Document vVd1KQYbr4jnj4jjbBJN5YdGm

S COMMUNICATIONS TO AL TRADE COMMISSION OFFICE OF THE MEDICAL DIRECTOR f e d e r a l Tr a d e c o mmis s io n WASHINGTON October 16, 1943. IN REPLYING 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 generaJLly 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 would 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 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 vrith this problem. Very sincerely yours. V. J. J. DURRETT, M.D., Director 3 Medical Advisory Division. Enclosures FTC Act Memorandum 12/19/42 KZ 00i38io8 g FEDERAL TRADE COMMISSION ACT 3 o ^ a <-* 2O C<D! 3 o,, 51* CO 3 St t o" gg "V OP Kb CO 2". H g o 2 o- to. P O o H <0 te|Hg z s 3 O 3* 3T. 3o 35 3 a hj Z* ECOD P a CO S' & H> O S3 S S g 35 o 5 g c+ eg' B CD 3 CD 52. 8 co a rtaJ h*fs o L a^B g s Q 3' 311tB , to S- ^ CcMOo*# ii^ ^0 <s>, co > O hda a a 2 a- p Q p <7+- i-S cl g* ^ _ *-* o aa. r^, p 2" a^ p 2. L ^ x xn g c p . 5P w 3 B a- co g a X 3rt-. a |rt- ^ ^ o P i5--73- o <2 * CC>--OOl* O S' "* s- ag-g <>> " ^ 8 g ~S S'8 S rtat-l _j ft Xir p <5 b ^ ag KJ P p p3. 52. g 2-X cn ^ :o PO _ VL w> ~p po E-J Kb W <3 j| s?3 ~ cx g. Kb & o ^ P >a O' P co i-j a u.1^ |-as, 2. P f a 08 S'. S' x 3, CO 2. o a << B a r P5. a fe- ^ o H a cr ^ g- 03 Po 1=2 H, 2CD^ 2CD p3 . rt B -T- g * o a g ?g^ 'cOo ' a --N P O " I g & O sa Kb o r H* j-g O & Bo p- . o P to oCO tr a a to-1 p tr* P rt a*< rt wP 1 3 < rt g. rt _ 3? 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P. o 3 cr " co 3 rrf=* KB 0013376 fb P p- ft A b a* P CD rt rt CD Cfi CD a ft- 3S CD ^ ^ M ^P o m rt g CD ^. 2 ft p pft 02 fD >a p rd- cr* O CD rt ftCD ro CD t-- p to CD P cd CD b CD P- ft rt CD ft 3 CD rt ft p t-4 6 CD ft p * o ft* CD to CD CD b rT. ft CD O <D P a Si si: o 02 O ^ d o p JcS 5 3 o ^g n O CD ^ o 'rt 2 P p P P- d O co lsrg>s to o'^ 'S rt If I S'o ft. 9 U CDCO 200 P CD 8 a P fb 5* 3- 3o CD qPi-'P- r3"t*" CD p 2 H g ^ g ft CD o ft 05 2 " 23 T 3 g p id H to o 3 >3 p 3" o S rtrt p 3 ^ -*CD l>Pr> ft CD P o to' ft. ro |3. tr g CGH> s a to .ft ^D 2^ a ft P-* o rto 3^ co CD rt o * o' HI 3 rt* <d> 3H oo ft<fb p CD O oa CD CD Cl P- P' _ _ CD ^ P cr* ro ft- c d a-* ^<2 ft fot a--> ft Cl 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 sane 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. K Ef Ot oo r/j r<i } jL O -1 N16604.02 4*C/?$t- r ' The 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-incmstrial 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 lead toxicity on the basis of the total amount of lead which reaches 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 York 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 tin '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 rubifaciant such as canth&rides. 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 sever and the opinion of those reporting was that many cases escaped recognition, especially mild cases. KE" 001 33/3 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. 8. 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 suff'i 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? /Sec. 201. For the purpose of this Aet^/ (n) 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 ci*stomary or usual* This section of the Act is strikingly like Section XV of the Federal Trade Commission Act, K CI 38vO -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 and both the Food, and. Drug Adrainlstrntion and the U. . Public Health 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. 0013380 -4- It is the further opinion of this Division that if such directions for use neglect to instruct the user 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 -nay result, vs; will not be able to produce witnesses who ha,ve recognised instances of such injury In their practice. The testimony which can be 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 '-mow of where testimony has been & part of the procedure before the Commission. Dr. hraith 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 lead 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. K 0013381 -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, 1942 to suggest this) mch of the possible protective value --6-- . ,, to the public health of the Federal Trade Commission Act is lost in other more important but penerally similar circumstances. Kosrectfully sub-idt,ted: J. J. DWWETT, M*D., Director, fledical Advisory Division. December 19, 1942. KE -> o>J o a