FDA WARNING_LETTER - pomegranate consulting, llc, pomegranate consulting, ltd. - August 17, 2020

On August 18, 2020, the FDA issued a Warning Letter to DxAllergy Solutions, LLC, regarding the sale of an unapproved "COVID-19 test package" on www.elizabethyarnell.com. The FDA reviewed the website on August 17, 2020, and found the product offered for direct sale to consumers for at-home use, intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure.

The product is deemed a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). It is adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. § 351(f)(1)(B)) because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act (21 U.S.C. § 352(o)) as the firm failed to notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act (21 U.S.C. § 360(k)). The introduction or delivery of this product into interstate commerce is prohibited under section 301(a) and