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MEMORANDUM SUBMITTED TO THE COMMITTEE ON INTERSTATE AND FOREIGN COMMERCE AT THE HEARING ON FOOD AND DRUG BILLS HELD ON JULY 22, 1935

SUBJECT

A proposed amendment giving to importers of food, drugs, devices, and cosmetics the right of review of decisions of the Department of Agriculture excluding such products.

In none of the pending bills has any provision been made for relief to an importer of food, drugs, devices, and cosmetics from a decision of the Department of Agriculture excluding them, no matter how arbitrary such ruling might be or how little justification may exist for the ruling.

This is a situation which has existed under the present Food and Drugs Act and which has worked unfairly so far as the interests of importers are concerned.

For instance, under the provisions of S. 5, the Secretary of Agriculture may hold a hearing upon any imported food, drugs, devices, and cosmetics, and if it appears from an examination of such samples, or otherwise that the provisions of the act are violated, the Secretary of the Treasury shall refuse delivery to the consignee and shall cause the destruction of such article unless it is exported by the consignee or owner within 3 months.

The determination of the Secretary of Agriculture is the finding of an executive department and is not subject to review by the courts or in any other way. The proposed law (S. 5) gives the right to the Secretary of the Treasury to find violations of this act in such controversial matters as "false advertising ", "unsanitary conditions of manufacture, processing, or packing ", and "misbranding", and leaves the importer helpless to reverse or even effectively protest an adverse decision which can only be based on opinion in a field where opinion is frequently divided.

In this situation a new medical product or article of food or cosmetic, accepted and approved abroad, could be barred from this country in the event that the Secretary of Agriculture or any expert called in for his opinion was not willing to accept it, or even to investigate its merits.

This is the only law covering imported articles which denies to the importer any redress from an unfair ruling.

Under the tariff act this principle is recognized, and ample provision is made for a protest by the importer to the collector, causing a reconsideration of the case, then an appeal to the United States Customs Court, then an appeal to the Court of Customs and Patent Appeals, and finally, in a proper case, the Supreme Court may require the controversy to be certified to it for review.

Thus under the tariff act every opportunity is given to the importer to clarify every question of law and fact relating to the law or its enforcement. How different this is from the food and drugs act, where the only protest which may be made must be made to the Department which has already determined the issue against the imported article. The hearing granted the importer means nothing, because this hearing is not ordered by the Secretary until he has determined in his own mind that the article should be excluded.

Care has been taken to give the domestic dealer in these goods every opportunity for a court review of a disputed question. Should he disagree with the Secretary of Agriculture upon the interpretation of the law or on a question of advertising or misbranding, the Secretary of Agriculture must proceed against the dealer or the product in a district court of the United States, where the question may have a judicial determination with a right of review of such decision on appeal.

And in S. 5 the right is expressly given to the dealer in domestic products to restrain by injunction the enforcement of any regulation of the Department which is held to be unreasonable, arbitrary, or capricious, or not in accordance with the facts or law.

At this time, perhaps more than ever, imports should be encouraged and the economic benefit to this country of such imports should be, as it is, recognized. It is furthermore only fair that the importer should be placed on an even basis with the domestic dealer in the right to have a fair court test of any question relating to his business.

It is therefore respectfully requested that any bill approved by this honorable committee provide for a review by the Court of Customs and Patent Appeals of any decision of the Secretary of Agriculture or the Secretary of the Treasury

excluding any food, drugs, devices, or cosmetics imported or offered for import into the United States. Respectfully submitted.

WALTER L. POST,

Attorney at Law.

JULY 19, 1935.

