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FOOD, DRUGS, AND COSMETICS
authorities on therapeutics with the mere stntement that that is only hearsay evidence.
Finally, we find that parngraph (c) providos 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 jnnitor, if he wishes. It is there in the law; nothing to limit it. Of course, Judge Campbell would nover appoint anyone but a competent officer, but that provision is written authorizing the selection of any employee. Under this, the subordinate who write 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 benr 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 plend 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, ho also operates as a prosocuting 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 inuch, 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 “be may deom necessary.". This in effect confers upon the Secretary of Agriculture practically unlimited power over the labeling of inodicinal products of every kind other than those recognized in the U.S.P. and N.F.
Parngraph (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 othor, etc.
Paragraph (g) authorizes the Secretary to docide 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 othors which he may declare liable to deterioration.
Tho langunge of the first clauso of paragraph (h) that a drug will be misbranded "(1) If its container is so made, formed, or fillod as to mislend the purchaser" leaves much to be desired, since it does not specify the kind of acts from which an attempt to mislend the purchaser can be inferred. Such omissions must, of course, be supplied by regulations.
Parngraph (i) of this section would by legal enactment destroy the distinction between "antisoptics" and "disinfectants" us hitherto recognized by authors and teachers.
FOOD, DRUGS, AND COSMETICS
Since the time of Prsteur and Lister, antiseptics have been understood to be such agents as aro unfavorablo or which retard the growth of micro-organisms, without necessarily destroying them, while the terms "disinfectants", "bactericides", und "germicides" have boen understood to refer to agents which will absolutely destroy the lives of such organisms. Disinfectants muy be reduced to antiseptics by mere dilution, but all antiseptics do not necessarily become disinfectants through concentration.
Under the operation of this parngraph nothing could be legally called an antiseptic unless it was capable also of acting as a disinfectant, gernicide, or bactericide, and labeled with the kinds of orgunisms it is cupablo of destroying, and the length of time it must remain in contact to cause their death.
As the distinction between antiseptics and gerinicides is an invention of Mother Nature herself wo vonture 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 labol.
Section 9. False advertisoment.
An advertisement of any fooll, drug, or cosmetic shall be deemed to be false If in any particular it is utrue, or by mabiguity or inference creates a misleading isupression regarding such food, drug, or cosmetic.
Here again is exhibited the inistnken impression that the therapeutic action of a drug can be usserted with the same precision as the reactions upon each other as well-known choinical ugents. Unfortunately this is not true, and under the language employed the opinion of the Secretary of Agriculture would supply the standard which must bo mot, and this in many cases could not be ascertained until after the goods had been distributod in interstute commerce.
Purugruph (b) rocitos thut
An advertisement of a drug shall also be deemed to be false if it includes (1) the name of any discase for which the drug is not a specific cure but is a palliative, and fuils to state with outal prominence and in iinmediate 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 contrury tu tho general agreement of medical opinion,
This language is nearly identical with that in section 8 douling with the misbranding of drugs, and while to a layınan it may soon to be definito, its real meaning when critically, exaininod is seen to be very uncertain. It employs the saine ambiguous and undefined terms "discase", "spocific 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 advertiseinont may be construed to be eithor true or falso, as will best suit the opinion of the administrative oflicor. In other words, the standard of truth and falsity will be the opinion of the Socrotary 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 wore. 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
FOOD, DRUGS, AND COSMETICS
by a single individual in tho 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 bo doomed 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 sulijoct of self-medication, and for which no remedy may be advertised oither directly or indirectly.
From the standpoint of applied psychology this is probably the most clevor paragraph in the ontira bill. If the paragraph simply authorized the Secretary to designato a list of affections for which remedios might not be advertised, there would be a goneral outcry Agninst the proposition, but by clevorly prefacing it with a list of diseases not ordinarily amonable to self-treatment the attempted vast oxtension of tho Secretary's authority is not so plainly ovident.
Tho naning of this largo number of discasos also suggests a desire to create a popular belief that package remedies the labels of which indicate that thoy are intended for the trentmont of such ailments are fairly numerous, whoreas, as a inntter of fact, they are not to bo found in tho average drug store, and exist only in holes and corners, or aro being put out by that class of legally registered physicians who carry on a sort of mail-order business.
A very reinarkablo provision in this parngraph is that“no advertisement slinll be doomed to be false---if disseminnted to mombers of the modical and pharmacological professions only or appears in scientific periodicals".
This leads to tho qucor situation that the same advertisoment will be either true or snlso according to tho medium in which it appears. If published in a medical journal, it will be legally true even if it bo clearly and demonstrably false. If published in a duily or weekly nowspaper, it will bo criminally fnlso ovon if it be literally and absolutely truo. The man who prints a knowingly false advertisement in a medical journal is to go froe; but the man who prints an entirely truthful advertisement in the daily press will be finod nnd sont to jail.
