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FOOD), DRUGS, AND COSMETICS

THURSDAY, DECEMBER 7, 1933

UNITED STATES SENATE,
SUBCOMMITTEE OF THE COMMITTEE ON COMMENCE,

Washington, D.C. The subcommittee met, pursuant to call, in room 335 Senuto Ollice Building, at 10:30 a.i., Senator Royal 'S. Copeland, presiding.

Present: Senators Copeland, McNury, ind Caraway.

Senator COPELAND. The hearing will como to order, plense. We have a crowded room. I am sorry wo huve not chairs (nough for everybody: Perlinps we can secure enough after uwhile to fill the room. We had to go froin a room which we lind arranged into this farger one, and even this seems to be crowded. So you will help us a lot if you will be as quiet is possible.

This is a heuring of the subcommittee of the Committee on Cornmorce to consider Senato Bill 1944, and the record at this point will show u copy of the bill.

(S. 1944 is as follows:) In the Senate of the United States, June 6 (calendar day, June 12), 1933.

Mr. Copeland introducerl the following bill; which was read twice and referred to the Committee on Commerce.

A BIT.L to prevent the manufacture, shipinont, nur sale of adulruter or inisbranded food, drugs, and cometies, and to rogute Laulic clcriu, lu pre von! thu lalulverlijuwont of fuurd, unum,ind cosmetics, 1:4!lur other purse's

Be il cnacted by the Senate and House of Represenlatives of the l'nited States of America in Congress assemblal, Thint this Act muy be cited is the "Federal Food and Drugs Act.

DEFINITIONS

Sec. 2. As lined in this Act, unless the context uthierwise indicates:

(a) The term “foull” includes all substances and preparations used for, or entoring into the composition of, food, trink, confectionery, or condiment for Dan or other animals.

(b)) The term "rus" includes (1) all substancos and preparations recognized in the limited States Pharmacoporil or National l'oriuuliry or supplements thereto; and (2) all substances, preparations, and devices intended for rise in the curv, miligution, treatment, or prevention of incano in man or other unimuls; and (3) all $11!tances and preparations, other than food, and all devices, iltended tu alloct the structure or any function of the body of mun or other animals. 2

1 The term "Cosmetic includes all substances and preparations intended for cleansing, or ultering the appearance of, or promoting the attractiveness of the person. Except ils indicrttui in paragraph (0)) (3) of this section, the definitiunt of food, (Iruk, and costhetic slnil ont be construed in many exclusive.

(il) The term "territory MC2018 119 territory or DUHBCNSION of the United Slotes.

(0.1 The form "interstule commerce" means (1) Commerce between illy Stato or Territory :lnd illy place outside thereof, or between points within the sume State or Territory borit through any place outside thereof, and (2) corumerce and manfacture within the District of Columbiat or the Canal 2one or within any territory in organized will it legislative body.

FOOI), DRUGS, AND COSMETICS

PO The term “person" includes individual, partnership, corporation, and association.

(9) The term "Secretary" means the Secretary of Agriculturr.

(1) The term "label" imeans tlor principal lalel cor lubois (lipoli lie i .miestinte container of any level, drug, or Cosme:i", 14 (2) upon thor outside contaiver or wrapper, if any there bır, or the retail package of 2015 fooll, drug, or Cosmetic.

(i) The term "labeling" includes all abode oni ottirs writ:ei, porintról, and graphic mallor, in illy form whatsoever, :lccompanying any foori, drug, or Cosmetic

The term "dvertisements includes all representations of f:161 or opinion disseminated in any mor or by any means other than by the Inbeling.

(k) The term “in package forin" incluries wrapport mcats cncloser in paper or other materials as prepared by the manufacturers thereof for sale.

ADULTERATION OF FOOD

sec. 3. A food shall be deemed to be uluitortod:

(a) (1) Ilin is oir nay be da!! Rosons to ! 11h; or (2) ir il bears or contains :!!1 V noiteet poisonous or acheter deletcrious ruinance probiilitail, or in excess of Iliri limits of twieranno prescribicul, boy regulations as hereinster providers; or (3) ir it consists in whole or in part of any liable, putril, or cjenom;"Bel nullontallice; or!) ir il buasi lucro proprei. parkiral, or hele innler insanitary conditions wherely it may hirve berimpose contabililord will dibile; or (o) ir it is 10. produce of a siis. real: nimal or of all animal which has linnad ollicruise than lig' slaugliter; or (li) ir its container is composed of :1118 poisoms or deleterious substance which mas loy cunt:11111:11on rronder the contents injurious to, boniti.

