Document e71D77501zgzVZOmav1RZ1GL4

FILE NAME: Johnson & Johnson (JAJ) DATE: 1985 Dec DOC#: JAJ027 DOCUMENT DESCRIPTION: Confidential Report - J&J Baby Powder Q&A 7* j i. * JOHNSON * JOBMSOH BABY POWDER owsnows and answers Protected Docum ent-Sub)ect to Protective Order CONFIDENTIAL December, 1985 JNJNLS1JI08S13S47 The attached Question and Answer document has been developed for limited internal distribution in response to the need for clarification of issues relating to baby powder and talc. Specifically, its sole purpose at this time is to provide designated company spokespersons with answers to questions which could be raised by the press. It is not meant for distribution to anyone other than the individuals who will act as company spokespersons as necessary. Those recommended as spokespersons are James Murray, Assistant Director, Corporate Public Relations James Utaski, President, Johnson s Johnson Baby Products Co. William Egan, Vice President, General Manager Jim Dettre, Director of Communications The 82 answers in the document were written in anticipation of potential questions. Many questions and answers were intentionally developed as versions of others already in the document in an effort to anticipate all angles of questioning and to prepare the spokespersons with responses whicht 1) Stand on their own as reflective of the corporate position. 2) Reflect and reinforce the approved communications objectives developed during a media training session. These communications objectives are: Protected Document-Subject to Protactiva Order JNJNL61 000013948 a) JOHNSON'S Baby Powder used properly is safe. Extensive, scientifically documented evidence supports this claim as does the Food and Drug Administration (FDA). b) it is unlikely that anyone knows more about safe, high-quality baby care than .the Johnson & Johnson Baby Products Company. To ensure continued confidence in our baby powder, we will conduct research as needed to reconfirm the safety of the product. The Q & A document will be revised and updated as events or new research findings impact on the scope of potential questions or on existing responses. Protected Document-Subject to Protective Order December, 1985 JNJNL61JJ00013849 JOBBSOH'S BABY POWDER Question and Answers Page I. Talc - Cancer 1 II. Talc - Inhalation ....................... 9 III. Talc - T r a n s l o c a t i o n ........................... 14 IV. Talc - M i s u s e ................................... 20 V. Baby Powder - Benefits and U s e s ................ 25 VI. Baby Powder - Manufacturing . . . . . . . . . . 28 VII. Baby Powder - General . 1 . . . . . ............ 32 VIII. Medicated T a l c s .............................. 34 IX. Baby Cornstarch ................................. 36 X. Test Market - Baby Powder with.Cornstarch . . . 39 XI. Johnson & Johnson Policy and General Questions ........ . . . . . . . . . . . . . . 4 3 XII. Index of Q u e s t i o n s ........................... 49 Protected Document-Subject to Protective order Decembert 1985 JNJNL81JW00139SO I. TALC - CANCER Protected Document-Subject to Protective Order December, 1985 JNJNLB1_0000139S1 - 2- Q* Does talc cause cancer? A: Extensive research in both animals and humans has not shown talc to be carcinogenic nor to have any potential for causing cancer. 2. 0* Dr. Daniel Cramer in the journal Cancer has linked the use of talcum powder to ovarian cancer. Could you comment? A: Thorough research and testing by the FDA, the medical community and Johnson & Johnson does not support Cramer's hypothesis of such a link. The most recent study in this area contradicts Dr. Cramer's findings, in an October 14, 1983 Journal of the American Medical Association (JAMA) letter to the editor, a team of doctors (McGowan et al) from the National Institutes of ( Health (NIH) and George Washington University in Washington, D.C. conducted research that supports existing studies that show no overall association between talc use and risk of ovarian cancer. Dr. Cramer's study is an epidemiological one, which merely examined factors which might be associated with the disease. The author of the study has himself acknowledged that the evidence is rather tenuous, it does not show a cause and effect relationship. As a retrospective study, it relied on individuals' memories to recall events and habits that took place over a 20-year period. December, 1985 Protected Document-Subject to Protective Order JNJNL1_0000139S2 - 3 - Q* We know that asbestos causes cancer do we not? A: We are not experts bn asbestos, but there is strong evidence that very heavy exposure to asbestos fibers can cause cancer, especially in those people that smoke. 4. Q: Haven't they found traces of asbestos in talcum powders? Al Npt in JOHNSON'S Baby Powder| Since the 1940's, when the technology first became available, Johnson & Johnson has been consistently examining its talc to ensure that it is free of abestiform minerals'1 Johnson & Johnson's talc is a pure, high-grade talc, safe for proper use among infants and adults. Prior to 1976, when strict quality control was initiated, some talcum powders could have contained asbestiform particles -- not JOHNSON'S Baby Powder, however. . The FDA has since been conducting tests on a regular basis and has declared all talc-based baby powders to be free of such particles. Johnson & Johnson's quality control techniques ensure that JOHNSON'S Baby Powder is made from the purest, safest talc. 5. Os If your own studies should link talc to ovarian cancer, will you pull JOHNSON'S Baby Powder off the market? A: If our tests confirmed a cause and effect relationship, we would remove it. The consumer and the safety of our products are our primary concerns. Protected D ocu m e n t-Su bje ct to Protective O rder JNJNL61_000013963 4 Q: Why didn't you find this link in your own testing? A: This link is a hypothesis and is contradicted by the fact that independent scientists, the FDA as well as Johnson & Johnson have tested the chemical and physical properties o our talc and found no evidence of carcinogenicity. 7. 0: When did you first become aware of the carcinogenic properties of your product? A: Research shows there are none. Our product, JOHNSON'S Baby Powder has been thoroughly tested. Our research, as well as that of the government and the medical community, confirms its safety. 