4. The regulatory authority shall report to the Congress in January of each year all regulations promulgated during the calendar year preceding. Such rules and regulations shall be published as an appendix or supplement to the Statutes at Large or in some other authoritative manner.

5. In event of an emergency, the President may waive the requirements for notice and publication for a stated period, and temporary regulations may be published to meet the emergency, but in any such event the regulations so promulgated shall be in force only so long as may be necessary to permit the promulgation of regulations in the regular manner.

In 1928, because of what seemed to be abuses of the regulatory authority then vested in certain officers of the Treasury Department, a bill along the lines stated above drafted on behalf of the American Medical Association and introduced in the House of Representatives by the then chairman of the Judiciary Committee. House bill 13412, Seventieth Congress, first session, A bill to regulate the promulgation of regulations in certain cases, with reference to alcohol and narcotics. A typewritten copy of that bill is attached.

Of course, the regulations to which the foregoing memorandum relates are only such as are intended to govern the conduct of the public and of industrial and trade interests; such as have the force and effect of law. Regulations intended to govern the conduct of officers and employees in the Department of Agriculture should obviously be promulgated by the Secretary of Agriculture, unhampered by outside influences and in such manner and form as the Secretary deems best. The foregoing memorandum has reference to rules and regulations generally. Possibly standards and tolerances should be determined and established in the manner outlined above for the determination of the form and content of rules and regulations. On the other hand, in view of the highly technical character of the matters entering into the determination of standards and tolerances, it may be better to entrust their determination to some technically informed, permanent board. In any event it seems best that there should be such a board, if not to promulgate standards and tolerances, then to advise the promulgating authority with respect to them. A memorandum relating to the determination of standards and tolerances accompanies this memorandum.

[H.R. 13412, Seventieth Congress, first session]

A BILL To regulate the promulgation of regulations in certain cases, with reference to alcohol and narcotics

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That for the purposes of this act the following words have the meanings assigned to them, respectively, unless the context otherwise requires:

(1) 'Department" means the Treasury Department and any bureau, division, office, and officer thereof.

(2) "Regulation means any order, no matter how it may be officially designated, promulgated by the Department to regulate the importation, production, manufacture, sale, distribution, and use of alcohol and alcoholic liquors, or of narcotic and other habit-forming drugs, for nonconformity with which a penalty may be imposed, either by fine or imprisonment, or suspension or revocation of any registration or of any license or permit, or forfeiture of a right or privilege that has been granted by the Department. It does not include (a) orders merely interpretive of a statute, regulation, or decision, which do not change a rule of conduct or add to or substract from penalties already provided; or (b) regulations which affect only the internal management or discipline of a department; or (c) orders, judgments, and decrees made in the ordinary course of business in specific cases regularly before the Department for adjudication.

SEC. 2. No regulation promulgated by the Department by virtue of any act of, Congress now in force or hereafter enacted to govern the importation, production manufacture, sale, distribution, and use of alcohol and alcoholic liquors or of narcotic and other habit-forming drugs shall be of any force or effect unless— (1) Notice of the contemplated promulgation of such regulation is given; (2) A hearing is had wherein such persons as may be affected by such regulation may be heard; and

(3) The regulation is promulgated and published, all as hereinafter provided. SEC. 3. Notice of the contemplated promulgation of a regulation shall be published in Treasury Decisions. This notice shall contain: (1) A copy of the proposed regulation; and (2) the date or dates, time or times, and place or places at which the Department will hear such persons as may be affected by the proposed

regulation. No hearing shall be held before the expiration of 15 days after the first publication of this order.

The

SEC. 4. Hearings shall be held by the Department in accordance with the published notice, at which any person who may be affected by the contemplated regulation may be heard in person or by counsel or agent and may file a brief. Department shall have discretion to determine whether one or more hearings shall be held, whether such hearings shall be held concurrently or consecutively, and when and where such hearings shall be held, and shall designate the persons who are to hold them. The Department may at any such hearing continue the same, in its discretion, to any time and place that may then and there be fixed.

SEC. 5. Notice of any regulation that has been made by the Department shall be given by publication in Treasury Decisions. This notice shall include (1) a copy of the regulation as made or issued and (2) a statement of the time, not less than 15 days after the first publication of such notice, when the regulation will become effective.

