Document 6RpBkzqeZZn1QR5oe2zaaJg66

Mic h a el F. Ma b k e l Wayne K . Hil l Walter E. Btl h le y Lav Ott ic e s Ma r k e d , H ix x Sc B y b r U e y Commonwealth B uilding IASS K S t r e e t , N TV. Wa s h in g t o n , D. C. go o o e (20S) aaa-esao July 16, 1975 Mr. George J. Dippold Whittaker, Clark S Daniels, Inc, 1000 Coolidge Street South Plainfield, New Jersey 07080 Dear Mr. Dippold; For your incidental information and possible interest, we enclose herewith a Xerox cony of a story from the July 14 issue of F-D-C Reports relating to a recommendation for use of talc in antiperspirants, Best wishes, Sincerely yours, W K H ;vx Enclosure cc: Mr, Frederick F. Roesch X JW Wayiie K. Hill |_ Ii PLAINTIFFS EXHIBIT WCD-201 LoGiudice/WCD/0319 July 14, 1975 F D-C REPORTS TAG 3 DRUG/COSMETIC PRODUCTS* INTERMEDATE: COMPONENTS: Chemical industry witnesses , were joined by HEW during Rep. Van Deerlin's (D-Calif.) Consumer Protection & Finance Subcmte. July 9-11 hearings on toxic sub stances legislation in urging further exemptions tram Environmental Protection Agency (EPA) control of intermediates destined for Inclusion in drugs and cosmetics (see preceding T&Gs). The Senate's TunneyHait Magnuson bill rod three House bills already exempt drugs per se from EPA control of chemicals presenting " unreasonable risk to,health or the environment" ("The Pink Sheet" June 9, T&G-2). 51 Reps. Eckhardt (D-Tex.) and McCollister (R-Neb.) conducted a constant duel during Q-&.-A with witnesses over their bills. The chemical industry leaned toward the less stringent controls of the McCollister bill (HR 7664), which includes exemption o f research chemicals (also exempted by S 776), and objected to Eckhardt's (HR 7229) tougher provi sions, such as "excessively broad premarket testing" and reporting health and safety studies for the past 40 years on all chemical substances. D ow Chemical, General Counsel J.H. Hanes testified, was opposed to passage o f "any toxic substances bill," which Dow termed the "Chemical Industry Control A c t," giving "sweeping" and "neai dictatorial powers" over the chemical industry to EPA. SOCMA VP Normand Phaneuf, who is president o f Lakeway Chemicals, also complained o f "near dictatorial powers" the bills would give EPA. 51 Most negative bill o f all, in the chemical industry's view, is Rep Brodhead's (D-Mich,) HR 7548, which makes EPA premarket certification mandatory for most new chemicals substances and new uses fo r established chemical substances where: substantial amounts o f a chemical are produced; the chemical will result in substantial consumer or worker ex posure; the chemical is closely related to chemicals known to he hazardous; and other federal agencies have listed the chemical as causing cancer, birth defects or gene mutations. 51 "The Senate," Eckhardt wanted, "might not stand for a bill" without strict premarket screening of chemicals questionable as to unreasonable risk to health or environment. The Eckhardt and McCollister hills 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 & Related Programs, created by former Asst. Secty. for Health Edwards. Joseph K, Wagoner added that Natl. Institute for Occupational Safety & Health (NIOSH), 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 F.PA and HEW over "control of chemical substances which may be used In products regulated by the FD&C A ct." -o / s USE OF TALC "OKed" BY FDA's PTC ANTIPERSP1RANT ADVISORY PANEL mateJeutilnyg,9-f1o0l \ lowing industry presentation at open session organized by the Cosmetic. Toiletry & Fragrance Assn. (CTFA). Talc can be used in antiperspirants, OTC panel reportedly decided In closed session, if it meets the 0.5% limit for asbestos content, as determined by the CTFA analytical method Panel expressed hope for further refinements in the method for detecting asbestos content, and indicated that the limit was established pri marily on the basis of detectability, Tather than on a determination of safety. Tentatively, panel has decided ^ that no existing antiperspirant can be considered safe and effective, but there was no implication in this decision that aluminum chlorhydrate is in any danger. Basis of panel's decision, it is understood, is a desire to spur reseaich demonstrating effectiveness o f antiperspirants containing ingredients regarded as safe. Mid-Aug. LoGiudice/WCD/0320 T&G-4 F-D-C REPORTS July 14, 1975 meeting o f panel is expected to tackle the problem o f establishing testing criteria for determining effective ness. Sept, meeting will get into the question o f statistical evaluation of the effectiveness o f antiperspirants, based on flora readings after application to axilla. 11 "We strongly believe that the data presented and reviewed support the conclusion that cosmetic grade talc as used m cosmetic and toiletry products is not a hazard to health and should be categorized as generally recognized as safe." asserted Gavin Hildick-Smith, MD, J&J medical affairs director during open session presentation. He said: "No 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 vitro studies o f 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 .P . Rolle, PhD, J&J asst, manager of analytical re search explained, noting industrial talc is a very impure product, often containing less than 50% talc. He defined cosmetic talc as a " material used in cosmetic and pharmaceutical applications (containing) more than 90% talc." 9 CTFA's task force on talc's asbestos content convinced him that " there is no detectable amount o f chrysotile in cosmetic talc," its chairman Rolle 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 panel consultant Albert Miller o f Mt. Sinai Hospital disagreed, stating X-ray diffraction was Jess sensitive than electron microscopy. He also maintained that any light microscopic m ethod would miss the very small fibers which "might very well be the most pathogenic." 9 Miller, in his closing remarks to the panel, said the most important, issue was the asbestos content of cosmetic talc. He asserted that Arthur Langer. also o f Mt. Sinai 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% anthophyllite and tremolite, he said. Rolle said that Langer's study had been the subject o f a New 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. 9 Cartcr-Wallace Asst. Research Director R. Wulf, PhD, reported that his firm had con ducted 90-day inhalation tests on monkeys and albino rats exposed to Light Powder Arrid and Arrid X X . " No adverse effects attributed to inhalation of the talc materia] were observed," he stated The talc in these antiperspirants, he reminded the panel, was an in active vehicle. " No claims of efficacy are made for the inactive talc ingredient," he said. A,P Wehnet, DMD, Batelie Pacific Northwest Labs, informed the panel of a completed study, about to be published, o f inhalation o f J&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- R E D NO, Z " R O L L E R C O A S T E R ": C H A N C ES NOT M UCH B ETTER than 50/50 that FDA's '` ` carcinogenicity rat study can be salvaged. FDA Div. o f Food & Color Additives Consumer Safety Officer Gerald McGowin explained th a t all the rats have been sacrificed - following the discovery that a still undetermined number o f the total 500 study animals were administered incorrect dosage levels. Before determining degree of validity of the LoGiudice/W