106 FOOD, DRUGS, AND COSMETICS authorities on therapeutics with the mere statement that that is only hearsay evidence. Finally, we find that paragraph (c) 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." He may designate the janitor, if he wishes. It is there in the law; nothing to limit it. Of course, Judge Campbell would never appoint anyone but a competent officer, but that provision is written authorizing the selection of any employee. Under this, the subordinate who writes the opinion, decides the procedure and the kind of evidence that is to be introduced, writes his own conclusions into the record, and turns the record over to the Secretary of Agriculture, and he accepts this as conclusive of the facts. Senator COPELAND. Do you bear in mind that Mr. Campbell suggested an amendment at this point? Dr. BEAL. Yes; and I think it was an excellent suggestion in the line of real justice and fairness, but, taking the terms of the bills as written, the accused is first required to plead his cause in a court, the presiding officer of which first makes the law, and in such case the law is his own regulation, and that presiding officer prescribes the method of procedure, and that presiding officer also prescribes the rules of evidence, and, in addition to these functions, he also operates as a prosecuting witness, judge, and jury, and then, if in this case he finds the accused guilty, the presiding judge next appears as a prosecuting witness in the court above, which is the Federal District Court. Senator COPELAND. Thank you very much, Doctor. The remainder of your address may, as I stated previously, appear in the record. Dr. BEAL. In addition to formula disclosure the Secretary is also authorized to require the appearance on the label of such further information as "he may deem necessary.' "1 This in effect confers upon the Secretary of Agriculture practically unlimited power over the labeling of inedicinal products of every kind other than those recognized in the U.S.P. and N.F. Paragraph (f) of this section requires that U.S.P. and N.F. drugs be packaged and labeled as directed in these volumes, as for example, the shape and color of mercury bichloride tablets, the size and color of bottles containing spirits of nitrous ether, etc. Paragraph (g) authorizes the Secretary to decide as to what drugs are liable to deterioration, and to prescribe the style of packaging and labeling of such drugs. Under the language employed this will apply to those of the U.S.P. and N.F. and to all others which he may declare liable to deterioration. The language of the first clause of paragraph (h) that a drug will be misbranded"(1) If its container is so made, formed, or filled as to mislead the purchaser" leaves much to be desired, since it does not specify the kind of acts from which an attempt to mislead the purchaser can be inferred. Such omissions must, of course, be supplied by regulations. Paragraph (i) of this section would by legal enactment destroy the distinction between "antiseptics" and "disinfectants" as hitherto recognized by authors and teachers. FOOD, DRUGS, AND COSMETICS 107 Since the time of Pasteur and Lister, antiseptics have been understood to be such agents as are unfavorable to or which retard the growth of micro-organisms, without necessarily destroying them, while the terms "disinfectants", "bactericides", and "germicides" have been understood to refer to agents which will absolutely destroy the lives of such organisms. Disinfectants may be reduced to antiseptics by mere dilution, but all antiseptics do not necessarily become disinfectants through concentration. Under the operation of this paragraph nothing could be legally called an antiseptic unless it was capable also of acting as a disin fectant, germicide, or bactericide, and labeled with the kinds of organisms it is capable of destroying, and the length of time it must remain in contact to cause their death. As the distinction between antiseptics and germicides is an invention of Mother Nature herself we venture the prediction that it will continue to exist even through the mighty voice of Congress shall decree that it may not be mentioned on the label. Section 9. False advertisement. By paragraph (a) of section 9- An advertisement of any food, drug, or cosmetic shall be deemed to be false If in any particular it is untrue, or by ambiguity or inference creates a misleading impression regarding such food, drug, or cosmetic. Here again is exhibited the mistaken impression that the therapeutic action of a drug can be asserted with the same precision as the reactions upon each other as well-known chemical agents. Unfortunately this is not true, and under the language employed the opinion of the Secretary of Agriculture would supply the standard which must be met, and this in many cases could not be ascertained until after the goods had been distributed in interstate commerce. Paragraph (b) recites thut An advertisement of a drug shall also be deemed to be false if it includes (1) the name of any disease for which the drug is not a specific cure but is a palliative, and fails to state with equal prominence and in immediate connection with such naine that the drug is not a cure for such discase; or any representation, directly or by ambiguity or inference, concerning the effect of such drug which is contrary to the general agreement of medical opinion, This language is nearly identical with that in section 8 dealing with the misbranding of drugs, and while to a