# FDA WARNING_LETTER - Indigo Naturals - April 02, 2020

Source: https://www.keypedia.com/records/warning_letter/indigo-naturals/299a75b4-1e4d-4070-8fcd-e608bb8a2235

> FDA WARNING_LETTER for Indigo Naturals on April 02, 2020. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Indigo Naturals
- Inspection Date: 2020-04-02
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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,

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Richard A. Quaresima](https://www.keypedia.com/people/richard-a-quaresima/d0be06fa-21e5-46d0-879d-95af9663066c)

Company: https://www.keypedia.com/companies/indigo-naturals/c8efd57b-54cb-412b-ac23-e570b1ec9e44

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c