Document 37rkY5MMwdGya5oEerqyxmBYE

C O SM ETIC TO ILETRY - feg g r a n c e ASSOCIATION, IMC. 1110 VERM O NT AVE., N W , W ASHINGTON, D.C. 20005 TO :_________ Talc Subccm nittee_______ FROM; - C harles Haynes__________ SUBJECT : ' Talc fnhala-hicai - Update tDATE . November 12. 1981_______ Gentlemen: The attached inform ation i s f a r your f i l e and re p re se n ts an update ,to th e in h a la tio n memo we sen t an J u ly 31 1981. E n clo su re cc: Standards Oonmittee CRH:iny PLAIMTIFFS EXHIBIT WCD-400 Goodhue WCD 000232 * O ctober 30, 1981 ENI 81-20 Page 12 NO NED FOR.STRICTER BABY SHWOO TESTING IDA denied a c itiz e n p e titio n by th e Jchnarai 6 Johnson Baby Products Oanpany asking th e Agency to e stab lish a nandatory ra b b it eye irrita n c y te s tin g standard Car baby shampoo prodacts* flie Agency **viinad to e sta b lish s tr ic te r standards fo r baby shanpooa, because d ata subm itted by Johnson 6 Johnson did not support the need fo r a "separate standard o f ad u lteratio n fo r products l abeled 'baby shampoo1 as acnpamd to those sinply labeled 'shanpoo.,n la ECft's opinion, th ese data d id r o t shew th a t b ab ies1 eyes sig n ific a n tly d iffe r morphologically and physiologically from ad u lts eyes and,' th erefo re, are note severely in ju red when a sbanpoo accidentally enters the eye. ' "3h tiie absence o f a la b e l statem ent to th e contrary," th e ru lin g s ta te s , " itjn u s t be preymed th a t a 'shampoo1 i s intended fo r use by aanstmers o f a l l ages, as m xh as a 'baby cha^oo i s not exclusively intended fo r use on b a b ie s.. .Gbnsumars expect a reg u lar and a 'b aty tiianpoo to be equally safe." "PARENTAL NE0JGENCE" NO REASON FOR FEGULATOPY.ACTION IDA fonied a c itiz e n p e titio n ashing th e Agency to require talcu n poedar to bear a lab el warning, nrh u, i^gb out o f tm ** o f ch ild ren ," o r " If in h alatio n occurs, take im nediatejy to n earest room.* Tto pHnn aiaft denies th e p etitio n - request to require c h ild -re sista n t closures fo r auto products. STA refused both requests an grounds th a t "parental negligence" is-n o t an excuse fo r regulatory a c tio n . The p e titio n e r mjwlMWi maUr! lite ra tu re rep o rtin g 28 cases o f in fan ts th e had accid en tally i r^aiad massive aaounts o f talcu n powder. Semen o f th e in fan te reportedly food aa a re s u lt. She H ft tills in fo rm tio n -f^iad to document a s u ffic ie n t h ealth hazard o f widespread public concern to req u ire a lab el warning. "Infrequent re p o rts o f in ju ry associated w ith accident a l , massive inhalation o f tale pewder by in fan ts as a re s u lt o f p aren tal negligence, unfortunate as th e cases may be, is n ot a su ffic ie n t teijste fo r tak in g th e a c tio n ...re q u e ste d ," th e FDR denial s ta te s . j n a tte r o f d iU c rre s is ta n t packaging f a lls under th e au th o rity o f th e U.S. consumer Product Safety Oatm isslon. The adm ission advised FCA th a t "the law re q u irin g ^ d u ld -re sistm t m ckaaing only ap p lies to products whitii have been shorn to cause (or have the p o te n tia l to s a r i personal in ju ry o r illn e s s in children under 5 years o f age because o f th e way those stostanoes are packaged." lb require c h ild -re s ista n t packaging, i t o u st be demonstrated that a <*il<3'a th e "d irect re s u lt o f tb s ch ild being ab le to gain access to th e contents o f a v e n tio n ^ y packaged product. ..in ju rie s re su ltin g from products l e f t open o r unattended do not tech n ically meet th is xequiremant, " th e OonniBaicm to ld FDfte i i ] Goodhue WCD 000233 /D REPORTS "The Rose Sheet'* -r d t Z J / d ^ t t, / ? f / v/ T " / ^ c. /J r '1' THE NEWS THIS WEEK leontinuad) f / ^ A r - fyx ^ "Tsuic Stef? Pag 2 merce Dept., the Japanese govt, and the JCIA. The 148 ingredients in the dictionary are listed by code number, Japanese name, chemical name, CTFA-adopted name and the chemical structure. The final dic tionary nomenclature will conform with the CTFA adopted names.............................................. .. . page 7 * * INDEX GAINS 2. 1% . BOUVED BY SHAKLEE, ALBERTO-CULVER, GILLETTE & MINNETONKA increases in a holiday-shortened Labor Day week. Losers outpace gainers as Neutrogena, Noxell and Fabarga all post point-or-more losses. Revlon closes at second new low for the year. Diversifieds advance for the first time since the week o f July 31, with point-plus gains turned in by J& J (up 2-3/8), Squibb (up 2), and B-M (up 1-1/4). ............................... ..................................................................................... Page t o Q 2 | MY POWDER IHHAUT1QH HAZARD: "PtflB B9" POSSIBLE CASES of baby powder aspiration re ported to the Nassau County Medical Center Poison Control Center in the first half of 1981, according to a center spokesman. The figure represents a follow-up to an earlier center study on incidence o f baby powder inhalation in children under five conducted last year under the direction of two American Academy of Pediatrics Fellows, Howard Mofenson, MD, and Joseph Greensher, MD. In an article published in the August issue of Pediatrics, the researchers said that o f 4,292 calls received by the center during the first six months of 1980, 40 cases concerned baby powder inhalation. T The article describes the cases o f 34 baby-powder inhalation patients reached for follow-up analysis in the study. In 14 cases, coughing was the only symptom and in five cases sneezing was reported, the article noted. More serious symptoms turned up in 12 cases: five episodes each of difficult breathing and vomiting and one incident of cyanosis, "a bluish discoloration due to a reduced level of hemoglobin in the blood." In a footnote, the authors added: `*In the past month one o f our reports involved a child who required assisted ventilation on a respirator for several days." No follow-up analysis was done on the center's latest tally of baby-powder aspiration, the spokesman noted. Tale-baaed powder containing calcium ondecylanata haa been impli cated in the "m ajority" of caaes recorded by the canter to date, the spokesman said. 1 Asserting that " baby powder must be considered potentially harmful by parents and physicians,** the authors made three recommendations for eliminating the "inherent" safety hazard in the product class. Suggesting that " the 'look-alike* ap pearance o f talc containers and feeding bottles" is part of the problem, the authors urge mfrs. " to drastically change the containers and institute a safety device on the cap..." "1 1 In addition, a warning that " the ingredients may be harmful if aspirated" should be included on the talc containers, the authors suggest. Noting that results of the 1980 study were submitted to the Consumer Product Safety Commission a year ago, the spokesman said the center's latest findings will also be relayed to the agency. "Tits Roae Stwat" It published weekly (excapt the weak of Chrietmaa) by F-D-C Raport, Inc., t Natl. Pratt Bldg., Wath., D.C. 20045, Single copy aubacriptlon price: 1225.00 par year. Application to mail at lecond-cltta poataga ratat pending at Wash., O.C. P O S T M A S T E R ; Sand address changes to F-D-C Reports ("T h e Rose Sheet"), 1 Natl. Press Bldg., W ash., D.C. 2 0 0 4 5 Goodhue WCD 000234