lei) il) || :ny videohole constituent les iccu ili whole or in part abstracted therefrom; or (2) if :1.7 nudistallen last: 6111iilter wille vor in partilererur; or !:) ir mago or inferiority lines liepos concealed in :1115 Manier; or (b) if only 8111::reebies liemenilor librotherosushi seas to increase its milk or weighill, Il pontessor its mobile non istcsogg: 11, 11' 170;}!" Literoplive. :pcr.o.

foullit ii contrations and fears or continually alcohol, resinous glaze, or 116.10:19 trilise mbas!!!!poscopot : oborine : 110.1 ilivering

di fit crosst:4005 ::: 1:11 auior roller than one from a balco that has ben certificed how the Secretary in necone writingullions as lvereinafter provided

ADILTERATION OF DIOS

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liil. is prot siehjort!! pinjorovisions oor posur:u? Tapah (bo) of this section and its 12.11nt: 0 !!! Ili dhibhoors S:02 or its purile or folity falls below, that whici

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FOOD, DRUGS, AND COSMETICS

3

ADULTERATION OF COSAI ETICH

Sec. 5. A cosmiclic Niall be deemed to be adulterated:

(zu) If it is ur filly be injurious to ide liner under the conditions of use probcribod in the labeling tbervor, or wler sucli conditions of use us are custolliary or usual.

(b)) If it bears or contains any poisonous or deleterious ingredient prohibited, or in excess of the limits of tolerance prescribed, by regulations is hereinafter provided.

MISHRANDINO-GENERAL

Src. 6. A food, drug, or cosmotic shall be deemed to be misbranded:

(u) If its laiveling in !u any particular l'Hlse, or by ambiguity or inference creates a misleading impression regarding any lood, drup, or cosmetic.

(b) Il in puckayo lurin it fail to bear is label containink: (1) the namo and plict of business of the manufacturer, frackir, seller, or distributor; and (9) 1.0 cochruto stutomielite of the quantity of the contents ill auch torms of weight, Inorsure, or numerical count is may be prescribed by regulations of the Secretary: Provided, That under nubilivision (2) of this purngruph roasunalle variations shu!! bo permitted, and exemptions as to small packages of fools and Connolicu slull Iso uslublished, by regulativos pronorilol loy the Sterelwry: And provided further, Tlut much classes of vunned foorly as the Secretary finds, alter noticu and hearing, Arc, in accordance with the practice of the trade, Inbeledi in substantial quantities at uslublinlimentos other than the establinliments where prucessed or pickud, shall bu oxunpted by romlilations from the requirements of their paragraph during transportation from the establislunent where processer or pinckell to an establishmont for leveling, if such urticles aro labeled in conformity with the provisions of this Act prior to reinoval froin sneh labeling establishment.

(c) If any worl, statement, or other information required on the label to avoid muulteration or suisbranding minder any provisions of this Act is not prominoully placed thereon in such a manner is to be easily seen and in such terme 118 to be readily intelligible to the purulaşers and users of such articles under cuolvinary conditions of purchase and use.

MISARANJIVO OF FOOD

Sec. 7. A food sliall loc deemed to be ruisbranded:

(11) IT (1) its container is 50 mmarle', furmel, or lilled its to mislead the purchaser, or (2) its contents full below the stilhared or lill prescribed boy rejetilitin 18 hereinafler provider.

(1) If it is offered for nlc under the name of another good.

le) li it is an imitation of another foll, except that ro imitation shall neemed to be muistranderd uncor this porngripile it is bibel beard the world imia tulion"

int juxt:uposition with all in lype of the same size and provinent ils the nunc of the food inilated.

(il) II it purporis to be; or is represented 10% it food for which it definition of identity has been prescribseil luy regulattioilly its hereiuulter provided, itu! tu bear on its label the milline of the food delived in illohi terns its 1!1e regulation mpiecily, or (2) fuils to conturun to the definition.

(es) Trit purports to be or in representa: si lood for which standards of polis linvo lcon prescribed by regulations its lareimaflor provided, and ill finis teisi on ilo lahel, is so requirelliy the regulations, it standard of quality in such larm its the regulations specify, or (?) falls beinw llic taludared stated on the litsei.

() Ir il purportis lu le or in represented its is food for which no sletimijand on identity las been prescribed by regulitinns its licrinieller provided, 2010! ils !!!! Sails iw leir (1) tlie common or 11811:11 Date of the loud, ilmuy bonitor the counnoll om 11s0al studie of ench ingredient thereof in order of pie by weight; except thoice obices, llavors, illi iurliticial colors may tries in haettavien much without living cul spire, lliw Verr, or otrlilicial co!or.

