The FDA hasn’t authorized any graphene-coated masks and “is unaware of any face masks with graphene being legally marketed or distributed in the U.S. at this time,” she wrote.

In the U.S., any devices that include drugs, biologics [biological materials] or additives such as graphene…require FDA’s specific review and marketing authorization,” she said.

That also applies to any devices that have “antimicrobial or antiviral purposes.”