iThrive.health – FDA Warning Letter, Dec 3, 2020
On December 10, 2020, the FDA and FTC issued a Warning Letter to iThrive.Health (Alirio Zavarce) regarding unapproved and misbranded products related to COVID-19. The agencies reviewed iThrive.Health's website (https://ithrive.health/) and social media (https://www.facebook.com/iTHRIVE.health/) on December 2-3, 2020.
iThrive.Health, as an Amazon Associate, promoted vitamins, quercetin, zinc, and omega-3 products with claims implying they could mitigate, prevent, treat, diagnose, or cure COVID-19. These claims cause the products to be unapproved new drugs under FD&C Act section 505(a) and misbranded drugs under section 502. The introduction or delivery of these products into interstate commerce is prohibited under sections 301(a) and (d), and misbranding while held for sale after interstate shipment is prohibited under 301(k).
Examples of violative claims include blog titles like "How To Boost Your Immune System Naturally Against COVID-19?" and specific claims about Vitamin A, Vitamin C, Vitamin D, Quercetin + Zinc, and Omega-3's ability to fight COVID-19, inhibit viral replication, or reduce inflammation related to the disease.
iThrive.Health must immediately cease promoting
ID · 0cb494f5-b0d6-4b6e-ba80-5555b7dcf5f5
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