trask and roth inc. – FDA Warning Letter, Sep 22, 2020

On October 29, 2020, the FDA issued a Warning Letter to Trask and Roth regarding their "Lateral Flow Testing Device" sold on www.traskandroth.com and promoted on www.facebook.com/trashkandroth/. The FDA reviewed these sites on September 22, 2020.

The FDA determined the "Lateral Flow Testing Device" is intended for COVID-19 mitigation, prevention, treatment, diagnosis, or cure, classifying it as a device under section 201(h) of the Act. The product is adulterated under section 501(f)(1)(B) because it lacks FDA marketing approval, clearance, or authorization (PMA or IDE). It is also misbranded under section 502(o) as the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k).

The introduction or delivery of this product into interstate commerce is prohibited under section 301(a), and any act resulting in its misbranding while held for sale after interstate shipment is prohibited under section 301(k).

The FDA requires immediate corrective action. Within 48 hours, the firm must email COVID-19-Task-Force-CDRH@fda.hhs.gov detailing steps taken to correct violations, prevent recurrence, and provide supporting documentation. Failure to comply