layınan it may seem to be definite, its real meaning when critically exainined is seen to be very uncertain. It employs the same ambiguous and undefined terms "discase", "specific cure", and "palliative", and also refers to that very uncertain thing, "general agreement of medical opinion.' According to the meaning attached to these terms the same advertisement may be construed to be either true or false, as will best suit the opinion of the administrative officer. In other words, the standard of truth and falsity will be the opinion of the Secretary of Agriculture. These provisions are unsound for the reason that the uncertainty of construction which they permit would preclude the manufacturer from knowing what his legal obligations were. He might advertise his product according to the opinions of the best medical authority available and still find himself criminally liable through a one-sided construction of the statute. He might consult all the authors in a medical library and in the end find his advertisement condemned 108 FOOD, DRUGS, AND COSMETICS by a single individual in the Food and Drugs Administration who preferred to follow a different authority. Paragraph (c) of section 9 enumerates an alphabetical list of 37 different kinds of ailments, beginning with "Albuminuria" and ending with "Whooping cough" for which the advertisement of any drug in treatment shall be deemed to be false. In another subdivision of this paragraph the Secretary is given blanket authority to add to this list such additional ailments as he considers should not be the subject of self-medication, and for which no remedy may be advertised either directly or indirectly. From the standpoint of applied psychology this is probably the most clever paragraph in the entire bill. If the paragraph simply authorized the Secretary to designate a list of affections for which remedies might not be advertised, there would be a general outcry against the proposition, but by cleverly prefacing it with a list of diseases not ordinarily amenable to self-treatment the attempted vast extension of the Secretary's authority is not so plainly evident. The naming of this large number of diseases also suggests a desire to create a popular belief that package remedies the labels of which indicate that they are intended for the treatment of such ailments are fairly numerous, whereas, as a matter of fact, they are not to be found in the average drug store, and exist only in holes and corners, or are being put out by that class of legally registered physicians who carry on a sort of mail-order business, A very remarkable provision in this paragraph is that "no advertisement shall be deemed to be false--if disseminated to members of the medical and pharmacological professions only or appears in scientific periodicals". This leads to the queer situation that the same advertisement will be either true or falso according to the medium in which it appears. If published in a medical journal, it will be legally true even if it be clearly and demonstrably false. If published in a daily or weekly newspaper, it will be criminally false even if it be literally and absolutely true. The man who prints a knowingly false advertisement in a medical journal is to go free; but the man who prints an entirely truthful advertisement in the daily press will be fined and sent to jail. Taken as a whole the scope of the language employed in this section is such that the Secretary of Agriculture can by regulation prohibit the advertisement in daily and weekly newspapors of practically every remedy now offered in interstate commerce. Section 10: Tolerance for poisonous ingredients in foods and cosmetics and cortification of coal-tar colors. Section 10 authorizes the Secretary to determine what added substances in food or cosmetics "is or may be injurious to health", and either to prohibit the use of such substances or to limit the amount which may be present. It also authorizes him to certify to the harmlessness of certain coal-tar colors. Section 11: Definitions and standards for food. This section in very broad terms authorizes the Secretary to "establish, promulgate, and enforce definitions of identity and standards of quality and fill of containers of any food." In other words, instead of dealing with such matters by express provisions of law they are to be left wholly to the discretion of the Secretary, who may change his standards whenever he deems it to be necessary. FOOD, DRUGS, AND COSMETICS 109 Section 12: Licensing of factories and laboratories. Section 12 authorizes the Secretary of Agriculture in broad and general terms "to make such regulations governing the conditions of manufacturing, processing or packing" of any class of food, drugs, or cosmetics, "as he may deem necessary," and to require all such manufacturers, processors, or packers "to hold a permit conditioned on compliance with such regulations." The Secretary is authorized to issue permits for such periods of time as he may prescribe, and to suspend immediately the permit of any establishment where the regulations are violated. Authorized agents of the Secretary shall have free access to establishments operating under permit, so see that the regulations are being complied with, and denial of such free access will be sufficient ground for the revocation of the permit. Section 13: Factory inspection. Section 13 expands the powers granted in section 12, by authoriz ing any designated agent of the Secretary, after first obtaining