SEC. 6. The Treasury, and every department thereof that promulgates any regulation within the purview of this act, shall submit to Congress annually on the first Monday in December a report containing all regulations so promulgated during the next preceding fiscal year. All regulations so reported shall be published as an appendix to the Statutes at Large of the United States. The first report submitted by the Department shall contain all regulations promulgated by the Department by virtue of any of the acts hereinbefore specified, in force at the close of the next preceding fiscal year. The subject matter of the report thereafter submitted to Congress shall be arranged in the same order as the subject matter of the first report.

SEC. 7. No provision of this act shall be construed as limiting the discretion of the Department as to the subject matter of regulations to be made or issued.

SEC. 8. The Department shall supply copies of all regulations promulgated by it on application, and, in the discretion of the Department, free or on payment of the reasonable cost thereof.

SEC. 9. The President of the United States may, in his discretion, declare that an emergency exists and suspend the provisions of this act during the continuance of such an emergency. Any regulation promulgated without notice and hearing during such suspension shall be published as speedily as may be practicable in Treasury Decisions. As soon after such publication as may be practicable notice shall be given of the day or days, time or times, and place or places. at which the Department will hear such persons as may be affected by the published regulation, hearings shall be duly held, and the regulation as originally issued or as modified as the result of such hearings shall be repromulgated and republished, all in accordance with sections 3, 4, and 5 of this act. Any regulation promulgated without notice and hearing under authority of this section shall be in full force and effect, however, so long as may be necessary to allow for its repromulgation and republication in due course as herein provided.

SEC. 10. The courts of the United States shall take judicial notice of any regulation duly printed in the Statutes at Large under authority of this act, of any copy of Treasury Decisions duly authenticated under the seal of the Treasury Department, and of any copy of any regulation duly authenticated in like manner; and such publication or authentication, or both, of any such regulation shall be prima facie evidence of the making or issuing thereof in accordance with law.

SEC. 11. This act shall not impair the validity of any regulation promulgated prior to the passage of this act.

SEC. 12. This act may be referred to as the " 'Promulgation of Regulations Act."

SEC. 13. The expense incident to the carrying into effect of this act shall be borne by the appropriation for the expenses of the Treasury Department.

MEMORANDUM RELATIVE TO S. 1944

LABELING OF PRESCRIPTIONS

Section 8 (e) requires drugs not covered by other parts of the section, which relates to labeling, to be labeled so as to show the common name of the drug, if any, contained in it and the name, quantity, or proportion of each medicinal or physiologically active ingredient contained in it. Other parts of the same section require labeling in various other ways, as by showing the presence of

habit-forming drugs. There is nothing to except prescriptions from the requirements of this section. Certainly it is undersirable to require the labeling of prescriptions in this manner and the bill should be amended accordingly.

COOPERATION WITH THE STATES

A provision requiring the Secretary of Agriculture to cooperate with the proper officers of the several States in enforcing the Federal and State food, drug, and cosmetic laws would do good. A provision of that kind is in the act under which the Bureau of Narcotics was organized and has, I believe, operated well.

Undoubtedly, Federal food, drug, and cosmetic officers often come into possession of evidence of offenses that might be prosecuted under State food, drug, cosmetic, or fraudulent laws. If they were compelled by law to disclose such evidence to State and local officers doubtless many cases could be brought to trial that now go unprosecuted.

ADVERTISING

Language along the following lines would seem fairly to cover false and misleading advertising:

"No person shall publish or distribute any advertisement that is false or misleading in any particular; but no person shall be convicted or punished under this provision when he shows to the court before which he is tried that when he published the advertisement complained of he did not know and could not by reasonable diligence find out that it was false or misleading; and no publisher or other officer or employee of a newspaper shall be convicted or punished when the advertisement published or distributed shows the name and address of the person in the United States criminally liable for any falsity or for any misleading information or design in it."

BRIEF OF LAURA A. CAUBLE, OF NEW YORK CITY, ON BEHALF OF HOME MAKERS FORUM, INC.

By appointment of Mrs. Otto Hahn, president of Home Makers Forum, Inc., New York, of which I am a director, the oldest club in New York which devotes its entire efforts to the interests and problems of the home, I present the resolution of unanimous approval and endorsement of S. 1944 in principle and urge its enactment in the interest of consumers.