0 8. Q: In 1976, scientists found asbestos in 10 of 19 baby powders tested. How is that possible? A: Prior to 1976, when strict quality control was initiated, some talcum powders contained asbestiform particles, not JOHNSON'S Baby Powder, however. The FDA has since been conducting tests on a regular basis and has declared talc safe. SinciF the 1940's#~ when the technology first became available, Johnson & Johnson has been consistently eifaminihg its talc, and to endure- that it is free of ahsstiform minerals Johnson & Johnson's talc is a pure, high-grade talc, safe for proper use among infants and adults. December, 1985 Protected D ocu m e n t-Su b je ct to Protective O rder JNJNL61_000013964 5 Q: What is the relationship between talc and ovarian cancer? At There is no scientific evidence which shows that talc causes any form of cancer, in fact, the weight of extensive scientific evidence shows that talc is safe. As recently as October 14,- 1983 in a letter to the editor of JAMA, evidence questioning such a'link came to light. In that letter, a team of doctors (McGowan et al) from the National Institutes of Health (NIB) and George Washington University in Washington, D.C. state that their research reveals "no overall association between talc use and risk of ovarian cancer." Research undertaken by the medical community, the government and by Johnson & Johnson confirms the safety of talc. 10. Qs Don't you test for those sorts of things? At Yes, we do. Johnson & Johnson is deeply concerned with the safety of its products and is continously testing them for safety. Extensive research to date reaffirms our confidence in the safety of JOHNSON'S Baby Powder. 11. Qi Are you presently conducting tests for this? At Yes, Johnson & Johnson sells only talc that is thoroughly tested for safety. We are committed to on-going testing. Protected Document-Subject to Protective Order December, 1985 JNJNL61 000013956 6 Q: What kinds of tests does Johnson fc Johnson conduct? A: First, to ensure the talc is free from other elements or impurities, it is cleansed and tested at the mining and processing site. The testing for purity and safety has been ongoing since the 1940's singe the mid1960's, has included electron microscopic examination to ensure that the talc is free of deleterious materials. The testing process is repeated during packaging at the factory. The result is that only the purest, highest grade talc is used in JOHNSON'S Baby Powder. Moreover, over the years, Johnson & Johnson has joined independent researchers, and the government in extensive research. None of this research has shown talc to be a carcinogen. Qs Dr. Cramer's study indicates that women who use talc have three times the risk of contracting ovarian cancer than those who do not use it.. As a manufacturer, how do you respond to this? A; Thorough research and testing by the FDA, the medical community and Johnson & Johnson has not shown talc to be carcinogenic. The most recent study in this area does not support Dr. Cramer's findings. In an October 14, 1983 JAMA letter to the editor, a team of doctors (McGowan et al) from the National Institutes of Health (NIH) and George Washington University in Washington, D.C. conducted research that supports existing studies showing no overall association between talc use and risk December, 1985 Protected D ocu m e n t-Su bje ct to Protective O rd er JNJNL61 000013966 7 of ovarian cancer. Dr. Cramer's study is an epidemio logical one, which merely examined factors which might be associated with the disease. The author of the study himself acknowledged that the evidence is rather tenuous. It does not show a cause and effect relationship. As a retrospective study, it depended on individuals' memories to recall events and habits that took place over a 20year period. Q: Talc is closely related to asbestos. Isn't it likely that the two react in the same way?' As Talc and asbestos are two chemically distinct minerals. Importantly, it is the chemical and physical properties of asbestos that cause the damage that can lead to cancer. (For example, in contrast to abestos particles, whose shape is long, thin, and fibrous, talc particles are flat, platelike and nonfibrous.) Since 1976 the FDA has been conducting tests on a regular basis and declared talc safe. Furthermore, medical testing shows that talc and asbestos act very differently in human tissues, and has not shown talc to be carcinogenic. J&J talc source consistently has been examined and found to be free of ebbStiform minerals^ We own the talc mine which gives us complete control over the quality of talc used in our products. Protected D ocu m e n t-Su b je ct to Protective O rd er December, 1985 JNJNL61,,000013957 - 8 Q: What other studies have been done to determine the validity of this link between talc and cancer? At There are no studies confirming such a link. On the contrary, the FDA and many other independent scientists have confirmed that there is no evidence linking pure talc to cancer. JOHNSON'S Baby Powder does not contain asbestos, and we ourselves conduct exhaustive quality testing to assure its purity and safety. t Protected Docttment-Subject to Protective Order December, 1985 JNJNLS1JKM013M8 XI. TALC - INHALATION Protected Document-Subject to Protective Order December, 1985 JNJNU1JMQ0139S9 10 - Q: How about the allegations that talc can cause granulomas in the lungs? At These allegations result from rare reports of unusually large exposures not found in normal use of baby powder. 2. Ox What exactly are granulomas? At Granulomas are nodules of fibrous or scar tissue. 3. Qt Have studies been done linking disease to the miners of talc? A: Inhaling massive quantities of any dust or dust-like particles could cause a medical problem. Studies indicate that talc dust exposure to millers of cosmetic grade talc is not injurious to health* whereas miners of industrial talcs may contract lung scarring because of the mixed dusts they are exposed to. Qt Describe the kind of testing Johnson a Johnson has done on the safety of JOHNSON1S Baby Powder? At First* to ensure the talc is free from other elements or impurities, it is cleansed and tested at the mining and processing site. The testing for purity and safety has been ongoing since the 1940's and, since the mid-1960's, has included electron microscopic examination to ensure that the talc is free of deleterious materials. The testing process is repeated during packaging at the factory. The result is that only the purest, highestgrade talc is used in JOHNSON'S Baby Powder. Protected Docum ent-Subject to Protective Order JNJNL81JB00013960 11 Moreover, Johnson & Johnson, as well as the medical community and the government have been conducting research on talc for over 40 years to reaffirm its safety under various conditions. A study involving the inhalation of exaggerated levels of cosmetic talc during the life of hamsters showed no exposure**related problems. A subsequent inhalation study with hamsters found no translocation of talc to the liver, kidneys, ovaries or other parts of the body. / X recent study {Battelle, Pacific Northwest Laboratories, 1984) shows that even massive doses of talc placed ift the vaginas of monkeys did not. migrate to the ovaries. Johnson & Johnson is committed to ongoing research for its talc products. 