FDA WARNING_LETTER - Predator Nutrition - October 06, 2020

On October 23, 2020, the FDA and FTC issued a Warning Letter to Predator Nutrition (www.predatornutrition.com) regarding the sale of unapproved and misbranded products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The agencies reviewed the website on September 16, 29, and October 6, 2020, and also examined their Facebook page.

The products cited include Elixir (containing oxymatrine, berberine, ecklonia cava), Salidroside, Unbreakable (containing BPC-157), Vitamin C + Bioflavonoids & Rosehip, Vitamin D3, and Ashwagandha. The FDA determined these are unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act, violating sections 301(a) and (d).

Examples of violative claims include "Natural Ingredients Used in Treating Covid-19," "Berberine... broad antimicrobial action against viruses," "Oxymatrine – Antiviral," "Ecklonia Cava – Anti-Coronavirus," "Salidroside – Antiviral Properties," "BPC-157 was shown to reverse even severe lung damage," "Vitamin C... used in China among coronavirus patients," "Vitamin D - Helps Prevent Respiratory Infections," and "