Document G6zpjM7r7MVnKnq268np981dm

SCOMMUNICATIONSTO AUTRADE COMMISSION OFFICEOFTHE MEDICALDIRECTOR federal Trade commission WASHINGTON October 16, 194-3. INREPLYING PLEASE QUOTE Dr. Robert A. Kehoe University of Cincinnati College of Medicine Cincinnati, Ohio Dear Doctor Kehoe: The Federal Trade Commission is undertaking to determine whether or not there is a strong or dangerous probability that lead and sulfur hair dye may contribute in injury to health. These preparations usually contain from 1 to 3% of lead acetate and about the same quantity of suspended sulfur in a suitable perfumed liquid menstrura. The method of application is genersJLly to use a wet toothbrush and apply the preparation evenly to the hair and permit it to dry. After a lapse of six to 12 hours the hair is shampooed. As the hair grows it be comes necessary, at relatively short intervals, to apply the dye close to the scalp. In our review of the literature pertinent to lead poisoning we have observed the excellent work which you have reported. We would like very much to have the bene fit of your views with respect to the possibility of dan ger arising from the use of lead and sulfur hair dyes. There wrould probably be little absorption of lead from an intact scalp. However, if the hands are soiled with the preparation they may convey it to the mouth. If there is a scalp abrasion or an inflammatory process of the scalp, is their danger of absorption under these conditions? Do you feel that the directions for use of a lead and sulfur hair dye should inform the individual that if the hands are soiled they should be washed; that if the scalp is broken or inflamed the product should not be used; and that even in a healthy scalp application to it should be avoided as much as possible? The legal adviser of the Federal Trade Commission indicates that it is not necessary to prove that cases of injury have taken place, but that if it can be shown that there is a strong or dangerous probability that danger to health may result, steps may be taken under section 15 of the Federal Trade Commission Act to insure that the (Dr. Robert A. Kehoe) -2- October 16, 1943. users of these lead-containing hair dyes are given sufficient information about their use to avoid the danger. A copy of the Act is enclosed for your con I venience. We are also enclosing a copy of a memorandum to the Commission. Would you care to comment on the testimony of Dr. M. I. Smith quoted in this memorandum? Your views will be greatly appreciated and will assist the Commission in arriving at a proper decision in connection with this problem. Very sincerely yours, 5* J. J. DURRETT, M.D., Director, Medical Advisory Division. Enclosures FTC Act Memorandum 12/19/42 KZ 0013868 6604.01 FEDERAL TRADE COMMISSIONACT [Publ ic No. 203--63cl Congr ess, as amended by Publ ic--No. 447-- 75th Congress] [I-I. R. 15613 and S. 1077] AnAct To create a Federal Trade Commission, to define its powers and duties, and for other purposes. Be it enacted by the Senate and House of Representatives of the UnitedStates of Americain Congressassembled, That a commission is herebycreated andestablished, tobeknown as the Federal Trad Commission (hereinafter referredtoas the commission), whichshall be composed of five commissioners, who shall be appointed by the President, by and with the advice and consent of the Senate. Not more thanthree of the commissioners shall bemembers of the same political party. Thefirst commissioners appointed shall continuein officefor terms ofthree, four;-five, six, and sevenyears, respectively, fromthe date of the takingeffect of this Act, thetermof eachtobe designated by the President, but their successors shall be appointed for terms of seven years, except that any person chosen to fill a vacancyshall be appointed only for the unexpired termof the com missioner whomhe shall succeed:Provided, however, That uponthe expirationofhistermofofficeaCommissionershall continuetoserve until his successorshall havebeenappointedandshall havequalified. The commission shall choose a chairman fromits ownmembership. No commissioner shall engage in any other business, vocation, or employment. Any commissioner may be removed by the President for inefficiency, neglect of duty, or malfeasancein office. Avacancy in the commission shall not impair the right of the remaining com missionerstoexerciseall thepowersofthecommission. Thecommissionshallhaveanofficial seal, whichshall bejudicially noticed. Sec. 2'. That each commissioner shall receive a salaryof $10,000a year, payableinthe samemanner asthe salaries of the judges of the courts of the United States. The commissionshall appoint a secre tary, whoshall receiveasalaryof $5,000ayear, payableinlikeman ner, and it shall have authority toemploy and fixthe compensation of such attorneys, special experts, examiners* clerks, and other employees as it may fromtime totimefindnecessary for the proper ue 001336.) performance of its duties and as may be fromtime to time appro priated for by Congress. With the exception of the secretary, a clerk to eachcommissioner, the attorneys, and such special experts and examiners as the com missionmay fromtime to time findnecessary for the conduct of its Avork, all employees of the commissionshall be a part of the classi fied civil service, and shall enter the service under such rules and regulations asmaybeprescribedbythecommissionand bythe Civil Service Commission. All of the expenses of the commission, including all necessary expenses for transportation incurred by the commissioners or by iheir employees under their orders, in making any investigation, or Por: official business in any other places than in the city of Wash ington, shall be allowed and paid on the presentation of itemized vouchers therefor approvedbythe commission. Until otherwise provided- by laAV, the commission may rent suit able officesfor its use. The Auditor for the State and Other Departments shall receive andexamine all accounts of expenditures of thecommission. Sec. 3. That upon the organization of the commission and elec tion of its chairman, the Bureau of Corporations and the offices of Commissioner andDeputyCommissioner of Corporations shall cease to exist; and all pending investigations and proceedings of the Bureau of Corporations shall becontinuedby the commission. All clerks and employees of the said bureau shall be transferred to andbecomeclerks andemployees of thecommission at their pres ent grades and salaries. All records, papers, and property of the said bureau shall become records, papers, and property of the com mission, and all unexpended funds and appropriations for the use andmaintenanceof the saidbureau, includinganyallotment