Although face masks and respirators have become commonplace during COVID-19, consumers still struggle to find products that are legitimate and offer adequate protection for themselves and their families. With a proliferation of both credible and not-so-credible manufacturers and retailers, as well as varying regulatory requirements comparing masks available online and in stores is a confusing and difficult process. As the CDC underscores the importance of better-quality masks and respirators to mitigate the spread of the highly transmissible omicron variant, the increase in fraudulence and lack of clear guidelines for these now mass-marketed products proves troubling.

How did we get here?
Before the pandemic, medical face masks and surgical respirators were used primarily in the healthcare industry, with public usage uncommon in most regions. These medical-grade products undergo strict testing and review through regulatory bodies, like FDA and NIOSH. At the beginning of COVID-19, however, supplies of these medical devices were limited. Governmental bodies and public health experts advised the general public to wear cloth or other readily available masks, which are not regulated, and to save N95s for healthcare professionals.

During this time, recommendations from the Center for Disease Control and Prevention (CDC) and other public health experts simply emphasized the importance of wearing masks consistently and correctly. Faced with numerous barriers to mask usage, such as hesitation from new users, these guidelines placed little stress on the varying levels of safety and efficacy offered by these products. As countries across the globe issued national health emergencies and many municipalities released mask mandates, people around the world began to wear face masks for the first time in their daily lives.

Manufacturers were initially unable to keep up with this surge in demand. To quickly address this limited supply of masks and respirators, FDA issued an Emergency Use Authorization (EUA) to get these products to market faster. The EUA outlined reduced testing requirements for personal protective equipment (PPE) that decreased the amount of time needed to release these products into the marketplace.

Efforts by new and emerging manufacturers, testing facilities, and regulatory bodies provided manufacturers with enough time to make these products widely available and provided critical protection for both healthcare professionals and the public. The wearing of face masks, in combination with social distancing, enhanced hygiene practices, and the proliferation of free testing sites, resulted in reduced positive cases and hospitalizations.

Over the last two years, however, a lot has changed. Vaccines have greatly enhanced the success of prevention efforts and the supply of N95s has stabilized. Masks offering greater efficacy against COVID- 19 are now widely available. FDA has also revoked the EUA, requiring medical face masks and surgical respirators to undergo the full series of testing prior to market release for medical use.

Overall, these changes have been directed towards providing the greatest amount of protection for the largest number of people. However, consumers are now faced with countless mask and respirator brands to choose from. With limited tools to assess efficacy and safety, consumers often rely on online reviews from fellow consumers to inform their purchasing decisions.

These reviews, generally, are not from scientific sources and take many factors into consideration. Some popular products prioritize comfort and style without providing data on product performance. Worse, a few bad actors have taken advantage of existing fear and uncertainty to generate profit.

To combat misleading and ineffective products, governmental bodies, public health experts, manufacturers, and retailers have issued warnings for consumers. FBI cautions consumers to watch out for fraudulent COVID-19 related medical equipment and the CDC has published guidance on how to spot counterfeit products. 3M has issued guidance particular to misrepresentation of their products, and companies like Amazon have implemented product serialization services to allow customers to confirm a genuine product. However, none of these measures address the authenticity of product testing.

With many brands listing test results on their sites to bolster customer confidence, some containing doctored or fabricated reports, how can consumers know if tests results are legitimate and how can credible manufacturers differentiate their products from others on the market? Even hospitals, municipalities, and commercial buyers are not immune to this kind of deception. Nelson Labs receives regular requests for testing and report authentication but can’t accommodate the increased demand for requests.

In response to this confusion, Nelson Labs has launched the Nelson Labs Mark, a verification program for product testing that authenticates test reports and provides objective, verifiable performance data from its global laboratories. The offering will begin with verification for mask and respirator testing but will expand to other products as the market requires.

To further increase consumer confidence, the program utilizes two-factor authentication for consumers to easily confirm the legitimacy of a product’s testing. The company will allow products that have undergone testing with Nelson Labs to use a registered Nelson Labs Tested or Nelson Labs VerifiedTM mark and place a unique serial number on their product packaging and marketing, along with a corresponding web listing that includes detailed test reports outlining the performance of the product.

Today, face masks have become a household staple, as well as a requirement for many businesses, employers, and municipalities worldwide. Despite the pervasiveness of these products, widespread confusion still exists over the differences in mask brands, the amount of protection offered, and whether a product has truly been tested. The Nelson Labs Mark hopes to address this critical need for transparency and provide consumers with a scientific resource to help inform their purchasing decisions.