5. . Q: Isn't it dangerous to inhale talc? As Our research has shown that exposure to talc during normal cosmetic use is safe; however inhaling large quantities of any dust or dust-like particles may cause medical problems. 6., Qs What is "normal" use? A: By normal use we mean, for instance, powdering after diapering, a shower or bath. Protected D ocu m e n t-Su bje ct to Protective O rd er December, 1985 JN JN L61_000013i96i 12 Q t Why don't you put labels on your product to warn parents about "abnormal* use of talc? A: Several years ago the PDA was asked to impose such labeling. At the time we agreed with their decision that warning labels were neither necessary or effective. Today however studies show that consumers are more apt to read package labeling. Given this environment J&J has decided to modify its package label, and are in the process of developing more detailed instructional and cautionary information. Q: You're now teat marketing JOHNSON'S Baby Powder with cornstarch. Why does that prpduet package have a warning label and not JQJIHSON'S Baby-Powder with talc which is more dangerous? Our research has shown that normal use of cosmetic talc is safe.. As you said, JOHNSON'S Baby Powder with cornstarch is in the test market stage, and does offer instructional and cautionary labeling. We are in the process of developing this kind of labeling for JOHNSON'S Baby Powder. Protected D ocu m e n t-su b je ct to Protective O rder December, 1985 JN JN L81_000013M 2 - 13 - 9. 0: Don't talc particles stay in your lungs? At The air we normally breathe contains a lot of dust and our lungs are able to clear themselves very effectively. It takes very heavy exposures to overburden this normal clearing ability. Normal cosmetic use is hundreds of times less than exposures tested in animals that have not produced any adverse effects. 10. Qt Bow long does it take to clear your lungs of talc?' At Research in animals has shown that even with huge exposures# most talc is removed within 8 days, with the remainder being cleared within 3 months. 11. Q: Could talc cause emphysema? Ai Emphysemat a degenerative disease of the lungs caused by breakdown of the normal air sacks, has not been associated with talc under normal cosmetic use conditions. Protected Document-S ubject to Protective order December, 1985 JNJNL$1_000013M3 - 14 III. TALC TRANSLOCATION Protected D ocu m e n t-Su b je ct to Protective O rd er December, 1985 JNJNL81J500013984 15 Qt Can talc migrate from the external environment into the body? At Numerous scientific studies have supported what we have always known as the inherent biological implausibility of translocation of talc to the liver kidneys ovaries, and other parts of the body. Studies on hamsters found that after massive inhalation of talc there was no translocation of talc to the liver kidneys ovaries or other parts of the body. Studies in rabbits show that talc placed in the vagina does not migrate to the ovaries. And further evidence was provided by a 1984 study (performed by Battello pacific Northwest Laboratories) using monkeys which shows that talc placed.in the vagina does not translocate to the oviducts or ovaries. 2. Qt If there is no evidence for translocation of talc why has it become an issue? At Some scientists theorize that talc is able to translocate to parts of the body. The fact is, however, that the weight of scientific evidence does not support this theory. Protected Docum ent-Subject to Protective order December, 1985 JNJNL61_000013966 ' - 16 Q: What studies have been done to disprove translocation of talc? At Numerous scientific studies show that talc does not translocate to the ovaries, liver, kidneys, or other parts of the body. Studies on hamsters found that after massive inhalation of talc, no translocation occurred. Studies in rabbits show that talc, placed in the vagina, does not migrate to the ovaries* And further evidence was provided in a 1984 study (performed by Battelle, pacific Northwest Laboratories) using monkeys, which shows that talc, when placed in the vaginas of monkeys, does not translocate to the oviducts or ovaries. 4. Qt But haven't there been studies proving translocation of talc? Ax We are not aware of any studies that proved such a theory. Numerous scientific studies show that talc does not translocate. Most recently, in fact, a study (performed by Battelle, Pacific Northwest Laboratories, 1984) shows that talc, when placed in the vagina, does not translocate to the oviducts or ovaries. Protected Document-Subject to Protective Order December, 1985 JNJNL61 000013968 17 Q< What about the study by Bgli s Newton that proved translocation of talc to the ovaries? A: The 1961 Egli & Newton study, which used carbon black particles, did not prove translocation of talc to the ovaries. Moreover, a study by Battelle, Pacific Northwest Laboratories (1984) followed closely the procedures used in the 1961 study, and found that talc does not translocate to the ovaries. in this study, neutron-activated talc -- as well as the carbon black particles used in the 1961 study -- were deposited in the vaginas of monkeys. Neutron-activated talc is easier to monitor, andN reduces the problem of contamination from the environment. Carbon is one of the most common air pollutants, and this could easily account for the carbon particles found in the 1961 study. 6. Q: Explain the process by which talc moves from the outside of the body to the ovaries. A; This is a hypothesis only, and it is hard to imagine that the body's natural protective mechanisms would permit it. Moreover, the weight of scientific evidence falls heavily against this hypothesis. In fact, a recent study (Battelle, Pacific Northwest Laboratories, 1984) shows that even massive doses of talc placed in the vaginas of monkeys does not migrate to the ovaries. Protected Document-8 ubject to Protective Order December, 1985 JNJNL81_000013W7 - 18 - Qt Does talc cause pelvic inflammatory disease? A: Talc like any other foreign matter, will be irritating if introduced in unusual quantities into body cavities or tissues. There is no scientific evidence that talc can migrate to those cavities and tissues from normal everyday use of talcum baby powder. 