already madetoit bytheSecretaryof Commercefromthecontingent appro priation for the Department(of Commerce for the fiscal year nine teen hundred and fifteen, or fromthe departmental printing fund for the fiscal year nineteenhundred and fifteen, shall become funds and appropriations available to be expended by the commission in the exercise of the powers, authority, and duties conferred on it by this Act. Theprincipal officeof thecommissionshall beinthecityofWash ington, but it may meet and exercise all its poAvers at any other place. The commission may, by oneor more of its members, or by suchexaminers asit may designate, prosecute any inquirynecessary toitsdutiesinanypart oftheUnitedStates. Sec. 4. The Avords definedin this section shall have the folloAving meaningwhenfoundinthisAct, to Avit: "Commerce" means commerce among the several States or -with foreign nations, or in any Territory of the United States or in the District of Columbia, or between anysuchTerritory and another, or between any such Territory and any State or foreign nation, or between the District of Columbia and any State or Territory or foreign nation. "Corporation" shall be deemed to include any company, trust, so-called Massachusetts trust, or association, incorporated or unin corporated, whichisorganizedtocarryonbusinessfor its ownprofit or that of its members, and has shares of capital or capital stockor certificates of interest, and any company, trust, so-calledMassachu setts trust, or association, incorporated or unincorporated, without shares of capital or capital stock or certificates of interest, except partnerships, which is organized to carry on business for its own profit or that of its members. "Documentary evidence" includes all documents, papers, corre spondence, books of account, andfinancial and corporate records. "Acts to regulate commerce" means the Act entitled "An Act to regulatecommerce,"approvedFebruary14,1887, andallActs amend atory thereof and supplementary thereto and the Communications Act of 1934 and all Acts amendatory thereof and supplementary thereto. "Antitrust Acts"means the Act entitled"An Act to protect trade andcommerceagainstunlawful restraints andmonopolies,"approved July 2, 1890; alsosections 73to77, inclusive, of anAct entitled"An Act to reduce taxation, to providerevenue for the Government, and for other purposes,"approvedAugust 27, 1894; alsothe Act emitled "AnAct to amendsections 73and 76of the Act of August 27, 1894, entitled `An Act to reduce taxation, to provide revenue for the Government, andfor other purposes,'"approvedFebruary 12, 1913; andalsotheActentitled"AnActtosupplement existinglawsagainst unlawful restraints and monopolies, and for other purposes," approvedOctober 15, 1914. Sec. 5. (a) Unfair methods of competition in commerce, and un fair or deceptive acts or practices in commerce, are hereby declared unlawful. The Commissionisherebyempoweredanddirectedtoprevent per sons, partnerships, or corporations, except banks, common carriers subject to the Acts toregulate commerce, and persons, partnerships, or corporations subject to the Packers and Stockyards Act, 1921, except as providedinsection406 (b) of saidAct, fromusingunfair methods of competitionincommerceand unfair or deceptive actsor practices in commerce. 4 (b) Whenever the Commission shall have reason to believe that any such person, partnership, or corporation has been or is using an}7unfair methodof competitionor unfair or deceptiveact or prac tice in commerce, and if it shall appear to the Commission that a proceeding by it in respect thereof would be to the interest of the public, it shall issueandserveuponsuchperson, partnership, or cor poration acomplaint stating its charges inthat respect and contain inga notice of ahearing upon a day and at a placetherein fixed at least thirty days after the service of said complaint. The person, partnership, or corporationsocomplained of shall have the right to appear at the place andtime sofixedand showcause why an order shouldnot beenteredbytheCommissionrequiringsuchperson, part nership, or corporation to ceaseand desist fromthe violation of the .lawsocharged in said complaint. Any person, partnership, or cor poration maymake application, andupon goodcause shownmay be allowedbjf the Commissiontointervene and appear in said proceed ingby counsel or in person. The testimony in any such proceeding shall bereducedtowritingandfiledinthe officeof the Commission. If uponsuchhearingtheCommissionshall beoftheopinionthat the methodof competitionortheact or practiceinquestionisprohibited bythis Act, it shall make a report in writing in whichit shall state its findings as tothe facts and shall issue and causetobe served on suchperson, partnership, or corporationanorder requiringsuchper son, partnership, or corporationto cease and desist fromusing such methodof competitionor suchact or practice. Until the expiration of the time allowed for filinga petition for review, if no such peti tionhasbeendulyfiledwithinsuchtime, or, if apetitionfor review hasbeenfiledwithinsuchtimethenuntil thetranscript oftherecord iir the proceedinghas beenfiledin a circuit court of appeals of the United States, as hereinafter provided, the Commissionmay at any time, upon suchnotice and in suchmanner as it shall deemproper, modifyorsetaside,inwholeorinpart, anyreport oranyordermade or issuedby it under this section. After the expiration of the time allowedfor filing apetition for review, if nosuchpetitionhas been duly filed within suchtime, the Commissionmay at anytime, after notice andopportunity for hearing, reopen and alter, modify, or set aside, in whole or in part, any report or order made or issued by it underthis section, whenever intheopinionof the Commissioncondi tions of fact or of lawhave sochanged as to require such action or if the public interest shall sorequire: Provided, however, That the saidperson, partnership, or corporationmay, withinsixtydays after service upon himor it of said report or order entered after such a reopening, obtainareviewthereof inthe appropriate circuit court of appeals of the United States, in the manner provided in subsection 5 fc) Any person, partnership, or corporation required by an order of the Commission to cease and desist from using any method of competition or act or practicemay obtain a reviewof suchorder in the circuit court of appeals,of the United States, within any circuit where the method of competition or the act or practice in question was used or where such person, partnership, or corporation resides or carriesonbusiness, byfilinginthecourt, withinsixtydays1from the date of the serviceof suchorder, awritten petition prayingthat the