FOOD, DRUGS, AND COSMETICS 111 rates 100 percent in quality and in the truthfulness of its labeling and advertising, its shipment without the prescribed permit will nevertheless be a criminal act for which the full penalty of the law may be invoked. 6. "The refusal to permit access to or the copying of any record as required by section 14." Violation of any of the foregoing prohibitions is declared to be a misdemeanor. A first offense is to be punished by imprisonment for not more than 1 year or a fine of not less than $100, nor more than $1,000, or both fine and imprisonment. For subsequent offenses imprisonment may be 2 years and the fine $3,000, or both fine and imprisonment. If the first offense is willful, the penalty is imprisonment for not less than 6 months, nor more than 3 years, and a fine of not less than $1,000, nor more than $10,000, or both fine and imprisonment. Publishers are relieved of responsibility for false advertisements when they furnish the name and address of the person who authorized such advertisement. A dealer is relieved of responsibility when he can establish a guaranty signed by a person residing in the United States, to the effect that the guarantor accepts full responsibility for any violation of the act. The forging, counterfeiting, or simulation of any tag or label authorized by the Secretary of Agriculture may be punished by imprisonment for 1 year or a fine of $5,000, or both fine and imprison ment. Section 18: Liability of corporate officers. This section presents an expansion and amplification of the obligations of corporate officers as set forth in section 12 of the present Food and Drugs Act. An employer is made responsible for the "act, omission, or failure of any officer, employee or agent" when the latter is acting "within the scope of his employment or office." * The violation of any provision of the act "by a corporation or association shall be deemed to be a violation of the individual directors, officers or agents ** * who authorized, ordered, or did any of the acts constituting in whole or in part, such violation." Section 19: Injunction proceedings. By section 19 the repetitious introduction into interstate commerce of any adulterated or misbranded food, drug, or cosmetic, or the repetitious dissemination of any false advertisement is declared to be a public nuisance, and United States district courts are authorized to restrain the same by injunction. Violations of such injunctions are to be summarily tried and punished as contempt of court. In such injunction proceedings it shall not be necessary to show an intent to continue the offense. Section 20: Imports. Section 20 relates to the duty of the Secretary of the Treasury in respect to the importation of adulterated, misbranded, or falsely advertised food, drugs, and cosmetics; the delivery of samples to the Secretary of Agriculture, and the disposition of goods when condemned. In general these provisions correspond to requirements of the present Food and Drugs Act. Section 21: Publicity. 112 FOOD, DRUGS, AND COSMÉTICS This section requires the Secretary to periodically issue reports "summarizing all judgments, decrees, and orders which have been rendered, and all proceedings instituted and seizures made, including the nature of the charge and the disposition thereof." Under this language a manufacturer's reputation may be permanently clouded by the charges made against him, even though the court may find him guiltless of the offenses charged. This section also requires the Secretary to "cause to be disseminated such information regarding any food, drug, or cosmetic as he deems necessary in the interest of public health and for the protection of the consumer against fraud.” SECİON 22: Voluntary inspection service. Section 22 authorizes the Secretary to appoint what are termed "supervisory inspectors" to supervise and inspect all premises, equipment, methods, materials, containers, labels, etc., of manufacturers who file a request for such inspection. If and as long as the reports of such supervisory inspectors are favorable such manufacturers of food, drugs, or cosmetics are to be permitted to mark their products in such manner as may be provided by regulation to show that they have been officially inspected and consequently that they have Government approval. It would no doubt be very advantageous to a new firm struggling to get a foothold in the market to be able to have its products officially approved, signifying that they are as good as can be made, but this would not afford much satisfaction to firms which have been striving for half a century or longer to build up a reputation under their own brand and label. The salaries of such supervising inspectors and other expenses incidental to the establishment and continuance of such service are, of course, to be paid by the firms receiving the service. While called "voluntary inspection service", it is evident that if one establishment should adopt it, all others would be compelled to do likewise or have their products rest under suspicion that they will not bear official inspection. SEC. 23. General administrative provisions.-In statutes of an administrative character it is usually provided that the administrative body shall have power to make such rules and regulations as may be necessary to carry the provisions of the law into effect. Such provisions have been frequently reviewed by the courts, and decisions are unanimous to the effect that they do not authorize administrative officers to extend the scope of the law by the imposition of obligations not expressed in the law itself, nor to read into the law meanings other than those plainly intended by the lawmaking body. In the bill before us there is an evident intention to go to the extreme limit in conferring authority upon the administrative officer to influence the course of justice by reading into the law his own opinions expressed in the form of regulations, and, in many cases, to make his personal discretion the measure of the obligations imposed. Consider, for example, the provisions relating to the subject of hearings. Preliminary hearings before an administrative officer