8. Qt What is "normal" use? At By normal use we mean, for instance, powdering after diapering, a shower or bath. 9. Qi Describe the kind of testing Johnson a Johnson has done on the safety of JOHNSON'S Baby Powder? At First, to ensure the talc is free from other elements or impurities, it is cleansed and tested at the mining and processing site. The testing for purity and safety has been ongoing since the 1940's and, since the mid-1960's, has included electron microscopic examination to ensure that the talc is free of deleterious materials. The testing process is repeated during packaging at the factory. The result is that only the purest, highestgrade talc is in JOHNSON'S Baby Powder. Moreover, Johnson & Johnson, as well as the medical community and the government have been conducting research on talc for over 40 years to reaffirm its safety under various conditions. A study involving the inhalation of Protected Document-Subject to Protective Order December, 1985 JNJNL81J)000139iB - 19 - exaggerated levels of cosmetic talc during the life of hamsters showed no exposure-related problems* A subsequent inhalation study with hamsters found no translocation of talc to the liver* kidneys* ovaries or other parts of the body* A recent study (Battelle* Pacific Northwest Laboratories* 1984) shows that even massive doses of talc placed in the vaginas of monkeys did not migrate to the ovaries* Johnson & Johnson is , committed to ongoing research for its talc products* Protected Document~Subje<5t to Protective Order December* 1985 JNJNL81 0000"13989 20 TALC MISUSE ( Protected Document-Subject to Protective order December, 1985 JNJNU61 000013970 21 - Q* In Nassau County, in the first six months of 1980, there . were 40 cases of babies who ingested or inhaled various baby powders. Bow serious is this? A: By any standard this is serious and unfortunate, but these cases represent the misuse of various baby powders which, fortunately, did not have any'long-term effects. Large amounts of any small particle entering the nose or mouth can overwhelm the normal defenses and form a physical barrier to breathing. Parents must remember these products are not toys, and must exercise care around infants. Xn this time period there were more than 4,200 cases of accidental ingestions of various household products. This underscores the need for proper parental supervision of infants and children. 2. Q* Bow many suffocation deaths have there been? At We are not aware of any such deaths over the past 20 years. The deaths recorded in the scientific .literature prior to then occurred when the entire contents of a " container were accidentally emptied into a baby's mouth, causing actual physical obstruction. 3. Os Aren't medicated powders even more dangerous? A: This would depend upon the nature and potential toxicity of the medicating ingredient. Protected Document-Subject to Protective Order December, 1985 JNJNLS1JN0013S71 i. - 22 - Qi Why haven't you changed the shape of your bottle, since it looks like a nurser and babies are prone to suck on it? A: He have looked into incidents of misuse carefully and have concluded that the shape of the container is not the cause of accidents, since babies will tend to put almost anything in their mouths. The problem is in misuse -- parents who give the container to infants or leave it within the reach of infants. We do not feel that changing the shape of bur container will eliminate the rare incidents of mishandling or of parental negligence. Reports of inhalation due to misuse, though very unfortunate, are rare. With reasonable parental care, inhalation accidents can be prevented. 5. Q: Why are there no safety caps on JOHNSON'S Baby Powder? A: To try to prevent misuse, which is really the issue here, we provide extensive information along with our product on its proper usage. The best way to prevent acute, t i.e., one-time massive, inhalation by dumping in.a baby's mouth is to keep the product out of the reach of babies, as indicated in our proper use information -- advertising, booklets, and packaging. Protected D ocu m e n t-Su bje ct to Protective O rder December, 1985 JN JNUS1JJ00013972 - 23 - 6. Os If accidents are occuring* why aren't you warning parents about accidents in your labeling? At Several years ago the FDA was asked to impose such labeling. At the time we agreed with their decision that warning labels were neither necessary or effective. Today* however* studies show that consumers are more apt to read package labeling. Given this environment* J&J has decided to modify its package label* and are in the process of developing more detailed instructional and cautionary information. We have recently introduced JOHNSON'S Baby Powder with cornstarch in test markets in California* and the product package has this kind of detailed labeling. 7. Qt You're now test marketing JOHNSON'S Baby Powder with cornstarch, why does that product package have a warning label and not JOHNSON'S Baby Powder with talc? A: As you said* JOHNSON'S Baby Powder with cornstarch is in the test market stage* and does offer instructional and cautionary labeling. We are in the process of developing this kind of labeling for JOHNSON'S Baby powder. 8. Qs Why do you have to caution consumers about these products? Are they unsafe? At These products are safe. As a responsible company* we Protected Docum ent-Subject to Protective Order December* 1985 JNJNL61_000013973 24 feel that any time we can provide consumers with valuable information about the proper use of our products we should do so* In the current environment where consumers are more apt than ever before to read package labeling we could provide yet another value-added service to consumers. Protected Docum m t-Subjct to Protects Ordr December 1985 JNJNLB1_000013974 V. BABY POWDER - BENEFITS AND OSES Protected Document-Subject to Protective Order December, 1985 JN JN L81JM 0013975 - 26 1. Q: Baby powder is no longer being used in hospitals. Why not? A: This is not true of all hospitals. Given the frequency of diaper changing in a hospital -- to help keep the skin dry and prevent diaper rash ~ there is less dependence on a drying agent like talc or corn starch. Bs Baby powder is used in hospitals for general bed care. Nursery use of talc is limited and probably always has been limited because the frequency of diaper changing helps keep the skin dry and prevents diaper rash. There is. therefore, less dependence on a drying agent like talc or corn starch. 