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Two lawsuits against Johnson & Johnson concluded this year with the health care behemoth on the hook for nearly $200 million in damages for allegedly knowing their talcum powder can cause ovarian cancer – but not mentioning this on its label or anywhere else. How did this cosmetic end up doing so much harm?
As women have been coming forward with stories about their suffering, and often filing lawsuits accordingly, people are wondering how something with a powerful carcinogen can be distributed under the guise of a product that has been long-trusted by millions of people.
Talcum Powder Isn’t Regulated Like a Drug
It turns out there isn't a watchdog agency that is responsible for regulating cosmetics like talcum powder. Typically, the U.S. Food and Drug Administration would step in when it comes to regulating things like food, medicines, and medical devices. However, for cosmetics the FDA does not have jurisdiction to regulate what goes into the cosmetics like talc that people use frequently.
Although cosmetics do not require FDA approval before they go to market, this does not mean they are all unsafe. Cosmetics are required by the FDA “to be safe when consumers use them according to directions in the labeling, or in the customary or expected way.” A cosmetic manufacturer can fulfill this by doing its own product testing, according to the FDA.
Although a cosmetic manufacturer’s testing is not always as stringent as the FDA’s standards, all the ingredients must have been found safe by another manufacturer or independent researcher. If an ingredient has not been tested by a third party, the manufacturer must test the ingredient itself to ensure its safe for use.
It may seem like there is too much trust placed in cosmetic manufacturers to test their own products, but the FDA does do some independent testing to keep the industry in check. Aside from regulating cosmetics with color additives used for coloring foods, drugs, cosmetics or the human body, the FDA also periodically tests cosmetic products to make sure they don’t contain dangerous ingredients. The FDA readily admits they don’t have the resources to test all cosmetic products – it says so right on its website – but they will go out and buy a product to test it for toxic ingredients if there are safety concerns.
If after testing a product the FDA finds that it is contaminated or one of the ingredients has the potential to be harmful there is action in can take. Depending on what it finds, the FDA can issue a consumer alert, support regulatory actions, or issue guidance for the industry.
Talc Powder Deemed Unsafe for Some
Millions of people used talc powder before growing concern about its safety led the FDA to conduct research into it beginning in 2007. However, the FDA only sought to gauge the asbestos levels in the powder, a substance that would explain why talc powder is carcinogenic. The FDA did not find any asbestos, though, and talc powder remained on the market, deemed presumably safe.
The three lawsuits that ended with Johnson & Johnson on the hook for $197 million were not brought because of asbestos, though. Women around the country reported getting ovarian cancer after repeated use of talc powder, despite there being no asbestos in it. The FDA did everything within its legal bounds, but the cosmetic product was still able to harm those who used it.
The regulatory realities and the lawsuits underscore the need for companies to be held accountable for making products that help, not harm, people.
If you would like to read more about how Johnson & Johnson’s talc powder is potentially carcinogenic, please visit our talc powder information page.