The US Department of Defense has formed a partnership with a small lab, Valisure, to address the issue of dangerous chemicals in America’s drug supply. This comes as the reliance on Chinese and Indian manufacturers for common medications has increased, resulting in the presence of cancer-causing substances in certain drugs. The Food and Drug Administration (FDA) has been criticized for its slow response to this issue. Under the multi-year agreement, Valisure will independently test numerous drugs for harmful substances and provide a risk assessment. The lab has already been at the forefront of identifying carcinogens in products like hand sanitizers, dry shampoos, sunscreens, and medications. By testing and rating samples of drugs, Valisure will also help the DoD identify manufacturers that produce potentially harmful products. This partnership aims to complement the FDA’s regulatory efforts and provide transparency regarding drug quality. It is worth noting that Valisure has previously discovered toxic chemicals and carcinogens in products made by major manufacturers, leading to recalls. The lab has cited the difficulty of regulating drugs and their ingredients due to the shift in production to countries like India and China. Concerns have been raised about the FDA’s inspection of drug manufacturing in these countries. Valisure has found cancer-causing substances like nitrosamine, benzene, and N-Nitrosodimethylamine (NDMA) in certain batches of medications and products. These substances have been associated with various cancers and harm to reproductive organs. Brand names like Zantac, Neutrogena, Pfizer’s Accuretic and Chantix, as well as various dry shampoos, sunscreens, and hand sanitizers, have been affected. Valisure’s findings have led to voluntary recalls and reformulations by companies. While the partnership with Valisure is a step forward, it only addresses medications, leaving consumers at risk when it comes to cosmetics and personal hygiene products. The FDA lacks legal authority to regulate or approve these products before they reach the market. The agency has standards for drug and product safety and effectiveness but faced challenges during the Covid-19 pandemic, resulting in delays and shortages. The FDA inspects domestic manufacturing facilities and conducts inspections in response to complaints or suspicions of non-compliance. However, drugs and products from outside the US are not subject to the same level of scrutiny. The FDA reviews imported drugs to determine their admissibility and blocks entry to those that are adulterated, low quality, misbranded, lack necessary information, do not comply with label rules, or have not been proven safe and effective. For cosmetics and some personal hygiene products, the FDA does not have legal authority to approve them before they go to market. While there are laws governing these products, including regulations against misbranded products, the FDA does not have a set of required tests to demonstrate safety. The FDA emphasizes that protecting Americans is its top priority and that approved products are of high quality. The agency is working on developing a safe and secure drug supply chain. It also advises healthcare systems to use validated methods and labs for additional testing to ensure accurate results.
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