Medical Device Regulations May Expand to Include Talc-Containing Feminine Hygiene Powders
U.S. health officials are thinking about whether talc-based hygiene powders should be more tightly controlled under the laws for medical devices
Tuesday, September 2, 2025 - Federal authorities are looking at a new plan that might change the classification of feminine hygiene powders that contain talc to medical devices. This would greatly increase the amount of control over these common personal care items. Talc-based powders have been sold for daily usage around the vaginal area for a long time, but they are now considered cosmetics. Lawsuits and scientific studies that have raised concerns about the cancer risk of talcum powder, especially for ovarian cancer. Women have been using these powders for decades without being told about the possible risks. Critics believe that the lack of a cancer warning on talcum powder has left many people in the dark about how breathing it in or putting it on their genitals could lead to health problems in the long term. If these goods were put in the medical device category, makers would have to show that they are both safe and effective before selling them. They would also have to report any negative health effects more strictly. This would be a big change in how regulators look at feminine hygiene products, which have mostly been free from the same level of scrutiny as medical tools or drugs.
The U.S. Food and Drug Administration (FDA) says that medical devices are things like surgical tools, diagnostic equipment, and some health-related drugs that are meant to diagnose, cure, treat, or prevent disease. The FDA has said that it is looking at whether talc-based hygiene powders should be included in this group because they are used a lot in sensitive areas of the body and there are rising health concerns about using them for a long time. If the amendment is granted, firms would have to apply for premarket approval, test their products, and use clearer ingredient labels. This decision was largely based on research that showed talc particles can pass through the reproductive canal and may become stuck in ovarian tissue, causing irritation and, in some cases, cancer. The government has also heard from scientific advisory committees and consumer groups that want tighter rules to protect consumers. Lawyers warn that the change could affect litigation that is still going on and those that will happen in the future by making it clear that these goods should never have been seen as just cosmetics in the first place.
If talc-based feminine hygiene powders are classed as medical devices, it could affect the rules for all personal care goods in a big way. Companies might have to change the way they make their products, include more specific warnings, or stop making some lines altogether. The change would probably make things clearer and safer for customers, which would help women make better choices about what they put on their bodies. The reclassification might also lead to changes in rules in other nations, since they generally follow the FDA's lead. In court, it may help plaintiffs who say they were deceived about the hazards, especially if the product's design and intended usage now fit the standards for a medical device.
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