FDA WARNING_LETTER - Sparrow Health & Performance LLC - December 21, 2020

On December 21, 2020, the FDA and FTC issued a Warning Letter to Sparrow Clinic regarding the sale of unapproved and misbranded products related to COVID-19. The agencies reviewed Sparrow Clinic's websites (sparrowclinic.com, Facebook, Instagram) since September 17, 2020, and found products including Organic Liposomal Vitamin C, Nanoemulsified D3K2, and Immune Support Package (with optional Smart Silver) were offered for sale with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). Examples of violative claims include "proactive coronavirus prevention plan," "combat an existing viral infection," and linking products to hospital treatments for COVID-19. Metatags like "Human Coronavirus: Immune Support Kit" also contribute to the intended use.

Sparrow Clinic must immediately cease selling these unapproved products and take corrective action.