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

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