FDA Considers Black Box Warning on Remaining Talc-Based Products
U.S. officials are thinking about putting the strongest possible warning label on personal care products that still include talc
Tuesday, September 2, 2025 - The FDA is currently looking into whether or not talc-based items that are still on store shelves should have a black box warning, which would be the highest level of warning about possible health hazards. In the past few years, a lot of companies have changed the formulas of their talcum powder products or stopped selling them altogether. However, there are still certain cosmetic-grade talc powders that are allowed to be sold in the US. If the FDA goes through with it, the new warning would be the strongest ever on a cosmetic product. It would tell people that using talc near the genitals may raise the risk of ovarian cancer. The decision comes as more and more scientific data and lawsuits from thousands of women who believe they got cancer after using talcum powder for years pile up. Lawyers for talcum powder cancer victims say that tougher labels are long overdue and that any product that is related to such serious claims should come with obvious, unavoidable warnings. For people who are suing over talcum powder cancer, a black box label could make their claims stronger by showing that the risk was known but not properly disclosed.
The FDA says that black box warnings are usually only used for prescription pharmaceuticals that have serious or life-threatening dangers. However, the agency can require comparable labeling on cosmetics when public health is at risk. The FDA doesn't officially ban talc in cosmetics, but it has said that there are rising worries about asbestos contamination and the consequences of long-term exposure. Recent scientific evaluations have suggested that using talc on a frequent basis in the genital area may be linked to ovarian cancer. The FDA is looking into this because of growing public outcry and suggestions from independent advisory bodies. Legal experts think that if the FDA publishes a black box warning, it might lead to more lawsuits against makers who haven't yet pulled their goods off the market. It could even cause stores to discontinue carrying certain items altogether. For consumers, the possible modification in the label means that regulators are going to be more proactive after decades of disagreement about the safety of talc.
A black box warning might completely change the way cosmetics safety standards are set. If it happens, it will probably be used as an example of how authorities can deal with health risks outside of the pharmaceutical industry. The talc industry would lose a lot of public trust, which could speed up the end of talc use completely. For customers, especially those who don't know about the risks, the label would be a clear visual warning that using the product more could have serious effects. This could possibly lead to similar proceedings being taken against other contentious substances in personal care goods. Over time, black box warnings may be more widespread on things that aren't drugs but are thought to be cancer-causing or poisonous.
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