order of the Commission be set aside. Acopy of such petition shall be forthwith served upon the Commission, and thereupon the Commission forthwith shall certify andfileinthe court atranscript of the entire record in the proceeding, including all the evidence takenandthereport andorderoftheCommission. Uponsuchfiling of the petition andtranscript the court shall havejurisdictionof the proceeding and of the question determined therein, and shall have power tomake andenter uponthe pleadings, evidence, and proceed ings set forth in such transcript a decree affirming, modifying, or setting aside the order of the Commission, and enforcing the same to the extent that such order is affirmed, and to issue such writs as are ancillary to its jurisdiction or are necessary in its judgment to prevent injury to the public or to competitors pendente lite. The findings of the Commissionastothe facts, if supportedbyevidence, shall beconclusive. Tothe extent that the order of the Commission is affirmed, thecourt shall thereuponissueits ownorder commanding obedience to the terms of such order of the Commission. If either partyshall applytothecourt forleavetoadduceadditional evidence, cT; and shall showto the satisfaction of the court that such additional -"O evidence is material and that there were reasonable grounds for the If""' failure to adduce such evidence in the proceeding before the Commission, the court may order such additional evidence to be taken before the Commission and to be adduced upon the hearing in such manner and upon such terms and conditions as to the court may ^4 seemproper. The Commission may modify its findings as to the facts, or make newfindings, by reason of the additional evidence so taken, and it shall file such modified or newfindings, which, if supported by evidence, shall be conclusive, and its recommendation, if any, for the modification or setting aside of its original order, with the return of such additional evidence. The judgment and decree of the court shall befinal,'except that the same shall besub ject toreviewbythe Supreme Court upon certiorari, as provided in section240oftheJudicial Code. 1Section r(a) of the amendingAct of 3038 provides: Sec. n. (a) In case of an order by the Federal Trade Commission to cease and desist, served on or before the date of the enactment of this Act, the sixty-day period referred to in section 5 (c) of the Federal Trade Commission Act, as amended by this Act, shall 6 (d) The jurisdiction of the circuit court of appeals of the United States to affirm, enforce, modify, or set aside orders of the Commis sionshall beexclusive. (e) Suchproceedings inthecircuit court of appeals shall begiven precedenceoverothercasespendingtherein, andshallbeineveryway expedited. No order of the Commission or judgment of court to enforcethesameshall inanywiserelieveor absolveanyperson, part nership, or corporation fromany liability under the Antitrust Acts. (f) Complaints, orders, and other processes of the Commission under this section may be served by anyone duly authorized by the Commission, either (a) by delivering a copy thereof to the person to be served, or to amember of the partnership to be served, or the president, secretary, or other executive officer or a director of the corporation to be served; or (b) by leaving a copy thereof at the residence or the principal officeor place of business of such person, partnership, or corporation; or (c) by registering and mailing a copy thereof addressed to such person, partnership, or corporation at his or its residence or principal officeor place of business. The verified return by the person so serving said complaint, order, or other process settingforth the manner of saidservice shall beproof of the same, and the return post office receipt for said complaint, order, or other process registered and mailed as aforesaid shall be proof oftheserviceofthesame. (g) An order of the Commissionto ceaseand desist shall become final-- (1) Upon the expiration of the time allowed for filing a petition for review, if no such petition has been' duly filed within such time; but the Commission may thereafter modify or set aside its order to the extent provided in the last sentence of subsection (b);or (2) Upon the expiration of the time allowed for filing a petition for certiorari, if the order of the Commission has been affirmed, orthepetitionfor reviewdismissedbythecircuit court of appeals, andnopetitionfor certiorari has beenduly filed; or (3) Upon the denial of a petition for certiorari, if the order of the Commission has been affirmed or the petition for review dismissedbythecircuit courtof appeals; or (4) Upon the expiration of thirty days from the date of issuance of the mandate of the Supreme Court, if such Court directs that the order of the Commission be affirmed or the petitionfor reviewdismissed. (h) If the Supreme Court directs that the order of the Commis sion bemodified or set aside, the order of the Commission rendered in accordance with the mandate of the Supreme Court .shall become 7 final upon the expiration of thirty clays fromthe time it was ren dered, unless within such thirty days either pai'ty has instituted proceedings to have such order corruptedto accordwith the mandate, in whichevent the order of the Commissionshall becomefinal when socorrected. (i) If the order of the Commissionis modifiedor set asidebythe circuit court of appeals, and if (1) the time allowed for filing a petition for certiorari has expired and no such petition has been duly filed, or (2) the petition for certiorari has been denied, or (3) the decision of the court has been affirmed by the Supreme Court, thentheorder oftheCommissionrenderedinaccordancewith themandate of the circuit court ofappeals shall becomefinal onthe expiration of thirty days fromthe time such order of the Commis sion was rendered, unless within such thirty days either party has instituted proceedings to have such order corrected so that it will accord with the mandate, in which event the order of the Com missionshall becomefinal whensocorrected. (j) If the Supreme Court orders a rehearing; or if the case is remanded by the circuit court of appeals to the Commission for a rehearing, and if (1) the time allowed for filing a petition for certiorari has expired, and no such petition has been duly filed, or (2) the petition for certiorari has been denied, or (3) the decision of thecourt has beenaffirmedbythe Supreme Court, thenthe order of the Commissionrendered upon suchrehearingshall becomefinal inthesamemanner asthoughnoprior order ofthe Commissionhad been rendered. (k) As usedinthis sectiontheterm"mandate,"incase amandate hasbeenrecalledpriortothe expirationof