This is the same resolution presented here at the December 8 hearings by Mrs. Malcolm P. MacCoy, president of the New York City Federation of Women's Clubs, Inc.

May I explain that this form of endorsement in principle is the form used by women's organizations to put themselves on record in case there may be delay or minor changes in a bill before its final passage; and to avoid approval of an emasculated bill apparently filled with teeth whose jaw is locked against enforcement.

S. 1944 may well have a few minor changes as suggested by Mr. Campbell; section 3 (c), page 4, line 21, change the period to a comma and add "and mascatory substances in chewing gum.'

Section 17 (d), page 24, line 20, substitute "unless" for "if"; line 21, substitute "refuses to furnish" for "furnishes". Sec. 23 (c), page 31, line 2, substitute "In formulating regulations," for the word "The" at the beginning of the sentence.

Dr. Emerson cut the Gordian knot of "general agreement of medical opinion" by inserting "contemporary" after "agreement of "

Mr. Donald G. Burke's suggestion of a conference for remedial action in the nature of an informal discussion and agreement on all problems between a manufacturer and the administration seems to be feasible though I naturally have not given careful thought to the relations.

Conference may be effective, quick, and inexpensive as a first step in understanding and getting at a subject.

The

Any question of proving intention, or "proof of intent" is impossible. customer is cheated, endangered and/or injured, regardless of intention or intent. Protect the consumer before the question develops to the danger point. In relation to deteriorated drugs: It seems reasonable to establish limits of sale from producer to consumer on those products which may lose their quality or power of action by aging, for example ergot, so as to be useless when needed.

Our

Kodak films and

milk in New York bears a label "not to be sold after X date." other products are subjected to the same regulation. Why not? "The bill robs the public of the right to self-medication." It does not. It prevent advertisement or labeling of medicines for cancer, tuberculosis, diabetes, arthritis, and other diseases which are incurable.

It requires medicines which are not cures to be labeled, "Not a Cure—only a Palliative" when that is the truth.

"The bill will cause public and political resentment which will lead to reactions like those against the eighteenth amendment."

How can it when all the provisions of the bill are in the public interest, insuring that foods, drugs, and cosmetics will not jeopardize health and are honestly labeled and advertised?

"The bill gives too much power to the Secretary of Agriculture (to make standards; to place factories under a permit system; to enter factories for purposes of inspection; to enjoin a manufacturer from further violation of the law, etc.)." There is no danger in conferring such authority, since it is a rule of the Supreme Court that any regulation or standard made as a result of congressional authority to do so, must not be unreasonable, capricious, or arbitrary, and besides all such conferred authority is subject to review of the courts.

"The bill authorizing the Secretary of Agriculture to place manufacturing plants under inspection, will build up an immense army of inspectors and make the Secretary a czar over industry.'

This authority is pernicious and can be exercised only if the manufacturer applies for and requests inspection. Such service is now being carried on by some other agencies in a similar way and this is the way the inspection of meat is carried on. The meat packers benefit by it.

"The bill will increase taxes to care for an elaborate set-up for Federal enforcement."

The cost of enforcement of present law is less than 1 cent per capita. No new enforcement machinery is being set up. It will not appreciably increase cost― now 1 cent per capita.

"The bill will hurt business and depress values invested in advertising business." If elimination of false and misleading advertisements will do so then such a consequence will result. But in the long run, advertising stands to be the gainer in the end.

"The bill will stifle the growth of food, drug, and cosmetic industries."

It will do so only to the extent of restricting unfair competition of small dishonest minority now using dirty, impure, poisonous, and injurious ingredients. "The bill will destroy advertising efficiency."

The claim is absurd as it assumes that advertising which is now essentially honest cannot be both_truthful and efficient. It will give a new psychological slant to advertising. It will inspire invention and create new needs for advertising. No honest advertiser needs to fear anything.

Because of my training in nutrition, public health, economics, and sociology at Columbia University and the following 20 years of active work upon publichealth problems; because I have worked with every commissioner of health of New York since 1914 on some major health problem, and served as deputy commissioner of public markets of New York City in charge of information and conservation, and as teacher and lecturer on food, nutrition, and health in many localities I know conditions and may fairly qualify as an expert-one who knows the problems to be met and solved by S. 1944.

I speak for myself as a consumer with competent knowledge and information upon which to ground opinions and form judgments.