2. Qs There's no medical benefit to baby powder, is there? A: Talc is not presented as having a medical benefit, it is not a drug. Baby powder is a dry lubricant for use after a shower, exercise, diaper change or baby's bath. The flat platelike talc particles slide easily over one another to provide lubricity. JOHNSON'S Baby Powder is moisture repellent and has been proven effective in reducing friction and providing cool, dry comfort for nearly 100 years. For infants, the use of baby powder can encourage parental touching and caressing which fulfills documented psychological needs for "touching and bonding." Protected D ocu m e n t-Su bje ct to Protective O rd er December, 1985 JNJNL61_000013976 27 3 Q* Does baby ponder prevent diaper rash? A: Talc is a dry lubricant and a moisture repellent to be used after a diaper change. Its lubricity has been proven effective in reducing friction and its moisture repellent action helps protect skin from the irritation of vet diapers. Qs The Lancet, a leading British medical journal sayss * "There is no reason to believe that normal exposure to talc in the past led to cancer." What constitutes "normal" exposure? A t Normal exposure is the reasonable# everyday u s e of baby powder. This means application after a shower, exercise or after a diaper change. Protected Docum ent-subject to Protective Order December, 1985 JNJNL81_000013977 VI. BABY PONDER - MANUFACTURING Protected Document-Subject to Protective Order December, 1985 JNJNLB1J)0001397B 1. Q: Where does tale case from? At It is a mineral, occurring naturally in the earth. Talc is from deposits around the world. Johnson & Johnson's own talc mine is located in Vermont. 2. Qs Bow is it mined? At Johnson & Johnson mines only the highest grade talc. It is ground, then "washed" and purged of impurities. Zt is then transported to the manufacturing plant in specially sanitized containers. Before packaging, again it is tested for impurities. Johnson t Johnson uses the utmost care and responsibility in bringing the highest possible quality baby powder to market. 3. Qt Describe the kind of testing Johnson s Johnson has done on the safety of JOHNSON'S Baby Powder? A: To ensure that the talc used in JOHNSON'S Baby Powder is free from other elements or impurities, it is cleansed and tested at the mining and processing site. The * testing for purity and safety has been ongoing since the 1940's and, since the mid-1960's, has included electron microscopic examination to ensure that the talc is free of deleterious materials. The testing process is repeated during packaging at the factory. The result is that only the purest, highest-grade talc is in JOHNSON'S Baby Powder. Protected Document-Subject to Protective Order December, 1985 30 Moreover, Johnson & Johnson, as well as the medical community and the government have been conducting research on talc for over 40 years to reaffirm its safety under various conditions* A study involving the inhalation of exaggerated levels of cosmetic talc during the life of hamsters showed no exposure-related problems* A subsequent inhalation study with hamsters found no translocation of talc to the liver, kidneys, ovaries or other parts of the body. A recent study (Battelle, Pacific Northwest Laboratories, 1984) shows that even massive doses of talc placed in the vaginas of monkeys did not migrate to the ovaries. Johnson & Johnson is committed to ongoing research for its talc products. 4. Q: Mineral talc and asbestos are often found in the same mines. What safety controls do you have to maintain purity of product? ' At Johnson & Johnson is one of the few consumer product companies in the U.S. that owns its own talc mine. This allows us to have complete control over th quality of talc used in our product. J^J talc source consistently has been examined and found to be free of abestiform minerals. This selected high-purity talc ore undergoes an extensive cleansing process to remove impurities and Protected Document-Subject to Protective Order December, 1985 JNJNL61_000013MO - 31 - * scientific analysis and microscopic examination to confirm the absence of asbestiform minerals. The process selects the platy form of talc for superior lubricity. The selection process is especially effective in eliminating non-platy shapes. The talc is shipped to our plant in specially sanitised containers to maintain this purity. Before packaging, it is once more scientifically tested to insure this purity. Protected Document-Subject to Protective Order December. 1985 JNJNL61 00001S981 VII. BABY POWDER - GENERAL Protected Document-Subject to Protective Order December, 1985 JNJNL81 000013982 - 33 - Q: l your wife asked how safe baby ponder is for your own baby, what would you tell her? A; X would tell her that JOHNSON'S Baby Powder is safe and I would assure her that nearly 100 years of use and extensive scientific evidence supports this. Johnson & Johnson is recognized around the world as an extraordinarily responsible company, concerned first with the safety of our products and the health of the consumer. 2. Q: What's in JOHNSON'S Baby Powder? A: JOHNSON'S Baby Powder contains pure, high-grade toiletries tal, a naturally occurring mineral, and a very small amount of perfume -- the most recognized smell in the world) 3. Qs Is there any difference between mineral talc and cosmetic dusting powder? A: Mineral talc is the naturally occuring element; cosmetic dusting powder is a particularly platy grade of mineral talc carefully processed with fragrances added. Qt Xs baby powder safe? A: JOHNSON'S Baby Powder, nearly 100 years on the market, can be used properly with confidence by consumers. Thorough testing, undertaken by the scientific community, the Food and Drug Administration and by Johnson & Johnson has continuously reaffirmed the safety of baby powder. Protected Document-Subject to Protective Order JNJNL61 000013983 34 VIII MEDICATED TALCS Protected Document-Subject to Protective Order December, 1985 JNJNLS1JD000139M 1 0* Isn't it better to use medicated talc? A: If the skin is irritated and requires a medicine to help in its treatment, a physician should be consulted, particularly if there is persistent or recurring irritation of the skin* 2. Q* Are there toxic elements in medicated talcs? At Medicated talcs contain drugs to treat minor skin irritations. As with all drugs, safety and effectiveness depend on following the directions for its intended use. All talcs, including medicated ones, are for external skin applications only. Protected Docum ent-Subject to Protective Order December, 1985 JNJNL61 IX. BABY COWISTARCH Protecttd Document-Sutiject to Protective Order December, 1985 JNJNL61_0000139BB - 37 - Qs Why did you introduce a cornstarch powder? At While talc provides a moisture repellent barrier on the skin, cornstarch absorbs moisture to make skin feel dry. It was found that some consumers preferred it, and we wanted to provide them with a superior cosmetic grade cornstarch. 