To the Committee on Interstate and Foreign Commerce of the House of Representatives of the United States:

We have been advised that a hearing will be hold by your subcommittee on Monday, July 22, on the so-called "Copeland bill" (S. 5), as well as upon H. R. 8805 and H. R. 6906, all of which have some relation to the regulation of the conditions under which certain foods, drugs, and cosmetics may be dispensed to the public in the United States. As a manufacturer whose interests are naturally vitally concerned with such legislation, we have heretofore appeared through our representatives before the Committee on Commerce of the Senate, where we recorded our approval and recommendation of the Copeland bill with certain slight modifications, and we wish now to present our views briefly to your committee. We have naturally given very careful attention to the provisions of S. 5 and have also studied H. R. 6906, introduced by Mr. Mead, and more recently we have examined the provisions of H. R. 8805, introduced by Mr. Sirovich. In our judgment, the necessity for legislation along the general lines of the Copeland bill is patent, and it is our belief that the manufacturers of drugs who have in mind their responsibility to the public are strongly in favor of the adoption of new legislation which will strengthen and improve the existing Federal food and drug laws.

Our examination and study of the proposed legislation leads us to the definite conclusion that of this legislation, S. 5 is the most effective proposal for checking practices connected with the sale of foods, drugs, and cosmetics which now or in the future may endanger the public health and impose upon the consumer. This bill contains the amendments which have been made to it since it was originally introduced in the previous session of the Congress, and we are convinced represents careful thought and consideration of the many diverse interests which are affected by it. Although the recommendations of the Food and Drug Administration are properly perhaps not the sole consideration in determining the merits of the proposed legislation, in view of the long experience of that administration in this field and its efficiency and integrity in the administration of the present laws, the recommendations of that administration are entitled to great consideration. We believe that S. 5 incorporates to a greater extent than any other proposed bill the recommendations of that administration, and this, we believe, is a very important reason for its adoption. The differences between H. R. 6906 and S. 5 are Lot great and the former bill shows the result of careful consideration and knowledge of the needs for further legislation on this subject. The general administrative provisions of H. R. 6906 differ, however, somewhat from S. 5, but a comparison of the two indicates that the administrative provisions of S. 5 extend further than the Mead bill, powers which have not heretofore reposed in the Government.

We believe, however, that in S. 5 there are sufficient safeguards against arbitrary action on the part of officials of the Department to warrant the manufacturer in believing that his legitimate interests will not be unduly prejudiced by the enactment of these sections of the bill. With these safeguards provided for it would seem advisable to afford the Food and Drug Administration ample powers to enforce the provisions of the bill. We definitely do not favor the introduction of the Federal Trade Commission into the administration of the provisions of this legislation. In our judgment, the introduction of that Commission would only result in dual and, perhaps, conflicting control, resulting in added expense both to the Government and to industry. We are also definitely of the opinion that H. R. 8805 is not a desirable bill to be adopted. The introduction of further registrations of trade marks and formulas and the creation of additional boards will not, in our judgment, be effective to accomplish the desired results. We do not believe it is necessary at this time to discuss in detail the provisions of this bill, many of which, however, we believe to be faulty.

In view of the care, thought, and work which have been devoted in the preparation of S. 5, we wish strongly to urge upon you its adoption in substantially its present form.

We are refraining from making any minor suggestions in the hope that the sage of the bill will be expedited if it is recommended by you substantially

in its present form. We have, however, one suggestion which we believe to be of definite importance, and, in our judgment, it can be adopted without any difficulty. The bill in its present form in this respect, we believe, is definitely unfair, and we, therefore, wish to urge that the following suggestion be adopted and recommended by your committee.

Under the wording of the present bill it would be possible and, indeed, practically unavoidable to place the stigma of adulteration upon the products of reputable manufacturers which by reason of their natural ingredients are liable to become deteriorated in some period of time after their sale. Manufacturers would have no objection to the designation of such drugs as deteriorated, but when through absolutely no fault of their own these drugs fall below standard strength they should not be designated as "adulterated", which designation carries with it, at least to the public, implications of deliberate or careless acts on the part of the manufacturers. We therefore strongly recommend to your committee the insertion of a new paragraph at the foot of section 401, reading as follows:

"Any provision in this Act to the contrary notwithstanding, a drug shall be deemed to be adulterated only for reasons other than its deterioration in potency occurring after its introduction into interstate commerce."