are in the nature of minor judicial proceedings. As provided for in the existing Food and Drugs Act they bear a relation to United States district courts roughly analogous to the relation of ordinary magistrates' courts to courts of common pleas. While such tribunals need not FOOD, DRUGS, AND COSMETICS 113 proceed with the stiff formality of courts of record, it is nevertheless presumed that they will have due regard to the substantial rights of the accused, that they will afford him opportunity for a fair presentation of his defense according to established rules of evidence before an impartial court, and that the questions presented will be decided upon their merits by a judge whose personal or official interests shall not be involved in the disposition of the case. By comparing various provisions of S. 1944 relating to regulations and hearings the following conditions appear: (1) That paragraph (5), section 17, makes it an offense, subject to the full penulty of the law, to violate a regulation prescribed by the Secretary, which regulation he may impose, amend, or withdraw at his own discretion. (2) That certain provisions of the bill are set forth in such general terms that the specific acts constituting an offense must of necessity be prescribed and defined by regulation. In other words, that obligations upon manufacturers and shippers of medicinals will be such as the Secretary of his own motion nay impose, and which may be one thing today and another and quite different thing tomorrow. (3) That in questions of opinion not susceptible of exact proof or disproof by experimental evidence, as for example, what shall be accepted as contrary to the general agreement of medical opinion", the opinion of the agent who conducts the hearing will control, since he will designate the particular authority to be accepted as representing the general agreeinent of medical opinion. (4) That by paragraph (a) of section 23, the Secretary of Agriculture is authorized to prescribe "such regulations as he may deem necessary for the efficient enforcement of the functions vested in him"-not such as are necessary to enforce the provisions of the law, but such as he may deem necessary for the discharge of his functions as he may interpret them. (5) That the Secretary's regulations are to be imbued "with the force and effect of law as to notice and conduct of hearings." Under this the notice of a hoaring may be 30 days or 24 hours; the Secretary can decide whether the accused may be represented by legal counsel or must present his own defense; can decide the method of procedure, the kind of evidence to be admitted, and the kind to be rejected. The Secretary is not required to specify the authority upon which he relies to support his conclusions that an article is adulterated, Inisbranded or contrary to the general agreement of medical opinion, and may reject the opinions of authors with whom he does not agree on the ground that printed books are only heresay evidence. (6) That the purpose is to confer upon the Secretary power to control the result of such hearings further appears in paragraph (c) which provides that "hearings authorized or required by this act shall be conducted by the Secretary or such officer or employee as he may designate for the purpose. The findings of fact by the Secretary shall be conclusive if in accordance with law." Under this the subordinate who actually presides at the hearing will accept or reject evidence as it meets with his approval, write his own conclusions into the record, and these will constitute "the findings of fact" which the Secretary will accept as conclusivo against the accused. 114 FOOD, DRUGS, AND COSMETICS Thus from the terms of the bill as written the accused must plead his cause before a court the presiding officer of which makes the law-in such cases called "regulations"-who prescribes the method of procedure and rules of evidence, and in addition to these functions also officiates as prosecuting witness, judge, and jury. And finally, having decided adversely to the accused, the judge in this preliminary trial next appears as prosecutor in the case before the Federal District Court. Section 24: Liability for personal injuries. Section 24 introduces something not common in statutory law, by providing that "a right of action for damages shall accrue to any person for injury or death proximately caused by a violation of this act." By a unanimous line of English and American decisions persons injured by a fraudulent or improperly labeled medicine can recover full damages in any court of competent authority, and in numerous instances such damages have been awarded, Why, therefore, encumber a United States statute with such a provision when an injured party already possesses an adequate remedy which can be pursued in the State courts? The new provision if enacted would only be an invitation to blackmailing claims and suits. At common law the defendent in a damage suit would have the right to plead contributory negligence and to show that the injury complained of was due primarily to the negligence of the plaintiff. That he would have such right of defense under this bill, if enacted, is not entirely certain. Section 25: Separability clause. This section provides that if any part of the act shall be declared unconstitutional, the remainder of the act shall not be rendered invalid thereby. Section 26: Effective date and repeals. Section 26 declares that the new act shall become effective six months after the date of its approval, at which time the present Food and Drugs Act shall cease to be effective, and also enumerated a list of other existing acts the provisions of which shall not be affected by the enactment of S. 1944. A committee appointed by the National Drug Trade Conference has prepared a bill amending the Food and Drugs Act of June 30, 1906, as amended. I shall submit that bill for inclusion in the record at this point. In the suggested bill each section is designated by the number as given in the United States Code; also by section number of the original act; matter to be deleted is given in brackets; new matter in italic. The bill reads: A BILL To amend the Food and Drugs Act, June 30, 1906, as amended August 23, 1912, March 3, 1913, March 4, 1913, July 24, 1919, January 18, 1927, and July 8, 199, for preventing the manufacture, sule, or transportation of adulterated or misbranded or poisonous or deleterious foods, drugs, medicines, cos metira, and liquors, and for regulating traffic therein, and for other purposes 8717. SECTION 1. