75TH CONGRESS HOUSE OF REPRESENTATIVES (REPT. 2139 3d Session Part 2 FOOD, DRUG, AND COSMETIC ACT APRIL 21, 1938.-Ordered to be printed Mr. CHAPMAN, from the Committee on Interstate and Foreign Commerce, submitted the following MINORITY VIEWS [To accompany S. 5] The undersigned, members of the Committee on Interstate and Foreign Commerce, submit the following minority views with respect to one of the most important features of the bill, namely, provisions for court review of regulations of section 701 (f). It is our view that the bill, if enacted with this review provision, will not afford any substantial improvement in consumer protection over the terms of the present law. In fact, in some respects it represents an impairment of the consumer-protective features of the present law. Section 701 (f) sets up a method of court review of regulations that is wholly unprecedented. It is specifically provided that this method of review is in addition to, and not in substitution for, other methods. of review provided by law, such as equity proceedings and proceedings under the Declaratory Judgment Act. Regulations subject to this new form of review relate to the identity and quality of food; to requirements for informative labeling of special dietary food, such as that used by infants and invalids; to food contaminated with disease organisms where distribution might result in serious epidemics; to the addition of poisons to food; to the certification of coal-tar colors for use in foods, drugs, and cosmetics; to establishing adequate laboratory tests for important official drugs; to the listing of narcotic and habit-forming drugs; to label warnings against probable misuse of dangerously potent drugs; and to label directions for the preservation of potent drugs liable to deterioration. These provisions constitute the very heart of any worthy food and drug legislation. If the public health and welfare are to be adequately safeguarded, regulations putting these provisions into effect should be promptly and effectively enforceable and certainly should be subject to no greater restrictions and delays in review by the courts to determine their validity than regulations authorized by other Federal laws which deal with economic questions rather than the vital questions of public health concerned in this legislation. Section 701 (f) permits any person who will be adversely affected by one of the regulations listed above to file, any time within 90 days after the regulation has issued, a complaint in the district court for the district where such person resides or has his principal place of business to enjoin the Secretary of Agriculture from enforcing the regulation. For example, if a regulation is issued requiring label warnings against probable and dangerous misuse of a certain class of patent medicine, then each manufacturer of that class of medicines and each dealer who profits by the sale of the medicines may file a complaint in his local district court to enjoin the enforcement of the regulation. If a single district judge could be found who would issue an injunction against such enforcement, the regulation could not be enforced at any place in the United States, even though every other district judge in the country had refused to issue an injunction. The provision would therefore clothe each and every district judge with authority to block the enforcement of a regulation throughout the United States. This is an extraordinary extension of jurisdiction and an extraordinary grant of power never heretofore seriously advanced in the entire history of the country. As suggested in the letter of the Secretary of Agriculture, a copy of which is hereto attached, if there is to be an exploration into new forms of court review of administrative regulations specifically authorized by congressional enactment, it is our conviction that such experimentation should be made in fields other than those of vitally important health laws. Even if the injunction which blocks the enforcement of a regulation can be overturned in appellate courts, there is a provision under the preceding subsection (701 (e)) whereby the question can be reopened and the regulation again subjected to the same hazards. This provision requires that— the Secretary, on his own initiative, or at the request of any interested industry or substantial portion thereof, shall hold a public hearing upon a proposal to issue, amend, or repeal any regulation [Italics supplied.] * If the manufacturers of the class of patent medicines referred to above, or any substantial proportion of such manufacturers, demanded a public hearing on a proposal to amend or repeal a regulation previously validated by the courts after litigation under subsection (f), the Secretary would have no alternative but to hold such a hearing and to follow the prescribed procedure laid down by subsection (e) under which he would issue an order continuing the regulation in effect. The continuation of the regulation by such order would then become subject within the 90-day period prescribed, to the filing of a second crop of complaints throughout the United States. If a single district judge could again be found to issue an injunction, the regulation would again be rendered ineffective. In most of the industries affected by the bill there are sufficient minorities, vociferously opposed to any form of regulation, to form a substantial proportion of the industry. These could be depended upon in practically every instance in which a regulation is required for the protection of public welfare to resort to the tactics above described and prevent indefinitely the effectuation of the purpose of the law. The procedure set up in the bill to restrain the Secretary, while in form only seeming to protect industry rights, in effect amounts to the placing of the control of enforcement in the hands of those whose interests are contrary to public welfare and who have created the need for legislation. It is true that the scope of the old law is broadened by the bill to include cosmetics, therapeutic devices, and certain drugs which are not now subject to regulation. It is true that in many instances the definitions of adulteration and misbranding have been expanded and strengthened, although even these improvements are studded with a notable number of exceptions. It is also true that the procedural provisions have been strengthened through authorization of injunction proceedings, although this, to some extent, is nullified by changes from the seizure section of the existing law, particularly that under which trial of seizure cases will in many instances occur in producing jurisdictions before juries whose sympathies would ordinarily be with local industries rather than in consuming jurisdictions where juries would be expected to display less bias. Weighing the advantages and disadvantages for the protection of consumer welfare presented by the terms of this bill, we are unable to escape the conclusion that because of the extraordinary provision for court review of regulations in section 701 (f), which would postpone indefinitely the consumer protection that can now be afforded in some degree by the present law in much of the field to be covered by these regulations, it would be better to continue the old law in effect