A corresponding change should be made in section 711, which provides for the seizure of drugs which have become adulterated. There is no doubt that drugs which have merely become deteriorated should be liable to seizure to the same extent as adulterated drugs, but to carry out the distinction we recommend the insertion after the word "misbranded", in section 711 (a), the following words: "or that has deteriorated in potency after its introduction into interstate commerce."

Respectfully submitted.

NEW YORK, N. Y.

E. R. SQUIBB & SONS.

BRIEF OF THE MOUNTAIN VALLEY SPRINGS Co., WASHINGTON, D. C., CONCERNING PROPOSED CHANGES IN THE COPELAND BILL

To Committee on Interstate and Foreign Commerce, House of Representatives: We strenuously object to that part of section 601 (d) which forbids advertising a drug as having a therapeutic effect in the treatment of Bright's disease and vascular diseases. These two diseases should be stricken from the list, as Mountain Valley Mineral Water has been prescribed by prominent physicians in treatment of Bright's disease and certain vascular diseases for over 30 years.

We do not object to the act providing that these two diseases may be added to the list by a committee on public health if it should so determine after due notice and public hearings.

We also believe that the Secretary's publicity propaganda powers should, be limited to section 715 (a) and the first sentence in (b), and that the last sentence in section 715 (b) should be stricken from the bill, as it gives subordinates in the Department of Agriculture the right to vent personal prejudices prior to a court decision or determination by committee on public health.

We also object to section 701 (a), which contains a broad delegation of power to the Secretary. The act speaks for itself, and if any further regulations are necessary which cannot be promulgated by the Federal Trade Commission, which is a judicial body, or by the committee on public health, which we hope will be a judicial body, then the act should define and limit the Secretary's power to make regulations. Otherwise criminal penalties may be imposed and a legitimate business curtailed because of a regulation issued by the Secretary, which regulation, while not contrary to the act, nevertheless goes beyond the wording of this act and the intention of Congress.

We earnestly recommend that the administration of the whole of section 601, which concerns advertising, be given to the Federal Trade Commission, a judicial body of long standing and great familiarity with business practices, which would afford opportunity for an impartial hearing before court action is instituted.

Mr. CHAPMAN. The committee will resume its hearings at 10 o'clock Wednesday morning.

(Thereupon the subcommittee adjourned until Wednesday, July 24, 1935, at 10 a. m.)

AMEND THE FOOD AND DRUGS ACT

WEDNESDAY, JULY 24, 1935

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE OF THE COMMITTEE ON
INTERSTATE AND FOREIGN COMMERCE,
Washington, D. C.

The subcommittee met at 10 a. m., Hon. Virgil Chapman (chairman) presiding.

Mr. CHAPMAN. The committee will please be in order.

STATEMENT OF WALTER G. CAMPBELL, CHIEF, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF AGRICULTURE-Resumed

Mr. CHAPMAN. Dr. W. G. Campbell, Chief of the Food and Drug Administration, appeared Monday and will resume his statement. Dr. Campbell.

Mr. CAMPBELL. Mr. Chairman, mindful of your comment on Monday that I would be expected to conclude my statement today and give to the members of the committee an opportunity for questioning and permit others who are here from out of town and wish to be heard on this bill an opportunity to make a statement, and being in hearty sympathy with the apparent purpose of the committee to expedite the hearings in this way, I will, with the committee's permission, modify the character of the statement which I first undertook to make. Instead of making a detailed discussion or an analysis of the provisions of this measure, section by section, I will address myself merely to the outstanding contributions of the Copeland bill over the present law for public protection.

Prior to doing that, I wish to submit some amendments which the Department has to offer. These amendments are in large part, Mr. Chairman, purely of a structural character.

The committee knows, of course, that manifold amendments were passed to the bill on the day of its final consideration in the Senate. There had been innumerable editions of the committee print of the bill and inevitably there was some confusion and unavoidably there have been omissions or the insertion of words that give contradictory or strange significance to some of the provisions. It is for the correction of such omissions that I have suggested the change on page 2, line 22, to delete the word "the" before "use" and to insert it in line 23 before "diagnosis."

On page 11, line 17, we suggest striking the word "thereafter " and inserting therefor the words "after the effective date of such regulations."

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