FDA WARNING_LETTER - BMHshop - March 29, 2021

The FDA issued a Warning Letter to bmhshop.com on April 26, 2021, following a March 29, 2021, website review. The firm was found to be selling "KN95 Dust Masks," "Medical/Surgical masks," and "Kids Mask Disposable Protective Mask Safety Masks Children Prevent Disease Mask" with claims related to the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. These products are classified as devices under 21 U.S.C. § 321(h).

The products are deemed adulterated under 21 U.S.C. § 351(f)(1)(B) because the firm lacks required premarket approval (PMA) or investigational device exemption (IDE) (21 U.S.C. § 360e(a), 21 U.S.C. § 360j(g)). They are also misbranded under 21 U.S.C. § 352(o) for failing to submit a 510(k) premarket notification (21 U.S.C. § 360(k)), and under 21 U.S.C. § 352(a) due to false or misleading labeling. Specifically, the website displayed "HealReg Service," "Shenzhen," and "Huizhou" Certificates bearing the FDA logo, implying official FDA approval or endorsement for the products and their manufacturers, which is misleading and violates 21 CFR 807.39, despite small-print disclaimers.

The FDA requires immediate cessation of sales for these adulterated and misbranded products. The firm must respond in writing within 15 business days, detailing corrective actions, preventive measures, and a timetable. Failure to comply may result in product detention or refusal of admission into the U.S. and notification to foreign regulatory officials.