You may have heard about juries awarding large verdicts in lawsuits in North America alleging that talc-based Johnson’s Baby Powder can cause ovarian cancer or mesothelioma.
But you may not know this: in the majority of U.S. jury trials, juries have concluded that Johnson & Johnson’s former product was not responsible for the plaintiffs’ cancer. In other instances, judges have dismissed cases outright based on their own review of the facts, and many of the verdicts against Johnson & Johnson that have been through the appellate process have also been overturned.
Despite the evidence presented in court, and the fact that Johnson & Johnson discontinued the sale of Johnson’s Baby Powder in the United States and Canada in 2020, there continue to be more lawsuits filed in North America and a few extraordinary verdicts in U.S. state courts that have contradicted the science. Additionally, Johnson & Johnson divested its consumer health business years ago. As a part of that separation, Kenvue retained the responsibility and any purported liability for talc related litigation outside of the United States and Canada[CB1] .
The stories of anyone suffering from any form of cancer are tragic. We sympathize deeply with these patients and their families, and we appreciate that they seek answers. The science and the facts, however, show that their illnesses were not caused by their use of our talc-based products.
Decades of independent scientific testing have confirmed that talc safe, does not contain asbestos and do not cause cancer.
The facts
1.
At every stage of the Johnson’s Baby Powder manufacturing process we ensured that the cosmetic talc used was not contaminated with asbestos. Only about 5% of talc is used for cosmetic purposes. The rest is used in industrial materials such as roofing, building materials, or ceramics. Before any talc mine was qualified to be a source for our talc products, we evaluated the mine with expert geologists who know all the aspects of how and where mineral deposits form.
Governmental and academic reports on the mines where we have sourced talc in the United States and Canada confirm that these talc ores used in our product did not contain asbestos.
2.
In the 1970s, preliminary and erroneous reports based on unreliable testing methodology were recounted in the media suggesting that there could be asbestos contamination in our talc. Scientists from all over the world, including those working for the FDA, studied the issue for years and ultimately concluded that Johnson & Johnson’s talc was not contaminated with asbestos.
As technology advanced, scientists and regulators agreed on methodologies to reliably and accurately test for asbestos in talc. Johnson & Johnson not only met those standards but exceeded them by using state of the art methodologies to reliably and accurately test for asbestos in talc. This means we examined our talc not only through traditional microscopes, but also with electron microscopes that permit extremely high magnifications.
In the 1970s and 1980s, we gathered samples every hour from our talc processing facilities so that we could test it for asbestos. Samples of ground talc ore were combined and tested at least every month. Samples of this talc that was ready to be packaged were combined and tested at least every other week. And as an additional audit, every quarter, those samples were also tested again.
There was—and remains—a point to all this testing: The more you repeat a test, the higher level of certainty and assurance you get from that test. If you just test it once, you’d only have a certain level of assurance. Testing week after week over years with the same result affords a high level of confidence that our product does not contain asbestos.
3.
Allegations that talc posed a harm to consumers was a concern Johnson & Johnson took very seriously, and we asked a number of independent institutions, laboratories, and universities to test our talc to prove it was free of asbestos. These tests provided evidence that our talc does not contain asbestos. Those institutions include:
- The U.S. Food and Drug Administration
- The U.S. National Institute for Occupational Health and Safety
- Harvard School of Public Health
- Massachusetts Institute of Technology
- Mount Sinai Hospital
- Princeton University
- Colorado School of Mines
- Dartmouth University
- Geological Society of the United States
- Atomic Energy Commission at Harwell (England)
- Cardiff University (Wales)
- Mining Institute of Torino (Italy)
- RJ Lee Group
- McCrone Associates
- EMV Associates
- ES Laboratories
4.
