FDA WARNING_LETTER - LVWellness & Aesthetics - October 15, 2020

On October 15, 2020, the FDA issued a Warning Letter to LVWell, LLC, following a review of their websites (www.lvwell.com and www.facebook.com/lvwellnessaesthetics/) since August 5, 2020. The FDA observed the sale of products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19, which are unapproved, adulterated, and misbranded.

Specifically, the "COVID-19 ANTIBODY TEST KIT" is cited as an adulterated device under section 501(f)(1)(B) of the FD&C Act (21 U.S.C. § 351(f)(1)(B)) due to the lack of an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) (21 U.S.C. § 352(o)) for failure to notify the agency of intent to introduce the device into commercial distribution. The FDA emphasizes that no COVID-19 serology test for at-home use has been approved, cleared, or authorized.

Additionally, the "ViraFend Multi-Virus Defense" product is identified as an unapproved new drug sold in violation of section 505(a) (21 U.S.C. § 3