FDA WARNING_LETTER - NRP Organics Ltd - March 25, 2020

On April 8, 2020, the FDA issued a Warning Letter to NRP Organics after reviewing their websites (www.nrporganics.com, www.coronaviruscures.com) and social media (www.facebook.com/nrporganics, www.instagram.com/nrporganics) on March 25, 2020. The firm was found to be selling "Fortify Humic Beverage Concentrate" and "Electrify Fulvic Beverage Concentrate" in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products were 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). Their introduction into interstate commerce violated sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The FDA emphasized the public health emergency declared for COVID-19.

Although the websites appeared to be down, the FDA required the firm to prevent recurrence of these violations. The firm must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing steps