# FDA WARNING_LETTER - iThrive.health - December 03, 2020

Source: https://www.keypedia.com/records/warning_letter/ithrivehealth/0cb494f5-b0d6-4b6e-ba80-5555b7dcf5f5

> FDA WARNING_LETTER for iThrive.health on December 03, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: iThrive.health
- Inspection Date: 2020-12-03
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/ithrivehealth/ab90bd70-40b0-461b-b6bb-c549a88e6e31

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c