![]() “Manufacturers are responsible for preventing unacceptable impurities and contaminants in their products.” Impurity Testing “The FDA’s highest priority is protecting public health and keeping unsafe products out of the US market,” she said. While the FDA views its oversight of drugs, including products like sunscreen and antiperspirant, as robust, Harrison said Congress hasn’t updated the agency’s ability to oversee cosmetics, such as dry shampoo, “despite rapid expansion and innovation in the industry.” The agency has also released guidance to help drugmakers navigate new contamination issues in the last few years. Once a problem with a product arises, the FDA “works swiftly to protect the public from potential harm,” she said. The FDA sets minimum testing standards drug companies must follow and relies on those manufacturers to ensure their products are safe, Audra Harrison, a spokeswoman for the agency said. By the time Valisure started its research on the medication, there had also been some recalls for contaminated blood pressure pills for the same chemical contamination that had already been suspected in Zantac, adding to the urgency. Concerns over the drug had been raised for more than a decade in academic literature. But it wasn’t a stroke of genius that first led Valisure to test the drug for carcinogens. The drug had been on the market for about 35 years and been taken by millions worldwide - adults with ulcers and heartburn, teenagers with indigestion and even babies suffering from reflux. On every step of that journey, the Food and Drug Administration, the agency responsible for safeguarding consumers from these problems, has lagged behind the small lab. ![]() “When such big numbers of people are exposed, years of exposure with a well-defined carcinogen, there is no doubt there’s unacceptable risk.” “I feel that we’ve already saved many lives,” Light said. In the course of just three years, Valisure’s quest to hunt down cancer-causing chemicals in everyday products has impacted pharmaceuticals and consumer goods in markets worth an estimated $9 billion that touch the lives of tens of millions of Americans. and Beiersdorf AG have all issued recalls or halted sales following Valisure’s findings. Procter & Gamble Co., Johnson & Johnson, Unilever Plc, CVS Health Corp. The lab has also warned of contaminants in a popular diabetes treatment. ![]() Then Valisure alerted consumers to dangerous chemicals in spray antiperspirants, and, more recently, dry shampoos. Next came the lab’s evidence of leukemia-causing benzene in sunscreens. Valisure truly shot into the public eye last year when it was the first to warn that some widely used hand sanitizers had high levels of carcinogens. Some two dozen companies were selling versions of the drug at the time. The findings, published in 2019, helped lead to massive recalls and eventual market withdrawal. Light is the co-founder and chief executive officer of Valisure, the independent testing lab that first released research showing that Zantac and its generic forms were contaminatedwith a toxic chemical known to cause cancer. Listen and subscribe to The Big Take on iHeart, Apple and the Terminal. Omny Studio: The Tiny Lab Finding Poison In Your P. In the process, he’s also become a stand-in, protecting the American public from cancer-causing chemicals in place of a federal regulator that’s failed to do the job. But Light didn’t create Zantac - he nearly destroyed it. One floor above his office is the lab where groundbreaking Zantac research took place. A globe, then a t-shirt, next a hat - all stamped with the drug’s branding. ![]() He quickly moves on to a Zantac wine glass from 1983, when the heartburn drug was approved for sale in the US, and then a white and blue Zantac Swiss army knife. It’s emblazoned with the trademark lettering of Zantac, the blockbuster heartburn drug. The curly haired scientist lights up with boyish enthusiasm when he picks up a black coffee mug from the endless array of memorabilia in his office. David Light can’t wait to show off his tchotchkes. ![]()
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