Susan Blumenthal, a retired rear admiral and former U.S. assistant surgeon general, is senior medical adviser at Amfar, The Foundation for AIDS Research, a senior fellow in health policy at New America, and a visiting professor at the MIT Media Lab. Emily Stark is a research associate in health policy at New America.
Imagine trying to buy sunscreen without knowing how much the product will protect you from the sun. Thankfully, your decision is made easy. All you need to look for is one number on the package — the sun protection factor, or SPF.
Buying masks to protect you from covid-19 can — and should — be just as easy. That’s why we propose a government-backed program that would evaluate and label masks for consumers like the Food and Drug Administration does for sunscreens.
Not all masks are equal, and with so many options available online and in stores it’s easy for consumers to be confused about which to select. The Centers for Disease Control and Prevention recently attempted to provide clarity, recommending high-quality face coverings, such as N95s or KN95s, to help fight the very transmissible omicron coronavirus variant.
But labels for these masks are difficult to understand, and you shouldn’t have to be a sleuth to tell if what you’ve purchased is counterfeit. Authentic N95 masks carry a NIOSH stamp, meaning they have been certified by the National Institute for Occupational Safety and Health. They should also have an approval code (“TC-84A,” followed by four additional numbers), an expiration date for their particle-repelling electrostatic charge and headbands rather than ear loops for straps. (Fortunately, the Biden administration has begun distributing these masks free of charge via pharmacies and community health centers and will be driving up production, so finding authentic ones should be easier.)
Meanwhile, KN95 masks that are made in China are marked with the number “GB2626-2019” to show that they have passed the Chinese government’s standards for filtering 95 percent of very small particles. However, the CDC estimates that about 60 percent of KN95 respirators sold in the United States are counterfeits. KF94 consumer masks are manufactured in South Korea according to standards set by that country’s government with a product name and manufacturer on the package.
Surgical masks for use in medical settings are regulated by the Food and Drug Administration, but most of them do not have a particle filtration level on their packaging. Many surgical and cloth masks, often manufactured in other countries, are falsely marketed and sold as FDA cleared or certified. The majority of available masks are uncertified by a U.S. government agency.
These challenges in identifying high-quality protective face coverings underscore the urgent need for a federal consumer mask certification and labeling program, as we have previously written. The science is clear: The wearing of masks is essential for stopping the spread of the virus that causes covid-19. Any mask is better than no mask, but such a federal certification and labeling program would allow Americans to make informed choices about their mask’s protection level with ease and confidence.
Our proposed program would create benchmarks for each mask’s level of particle filtration, leakage amounts, comfort, fit and breathability, among other criteria. Establishing these standards would provide consumers with an easy-to-use rating system for comparing masks and the ability to choose products based on an evaluation of their performance.
Manufacturers would need to clearly display these rankings on their masks and respirators. Additionally, product packaging should include guidance about how to properly wear the mask, whether it can be reused and how to clean it. Without such a system in place, the public will remain unaware and possibly unprotected. The mask they have purchased might provide 95 percent protection against virus particles, or only 10 percent.
The U.S. government should also prioritize an initiative to design next-generation N95 masks. They should be comfortable to wear, have more than a 95 percent particle filtration rate, low leakage levels and made of advanced, lightweight materials. These masks must be designed in different sizes and styles for women, men and children.
Such efforts to develop new products have begun in the private sector and academia, and a government agency, the Biomedical Advanced Research and Development Authority, has issued a challenge for designing innovative masks. Especially important for these initiatives is to find nontoxic, biodegradable or easily recyclable products to protect the environment from the effects of mass mask disposal.
Funding such an initiative and bringing production of next generation masks to scale using the Defense Production Act or other mechanisms must be a priority. The health and economic devastation caused by covid-19 and the likelihood of airborne environmental threats such as wildfire smoke and air pollution have heightened the urgency to modernize today’s masks for new hazards on the horizon. If we act now, we can develop tools to save lives against invisible enemies of the 21st century.