Document 0wvzX3K31JjYYp5d3wd2j37m

J u l y 18, 197* WH I T T A K f t , C L A R K & D A N I E L S , I N C . f-'QR S e e D is t r ib u t io n L i ; ATT: SUBJ:, F . D . C . R e p o r t - i a l e INTER - OFFICE CORRESPONDENCE B U LLET IN ; T h e a t t a c h e d copy o f t h e J u l y 14-th i s s u e of th e F . D . C . R e p o r t c l e a r l y d e s c r i b e s the safety of T alc for u se in a e ro so ls . P le a s e a r r a n g e fo r c o p ie s to be sen t to all o u r T a lc c u s to m e r s . It is cr.e cf the m c ^ t im portant cetaitad re p o rts on T alc safety frem W ashington. U se it to good a d v a n ta g e a n a a s soon a s p o s s ib le . F FR /d rr, Distribution; M r. C,U. Driscoll M r. J . C . W oodruff ^ M r . G .J . Dippold M r. Russ Steubing M iss D oreen M ultady M .rs. Dorothy Blount M rs. Julia Bonechi V FRED RCESCH M r. Cliff Em ery M r. Ray K lam m es M r. C harles Lorr.csrdi Sales Cask All S alesm en M rs . Anne McAndrew PLAINTIFFS EXHIBIT WCD-245 WCD0300 `ily 14. 19 75 F-D-C K IU 'O R T S TiC-3 ^ ( O DI U' C/COS\ U: TI C PRGDUCTS' INTERMEDIATE COMPONENTS: Chemical witnesses V- ' , were joined by HEW Junng Rep. Van Decrlin's (D-Oalif.) Consumer Protection A Finance Subemte. Juiy *5-1 S hearings on toxic sub stances legislation in urging further exemptions from Environmental Protection Agency (EPA) control of intermediates destined for inclusion in drugs and counciia (sec preceding TACO- Tire Senate's Tunney- Hart Magnuson bill and three House bills already exempt drugs per se from EPA control o f chemicals presenting "unreasonable risk to health or the environment" ("The Pink Sheet" June 9, TJ*G-2). 1 Reps. Eckhardt (D-Tex.) and .McCollistcr (R-Neb.) conducted a constant duel during Q-il-A .ith witnesses over their bills. The chemical industry leaned toward the less stringent controls of the McCollistcr bill (HR 7664), which includes exemption of research chemicals (also exempted by S 776), and objected to Eckhardt's (HR 7 239) tougher provi sions, such as "excessively broad premarket testing" and reporting health and safety studies for the past 40 years on all chemical substances. Dow Chemical, General Counsel J.H. Hanes testified, was opposed to passage of "iiuy toxic substances bill," which Dow termed the "Chemical Industry Control Ac:," giving "sweeping" and "near dictatorial powers" over the chemical industry to EPA, SOC'AA VP Normand Phaneuf, who is president of Lakeway Chemicals, also complained of "near dictatorial powers" the bills would give EPA. 1 Most negative bill o f all, in the chemical industry's view, is Rep. Brodhead's (D-Mieh,) HR 754S, which makes EPA premarket certification mandatory for most new chemicals substances and near uses fo r established chemical substances where: substantial amounts of a chemical arc produced; the chemical will result in substantial consumer or worker ex posure; the chemical is closely related to chemicals known to be hazardous; ar,J other federal agencies have listed tltc chemical as causing cancer, birth defects or gene mutations, i "The Senate." Eckhardt warned, "might not stand for a bill" without strict premarket screening o f chemicals questionable as to unreasonable risk to health or environment. The Eckhardt and McCollistcr bills restrict premarket screening to selective chemicals on a list to be compiled by EPA. HEW's David Rail testified that the dept, is already deeply into toxicity controls with the HEW Cmte. to Coordinate Toxicology A. Related Programs, created by former Asst. Seely, for Health Edwards. Joseph K. Wagoner added that Sail. Institute for Occupational Safety A. Health (NIOSll), Center for Disease Control, puts out an annual list of 17,000 toxic substances. Rail sided with industry not only on the jurisdictional question, but in opposing controls on research chemicals. He voiced a need " to clarify the delineation of authority" between EPA and HEW over "control of chemical substances which may be used in products regulated by the FD&C Act." -0 - USE OF TALC "OKed" BY FDA's OTC ANTIPERSPIRAMT ADVISORY PANEL at July 9-10 meeting, fol lowing industry presentation at open session organized by the Cosmetic, Toiletry & Fragrance Assn. (CTFA). Talc can be used in anliperspirants, OTC panel reportedly decided in closed session, if it meets thi 0.5% limit for asbestos content, as determined by the CTFA analytical method. Panel