permission of the owner (1) To enter any factory, warehouse, or establishment in which food, drugs or cosmetics are manufactured, processed, packed, or held for shipment in interstate commerce, or are held after such shipment, or to enter any vehicle being used to transport such food, drugs, or cosmetics, in interstate commerce; and (2) to inspect such factory, warehouse, establishinent, or vehicle and all equipment, methods, processes, finished and unfinished materials, containers, and labels there used or stored. The provision that the inspector must have permission from the owner or manager before entering upon his inspection means nothing, since those who do not permit free access of inspectors to their establishments may not ship their products in interstate commerce. Thus by the terms of sections 12 and 13 the entire process of food, drug, and cosmetic manufacture, and of their labeling and shipment is placed within the unrestrained control of the Secretary of Agriculture. The denial of free access of inspectors, or the keeping secret of a single article of equipment, of a single item of any method or process of manufacture, or of any other item of information demanded will be sufficient ground for excluding the entire production of a factory or laboratory from interstate commerce. No method for an appeal from or the review of the Secretary's decisions is provided, and no limitation is placed upon his power to issue, withhold or revoke permits, except that his will must be expressed in the form of regulations, which under other sections of the bill he has almost unlimited authority to issue. Proceedings against violators of regulations are to bo through injunction and contempt of court, proceedings in which the accused cannot demand a trial by jury. To provide for the inspection of the thousands of factories and laboratories devoted to the production of foods, drugs, and cosmetics we can envisage a body of inspectors approximating the United Statos Army in numbers-a body of political appointees having the power of life and death over the establishments inspected that would make the Secretary of Agriculture the most potent political factor in the Federal Government. SEC. 14. Records of interstate shipment. 80890-84-8 110 FOOD, DRUGS, AND COSMETICS By section 14, carriers and receivers of food in interstate commerce are required to submit records to authorized agents of the Secretary. Refusal to submit such records is made a criminal offense.. SEC. 15. Investigation and Institution of Proceedings. Section 15 authorizes the Secretary of Agriculture to conduct investigations either through his own appointees or through officers of any State, Territory, or political subdivision thereof. The Secretary, before reporting violations to the United States attorney for prosecution, is required to afford opportunity for hearing to interested partios "in accordance with such regulations as the Secretary shall prescribe." There is, however, no provision for such preliminary hearing when the violation is reported by an officer of a State, Territory, or political subdivision thereof, so that when a United States attorney institutes a suit on information filed by a State or territorial official the only notice the defendant may have is when he is called upon to answer criminal proceedings in a Federal District Court. SEC. 16. Seizures. Paragraph (a) of Section 16 authorizes seizure and condemnation of articles adulterated or misbranded under the Act, or which are the products of establishments the operators of which do not hold permits as required by the regulations. Parties to à condemnation proceedings may, by obtaining an order from the court, secure a "representative sample of the article seized," for the purpose of a duplicate analysis, but under the bill as writton the defendant apparently cannot demand such sample as a matter of right. Methods of procedure are provided for the destruction, sale, or other disposition of articles condemned. Under certain conditions articles condemned for adulteration or misbranding may be returned to the owner under bond, but when condemned because the owner did not possess a permit as required by regulations the articles must be destroyed, and the cost of all proceedings will be assessed against the owner. Agents of the Secretary of Agriculture are relieved of personal responsibility for wrongful seizures when they have acted by his discretion or by direction of duly designated officer of the Food and Drug Administration. In other words, the Secretary can authorize his agents to perform unlawful acts without danger to themselves. SEC. 17. Penalties. The following acts are specifically prohibited 1. The introduction into interstate commerce of any adulterated or misbranded food, drug, or cosmetic. 2. The receipt in interstate commerce of any such adulterated or misbranded article, or the delivery or proferred delivery of the same. 3. The dissemination of any false advertisement by radio-broadcast, United States mails, or "interstate commerce." 4. The "dissemination of a false advertisement by any means." 5. "The introduction into interstate commerce of any food, drug, or comestic if the manufacturer, processor, or packer does not hold a valid permit when so required by regulations under section 12." Note that the crime in this case is not the shipment of an adulterated, misbranded, or falsely advertised article, but its shipment without a permit from the Secretary of Agriculture. If the article. |