. They are the result of about 2 years of study by a committee of the New Jersey Medical Society.

Mr. KENNEY. Doctor, is it your view that this bill simplifies the construction and enforcement of the act?

Dr. BURRITT. By repealing all of the court actions under the original bill it will be quite a number of years befor any court opinion can be built up to enforce the proposed law.

Mr. CHAPMAN. Doctor, how many were present at the meeting of the medical society when that resolution was adopted?

Dr. BURRITT. It was adopted by the official house of delegates, of which I believe there are 270 members. I may be incorrect about that, but that is about it.

Mr. CHAPMAN. Thank you very much, Doctor.

Representative Connery, of Massachusetts, desires to file a brief on behalf of Mr. William P. Jacobs, which will be filed.

(The chairman ordered the following statement of William P. Jacobs, executive vice president, Institute of Medicine Manufacturers, inserted in the record:)

Gentlemen, my name is William P. Jacobs, 40 Worth Street, New York, N. Y., executive vice president of the Institute of Medicine Manufacturers.

In appearing before you today I am representing a large group of well-known, reputable manufacturers of legitimate drug products which have been advertised throughout America for years and have been generally accepted by the consuming public-products the merits of which have long since been proven by public acceptance.

We are not opposed to a food and drug bill. We are very much in favor of truth in advertising and honesty in manufacture and sale of drug products. We take no exception to many of the provisions suggested in the several food and drug bills which you have before you for consideration at the present time. In general, however, we believe that public health, and the interests of manufacturers and advertising people alike, can be better served through a strengthening of the present Food and Drug Act rather than by the substitution of an elaborate, intricate, more or less bureaucratic type of legislation, such as has been recently presented to you.

We would rather remind you that the present Food and Drug Act required 29 years of court interpretation and State legislative acquiescence, as well as an expenditure of millions of dollars by Federal Government and by industry in interpreting and testing it to bring it to its present state of usefulness. We believe it would be extremely unfortunate to lose all of that valuable ground which has been gained, and we would greatly regret to see the Federal Government and industry forced into a repetition of the long and arduous task of reestablishing the constitutionality and practicability of a brand-new food and drug bill.

We are very much concerned with the effect of uncertainty upon the industry, as we have observed it during the past 2 years as a result of suggested new food and drug legislation. We anticipate that an intricate new bill would magnify that uncertainty, greatly reduce sales of drug products as well as advertising lineage.

We certainly hope, therefore, that your committee will see fit to so amend the present food and drug law, or the suggested bills, in such a way as to minimize this inevitable element of uncertainty.

We will now mention a few of the objections which we find in the Copeland bill, S. 5, and briefly state our reasons for the objections, and in order that this study may be of some constructive assistance to the subcommittee, we will complete this presentation by the listing of several amendments to the Copeland bill which will, in our judgment, make it more acceptable and more workable.

PRINCIPAL OBJECTIONS

Among the principal objections or shortcomings of S. 5, we wish to point out that the proposed legislation in its complicated set-up grants entirely too much authority to the Secretary of Agriculture. We realize that this auhority has been greatly reduced by amendments, but we are confident that the authority should be even further reduced. With similar bills, the courts have decreed that Congress has no right to delegate authorities to others such as are provided in many places in S. 5. S. 5 is a skeleton bill and is capable of a multiplicity of interpretations, which will in the final analysis have the form and force of law itself. We question whether it is in the interest of public health or in accordance with the Constitution of the United States.

The Copeland bill provides for factory inspection, which will, in our judgment, be impractical, impossible of execution with a limited appropriation, and will lead inevitably to an examination of secret processes and formulae by agents of the Government. We believe that such a step is unwarranted and not in the interest of public health, and that it can easily lead to the acquiring of personal property without due process of law.

Section 402 (F) (2) provides for a declaration of active ingredients and will in its practical application undoubtedly lead to a condition that will be tantamount to a disclosure of secret formulae. Such a provision will not, in our judgment, be in the interest of public health, will lead to confuse rather than inform the public, and will encourage the two major enemies of legitimate sales and distribution today-namely, substitution and counterfeiting.

S. 5 sets up penalties for minor infractions which in many instances will be entirely too severe, and will result in the discouragement of advertising of legitimate products by small but honest manufacturers who will be afraid to risk the possibility of a barrage of Federal regulations.

We think that S. 5 should be materially amended to lighten the penalties and avoid dual attention to the same offense in order that it may be more practical. The amendments will be specifically suggested later in this presentation.

Advertising is at present regulated effectively by the Federal Trade Commission. The Copeland bill proposes to have it likewise regulated by the Food and Drug Administration, though it carries a provision which is meaningless, and which in section 717 (A) reads as follows:

"And provided further, That nothing in this act shall impair, or be construed to impair, or diminish the powers of the Federal Trade Commission under existing law."

On the face of it, this provision sets up a dual control of advertising which will be unnecessarily expensive, unwieldy, and cause serious complications. We recognize the right of the Department of Agriculture to regulate not only advertising but the manufacture and sale of products which are imminently dangerous to health, for that is their true function. However, the protection of the public pocketbook is not by any stretch of the imagination the true function of the Department of Agriculture, for there is, and has been, set up for many years, under the Federal Trade Commission Act, an able body for the performance of this function.

By all means, the Copeland bill should therefore be amended to avoid this duplication and to limit the Department of Agriculture to activities which are truly within the scope of their functions. This, it seems to us, is a most important fallacy in the suggested Copeland bill and one which certainly necessitates an amendment.

The several amendments which we suggest are presented as follows:

PAGE 21. "FALSE ADVERTISEMENT" DEFINED

"An advertisement * *

shall be deemed to be false if it is false or misleading in any particular relevant to the purposes of this act

*

PAGES 29 TO 31

Nine offenses are specified, and severe penalties prescribed. Among the major offenses of adulteration, misbranding, forgery, and use or disclosure of trade secrets by officials, we find minor offenses of disseminating false advertisements. (Sub. 4 and 5, p. 30.)

Nearly all articles of commerce advertised and sold in interstate commerce are pure, wholesome, useful, safe, and commonly bought and used by everyone. Very few articles advertised are dangerous to health or person. Why should sellers of articles that are not injurious be branded as criminals because, perchance, some statement appearing in an advertisement may later be found to be misleading, and therefore a false advertisement within the definition on page 21.

Such drastic punishment for publishing advertisements containing statements that may be adjudged to be misleading under the definition on page 21, when the article advertised is not dangerous to health or person, is too severe to be enforced.

Have we reached the time when people must be imprisoned for minor offenses?

The people will not support such laws, and juries will not convict.

If the article advertised is imminently dangerous to health or person, the seller-advertiser should be severely punished, and such an article should not be advertised or sold. In such cases punishment should not be limited to "false" advertisement but should extend to any advertisement, whether true or false. Such dangerous articles should not be advertised or sold to the general public under any conditions.

PAGE 31, LINES 17 TO 25-PROVISO

The Senate evidently considered such penalties too severe if the article was not imminently dangerous to health, or the advertisement grossly deceptive, and added this proviso: