Indigo Naturals – FDA Warning Letter, Apr 2, 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,
ID · 299a75b4-1e4d-4070-8fcd-e608bb8a2235
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