thirty days fromthe date of issuancethereof, meansthefinal mandate. Pv. C"OO (l) Anyperson, partnership, or corporationwhoviolates anorder o of the Commissiontoceaseand desist after it has becomefinal, and whilesuchorderisineffect,shall forfeit andpaytotheUnitedStates acivil penaltyofnotmorethan$5,000foreachviolation, whichshall accrue to the United States and may be recovered in a civil action w broughtbythe United States. Sec. 6. That thecommissionshall alsohavepower-- (a) Togather andcompileinformationconcerning, andtoinvesti gate fromtimeto timethe organization, business, conduct, practices, andmanagement of anycorporationengagedincommerce, excepting banksand commoncarriers subject tothe Act to regulate commerce, andits relationtoother corporations andtoindividuals, associations, and partnerships. (b) Torequire, by general or special orders, corporations engaged in commerce, excepting banks, and common carriers subject to the 8 Act to regulate commerce, or any class of them, or any of them, respectively, tofilewiththecommissioninsuchformasthe commis sion may prescribe annual or special, or both annual and special, reports or answers in writingto specific questions, furnishing to the commissionsuchinformationasit mayrequireastotheorganization, business, conduct, practices, management, and relation to other cor porations, partnerships, and individuals of the respective corpora tions filing such reports or answers in writing. Such reports and answers shall be made under oath, or otherwise, as the commission may prescribe, and shall be filed with the commission within such reasonableperiod asthe commissionmayprescribe, unless additional timebegrantedinanycasebythe commission. (c) Whenever afinal decreehasbeenentered against any defend ant corporation in anysuit brought bythe United States toprevent and restrain any violation of the antitrust Acts, to make investigation, uponits owninitiative, of the manner in which the decreehas beenorisbeingcarriedout, andupontheapplicationoftheAttorney General it shall be its duty to make such investigation. It shall transmit totheAttorneyGeneral areport embodyingitsfindingsand recommendationsasaresult ofanysuchinvestigation, andthereport shall bemadepublicinthe discretionof the commission. (d) Upon the direction of the President or either House of Con gress to investigate and report the facts relating to any alleged violations of the antitrust Acts by any corporation. (e) Upon the application of the Attorney General to investigate and make recommendations for the readjustment of the business of any corporation alleged to be violating the antitrust Acts in order that the corporationmay thereafter maintain its organization, man agement, andconduct ofbusinessinaccordancewithlaw. (f) Tomake public fromtime to timesuchportions of the infor mation obtained by it hereunder, except trade secrets and names of customers, as it shall deemexpedient in the public interest; and t makeannual andspecial reportstotheCongressandtosubmit there with recommendations for additional legislation; andtoprovide for the publicationofits reports anddecisions insuchformandmanner asmaybebest adaptedfor publicinformationanduse. (g) Fromtime totime to classify corporations and to make rules and regulations for the purpose of carrying out the provisions of thisAct. (h) To investigate, from time to time, trade conditions in and with foreign countries where associations, combinations, or practices of manufacturers, merchants, or traders, or other conditions, may affecttheforeigntradeoftheUnitedStates, andtoreporttoCongress thereon, with such recommendations as it deems advisable. 9 Sec. 7. That in anysuit in equity brought by or under the direc tion of the Attorney General as provided in the antitrust Acts, the court may, upontheconclusionof thetestimonytherein, if it shall be then of opinion that the complainant is entitled to relief, refer said suit to the commission, as amaster in chancery, to ascertain and re port an appropriate formof decree therein. The commission shall proceed upon such notice to the parties and under such rules of procedure as the court may prescribe, and upon the coming in of suchreport suchexceptionsmaybefiledandsuchproceedingshad in relationtheretoasuponthereport of amasterinother equitycauses, but the court may adopt or reject such report, in whole or in part, andenter such decree as the nature of the casemay in its judgment require. Sec. 8. That the several departments and bureaus of the Govern ment when directed by the President shall furnish the commission, uponits request, all records, papers, andinformationintheir posses sionrelating to any corporation subject to any of the provisions of this Act, and shall detail from time to time such officials and employeestothe commissionashemaydirect. Sec. 9. That for the purposes of this Act the commission, or its duly authorized agent or agents, shall at all reasonable times have access to, for the purpose of examination, andthe right to copyany documentary evidence of any corporation being investigated or pro ceeded against; and the commissionshall have power to require by subpoena the attendance andtestimony of witnesses andthe produc tion of all such documentaryevidence relating to any matter under investigation. Any member of the commission may sign subpoenas, CO andmembers andexaminersof thecommissionmayadminister oaths and affirmations, examinewitnesses, andreceiveevidence. O Such attendance of witnesses, and the production of such docu mentary evidence, may be required from any place in the United States, at any designated place of hearing. And in case of dis obedience to a subpoenathe commission may invoke the aid of any court of theUnited States inrequiringthe attendance andtestimony of witnesses and the production of documentary evidence. Any of the district courts of the United States within the juris dictionof whichsuchinquiryiscarriedonmay, incaseofcontumacy or refusal to obeyasubpoenaissuedto anycorporationor other per son, issue an order requiring such corporation or other person to appear before the commission, or to produce documentary evidence if soordered, ortogiveevidencetouchingthematter inquestion; and any failure toobeysuchorder of thecourt maybepunishedbysuch court asacontempt thereof. 