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That it shall be unlawful for any person to manufacture within any Territory or the District of Columbis any article of food, drug, or cosmetic which is adulterated or misbranded, within the meaning of this Act; and any person who shall violate any of the provisions of this section shall be guilty of a misdemeanor, and for each offense shall, upon conviction thereof, be fined not to exceed $500, or shall be sentenced to one FOOD, DRUGS, AND COSMETICS 115 year's imprisonment, or both such fine and imprisonment, in the discretion of.. the court, aud for each subsequent offense and conviction thereof shall be fined not less than $1,000 or sentenced to one year's imprisonment or both such fine and imprisonment, in the discretion of the court. 8718. SEC. 2. That the introduction into any State or Territory or the District of Columbia from any other State or Territory or the District of Columbia, or from any foreign country, or shipment to any foreign country of any article of food, drug, or cosmetic which is adulterated or misbranded, within the meaning of this Act, is hereby prohibited; and any person who shall ship or deliver for shipment from any State or Territory or the District of Columbia to any other State or Territory or the District of Columbia, or to a foreign country, or who shall receive in any State or Territory or the District of Columbia from any other State or Territory or the District of Columbia, or foreign country, and having so received, shall deliver, in the original unbroken packages, for pay or otherwise, or offer to deliver to any other person, any such articles so adulterated or misbranded within the meaning of this act, or any person who shall sell or offer for sale in the District of Columbia or the Territories of the United States any such adulterated or misbranded foods [or] drugs or cosmetics, or export or offer to export the same to any foreign country, shall be guilty of a inisdemeanor, and for such offense be fined not exceeding $200 for the first offense, and upon conviction for each subsequent offense not exceeding $300 or be imprisoned not exceeding one year, or both, in the discretion of the court: Provided, That no article shall be deemed misbranded or adulterated within the provisions of this Act when intended for export to any foreign country and prepared or packed according to the specifications or directions of the foreign purchaser when no substance is used in the preparation or packing thereof in conflict with the laws of the foreign country to which said article is intended to be shipped; but if said article shall be in fact sold or offered for sale for domestic use or consumption, then this proviso shall not exempt said article from the operation of any of the other provisions of this Act. 8719. SEC. 3. That [the Secretary of the Treasury,] the Secretary of Agriculture, and the Secretary of Commerce and Labor] shall make uniform rules and regulations for carrying out the provisions of this Act, including the collection and examination of specimens of foods, [und] drugs and cosmetics manufactured or offered for sale in the District of Columbia, or in any Territory of the United States, or which shall be offered for sale in unbroken packages in any State other than that in which they shall have been respectively manufactured or produced, or which shall be received from any foreign country, or intended for shipment to any foreign country, or which may be subinitted for examination by the chief health, food, or drug officer of any State, Territory, or the District of Columbia, or at any domestic or foreign port through which such products are offered for interstate commerce, or for export or import between the United States and any foreign port or country. 8720. SEC. 4. That the examinations of specimens of foods, [and] drugs and cosmetics shall be made in [the Bureau of Chemistry of the Department of Agriculture] such existing bureau or bureaus in the Department of Agriculture as may be directed by the Secretary of Agriculture, or under the direction and supervision of such bureau, for the purpose of determining from such examinations whether such articles are adulterated or misbranded within the meaning of this Act; and if it shall appear from any such examination that any of such specimens is adulterated or misbranded within the meaning of this Act, the Secretary of Agriculture shall cause notice thereof to be given to the [party from whom such sample was obtained] manufacturer of such article if known or if unknown to the party who caused said article to be introduced into interstate commerce. Any party so notified shall be given an opportunity to be heard, under such rules and regulations as may be prescribed as aforesaid, and if it appears that any of the provisions of this Act have been violated by such [party] manufacturer or such person who introduced the article in interstate commerce, then the Secretary of Agriculture shall at once certify the facts to the proper United States district attorney, with a copy of the results of the analysis or the examination of such article duly authenticated by the analyst or officer making such examination, under the oath of such officer. After judgment of the court, notice shall be given by publication in such manner as may be prescribed by the rules and regulations aforesaid. 8721. SEC. 5. That it shall be the duty of each district attorney to whom the Secretary of Agriculture shall report any violation of this Act, or to whom any health or food or drug officer or agent of any State, Territory, or the District of Columbia shall present satisfactory evidence of any such violation, to cause appropriate proceedings to be commenced and prosecuted in the proper courts of |