expressed hope for further refinements in the melhod for defecting asbestos rontent, and indicated that the limit was established pri marily on the basts of detectability, mlum than on a determination of safety. Tentatively, panel has deeded that no existing anttperspirant can be considered safe and effective, but there wus no implication in this decision rhai aluminum chlorhydrate is m any danger. Basis of panel's decision, it is understood, is a desire to spur * -- ;i-red;cnis regarded as safe, MM-Aua. WCD030I 'A F-D-C REPORTS July 14, 197? ) meeting of panel is expected to tackle the problem of establishing testing criteria for determining effective ness. Sept, meeting will get into the question of statistical evaluation of the effectiveness of annperspirants, based on flora readings after application to axilla. 1 "We strongly believe that the data presented and reviewed support the conclusion that cosmetic grade talc as used in cosmetic and toiletry products is not a hazard to health and should be categorized as generally recognized as safe," asserted Gavin Hiidick-Smirh, MD, J&J medical affairs director during open session presentation. He said' " Mo publication has been found which shows that any adverse effects arise from the normal use of cosmetic or toiletry products containing cosmetic grade talc." Furthermore, no data show cosmetic talc to be a carcinogen, nor have human skin tests demonstrated it to be a sensitizer, and thus an allergan, he noted. in viiro studies of cosmetic talc's biological activity, he said, indicate the substance is biologically inert when compared to free silica and asbestos dusts. Cosmetic talc is much more refined and purer than industrial talc and should not be judged in the same way, F,R. Rode, PhD, J&J asst manager of analytical re search explained, noting industrial talc is 3 very impure product, often containing less than 50% talc. Ha defined cosmetic talc as a "material used in cosmetic and pharmaceutical applications (containing) more than 90% talc." 5 CTFA's task force on talc's asbestos content convinced him that ``there is no detectable amount of chrysotile in cosmetic talc," its chairman Rollc said. He said a practical way for mfrs. to analyze the fiber content o f their talc would be through use o f X-ray diffraction equipment. Outside pane! consultant Albert Miller ofM t. Sinai Hospital disagreed, stating X-ray diffraction was less sensitive than electron microscopy. He also maintained that any light microscopic method would miss the very small libers which " might very well be the most pathogenic." 1 Milter, in his dosing remarks to the pane!, said the most important issue was the asbestos content of cosmetic talc. He asserted that Arthur Langer, also of Mt. Sinai's Environ mental Sciences Lab. had analyzed over 50 different cosmetic talc bath and baby powders and found many contained up to 30% finely ground quartz. Langer also discovered one widely-sold product contained 30% anthophyllitc and trcmolile, he said. Rolle said that Lunger's study had been the subject o f a Ness York Times article in the early 1970s, which was retracted the day following its publication after Langer informed the paper that the study was highly premature and the figures were wrong. 1 Carter-lVallacc Asst. Research Director R. Wulf, PhD, reported that his firm had con ducted 90-day inhalation tests on monkeys and albino rats exposed to li%kt Powder Arrid and A n d XX. "So adverse effects attributed to inhalation of the talc material were observed," he stated. The Ulc In these antiperspinnts, he reminded the panel, was an in active vehicle, "No claims of efficacy an; made for the inactive talc ingredient,'* he said. A.P. Wchr.cr, DMD, Batcllc PaciHc Northwest Labs, informed the panel of a completed study, about to be published, o f inhalation of 1&.J Baby Powder by hamsters. The study, which involved 30-day and 300-day exposures, found no treatment effects in the test animals' larynx, trachea, heart, liver, kidney, stomach, or uterus, he said. -0- RED NO. 2 "R O LLER CO ASTER": CHANCES NOT MUCH 8 E T T E R than 50/50 that FDA's carcinogenicity rat study can be salvaged. FDA Div, of Food Color Additives Consumer Ssfety O fficer Gerald McGowin explained ,u** "n K<'" ' f'-'u'i.-i-Ti - tnllnwinc the discovery that s still undetermined number of the total v* v r?'~ V*- ) > WCD0302