maskshell.com – FDA Warning Letter, Jul 6, 2021

On March 11, 2021, the FDA issued a Warning Letter to Maskshell.com for offering adulterated and misbranded products related to COVID-19. The FDA reviewed Maskshell.com and found the "KN95 Dust Masks," "Medical grade surgical mask," and "Kids Mask Disposable Protective Mask Safety Masks Children Prevent Disease Mask" for sale. These products are considered devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the “Act”) due to their intended use in mitigating, preventing, treating, diagnosing, or curing COVID-19.

The products are adulterated under section 501(f)(1)(B) of the Act because Maskshell.com lacks the required marketing approval, clearance, or authorization from the FDA (PMA or IDE). They are also misbranded under section 502(o) of the Act for failing to notify the agency of intent to introduce the devices into commercial distribution (510(k) premarket notification). Furthermore, the products are misbranded under section 502(a) of the Act because their labeling is false or misleading. Maskshell.com displayed screenshots from FDA's Establishment Registration & Device Listing Database and product certifications bearing the FDA logo, implying FDA approval, clearance, or endorsement, which is prohibited by 21 CFR 807.39. Despite disclaimers on some certifications