TI hereby authorized to prescribe loy rozwilions requirements for speed formation on thic lubei tinereuf les lie 11:1y deem nccessitry to p»ruberol. llie 1" si from deceptioni.

MISTICANDING ON DRUGS

Sec. 8. A drug shall be deemed to lie prisbrandeel:

(u) (1) If its lichoeling bears the name of illiy disease for which the c!ring is 11 & specitic cure bui is in pulittive, illud lails lo bear in juxtapositions and in letters of the saille size :und Jorumi once it rilielewerit !!!!! 'tie

4

FOOD, DRUGS, AND COSMETICS

cure for such disenxr; or (2) if its labeling beats ang representation, directly or loy ambiguity or insercuce, coucerning the effect of such drug which is contrary to the general agreement of medical opinion.

(h) If it is for internal we by mali and contains any quantity of any of the following narcotic or llypriotic substances: Alplin cucaine, barbital, beta eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, morphine, opiwn, parallchvile, peyote, sulphonmethane, or any narcotic or bypnotic derivative therefroin by actual or theoretical chemical reaction, and its label laila to bear the name and a statement, in the manner and form prescribed by reguintiona promulgnted by the Secretary, or the quantity or proportion of surli siebie stance or derivative in juxtnposition with the statement "Warning-May be habit forming.". The Secretary is hereby nuthorized, by regulations prescribed after notice and hearing, to designate as narcotics or hypnotics within the ineaning of this pargaraph auch other substances as he may find to porseks narcotic or hypnotic properties.

(c) Ir it contains any quantity of ethyl nicol ol, ethyl cther, or chloroform, and its Inbrl fails to bear a stntement, in the manner and form prescribed by regulations of the Secretary, of the quantity of proportion of such substance. (d) If it is not fulhjert to the provisions of paragraph (i) of thip

. nection, and its Inhering fails to bear complete and replicit directions for var: Provider, that the Secretary may by regulation exempt any drug from any requirement of this paragraph if he decins such requirement innecer:nry for the protection of public health.

(c) If it is not subject to the provisions of paragraph (h) of portion 4 and its label fails to bear (1) the common name of the drug, if any ther: be, and (2) the name and quantity or proportion of cach mierlicinal or pluysiologically active ingredient thereof. "The Secretary is bereby authorized to prescribe by reguin. tions requirements for such further information on the label of such drug as he may deci necessary to protect the public health.

(f) If its name in the same as, or simulates, a name recognized in the United Btaice Pharmacopocin or Nationnl Formulnry or any suppleinent thicreto officin! at the time auch drug is introduced into intorstate commerce, and it is not packAged and labeled as prescribed therrin.

(g) If it is n drug liable to deterioration, and is not packaged in such form or manner, or if its lal»cl fails to bcar A statement of such precautions, as the Secre. tary inay prescribe hy regulations, after notice and hearing, for the protection of public health. The Secretary is hereby authorized to designate by regulations, prescribed after notice and bearing, as druga liable to deterioration within the meaning of this paragraplı, such drugs as lie inny find to be liable to deterioration.

(h) (1) If its container is so inade, formed, or lilled on to mislend the purchneer; or (2) if it is an imitation of another drug; or (3) if it is offered for sale under the name of another drug.

(i) If It purports to be or in represented as n germicide, bactericide, disinfectant, or antiseptic for any use on or within the human or animal body and its Inbeling fnile to hear a statement of each auch usc and, plninly and conspicuously and in juxtaposition therewith, the method and duration of Appliration necessary to kill all micro-organisms in the vegetative or other active forin with which it comes in contact when so 1180d; except that no driig shall be deemed to be misbranded under this paragraph is its label bears a statement that it is a germicide, bactericido, disinfectant, or antiseptic for specific kinds of micro-organisms only, and its labeling bears a statement of each purported or represented 1se and, plainly and conspicuously and in juxtaposition there with the conditions, incluing duration of application, under which the drur kills all auchi aperilie kinds of micro-organisins in tlic vegetative or other active form with which it conies in contact when so vned.

FALSE ADVERTISE ENT

Sec. 9. (n) An arivertirencnt of n food, drug, or conmetic sholl be deemed to be false if in any particwar it is untrue, or by ambiguity or inference creates a misleading impression regarding such food, drug, or cosmetic.