Takon as a whole the scopo of the languago employed in this 80ction is such that the Secretary of Agriculture can by rogulation prohibit the advertisemont in dnily and wockly newspapors of practically every remody now offered in interstato coinmorce.
Soction 10: Tolerance for poisonous ingredients in foods and cosmetics and cortification of coal-tar colors.
Soction 10 authorizes tho Secretary to determino what added substancos in food or cosmetics "is or mny bo injurious to health", and either to prohibit the use of such substances or to limit the amount which may be prosent. It also authorizes him to cortify to the harmlessness of cortain coal-tar colors.
Section 11: Definitions and standards for food.
This section in very broad terms anthorizes tho Secretary to "establish, promulgate, and enforco definitions of identity and standards of quality and fill óf containers of any food.” In other words, instead of dealing with such mattors by express provisions of law they are to bo lost wholly to the discretion of tho Secretary, who may change bis standards whenover he doems it to be necessary.
FOOD, DRUGS, AND COSMETICS
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 requiro 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 suspond immediately thu pormit of any establishnient 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 froe accoss will be sufficient ground for the rovocation of the permit.
Section 13: Factory inspection. Section 13 expands the powers granted in section 12, by authorizing any designated agent of the Socretary, after first obtaining pormission of the owner
(1) To enter any factory, warehouse, or establishment in which food, drugs or cosmetics are inanufactured, processud, packod, or hold for shipment in interstate commerce, or ure held after such shipment, or to enter any vehicle being used to transport such food, drugs, or cosmetics, in interstate comnerce; and (2) to inspect such factory, warehouse, establishinent, or vehicle and all
quipinent, methods, processes, finished and unfinished niate als, containers, and labels there used or stored.
The provision that the inspector must have permission from the owner or manager before ontering upon his inspection means nothing, since those who do not permit free access of inspectors to their establishments may not ship their products in intorstato commerce.
Thus by the terins of sections 12 and 13 the ontire process of food, drug, and cosinetic manufacture, and of their labeling and shipınent is placed within the unrestruined control of the Secretary of Agriculture. Tho denial of freo access of inspectors, or the keeping secret of a single article of equipment, of a single item of any method or process of inanufacture, 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 inethod for an appoal from or the reviow 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 onvisage a body of iuspoctors approximating the United Statos Ariny in numbers--a body of political appointoes having the power of life and death over the establishments inspected that would make the Socretary of Agriculture the most potent political factor in the Foderal Government. Seo. 14. Records of interstato shipment.
FOOD, DRUGS, AND COSMETICS
By soction 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 tho Secrotary of Agriculture to conduct investigations either through his own appointees or through officers of any Stale, Territory, or political subdivision thorcof.
The Secretary, boforo reporting violations to the Unitod 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 preliininary hearing when the violation is reported by an officer of A State, Territory, or political subdivision thereof, so that when a United States attorney institutos a suit on information filed by a State or territorial official the only notice the defondant may have is when he is called upon to answer criminal proceedings in a l'ederal District Court.
SEC. 16. Seizures.
Porngraph (12) of Section 16 authorizes seizure and condemnation of articles adulterated or misbraniled under the Act, or which are the products of ostablishments the operators of whicli do not hold permits as required by the regulations.
Parties to a condeinnation proceodings mny, by obtnining an ordor from the court, securor “ropresentative sample of the article seized," for the purpose of a duplicate analysis, but under the bill ns writton the defendunt npparontly cannot domend suclı sample us a matter of right.
Methods of procoduro are provided for the destruction, salo, or other disposition of articles condemnod. Under certnin conditions Articles condemned for adulteration or misbranding inay be returnod to the owner under bond, but when condemned because the owner did not possess a pornit is required by rogulations the articles must be destroyod, and the cost of all proceedings will be assessed Against the owner.
Agents of the Secretary of Agriculture ore rolieved of personal responsibility for wrongful seizures whon they have acted by his discretion or by direction of duly designatod ollicer of the Food and Drug Administration. In other words, the Secretary can authorize hia ngonts to porform unlawful acty without danger to thomselves.
SEC. 17. Penaltios.
1. The introduction into intorstnto commerce of any adultorated or misbrandod food, drug, or cosmetic.
2. The receipt in'intorstnto commerce of any such ndultorntod or misbranded article, or the delivery or proferred delivery of the same.
3. Tho dissemination of any false advertisement by radio-broadcast, United States mails, or "interstate commercn.''
4. The "dissemination of a falso advertisomont by any monns."
5. “The introduction into intorstate 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 crimo in this case is not tho shipment of nn adultorated, misbranded, or falsoly advertised articlo, but its shipmont without a permit froin the Secretary of Agriculture. If the article