11/28/2023 0 Comments Benzene in sunscreen recall![]() The company has since sold its pharmacy operation to concentrate only on quality and safety testing. But they took things one step further and began testing each product to confirm everything they sold contained what they claimed, and didn’t have potentially harmful ingredients. By 2018, the pair had started a pharmacy that they attached to the lab and bought products wholesale like any pharmacy would, Light says. Valisure was founded as an independent laboratory by Light and his friend, Adam Clark-Joseph, PhD, in 2015. Says Andrews: “From these documents, it sure looks like the FDA dedicated a significant amount of time and effort inspecting Valisure, when their time and effort could have been better served investigating the source of benzene in consumer products.” Nevertheless, it wasn’t until late December-about half a year after the FDA’s inspection of Valisure ended and after CR highlighted how the agency had misled consumers on the dangers of benzene-that the FDA decided to advise companies on what to do if they find the carcinogen. During the COVID-19 pandemic, the FDA had limited in-person inspections only to facilities that were deemed high priority and “mission-critical.” The timing of the inspection alone seems odd, says Dave Andrews, senior scientist at the Environmental Working Group, an advocacy organization. That is why I am confused by this investigation and FDA’s stunning misunderstanding of what Valisure does and does not do.” “Instead of this ongoing hostility, FDA should embrace their efforts in the pursuit of safeguarding the public’s health. ![]() “Over the last several years, Valisure’s work has raised the alarm on both the quality and safety of drugs and personal care products for millions of consumers and their families,” she says. “I fear, whether deliberate or not, FDA is in the act of shooting the messenger,” DeLauro says in a statement to CR. Rosa DeLauro, D-Conn., whose district includes where Valisure is based, has tried to get answers from the FDA in the meantime, but to no avail. The agency has not discussed the matter directly with Valisure since the inspection ended several months ago. “As a general policy, the FDA cannot discuss any potential or ongoing investigations,” an agency spokesperson says. The FDA declined to respond to a detailed list of questions from CR on the matter. (Attorneys for the companies didn’t respond to requests for comment.) That includes cases filed over benzene contamination in sunscreen and the problems identified in Zantac. Manufacturers of some of the affected products have seized on the FDA’s report, using it to try to undermine lawsuits brought by consumers who purchased brands implicated in Valisure’s testing. The stakes are also significant for consumers’ public health and safety. But as the FDA continues to pursue its investigation, more regulatory enforcement action might be taken, potentially undermining Valisure’s ability to independently police the market. Indeed, documents obtained by CR through the Freedom of Information Act, which include summary reports of the inspection, don’t support the agency’s contention. “We don’t do regulatory work for anyone.” ![]() “I think we’re very clear in all of our disclosures and contracts that we do independent quality assurance,” says David Light, founder and CEO of Valisure. Valisure says that the agency has it wrong. The agency initiated the inspection because it believes Valisure conducts tests for companies seeking FDA approval to distribute products for sale, and has accused the company of violating applicable regulations. The dispute is essentially a bureaucratic one. Shortly after Valisure reported that it had found benzene in hand sanitizer, the FDA spent several weeks combing through the lab’s facilities and ultimately accused it of operating without proper regulatory approvals, according to previously unreported FDA documents obtained by CR. But the company itself has become the subject of an investigation by the agency that has stretched on for several months, Consumer Reports has found. Independent testing like Valisure’s is a critical part of the drug and product safety system because it can catch problems that the FDA, with its limited budget, might miss.
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