(b) An advertisement of a cirug shall also be deemed to be false if it includes (1) the name of any discare for which the drug is not a specific cure but is a Palliative, and fails to state with canal prominence and in immediato connection with such name that the drug is not a cure for sirla discarc'; or (2) my riporrectie tation, directly or loy numbignity or inference, concerning the effect of suel druk which is contrary to the general agreement of inedical opinion.

l'OOD, DRUGS, AND COSMETICS

5

(c) To discourage the public advertisement for sale in interstate commerce of drugs for diseases wherein sell-olietin may be especially dangeroust, or pale ently contrary to the interests of public leniti, illy advertisement of a cirug representing it directly or loy ambiguity or inference to have it.ly cloct in the tretinent of any of the following discuss shall be deemed to be fulso: AlbumiIliriu, itp pondicilis, arteriosclerosis, blood poisoni, bono diseases, Cincer, carbune clus, cholecystitis, diabetes, diphtherint, cropssy, crysipelus, gallstones, heart diseases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis ruedliit , paralysisi

, prewnonin, poliomyelitis, prostate glund vlisorders, pyolitis, scarlet lever, sexual impotenci, simils infections, smallpox, tuberculosis, tumors, typhoil, uremiu, voneral diseases, whoopilik cough; cxcept thut no alla vertiscipent shall be deemed to be false inder this purugraph is it is disseminated to nuembers of the medical oud plaarmacological professions only or appears in scientific periudicals Provideil, Thul whenever the Secretary, after noticu and henring, determines thalt in anilvanco in mollical science luns aucu any type of Holl-meclication sulu ilt to any of the discused chammeruteil above, he miny by regulative authorize the advertisement of drugs having curativo or therapeutio ellect for sich disense, mubject to such conditions and restrictions as he may deem nieocentry in the interests of public health: Provided further, That whenever the Sucretury, ulter botice and caring, cletermines that self-medicution for discutsch other their thung leroill numeri may be chpecially dangerous, or patently contrary to the interests of public health, lie is hereby authorized to promulgato regulations designating such other diseases as diseases within the meaning of this paragraph: Provider further, That this paragraplı shall not be construed as indicating that sell-nedicition for diseases ther than those uumed herein or desig, natod by regulations us the Secretary under tho authority licreof is sure or eftioncious.

STOLERANCES FOR POISONOUN INGREDIENTH IN FOOD AND COSMETICS AND

CHIITIFICATION OF COAL-TAR COLOR FOR FOOL

Swo. 10. (a) If the Secretary finds that the presence of an adderi poisonous or uddel dolutorious substance in or on lood or cosmetics is or may be injurious to the health taking into account other ways in which the consumer or user muy partuko of or be exposed to the same or other poisonous or deleterious substancos, thou the Secretary shall boy regulations promulgated after solice and licuring prohibit sich incleiuri suboslastices in ot on vult or cosmetics, or establish tolerancos limiting the amount therein or thorcon, to such extent as he may deem necessary La prevent much injury to lealtlı.

(b) The Secretary is hereby authorized to make regulations, after notice and hearing, for the curlilication of coul-tur colors which he finds to be hurinless for Use in fourt.

DEFINITIONS AND STANDARDS FOR FOOD

SEC. 11. The Secretary is hereby authorized to fix, establishi, and promul. gate delinitions of islentity and standards of quality and till of contuinor for any food. Whenever the Secretary deems that for the purposes of this Act any such desinition or standard sliould be established for any food, he shall give notice of a proposed clinition or standeel und of the time and place of a public heuring to be licia thorcon not less than thirty clays after the dute of such notico. After such public hearing the Secretary inily lix, establish, and promulgato celinition or standard for such food. Ti oletinition or standuri so promulgatod Henll ivecome ellertivé un auto lixed lay the Secretary, which date shall not be prior lo lilety lilys after its promulgation. Any suel delinition or stundurd inny be amended or repealed after notice and hearing us hereinbefore provided, and if unendlodd or repealed the amendment or repen! shall become elfective in the manner and itt the time hereinbesure provided.

PERMIT FACTORIES

SEC. 12. (n) Whenever the Secretary sinds thut the distribution in interstate convierou of any class of foort, crons, or (O:metics may, by reason of conditions surrowding the Aufacture, processing, or packing thereof, be injurious to health, and such injurious mixture cannot be undequiltely determined after suola articles live entered interstate cunumerce, bie is authorized, niter notice und hearing, to make such regulativlis governing the conditions of manufacture, processing, or preking as lie iluentin Cressary to protect the public heulth, and

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