2. Qt isn't it because it is safer? At Not at all. First, the safety of talcum powder has been continuously re-affirmed by Johnson ft Johnson, the medical community and by the government. And, we are always conducting research to ensure its safety. For some consumers who prefer the absorbency effect of cornstarch, we have JOHNSON'S Baby Cornstarch. For the consumer who prefers more softness and lubricity, there is JOHNSON'S Baby Powder. 3. Qt What's in JOHNSON'S Baby Cornstarch? At JOHNSON'S Baby Cornstarch consists of pure cornstarch * (99%), tricalcium phosphate, and fragrance. It is the highest quality cornstarch available. Protected Document-Subject to Protective Order December, 1985 JNJNU1JM0013887 - 38 4. Qs What is tricalcium phosphate? What is it used for? A: it's a very safe food grade material. It is added in small amounts to cornstarch to enable it to flow easily out of the container. 5. O When did you introduce your Cornstarch product? As 1980. Q: Surgeons who used to dust their gloves with talc now use cornstarch. Do they know something we don't? A: Cornstarch is a biodegradable substance which is better for use in surgical procedures where some of the powder on the-surgeon's gloves could be left in the body cavity or tissues. Protected Docum ent-Subject to Protective Order December, 1985 JNJNL61 000013988 X. TEST HARRET BABY BORDER WITH CORNSTARCH Protected Document-Subject to Protective Order December, 1985 JNJNL61_000013989 40 1. Qs hat is JOHNSON'S Baby Powder with cornstarch? At JOHNSON'S Baby Powder with cornstarch is a baby powder fdr consumers who prefer the absorbency of cornstarch. For the consumer who prefers more softness and lubricity, there is JOHNSON'S Baby Powder with talc. JOHNSON'S Baby Powder with cornstarch is the highest quality cornstarch available. Zt consists of pure cornstarch (99%), tricalcium phosphate, and fragrance. JOHNSON'S Baby Powder with cornstarch is currently in the test market stage. Zt is being test marketed in Los Angeles, San Francisco and Las Vegas, bur intent at this point is to take it national some time in 1986. 2. 0* What is tricalcium phosphate? What is it used for? A: It's a very safe food grade material. Zt is added in small amounts to cornstarch to enable it to flow easily out of the container. * 3. Qx Why is baby powder cornstarch offered only in a few parts of the country? At JOHNSON'S Baby Powder with cornstarch is currently in the test market stage. Zt is being test marketed in Los Angeles, San Francisco and Las Vegas. Our intent at this point is to take it national some time in 1986. Protected Document-Subject to Protective Order December, 1985 JNJNL81 000013M0 - 41 - 4. Q: Why is JtJ changing its flagship product to contain cornstarch? As We are not changing our flagship product.. JOHNSON*>S Baby Powder has been on the market nearly 100 years and it remains the baby powder preferred by consumers. We are expanding the product line to offer consumers a choice. For some consumers who prefer the absorbency of cornstarch* there will be JOHNSON'S Baby Powder with cornstarch. For the consumer who prefers more softness and lubricity* there is JOHNSON'S Baby Powder with talc. Qs What's the purpose of changing the name but not the product? A: It is a marketing decision. Our cornstarch product has proven it is worthy of the name of JOHNSON'S Baby Powder. 6. Qs Are you putting cornstarch in JOHNSON'S Baby Powder because you think talc is not safe? A: The safety of talcum powder continuously has been re-*affirmed by Johnson & Johnson, the medical community, and by the government. Consumers who prefer more softness and lubricity will be able to continue to use JOHNSON'S Baby Powder with talc. For those who prefer the absorbency of cornstarch, there will be JOHNSON'S Baby Powder with cornstarch. Protected Document-Subject to Protective order December, 1985 JNJNL61_0000138#1 - 42 - Q: Mien are you going to discontinue using talc in JOHNSON'S Baby Powder? A: We are not changing JOHNSON'S Baby Powder. We are expanding the product line to offer consumers a choice. For some consumers who prefer the absorbency of cornstarch there will be JOHNSON'S Baby Powder with cornstarch. For those who prefer more softness and lubricity there is JOHNSON'S Baby Powder with talc. . 8. Q t Why is there a warning label on JOHNSON'S Baby Powder with cornstarch and not on JOHNSON'S Baby Powder? A: JOHNSON'S Baby Powder with cornstarch is in a test market. We are in the process of including similar labeling on JOHNSON'S Baby Powder. Protected Document-Subject to Protective Order December 1985 JNJNL81_000013992 XI. JOHNSON & JOHNSON POLICIES AND GENERAL QUESTIONS Protected Document-Subject to Protective order December 1985 JNJNL81JD00013893 - 44 - Q: Why are so many products being tested for safety today? A: As scientific techniques are becoming more and more advanced, researchers are able to conduct even more rigorous studies on chemicals and products and reaffirm their safety. JOHNSON'S Baby Powder has been on the market nearly 100 years, it has been examined again and again, and all the evidence continues to say that it's a safe product for normal cosmetic use. 2. Q: How has the Tylenol incident affected Johnson & Johnson Baby Products? A: The whole country now understands that Tylenol was subject to criminal tampering. It has reaffirmed my faith that Johnson & Johnson will only market the safest product possible and will always keep consumers' interests above all others. 