FDA WARNING_LETTER - Nature’s Distributing; Club Clean Inc/BuyMedicalMasksNow.com - April 22, 2021

On May 28, 2021, the FDA issued a Warning Letter to the operator of buymedicalmasksnow.com following an April 22, 2021, website review. The FDA found that the "KN95 Mask FFP Level 2" and "3-ply Certified Masks FFP Level 2" were offered for sale with claims indicating their use for COVID-19 mitigation, prevention, treatment, diagnosis, or cure, classifying them as devices under 21 U.S.C. § 321(h).

These products were deemed adulterated under 21 U.S.C. § 351(f)(1)(B) because the firm lacked required premarket approval (PMA) or investigational device exemption (IDE). They were also misbranded under 21 U.S.C. § 352(o) for failure to submit a 510(k) premarket notification, and under 21 U.S.C. § 352(a) due to false or misleading labeling. Specific misrepresentations included stating the masks were "FDA Certified," unauthorized use of the FDA logo on the website and product packaging, and claims of high filtration rates for medical use to "Prevent the Spread of Coronavirus."

The FDA emphasized that these products had not been cleared, approved, or authorized. The unauthorized use of the