Fresh International, LLC – FDA Warning Letter, Jun 4, 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
ID · ec20287d-8d15-46bb-adf8-365d4d34f10d
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.