3. Q: If your own studies link talc to ovarian cancer, will you pull your talc products off the market? A: If such tests prove a cause and effect relationship, yes we would remove our talc products. Johnson & Johnson would never place baby powder users at unacceptable risk. The safety of the consumer is our primary concern. Protected Document-Subject to Protective Order December, 1985 JNJNL61JD00013994 45 - Qt You've had a lot of problems at Johnson ft Johnson. Bow many other products are under investigation? A; Talc is not under investigation# except to the extent that it like many products# is continually tested for safety. Johnson ft Johnson's primary responsibilities are to the consumer and as such we sell only the highest quality baby care products. We also investigate our medical products thoroughly# including post-marketing surveillance after they have FDA approval. 5. Qt Will Johnson ft Johnson pull its baby powder from the market if these allegations that baby powder causes ovarian cancer are true? At If removal from the market were required to protect the public# yes. The consumer has been and will continue to be our concern# and our actions will reflect this philosophy in all decisions. At Johnson ft Johnson# the effectiveness and safety of baby powder have been proven for nearly 100 years. As recently as October 14# 1983 in a letter to the editor of JAMA# a team of doctors (McGowan et al) from the National Institutesof Health (NIH) and George Washington University in Washington# D.C. state that their research reveals "no overall association between talc use and ovarian cancer." We at Johnson & Johnson# along with the scientific community Protected Document-Subject to Protective Order December# 1985 JNJNL61 0000139M and the government have vast knowledge and understanding of talc. This extensive research shows that baby powder properly used is safe. 6. Q: How are you people handling the crisis? A: There is no crisis involving baby powder. The tremendous body of evidence attesting to the safety of talc remains valid. We would just like to inform consumers that JOHNSON'S Baby Powder a product nearly 100 years pld is safe and that we are always conducting research to affirm this. We have always placed the consumer's safety above all else and will continue to do so. 7. 0* When were you first aware of the problems with baby powder? Ai In examining all the research undertaken on baby powder we are not aware of problems with it. Extensive research indicates that baby powder used properly, is safe. We do see an opportunity to clear up some public misunderstanding about our product and its use so it's a pleasure to talk to you about JOHNSON'S Baby Powder. Protected Document-Subject to Protective Order December, 1985 JNJNL.61 000013906 - 47 0 In light of all this controversy, when will you be pulling JOHNSON'S Baby Powder off the market? At The safety and effectiveness of JOHNSON'S Baby Powder have been proven for nearly 100 years. At Johnson & Johnson, concern for the consumer's safety and health is ourl*^>riority. As always, we will continue to act accordingly, reflecting this philosophy in all decisions. Qx What other products does Johnson ft Johnson Baby Products Division manufacture? Ax Johnson ft Johnson has a long history as a leading supplier of quality baby care products. Besides Baby Powder and Cornstarch, we also have Baby Cream, Baby Oil, Baby Lotion and Baby Shampoo. We also sell Johnson ft Johnson wash cloths, cotton swabs, gift sets, baby bath, soap, Sundown sun screen, Affinity Shampoo and Johnson & .Johnson Child Development Toys. 10. Ox Do you anticipate problems with those products in the future? A: We have no reason to believe there are problems with any of our products. All are thoroughly tested for safety before they are introduced, and on a continuing basis thereafter. Johnson ft Johnson is deeply committed to continuing to provide its customers with the highest quality and safest baby products. Protectad Document-Subject to Protective Order December, 1985 JNJNLS1_000013997 48 - 0* Are you conducting any tests right now to reassure your Baby Powder users? As To reaffirm the existing and extensive evidence supporting the safety of JOHNSON'S Baby Powder, Johnson & Johnson conducts tests on an ongoing basis First, to ensure the talc is free from other elements or impurities, it is cleansed and tested at the mining and processing site. The testing for purity and safety has been ongoing since the 1940's and, since the mid-1960's, has included electron microscopic examination to ensure that the talc is free of deleterious materials. The testing process is repeated during packaging at the factory. The result is that only the purest, highest-grade talc is used in JOHNSON 's Baby Powder. Protected Document-Subject to Protective Order December, 1985 JNJNL61_0000i38 49 XII IUDEX Protected Document-Subject to Protective Order December, 198 5 JNJNLS1JW M1399 50 iwpgx 9F qp|gxg|8 I. TALC - CANCER 1. Does talc cause cancer?........ ............... . 2 2. Dr. Daniel Cramer in the journal Cancer has linked the use of talcum powder to ovarian cancer. Could you comment?.......................... ............ 2 3. We know that asbestos causes cancer/ do we not?... 3 4. Haven't they found traces of asbestos in talcum p o w d e r s ? ......... ....... . 3 5. If your own studies should link talc to ovarian cancer will you pull JOHNSCSI'S Baby Powder off the market?..................... ........ . 3 6. Why didn't you find this link in your own testing?........... ................. ............. 4 7. When did you first become aware of the carcinogenic properties of your product?...... . 4 ( B. in 1976, scientists found asbestos in 10 of 19 baby powders tested. Now is that possible?...... 4 9. What is the relationship between talc and ovarian cancer?................................... 5 10. Don't you test for those sorts of things?........ 5 11. Are you presently conducting tests for this?..... 5 12. What kinds of tests does Johnson & Johnson conduct?.................. .................... . 6 13. Dr. Cramer's study indicates that women who use talc have three times the risk of contracting ovarian cancer than those who do not use it. As a manufacturer, how do you respond to this?...... 6 14. Talc is closely related to asbestos, isn't it likely that the two react in the same way?........ 7 15. What other studies have been done to determine the validity of this link between talc and cancer?........... ................. ............... 8 December, 1985 Protected Doeum*nU-Sufejct to PrdteethM Ortter JNJNL*1_000014000 - 51 Page II. TALC - INHALATION 1. How about th*. allegation* that talc can cause granulomas in the lungs......... . 10 2. What exactly are granulomas?......... ............. . 10 3. Have studies been done linking disease to the miners of talc?...... .................... .......... 