10 UpontheapplicationoftheAttorneyGeneral oftheUnitedStates,, at the request of the commission, the district courts of the United States shall have jurisdiction toissuewrits of mandamus command inganyperson or corporation to complywith the provisions of this Act or anyorder of thecommissionmadeinpursuancethereof. The commission may order testimony to be taken by deposition in any proceeding or investigation pending under this Act at any stageof suchproceedingor investigation. Such depositions may lie taken before any person designated by the commission and having power to administer oaths. Such testimony shall be reduced to Avritingby the person taking the deposition, or under his direction, and shall then be subscribed bythe deponent. Any personmay be compelled to appear and depose and to produce documentary evi dence in the same manner as witnesses may be compelled to appear andtestify and produce documentary eAddencebefore the commission as hereinbefore provided. Witnessessummonedbeforethecommissionshall bepaidthe same fees and mileagethat are paid Avitnessesin the courts of the United States, and witnesses whose depositions are taken, and the persons taking the same shall severally be entitled to the same fees as are paid forlikeservicesinthecourtsoftheUnitedStates. Nopersonshall beexcused fromattendingand testifying or fromproducing documentary evidencebeforethe commission or in obedi ence to the subpoena of the commission on the ground or for the reason that the testimony or evidence, documentary or othenvise, required of him may tend to criminate him or subject him to a penalty or forfeiture. But nonatural person shall beprosecutedor subjectedtoanypenaltyor forfeiture for or onaccount of anytrans action, matter, orthingconcerningAvhichhemaytestify, or produce evidence, documentary or othenvise, before thecommission in obedi enceto asubpoenaissuedbyit: Provided,That nonatural personsotestifying shall be exempt from prosecution and punishment for perjurycommitted in sotestifying. Sec. 10. That anypersonAvhoshall neglect orrefuse toattendand testify, or to ansAverany laAvful inquiry, or toproduce documentary evidence, if in his poAver to do so, in obedience to the subpoena or laAvful requirement of the commission, shall be guilty of an offense and upon conviction thereof by a court of competent jurisdiction shall be punished by a fine of not less than $1,000 nor more than $5,000, or by imprisonment for not more than one year, or by both suchfine andimprisonment. Any person Avho shall willfully make, or cause to be made, any false entry or statement of fact.in any report required to be made 11 under thisAct, or whoshall willfully"make, or causetohemade, any false entry in any account, record, or memorandum kept by any corporation subject tothis Act, or whoshall willfullyneglect or fail to make, or cause to be made, full, true, and correct entries in such accounts, records, or memoranda of all facts andtransactions apper taining to the business of such corporation, or who shall willfully remove out of the jurisdiction of the United States, or willfully mutilate, alter, or by any other means falsify any documentary evidenceof suchcorporation, or whoshall willfullyrefuse tosubmit tothecommissionor toanyof its authorized agents, for the purpose of inspection and taking copies, any documentary evidence of such corporation in his possession or within his control, shall be deemed guilty of an offenseagainst the United States, and shall.be subject, upon conviction in any court of the United States of competent jurisdiction, to afineof notlessthan $1,000nor morethan $5,000or toimprisonment for atermof not more thanthreeyears, or toboth such fine and imprisonment. If any corporation required by this Act to file any annual or special report shall fail so to do within the time fixed by the com missionfor filingthesame, andsuchfailure shall continuefor thirty days after notice of such default, the corporation shall forfeit to the United States the sumof $100 for each and every day of the continuance of such failure, which forfeiture shall be payable into the Treasury of the United States, and shall be recoverable in a civil suit in the name of the United States brought in the district where the corporation has its principal office or in any district in which it shall do business. It shall bethe duty of the various district attorneys, under the direction of the Attorney General of the United States, to prosecute for the recovery of forfeitures. The costs and expenses of such prosecution shall be paid out of the appropriation for the expenses of the courts of the United States. Any officer or employee of the commission whoshall make public any information obtained by the commission without its authority, unless directedby acourt, shall be deemedguilty of amisdemeanor, and, uponconvictionthereof, shall bepunished byafinenot exceeding $5,000, or by imprisonment not exceeding one year, or by fine andimprisonment, inthediscretionofthecourt. Sec. 11. Nothing contained in this Act shall be construed to pre vent or interferewiththeenforcement of the provisions of the anti trust Acts or the Acts to regulate commerce, nor shall anything containedintheAct beconstruedtoalter, modify, orrepeal the said antitrust Acts or theActs toregulatecommerceor any part or parts thereof. ^ co ^ r-~. Uj ' 12 Sec. 12. (a) It shall be unlawful for any person, partnership, or corporation to disseminate, or cause to be disseminated, any false advertisement-- (1) By United States mails, or in commerce by any means, for thepurposeofinducing, orwhichislikelytoinduce, directly or indirectly the purchase of food, drugs, devices, or cosmetics; or (2) By any means, for the purpose of inducing, or which is likely to induce, directly or indirectly, the purchase in com merceof food, drugs, devices, or cosmetics. (b) The dissemination or the causing to be disseminated of any false advertisement within the provisions of subsection (a) of this section shall be an unfair or deceptive act or practice in commerce within the meaning of section 5. Sec. 13. (a) Whenever the Commission has reason to believe-r- (1) that any person, partnership, or corporation is engaged in, or is about toengage in, the dissemination or the causing of the dissemination of any advertisement in violation of section 12, and (2) that theenjoiningthereof pendingthe issuance of acom plaint by the Commissionunder section 5, and until such com plaint is dismissedby the Commission or set aside by the court on review, or the order of the Commission to cease and desist made thereon has become final within the meaning of section5, wouldbetotheinterest ofthe public, heCommissionbyanyofits attorneysdesignatedbyit for suchpuriosemaybringsuit inadistrict court of the UnitedStates or inthe Jnited States court of anyTerritory, to enjoin the disseminationor he causing of the dissemination of such advertisement. Upon iroper showingatemporaryinjunction or restrainingorder shall be :rantedwithout bond. Anysuchsuit shall bebrought inthe district n which such person, partnership, or corporation