than to enact S. 5 with this provision. If there is to be exploration into new methods of court review, such a radical departure from the well-established Federal procedure as is here proposed should be the subject of a separate bill, applicable to all Federal laws authorizing regulations, to be considered on its own merits. This important health legislation should not be made the sole medium for such experimentation. Under date of March 28, 1938, the undersigned [Chapman and Mapes] submitted the then latest draft of section 701, the court-review section, of the bill to the Secretary of Agriculture and asked for his views in regard to the same. The following is a copy of his reply: Hon. CARL E. MAPES, House of Representatives. MARCH 29, 1938. MY DEAR MR. MAPES: Receipt is acknowledged of your letter of March 28, 1938, with which you enclose a copy of chapter VII, General Administrative Provisions, section 701, from the latest edition of S. 5 as agreed upon by the Interstate and Foreign Commerce Committee of the House. You ask for an expression of my opinion of the effect of the provisions of this section upon the administration of the measure. I am of the opinion that if section 701 (f) remains in the bill its effect will be to hamstring its administration so as to amount to a practical nullification of the substantial provisions of the bill. The clear intent of S. 5 is to close the channels of interstate commerce to food, drugs, devices, and cosmetics that are adulterated or misbranded. Because of the complex and technical nature of the subject matter involved a number of the most important definitions of adulteration and misbranding are incomplete and must have their clearly stated outlines filled in with scientifically accurate details before they can be enforced. The bill delegates to the Secretary of Agriculture the quasi-legislative power to ascertain the necessary technical facts and supply the details that will complete these definitions, thus effectuating the legislative will. The Secretary is entrusted with these powers in connection with sections 401, 403 (j), 404 (a), 406 (a) and (b), 501 (b), 502 (d), 502 (f) exclusive of the proviso, 502 (h), 504, and 604. These sections are extremely important. They relate to the identity and quality of food, to requirements with respect to special dietary food, to contaminated food, to poisonous substances in food, to coal-tar colors in food, drugs, and cosmetics, to determining adequate tests for official drugs, to narcotics and habit-forming drugs, to probable misuse of dangerously potent drugs, and to labeling drugs liable to deterioration. Section 701 (f) permits any person who will be adversely affected by any order authorized by the sections listed above to file, any time within 90 days after the issuance of the order, a complaint in the district court for the district where such person resides or has his principal place of business, to enjoin the Secretary from placing the order in effect. This subsection contains the unique provision directing the courts to permit the complainant to supplement the evidence recorded in the Secretary's hearing upon which the order was based. This constitutes an invitation to those who would obstruct the enforcement of a regulation to withhold or conceal evidence that should have been given in the hearing and to employ such evidence merely for the purpose of upsetting the order and thus postponing indefinitely the enforcement of the regulation. In the event such order is upset there is nothing to prevent the same complainant from instituting new proceedings on a new order and thereby causing further delay. In fact, every amendment of an order could be a ground for the institution of new proceedings. Even though a number of district courts might uphold an order, demanded alike by the public and by the overwhelming majority of the industry regulated, to terminate abusive practices, a single district court could enjoin permanently the enforcement of the regulation. Frankly, I regard this provision as unfair to the Department, to the public, and to the industries regulated, the majority of which unquestionably would support regulations, based on substantial evidence, which the Secretary of Agriculture would promulgate. It would constitute a serious impediment to orderly administrative operations. If a bill containing this provision were enacted it would not constitute any material contribution to the public protection that the Department cannot now extend under the existing law. In some respects it would afford even less protection than that afforded by the existing law, which is broad and general in its terms and is to some degree applicable and effective in the fields covered by the sections involved in this discussion. It is the Department's considered judgment that it would be better to continue the old law in effect than to enact S. 5 with this provision. If there is to be exploration into new fields of administrative law, may I urge that it not be in the field of vitally important public health legislation. There has not been sufficient time to permit the Department to ascertain the relation of the foregoing to the program of the President. Sincerely yours, H. A. WALLACE, Secretary. Attention is called especially to the following statements in the letter of the Secretary: I am of the opinion that if section 701 (f) remains in the bill its effect would be to hamstring its administration so as to amount to a practical nullification of the substantial provisions of the bill. It is the Department's considered judgment that it would be better to continue the old law in effect than to enact S. 5 with this provision. If there is to be exploration into new fields of administrative law, may I urge that it not be in the field of vitally important public health legislation. The section as submitted to the Secretary of Agriculture was the same as the section as reported by the majority of the committee, except in two particulars, one of which weakens the enforcement provision of the section, the other of which has no effect on it one way or the other, in our opinion. The committee amended the draft of the section as submitted to the Secretary, (1) by striking out of the committee substitute, page 82, line 19, after the word "shall", the words "if in his judgment sufficient reason appears for so doing"; and (2) by inserting, page 84, line 8, after the word "shall", the words "upon the showing that such additional evidence is material and that there were reasonable grounds for failure to adduce such evidence at the proceeding before the Secretary." As stated, the first amendment weakens the enforcement provision. of the section. The second one requires nothing more than a court would ordinarily require without it. If this bill is enacted into law with section 701 (f), the court-review section, in it, as reported by a majority of the committee, what started out as an effort on the part of the advocates of a more adequate food and drug law to enlarge the scope of the existing law, to fill in the loopholes in it, and to put more teeth into it, will end with having accomplished the directly opposite result and years of earnest effort will have gone for worse than naught. VIRGIL CHAPMAN, JERRY J. O'CONNELL, CHAS. A. WOLVERTON, |