# FDA WARNING_LETTER - Fresh International, LLC - June 04, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/fresh-international-llc/ec20287d-8d15-46bb-adf8-365d4d34f10d

> FDA WARNING_LETTER for Fresh International, LLC on June 04, 2020. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Fresh International, LLC
- Inspection Date: 2020-06-04
- Product Type: Food
- Office Name: Center for Food Safety and Applied Nutrition
- Summary: On June 15, 2020, the FDA and FTC issued a Warning Letter to the company operating websites www.frs.com, www.healthyenergy.com, and www.frs-international.com, and social media at www.facebook.com/FRSEnergyEndurance. The agencies reviewed these sites on April 1 and June 4, 2020.

The FDA observed the sale of quercetin-containing soft chew and liquid concentrate products, branded as Q-Force and FRS Healthy Energy, with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The letter cites the public health emergency declared for COVID-19 and FDA's urgent measures to protect consumers from unapproved products making COVID-19 claims. The company is required to immediately cease selling these unapproved and unauthorized products for COVID-19 related

## Related Documents

- [WARNING_LETTER - 2022-02-02](https://www.globalkeysolutions.net/records/warning_letter/fresh-international-llc/99491711-f911-4aef-90d0-3515be220102)

## Related Officers

- [Richard A. Quaresima](https://www.globalkeysolutions.net/people/richard-a-quaresima/d0be06fa-21e5-46d0-879d-95af9663066c)
- [Director](https://www.globalkeysolutions.net/people/william-a-correll/f9e634a2-8e56-4c9b-984c-304f0c7db122)

Company: https://www.globalkeysolutions.net/companies/fresh-international-llc/ff43f28b-6486-4af5-b235-1754783f0f9c

Office: https://www.globalkeysolutions.net/offices/center-for-food-safety-and-applied-nutrition/e04dc4e5-ee4f-4b0d-be8c-1139531ddab2