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FOOD, DRUGS, AND COSMETIOS
rates 100 percent in quality and in the truthfulness of its labeling and advertising, its shipment without the prescribed pormit will nevertholoss be criminal act for which the full penulty of the law may be invoked.
6. “The refusal to pormit 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 bo punished by imprisonment for not more than 1 year or a fine of not less than $100, mor more than $1,000, or both line and imprisoninent. 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 inore than 3 years, and a line of not loss 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 namo and address of the person who authorized such advertisernent. A dealer is relioved 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 tug, or label authorized by the Secrotary of Agriculture may be punished by, imprisonment for 1 year or a fine of $5,000, or both fine and imprison. mont.
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 einployer is made responsible for the "uct, omission, or fuilure 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 u 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."
Soction 19: Injunction proceedings.
By section 19 the repetitious introduction into interstate commerce of any adulteruted or misbranded food, drug, or cosmetic, or the repetitious dissemination of any false advertisement is declared to be a public nuisanco, 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 nocosbury to show an intent to continue the ollense.
Section 20: Imports.
Section 20 relates to the duty of the Secretary of the Troasury in respect to the importation of adulterated, misbrandot, or falsely advertisod food, drugs, and cosinetics; 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.
FOOD, DRUGS, AND COSMETICS
This section requires the Secretary to periodically issue reports "summarizing all judgments, decrees, and orders which have been rendered, and all procoedings instituted and seizures made, including the naturo of the charge and the disposition thereof."
Under this language a manufacturer's reputation may be permanontly clouded by the charges made against him, even though the court may find him guiltloss of the offenses chargod.
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."
Secion 22: Voluntary inspection service.
Soction 22 authorizes the Secretary to appoint what are termod "supervisory inspectors" to supervise and inspect all premises, equipment, methods, matorials, containers, labels, etc., of manufacturers who file a request for such inspection.
If and as long as the roports 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 inspocted and consequently that they have Government approval.
It would no doubt be very advantngoous 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 reputntion under their own brand and label.
Tho salaries of such supervising inspoctors and other expenses incidental to the establisbment and continuance of such service are, of courso, to be paid by the firins roceiving the sorvice.
While called "voluntary inspection service", it is evident that if one establishment should adopt it, all others would be compelled to do likewise or bavo their products rest under suspicion that they will not bear official inspection.
SEC. 23. General administrative provisions.-In stntutes of an administrative character it is usually provided that the administrativo 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 boon frequontly roviowod by the courts, and decisions are unanimous to the effect that they do not authorize administra. tivo oflicers to extend the scope of the law by the imposition of obligations not expressed in the law itself, nor to read into the law mennings other than those plainly intended by the Inwmaking body.
In the bill before us there is an ovidont intention to go to the oxtromo Jimit in conferring authority upon the administrativo officer to iufluence tho courso of justice by ronding into the Inw his own opinions expresscd in the form of regulations, and, in many cases, to make bis personal discrotion the measure of the obligations imposod. Consider, for example, the provisions relating to the subject of hearings.
Preliminary hearings before an administrative officer are in the nature of minor judicial procoedings. As provided for in the existing Food and Drugs Act thoy boor n relation to Unitod States district courts roughly analogous to the rolntion of ordinary magistratos' courts to courts of common plons. While such tribunals need not FOOD, DRUGS, AND COSMETICS
proceed with the stiff formality of courts of record, it is nevertheless prosumed that they will have due regard to the substantial rights of the accused, that they will afford himn opportunity for a fair pronontaltion of his dofonso according to establishod rules of ovidence 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 regulatious and hearings the following conditions appear:
(1) That paragraph (5), section 17, makes it an offense, subjoct to the full ponulty of the law, to violate a regulation prescribod by the Socretary, which regulation ho inay imposo, amond, or withdraw at his own discretion.
(2) That certain provisions of the hill are set forth in such general torms that the specific acts constituting an offense must us nocossity bo prescribed and defined by regulation. In other words, that obligations upon inanufacturers and shippers of medicinals will be such as the Secretary of his own motion niny impose, and which muy bo ono thing today and another and quito different thing toinorrow.
(3) That in questions of opinion not susceptiblo of exact proof or disproof by experimental evidence, as for example, what shall be accepted as “contrary to the genoral 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, tho Socretary of Agriculture is authorized to prescribe "such regulations as ho 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 doem necessary for the dischargo of his functions as ho inay 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 hoarings.'