resides or trans is business. (b) Whenever it appears to the satisfaction of the court in the aseof anewspaper, magazine, periodical, or other publication, pubished at regular intervals-- (1) that restraining the dissemination of a false advertise ment inanyparticularissueof suchpublication woulddelaythe delivery of such issue after the regular time therefor, and (2) that suchdelaywouldbeduetothe methodby which the manufacture anddistribution of such publicationis customarily conducted by the publisher in accordance with sound business 13 practice, and not to any method or device adopted for the eva sion of this section or to prevent or delay the issuance of an injunction or restrainingorder with respect tosuchfalse adver`tisement or aipyother advertisement, thecourt shall excludesuchissuefromthe operationof the restrain ing order or injunction. Sec. 14.2(a) Anyperson, partnership, or corporationwhoviolates any provision of section 12 (a) shall, if the use of the commodity; advertised may be injurious to health because of results fromsuch use under the conditions prescribed in the advertisement thereof, or under suchconditions as arecustomaryor usual, or if suchviolation iswithintent todefraudormislead,beguiltyof amisdemeanor, and upon convictionshall bepunished by a fine of not more than $5,000 or by imprisonment for not more than six months, or by both such fine and imprisonment; except that if the conviction is for a viola tion committed after a first conviction of such person, partnership, or corporation, for any violation of such section, punishment shall be by a fine of not more than $10,000 or by imprisonment for not more than one year, or by both such fine and imprisonment: Pro vided, That for the purposes of this section meats and meat food products duly inspected, marked, and labeled in accordance with rulesandregulationsissuedunder theMeat InspectionAct approved March-4,1907,asamended, shallbeconclusivelypresumednot injuri ous to health at the time the same leave official "establishments." tO (b) No publisher, radio-broadcast licensee, or agency or medium forthedisseminationof advertising, except themanufacturer, packer, distributor, or seller of the commodity to whichthe false advertise cr~o-'oS ment relates, shall be liable under this section by reason of the dis o seminationbyhimof any false advertisement, unlesshe.has refused, o on the request of the Commission, to furnish the Commission the nameandpost-officeaddresso'fthemanufacturer, packer, distributor, seller, or advertising agency, residing in the United States, who Ut caused him to disseminate such advertisement. No advertising agencyshall boliableunder this sectionby reasonof thecausingby it of the 'dissemination of any false advertisement, unless it has refused, ontherequest ofthe Commission, tofurnishtheCommission i thenameandpost-officeaddressofthemanufacturer, packer, distrib utor, or seller, residingin the United States, who causedit tocause the dissemination of such advertisement. 2Section 5 (b) of the amending Act of 19i>8provides: Src. 5. (b) Section 14 of the Federal Trade Commission Act, added to such Act by section 4 of this Act, shall take effect on the expiration of sixty days after the date of the enactment of this Act. 14 Sec. 15. Forthe purposes of sections 12,13, and14-- (a) Theterm"false advertisement"means anadvertisement, other' than labeling, -which is misleading in a material respect; and in determining whether any advertisement is misleading, there shall be taken into account (among other things) not only representations made or suggestedby statement, Avord, design, device, sound, or any combination thereof, but also the extent to Avhichthe advertisement fails to reA'eal facts material in the light of such representations or material with respect toconsequences Avhichmayresult fromthe use of thecommoditytoAvhichtheadvertisementrelatesunderthecondi tions prescribed in said advertisement, or under such conditions as arecustomaryorusual. No advertisement of adrugshall be deemed to be false if it is disseminated only to members of the medical profession, contains no false representation of a material fact, and includes, or is accompanied in each instance by truthful disclosure of, the formulashowingquantitativelyeachingredient of suchdrug. (b) Theterm"food"means (1) articles usedfor foodordrinkfor manor other animals, (2) cheAving gum, and (3) articles used for components of any such article. (c) The term"drug"means (1) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supple ment to'anyof them;and (2) articlesintendedfor useinthediagno sis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (4) articlesintendedfor useasacomponent of anyarticlespeci fiedin clause (1), (2), or (3); but does not include devices or their .'omponents, parts, or accessories. (d) Theterm"device" (except Avhenusedinsubsection (a) of this section) means instruments, apparatus', and contrivances, including Ihair parts and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, orpreventionof disease inmanor other animals; or (2) toaffect thestructureoranyfunctionof thebodyof man or other animals. (e) The term"cosmetic"means (1) articles to berubbed, poured, sprinkled, or sprayedon, introducedinto, orotherwiseappliedtothe humanbodyor anypart thereof intended for cleansing, beautifying, promotingattractiveness, oralteringtheappearance, and (2) articles intendedfor useasacomponent of anysucharticle;exceptthat such termshall not include soap. Sec. 16. Whenever the Federal Tra'de Commission has reason to believe that any person, partnership, or corporation is liable to a 15 penalty under section14or under subsection (1) of section5, it shall certify the facts to the Attorney General, whose duty it shall be to cause appropriate proceedings to be brought for the enforcement of the provisions of suchsectionor subsection. Sec. 17. If anyprovisionof this Act, or the applicationthereof to anyperson, partnership, corporation, or circumstance, isheldinvalid, theremainderoftheAct andtheapplicationofsuchprovisiontoany other person, partnership, corporation, or circumstance, shall not be affected thereby. Sec. IS. This Act maybecited as the "Federal Trade Commission Act." Approved September 26, 1914. Amended and approved March21, 1938. co PN. C?j V/V o Ut ) U. S . GOVERNMENT PRINTING O F F IC E? 1 9 3 6 ForsalebytheSuperintendentofDocuments, Washington, D. C. Price5cents MEMORANDUM FOR THE COMMISSION: Re: Lead and Sulfur Hair Dyea This Division has been requested to express its views with respect to the danger to health of hayr dyes containing 1 ad and sulfur. Before this request was made we asked the library to locate and make available to