10 4. Describe the kind of testing Johnson ft Johnson has done on the safety of JOHNSON'S Baby Powder?....... 10 5. Isn't it dangerous to inhale talc?.................. 11 6. What is "normal" use?.... .......................... 11 7. Why don't you put labels on your product to warn parents about "abnormal" use of talc?............... 12 8. You're now test marketing JOHNSON'S Baby Powder with cornstarch. Why does that product package have a warning label and not JOHNSON'S Baby Powder with talc, which is more dangerous?............ . 12 9 . Don't talc particles stay in your lungs?........... 13 10. How long does it take to clear your lungs of talc... 13 11. Could talc cause emphysema?......................... 13 III. TALC - TRANSLOCATION 1. Can talc migrate from the external environment Into the body?..... .................................. 15 2. If there is no evidence for translocation of talc, why has it become an issue?....................... . 15 3. What studies have been done to disprove translocation of talc?............................. 16 4. But haven't there been studies proving translocation of talc?.............................. 16 5. What about the study by Bgli & Newton that proved translocation of talc to the ovaries?............... 17 6. Bxplain the process by which talc moves from the outside of the body to the ovaries.......... ....... 17 December, 1985 Protected Docum ent-Subject to Protective order JNJNL61 000014001 - 52 Page III. (con't) 7. Does talc cause pelvic inflammatory disease?........ 18 8. What is "normal" use?.................... .......... 18 9. Describe the kind of testing Johnson & Johnson has done on the safety of JOHNSON'S Baby Powder?....... 18 IV. TALC - MISUSE 1. In Nassau County/ in the first six months of 1980 there were 40 cases of babies who ingested or inhaled various baby powders. How serious is this?....................................... . 21 2. How many suffocation deaths have there been?........ 21 . 3. Aren't medicated powders even more dangerous?....... 21 4. Why haven't you changed the shape of your bottle* since it looks like a nurser and babies are prone to suck on it?.......... ........................... 22 5. Why are there no safety caps on JOHNSON'S Baby Powder?.... ............... ................. *....... 22 5. if accidents are occurring/ why aren't you warning parents about accidents in your labeling?.......... 23 7. You're now test marketing JOHNSON'S Baby Powder with cornstarch. Why does that product package have a warning label and not JOHNSON'S Baby Powder with talc?........................... .............. 23 I 8. Why do you have to caution consumers about these products? Are th*y unsafe?....... ............... . 23 V. BABY POWDER - BENEFITS AMD USES 1. Baby powder is no longer being used in hospitals anymore. Why not?........................... . 2. There's no medical benefit to baby powder/ is there?........ ............ ....... .............. . 3. Does baby powder prevent diaper rash?.......... . 4. The Lancet* a leading British medical journal* says 'There is no reason to believe that normal exposure to talc in the past led to cancer." What constitutes "normal* exposure?.......... . Protect! Document-Subject ta Protective Order 26 26 27 27 JNJNL61_006014002 - 53 Page VI. BABY POWDER - MANUFACTURING 1. Where does talc cone from?.......................... 29 2. How is it mined?........ ............. .............. 29 3. Describe the kind of testing Johnson & Johnson has done on the safety of JOHNSON'S Baby Powder?....... 29 4. Mineral talc and asbestos are often found in the same mines. What safety controls do you have to maintain purity of product?............ . 30 VII. BABY PCMDER - GENERAL 1. If your wife asked how safe baby powder is for your own baby, what would you tell her?.... . 33 2. What's in JOHNSON'S Baby Powder?.................... 33 3. is there any difference between mineral talc and cosmetic dusting powder?........... .. . . w . . . ....... 33 4. Is baby powder safe?........................... . 33 VIII. MEDICATED TALCS 1. Isn't it better to use medicated talc?............ . 35 2. Are there toxic elements in medicated talcs?........ 35 IX. BABY CORNSTARCH 1. Why did you introduce a cornstarch powder?..... . 37 2. Isn't it because it is safer?....................... 37 3. What's in JOHNSON'S Baby Cornstarch?........ 37 4. What is tricalcium phosphate? What is it used for?............. 38 5. When did you introduce your cornstarchproduct?..... 38 6. Surgeons who used to dust their gloves with talc now use cornstarch. Do they know something we d o n 't ? ......... 38 Protected Document-Subject to Protective Order December, 1985 JNJNU1_00001400J 54 Page X. TEST MARKET -- BABY POWDER WITH CORNSTARCH 1. What is JOHNSON'S Baby Powder with cornstarch?..... 40 2. What is tricalcium phosphate? What is it used for?................................................ 40 3. Why is JOHNSON'S Baby Powder with cornstarch offered only in a few parts of the country?........ ....... 40 4. Why is JSJ changing its flagship product to contain cornstarch?.................... 41 5. What's the purpose of changing the name but not the product?..... ............. 41 6. Are you putting cornstarch in JOHNSON'S Baby Powder because you think talc is not safe?....... ....... . 41 7. When are you going to discontinue using talc in JOHNSON'S BabyPowder?.................... 42 8. Why is there a warning label on JOHNSON'S Baby Powder with cornstarch and not on JOHNSON'S Baby Powder?... 42 XI. JOHNSON & JOHNSON POLICIES AND GENERAL QUESTIONS 1. Why are b o many products being tested for safety today?......... .......... ........... ............... 44 2. How has the Tylenol incident affected Johnson & Johnson Baby Products?............. .......... ....... 44 3. If your own studies link talc to ovarian cancer, will you pull your talc products off the market?.................... ........ ................. 44 4. you've had a lot of problems at Johnson & Johnson. How many other products are under investigation?.... 45 5. Will Johnson s Johnson pull its baby powder from the market if these allegations that baby powder causes ovarian cancer are true?*.................... 45 6. How are you people handling the crisis?.... ........ 46 7. When were you first aware of the problems with baby powder?.......... ............... . 46 8. In light of all this controversy, when will you be pulling JOHNSON'S Baby Powder off the market?.... 47 December, 1985 Protected Docum ent-Subject to Protective Order JNJNL61_000014004