Under this tho notico of a hoaring may be 30 days or 24 hours; the Secretary can decide whether tho accused may bó represonted by legal counsel or nust prosent his own defense; can decido the method of procedure, the kind of evidence to be admitted, and tho kind to be rejected. The Secretary is not required to specify the authority upon which ho relics to support his conclusions that an article is adulterated, inisbranded or contrary to tho general ugreenient of medical opinion, and may reject the opinions of authors with whom he does not agree on the ground thet printed books are only heresay evidence.
(6) That the purpose is to confer upon the Secretary power to control the result of such heurings further uppears 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 ho 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 "tho findings of fact" which the Secretary will accept as conclusivo ngainst the accused.
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
By a unaninous 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 worded, Why, therefore, encumber a United States statute with such a provision when an injured party already possesses an adequnte remedy which can be pursued in the State courts?
The new provision if cnacted would only be an invitation to blackmailing claims and suits.
At conunon law the defendent in a damage suit would have the right to plend contributory negligence and to show that the injury complained of was due primorily 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 repeale.
Section 20 declares that the new act shall become effective six months after thọ date of its approval, nt which time the present Food and Drugs Act sball 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 Conforence has prepared a bill amending the Food and Drugs Act of Juno 30, 1906, as amended. I shall submit that bill for inclusion in the record at this point. In the suggested bill ench section is designated by the number as given in the United States Code; also by section number of the original act; matter to be dolotod is given in brackets; new matter in italic.
The bill reads: A BILI, To amend the Food and Drugs Act, June 30, luna, as amende! Allgust 23. 1012 March 2, 1913, March 4, 1911, July 24. 1919, JANUARY 18, 1977, An July, 110), for presenting the mountare, un, or transportation of ndulirented or mishrandert op MOISON" us of deleterious fools, drugs, medicines, coa main, and liquors, and for reguinting traiño therein, and lor other purposes 8717. SECTION 1. Be it enacted by the Senate and House of Represrnialines of the United States of America in Congress assembled, That it shall be unlawful for any person to manufacture within any Territory of the District of Columbia any Article of foorl, drug, or cosmelic which is indultcrater or misbranderl, within the meaning of this Act; and any person who shall violate any of the provisions of this section alinll be guilty of a mindemeanor, and for cach offense shall, ipon conviction thercor, be fined not to exceed $500, or shall be sentenced to one
FOOD, DRUGS, AND COSMETICS
year's imprisonment, or both such fine and imprisonment, in the discretiqu.of.::: the court, aud for each subsequent utfense and conviction thereuf 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. Sac. 2. That the introduction into any Stato or Territory or the Distriot of Columbia from any other State or Territory or the Distriot 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 inisbranded, within the meaning of this Act, is hereby prohibited; and any person who shall ship or deliver for shipment from any Štate or Torritory 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 Stuto or Territory or the District of Columbia from any other State or Territory or the District of Columbia, or foreign country, and haying so received, shall deliver, in the original unbroken packages, for puy or otherwise, or offer to deliver to any other person, any such articles so aclultorated or misbrauded within the inaning of this act, or any person who shull sell or offer fur unlo in the District of Columbia or tho Territories of the United Statos any such adulterated or misbranded fuods (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 deemned misbranded or adulterated within the provisions of this Act when intended for export to any foreign country and prepared or pucked according to the specifications or directions of the foreign purchaser when no substance is used in the preparation or pucking thereof in conflict with the laws of the foreign country to which suid 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. Thut (the Becretary of the Treasury,) the Secretary of Agriculture (, and the Secretary of Commerce and Lubor) shall make uniform rules and regulations for carrying out the provisions of this Act, including the colloction and exilinination 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 aluull be oflered 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 foreigu 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 ur country.
8720. SEC. 4. That the examinatious of specimens of foods, (and) drugs and cosmetics shall be made in (the Burcau of Chemistry of the Department of Agriculture) such existing bureau or bureaus in the Depariment 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 exuininations whether such articles are adulterated or misbranded within the ineaning of this Act; and if it shall appear from any such exumination 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 obtuinod) manufacturer of such article is known or if unknown to the party who caused said article to be inlroduced 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 nforesaid, 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 coinmerce, 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 otficer making such examination, under the outh 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 aforesuid.
8721. Sec. 6. That it shall be the duty of each district attorney to whom the Socretary of Agriculture shall report any violation of this Act, or to whom any health or food or drug oflicer or agent of any State, Territory, or the District of Columnbia shall present satisfactory evidence of any such violation, to cause appropriate proceedings tu be conuenced and prosecuted in the proper courts of