us a copy of a recently-compiled bibliography of the scientific*literature pertaining to lead toxicity cover ing the period from 1745 to the middle of 1942, which embraced some 5,000 references. This bibliography'was not available in Washington but access to it was given Mr. Irish who forwarded to us about 20 references to reports (in various languages) of lead poisoning due to cosmetics. Lead poisoning was recognized and described by Hippocrates, Pliny and Dloscorides. Acute lead poison ing is rarely met with, as only a fraction of the lead consumed is absorbed into the bloodstream. Chronic lead poisoning causes colic, constipa tion, anemia, loss of energy, incoordination of muscles, muscular atrophy, arteriosclerosis, kidney and liver damage and injury to the central nervous system, which may be manifest by paralysis, convulsions, delirium, coma, and death. The condition may completely disable, and last for years, with remissions and exacerbations depend ing on variations in the total Intake of lead. Severe cases are typical and easy to recognize, but it is impor tant to realize that milder cases of lead Intoxication are.difficult to recognize and may escape diagnosis entirely* Withdrawal of lead usually results in complete recovery but recovery may not occur in advanced cases, particularly where the symptoms arise as a result of extensive injury to the central nervous system. It is necessary in this country to protect about 800,000 industrial workers from lead injury, but lead poisoning is decreasing at the same time that the use of lead in industry is increasing. This favorable change is entirely due to measures taken to protect persons from contact with lead. The following data shows the decline in reported cases of lead poisoning in England: In 1900 there were 1,058 cases of lead poisoning reported} in 1910, 505 cases} in 1920, 289 cases} in 1930, 265 cases; in 1934, 198 cases. Ihe principal Industrial sources of lead sufficient to produce lead poisoning are paint manufacturing, paint ing, pottery-glazing, and raining, smelting, working, and salvaging lead. A large variety of non-industrial acci dental household contacts with lead result in more re ported pages of lead toxicity today than are attributed to industrial causes. Lead may readily enter the body through the respir atory tract or the alimentary tract. Some organic compounds of lead (tetraethyl lead) may enter the body in significant amounts through the unbroken skin, but absorption through the unbroken skin of the Inorganic compounds of lead is very slight. Lead is very slowly excreted and piles up in the body acting as a cumulative poison* A daily intake of as .little as 1/65 of a grain will frequently produce lead toxicity, It is therefore necessary to deal with the problem of load toxicity on the basis\ cof the total amount of lead which reach* the individual from all sources, rather than from the amount of lead which reaches the individual from any single source* In 1870, fifteen of sixteen hair tonics then avail able in Mew fork City contained lead, and the other prepa* ration contained silver nitrate. In 1384, one of five face powders, three of eight liquid face-enamels, and all of three cosmetic lotions contained load. This condition fortunately does not exist today* Lead and sulfur hairdyes in use at this time 'usually, but not always, contain from one to three percent of X ad acetate and about the same percentage of sulfur in a perfumed menstruum of glycerin and water to which is sometimes added coloring and a local scalp irritant and rubifacisnt such as can tharides. We are concerned here with the extent to which these lead-containing hair dyes are responsible for lead poison ing. Of approximately 5,000 references to lead toxicity in the scientific literature since 1745, the source of the lead was determined by the compilers of the bibliography in about 3,000 instances, of which eighteen involve cos metics (face powders, liquid face-enamels, theatrical grease-paint, and rouge) and three references indicated that lead-containing hair dyes had caused poisoning. The cases attributed to cosmetics were fatal or severe and the opinion of those reporting was that many cases escaped recognition, especially mild cases. gf 00133?- -2' In the literature we have found no statement which indicates that lead applied indiscriminately to the hair and scalp is safe. We have discussed this problem with the 17 S. Public Health Service and the Food and Drug Administration, and they are in agreement with this view* They also agree that if the person who uses a lead and sulfur hair dye uses proper precautions in its application the lead contained there in will not be a source of danger to health The Food and Drug Administration has instituted no cases in court charging danger to health against this class of preparation. They are advising manufac turers of lead and sulfur hair dyes that they should in their directions for use clearly indicate that the preparation should be applied sparingly to the hair, avoiding contact with the scalp, as much as possible, and if the hands are soiled in applying the preparation to the hair they should be washed immediately thereafter to avoid transfer of any lead from them to the mouth. They emphasize that the preparation should not be ap plied to the scalp where there exists inflamination or breaks in the continuity of the skin since it is known that therapeutic us of lead preparations'on broken skin surfaces has,resulted in lead toxicity to an extent suffi cient to discourage such treatment The authority for such recommendation to which they direct the attention of the manufacturer is contained in Section 201(n) of the Food, Drug, and Cosmetic Act, as follows? /See. 201 For the purpose of this Act^/ Tn) If an article is alleged to be misbranded because the labeling is misleading, then in deter mining 'whether the labeling is misleading there shall be taken into account (among other things) not only representations made or suggested by state ment, word, design, device, or any combination thereof, but also the extent to which the labeling falls to reveal facts material in the light of such representations or material with respect to conse quences which may result from the use of the article to which the labeling relates under the conditions of use prescribed in the labeling thereof or under such conditions of use as are ciisternary or usual. This section of the Act is strikingly like Section XV of the Federal Trade Commission Act* K 00 33870 -3 Before Dr, Miller left Washington he indicated to me that the problem presented by lead and sulfur hair dyes had not been finally and satisfactorily disposed