The FDA’s mission is to protect public health, including ensuring that cosmetics are safe and properly labeled. Over many decades, the FDA has repeatedly been involved in investigating and testing cosmetic talc, including Johnson & Johnson’s talc. In the 1970s, the FDA conducted a four-year intensive investigation into the issue of whether cosmetic talc products, including Johnson & Johnson’s, were contaminated with asbestos. As a result of this investigation, the FDA concluded that “none of the talcs used in these products [including Johnson & Johnson products] contained asbestos as a contaminant.”
In 1986, FDA stated there was no reason to put a warning label on cosmetic talc, citing the results of its studies and ongoing surveillance. The FDA stated that even “the risk from a worst case estimate of exposure to asbestos from cosmetic talc would be less than the risk from environmental background levels of exposure to asbestos … over a lifetime.”
In 2009-2010, the FDA tested raw talc from four talc suppliers—and confirmed that none contained asbestos.
Again in 2014, when investigating a potential correlation between talc and ovarian cancer, the FDA stated that there was no conclusive evidence that use of talc had a causal relationship with cancer.
In October 18, 2019, for the first time in the many decades that the FDA has tested Johnson & Johnson’s talc, FDA advised Johnson & Johnson that testing of a single lot of one bottle of Johnson’s Baby Powder revealed sub-trace levels of chrysotile asbestos contamination (0.00002%). At the same time, FDA noted that it had not detected asbestos when it sampled a different talc lot. Out of an abundance of caution, Johnson & Johnson Consumer Inc. voluntarily recalled the lot at issue in FDA’s testing. Johnson & Johnson Consumer Inc. immediately initiated a thorough investigation into the matter and is working with FDA to answer questions about the testing, including the integrity of the tested sample and the validity of the test results.
5.
Johnson & Johnson’s talcum powder products, including Johnson’s Baby Powder and its prior product Shower to Shower, were found to be safe to use by the most reliable scientific studies.
Ovarian Cancer: Four major independent cohort studies that followed more than 80,000 women who used talcum powder over a period of at least 6 to 24 years to determine if talcum powder use for feminine hygiene causes ovarian cancer concluded that the use of talc is not associated with increased risk of ovarian cancer. Prospective cohort studies are a well-accepted, highly reliable way to investigate whether there is an association between the use of, or exposure to, a product and a disease. In this type of study, groups of people are asked questions about different possible risk factors, including use of certain products, and then followed going forward for a period of time to collect relevant data. Cohort studies have helped scientists understand the link between smoking and lung cancer, high cholesterol and heart disease, and many other health topics we consider common knowledge today.The most recent cohort study, published in the Journal of the American Medical Association, pooled a number of these high-level epidemiological studies and found no statistically significant increased risk of ovarian cancer with talc use.
Some studies, called case-control studies have shown a small statistical association between ovarian cancer and talc use, while other similarly designed case-control studies have shown no association between talc use and ovarian cancer. Experts are skeptical of these case-control studies because the results are inconsistent, and when these studies show small positive results it could be due to limitations of the study design. The limitations of these studies include “recall bias,” which is when people with a disease are more likely to remember things in their past than people without a disease. In these case-control studies, the women know they have ovarian cancer, so will try hard to remember anything that might be important to why they got this terrible disease. This can artificially make it look like women with cancer used more talcum powder, when actually it is because they were better at remembering what their feminine hygiene habits had been over the years. Large, prospective studies are considered far more reliable, partly because no woman knows she will get ovarian cancer later—so they would not have any recall bias, and overall no association between talcum powder use and ovarian cancer has been found in these studies.
Mesothelioma: Mesothelioma is a type of cancer associated primarily with exposure to asbestos. Asbestos is a naturally occurring mineral that is found in the environment, and small quantities of its fibers are omnipresent in the air.
There are no sound scientific studies indicating that inhalation of cosmetic talc causes mesothelioma. In fact, several studies of thousands of people who were exposed to talc on a daily basis—through their work mining and milling talc powder—demonstrate that exposure to high levels of talc does not increase a person’s risk of developing mesothelioma.
Moreover, large-scale reports on patients who had a medical procedure done called talc pleurodesis—where talc is actually injected into their lungs—found that none developed mesothelioma.