FDA WARNING_LETTER - Indigo Naturals - April 02, 2020

On April 6, 2020, the FDA and FTC issued a Warning Letter to Indigo Naturals regarding unapproved and misbranded CBD products marketed for COVID-19. The agencies reviewed the company's websites, indigonaturals.net and www.facebook.com/IndigoNaturals/, on March 30 and April 2, 2020.

The FDA found that Indigo Naturals' CBD products were offered for sale 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) (21 U.S.C. § 331(a) and (d)).

The letter emphasizes the public health emergency declared for COVID-19 and the FDA's urgent measures to protect consumers from unauthorized products. Indigo Naturals was instructed to immediately cease selling these unapproved products for COVID-19 related uses. The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours,