FDA’s Emergency Use Authorization (EUA) program has allowed many new products to reach the market without a 510(k), according to Jeffery R. Nelson, chairman of Nelson Labs. While the rush of new products such as masks and respirators has helped meet urgent demands during the COVID-19 pandemic, it has also prompted some questions about product performance and authenticity. Nelson Labs, for instance, has been getting a dozen or more calls per week from municipalities and individual consumers inquiring whether a given product has been tested for performance. Nelson Lab’s customers are able to share details on product testing and verification with their own customers, but there hasn’t really been a convenient, consistent way for consumer users to identify whether a product has been tested—or if it is even authentic, said Nelson.
To fill that gap, this global provider of laboratory testing and expert advisory services is launching the Nelson Labs Mark, a verification program that authenticates test reports and provides reliable data on product performance. The mark can now appear on product packaging and marketing to indicate testing verification for masks, face coverings, respirators, gowns, and drapes. The marked products are also included in an online listing that references specific test results. “Think of it as a two-factor authentication,” Nelson said, for consumers to easily confirm product legitimacy.
“We want to drive transparency and give users an indication that products have been tested,” Nelson told MD+DI. “Unfortunately, there are some companies in that mix that haven't done testing at all or are misrepresenting their products’ capabilities and that makes it confusing for everyone. We want to give our customers who do their testing and have a bona fide product the ability to really show that on their product.
“We recognize the world needs a better way to recognize truly tested or verified products. Unfortunately, there's a lot of adulterated products out there that that are not real,” Nelson continued, adding that the mark will “help our customers differentiate their products in the marketplace.”
Paul Huish, senior director of global marketing, explained there are two levels in the program: “Nelson Labs Tested” and “Nelson Labs Verified.” Nelson Labs can also advise customers on testing and standards through its advisory services group.
The mark would be valid for two years. “We would ask that the manufacturer repeat essential testing, such as filtration efficiency, flammability, and breathability, at least once every two years to confirm performance,” Nelson told MD+DI. Huish adds that “these products are not typically required to be tested on a lot by lot basis, and so we're just asking the manufacturer to update their testing to ensure there is no change to the product.”
In addition to helping users understand a product’s performance, the program could also help users determine product authenticity. Nelson notes that both the FBI and the CDC have been warning consumers about the potential for fraudulent products on the market during the pandemic, and Nelson Labs has even seen unauthorized use of its company name on packaging. “There will be an enforcement part of this,” said Nelson, “meaning that we will require those companies who misuse our name or mark to stop, so only those who are authorized to use the mark could do so.”
When asked about future market needs beyond the pandemic, Nelson stated that “we have seen these types of occasional viral and infectious trends emerging more, and more if you go back to H1N1 or the coronavirus or any of the variants,” Nelson points out. “I do believe that PPE will continue to be a tool that is important for public safety into the future.”
The new program “empowers our customers with the use of the Nelson Labs Mark,” he said. “It improves safety and helps us get through this difficult time much faster. This is important during the pandemic, but I think it also is important even outside of a pandemic to be confident that we're buying a product best suited to the users' needs.”