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December 1, 2021

Why are there still so many counterfeit N95 masks in the U.S.?

Daily Briefing

    Amid rising Covid-19 cases worldwide, the demand for N95 masks has once again skyrocketed, Andrew Jacobs writes for the New York Times—but many who try to purchase these masks online or from big box retailers have unknowingly been sold counterfeit or defective alternatives that have not been approved by U.S. regulators.

    How prevalent are counterfeit masks in the U.S.?

    In the early days of the pandemic, medical facilities and states searched desperately for medical supplies amid a shortage of personal protective equipment (PPE). During that time, some organizations spent millions on counterfeit N95 masks—and nearly two years later, the United States is still full of fake N95 masks.

    According to Jacobs, even now, when consumers attempt to buy N95 masks, they often end up purchasing fake, poorly made KN95 masks—especially if they are shopping on Amazon. The KN95 mask is a Chinese-made mask often advertised as an N95 equivalent, even though they are not tested by U.S. regulators to confirm virus-filtering claims, Jacobs reports.

    The masks being sold through Amazon and other retailers are not authorized by FDA for use in health care settings. In fact, FDA last July rescinded its emergency use authorization for all imported masks not approved by CDC—including all Chinese-made KN95s. And while Chinese mask producers have been particularly brazen, according to Jacobs, U.S. regulators, watchdog groups, and industry executives have also accused several American companies of misrepresenting the level of protection in their face coverings.

    "It's really the Wild West out there with so many bad actors ripping people off," said Anne Miller, executive director of Project N95, a nonprofit working to help people access legitimate PPE.

    Overall, according to an analysis of sales data published by Jungle Scout, only a few of the 50 best-selling KN95 masks on Amazon are legitimate—and the companies selling masks of questionable quality made nearly $34 million in sales last month alone.

    For its part, Amazon on Monday said all high-filtration masks sold on its site were required to undergo a rigorous review process. "Before listing N95 and KN95 masks in our store, we verify that they are sourced from a trusted manufacturer by reviewing product packing, product description and invoices to trace the inventory, and we verify that the mask is not listed on the C.D.C.'s counterfeit mask list," said Amazon spokesperson Peter Kadushin.

    The problem with counterfeit masks

    According to U.S. regulators, watchdog groups, and industry experts, the increase in fake and poorly made masks poses a threat to public health because they offer a false sense of security, Jacobs writes, which increases the odds of exposure.

    And this is particularly true amid increasing case numbers and the rise of the omicron variant, Jacobs reports: Experts continue to emphasize the importance of masks—especially among unvaccinated individuals and the millions of Americans with weakened immune systems.

    "There are a lot of things about Covid-19 we can't control, like poor ventilation in buildings or whether other people are vaccinated, but aside from ensuring you and your family get vaccinated, wearing a high-quality mask is the single most important thing people can do to protect themselves and their kids," said Aaron Collins, a mechanical engineer who has tested hundreds of masks he purchased online.

    Accordingly, the situation has spurred many stakeholders to call for change and better regulation, Jacobs reports. For instance, Sen. Elizabeth Warren (D-Mass.) has for months urged Amazon to ban vendors who sell counterfeit masks and to modify its algorithms to lead consumers to the best respirators.

    "Amazon needs to do more to prevent consumers from receiving counterfeits and fakes, and the Department of Justice and Federal Trade Commission must act if these failures continue," she said in a statement.

    Separately, Judith McMeekin, FDA's associate commissioner for regulatory affairs, said, "Consumers should be aware of the proliferation of fraudulent and counterfeit masks and respirators sold online." (Jacobs, New York Times, 11/30)

    Learn more: How Covid-19 will impact the supply chain

    supply chain

    Covid-19 has revealed critical shortcomings in the health care supply chain. Shortages of personal protective equipment (PPE), ventilators, and other vital supplies have hindered the U.S. health care system‘s response to this crisis, and additional waves of shortages are likely in coming months.

    Read our take to learn three requirements for a more resilient, transparent supply chain in light of Covid-19.

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