of* He indicated that in his opinion these preparations v/ere not safe unless the recommended method of use took into account certain precautions He also indicated that he had been unable to find instances of lead poisoning which had been caused by the use of hair dyes. We have now reviewed all of the opinions by the Medical Advisory Division since 1938, which deal with lead and sulfur hair dyes. They have not beeryfentirely consis tent. These opinions in the aggregate clearly reflect a reluctance to agree that nothing should be attempted by the Commission to accomplish the observance of reasonable care in the use of these preparations, but. they also recognize that proof of danger may only be accomplished, if at all, by expert opinion testimony. Also, this Division in all of its opinions has definitely resisted and refused to give an opinion that these articles are entirely safe except where the directions for use call for reasonable care in their application to the hair. In ail instances where the manufacturer has stated or implied that the preparation is safe, the opinion has expressed the view that such a claim is false. This is the generally-held opinion anci both the Food, and. Drug Adrainlstrntion and the IT. Public a1th Cervice subscribe to it. The Sanitary Code of the Department, of Health of the City of Hew York requires the following to appear in the labeling of lead and sulfur hair dyes* "CAUTION* This product contains metallic salt. It is for external use only and must be used with care.15 This statement appears in the labeling of some preparations which have come to our attention. The Division has been handicapped by not having before it in all Instances complete labeling for these preparations so that it might be exactly deter mined what the manufacturerfs recommended conditions of use are. The customary or usual conditions of use are almost universally not set forth in the advertising. . It is the opinion of this Division that the direc tions for use of a given lead and sulfur hair dye which a manufacturer places in the labeling of the preparation re flect the customary and usual conditions of use for that particular product. Ab-'!1i^3.Jj o^ 6Q0a 4- It is the further opinion of this Division that if such directions for use neglect to instruct the u se r of the generally accepted steps required in the safe; use of the article, the advertising should do this. We hold the view that this information need not be set apart or seg regated and identified either in the labeling or in the advertising as a caution or warning, but that it will serve its purpose best if it is made an integral part of any descriptive matter that outlined the method of use of the article* In the event a manufacturer refuses to provide such directions for use and the Commission is required to pro duce proof that injury may result, we will not be able to produce witnesses who ha,ve recognised instances of such injury in their practice. The testimony which can bo produced and which is rather generally held by informed scientists is represented by the following excerpt from the testimony of Dr. M. I. Smith of the II. 8. Public Health Service, who appeared for the Commission in the Arvil Company case (Docket 3472), the only case in this class that we know of where testimony has been & part of the procedure before the Commission. Dr. Braith has not changed his opinion since he gave this testimony in 1939. A ***Lead acetate is not very often prescribed in the treatment of scalp diseases. It presents a distinct hazard of lead poisoning. ' Q What is the percentage of lean acetate in this product? . A There is about one per cent load acetate and while that much-- while lead acetate is usually not very readily absorbed from the skin it may be absorbed in some cases especially if there is any injury or trauma or abrasion or inflamma tory conditions or eczematous condition of the scalp to which it is applied. In such instances it is likely to be absorbed in snail amounts. Q Would it be harmful, Doctor? A It may be. It does not take very much lead, in continuous absorption to cause lead poisoning. According to the best authorities it is believed that daily absorption of a milligramme, one milli gramme of lead-- that is about l/65 of a grain, per day-- is .sufficient to cause chronic lead poisoning. 0013381 KE -5 Q What would be the effect of the use of this product over a period of time because of the presence of lead acetate? A I think there is a distinct hazard of absorb ing lead to a sufficient extent to cause lead poisoning in some cases* Q What are those cases? What do you mean fcy nln some cases?" A Well, the susceptibility-- Q (Interposing) Of the individual. A' -- to load poisoning varies a great deal. There is no way of telling whether a snail amount of lead such as one milligramme per day will caiise load poisoning in all cases, or 50 per cent of the cases, or whether it will take two weeks to cause chronic poisoning of lead., or two months, or two years. It varries according to the indi vidual. And then it is a question of absorption, it would depend, of course, upon the extent of ab sorbability of L-ad through the skin. If there is an abrasion on the skin there is a great chance of the absorption of lead, there is a greater chance of the lead poisoning, but if the skin is healthy there is probably little chance for lead to be absorbed from the skin. Q What results, Doctor, in cases where lead is ab sorbed through the scalp? A Well, you get chronic lead poisoning which causes lead lime on the gums, anemia, lead colic, a general condition of malaise, a condition of general muscular weakness. These are the characteristic symptoms of chronic lead poisoning. We do not have to have all the symptoms to rsake a case of chronic lead poisoning. Any one of them is sufficient to make a diagnosis of chronic lead poisoning if there is reasonable evidence of load absorption and that is generally determined by an analysis of the urine that lead is present. In the event such testimony is deemed by the Com mission to be insufficient to justify the position we recommend for lead and sulfur hair dyes, we express the hope that the decision will not rest on the point that positive proof of actual instances of injury is needed, for if this is in fact required to maintain sued a case, (we interpret Mr. Kelley*s memorandum of November 5, 194-2 to suggest this) m c h of the possible protective value / to the public health of the Federal Trade Commission Act is lost in other more important but penerally similar circumstances. osr eetfu11y subad t,teu: J. J. jjURKKTT, M.D., Director, fled!cal Advisory Division. December 19. 194- KE o>Jao