I have no business connections of any nature which influence my message to you, neither have I any reason to shirk my responsibility to other consumers or to hedge in my support of S. 1944.

I am for this bill. There may be slight minor changes some of which have been suggested. Make as few changes as may be consistent with the consumer's interest. Almost every speaker at the hearings of December 7-8 conceded that there is need for this bill. At the same time they offered suggestions which would destroy the bill. One of these was to insert the word "public" before the word "health" wherever it appears in the bill. That would destroy the bill. I have compared the act of 1906 as now in force with S. 1944 and with the sanitary code of New York City both of which measures I have observed in action since 1906. New York City has broad police powers and can quickly move to control new food or drug products, or any endemic, epidemic, or sporadic menace, or any threatening condition, fraud, or adulteration.

Note how quickly Commissioner Shirley W. Wynne, of the Department of Health, formulated definitions and enacted measures by the Board of Health to put under true labels in New York City the adulterated, fraudulent, and misbranded liquors which have flooded the Nation since the repeal of prohibition, December 1933. This was accomplished within a fortnight. Not many cities or communities have this police power.

It takes a long time to get a measure through Congress.

To

S. 1944 will give such control of these same frauds to the whole Nation. meet this need alone this bill should be enacted with the opening of Congress, January 3, 1934. The consumer has the right to know. This knowledge and protection would be of immediate educational value, better than many programs of so-called "prohibition education for temperance".

No person with knowledge of the making of the act of 1906 and its amendments in force; or with the facts in relation to the wide gaps left in the original mouthful of teeth by the compromises which in order to get any law, had to be accepted at that time by Dr. Harvey W. Wiley and his supporters, the valiant body of scientists and officials and the determined and spirited members of the General Federation of Women's Clubs, who then had no votes and were merely the family buyers and enduring silent partners in the greatest business in the Nation-homemaking; or who has made observations or had contact with or experience with the enforcement of the act; no person who has made any definite comparative study of the act of 1906 as it now stands with this Copeland bill (S. 1944) can fail to understand that S. 1944 is a timely consumer's measure.

Also, that it is writen by and under the direction of men who with 27 years of experience with the behavior, enforcement, and court decisions established for the protection of business as well as the consumer and upon whose knowledge, information and opinion S. 1944 has been introduced by a Senator who also knows the difficulties of endorsement by experience as Health Commissioner of New York City and will be fair in his support of the measure.

Who could serve the consumers better or be fairer to the body of business which has reaped such rich harvests from the consumer?

The food and drug division commands the loyal service and trustworthy interest of tried men. The enforcement act is lodged in the really safe Department of Agriculture.

Some speaker proposed a commission or committee of scientists. How many of us can recall the "board" which was appointed in Dr. Wiley's day to "restrain" him. A great Governor of New York got rid of over a hundred boards and commissions in order to get a State government which could be made to function. We are still doing without those commissions in New York and I think one would be out of place in this food and drug work. Competent, scientific advisors are constantly available to the United States Government in and out of the Department of Food and Drugs. Their advice is freely given and sought. S. 1944 will stop the holes left by the compromises and keep secure the teeth to meet the changes which the enlightening and complementary discoveries of biological, chemical, physical, and other scientific research have made possible and necessary, and will keep open the way for the early application of the principles to newer discoveries, products, and methods which may develop in the future.

Do I need to cite here the memorial to the Fifty-fifth Congress, second session, to show how changes and demands were met?

This memorial includes a recommendation for the passage of a food and drug bill which is almost identical with a bill drafted by Dr. Wiley and submitted to the various committees of Congress. This bill in Document No. 233, had the endorsement and whole hearted support of Dr. Wiley.

On page 3, section 5, the following definition is incorporated: "That the term 'drug' as used in this bill, shall include all medicines, recognized in the United States Pharmacopeia and National Formula and cosmetics for internal or external use." Cosmetics were omitted from the act as finally passed. This was a compromise.

Page 3, section 6, of the act, defining adulteration of food, sixth paragraph reads, "If it contains any added poisonous ingredient or any ingredient which may render such article injurious to the health of the person consuming it." The italic words were omitted from the act as finally passed. That was another compromise. The substance of these words forms one of the important provisions recommended in the Copeland bill (S. 1944).

On page 4, section 6, paragraph 9, referring to mixtures or compounds sold under their own distinctive names it is "Provided, That the same shall be labeled,