# FDA WARNING_LETTER - Griffo Botanicals - October 01, 2020

Source: https://www.keypedia.com/records/warning_letter/griffo-botanicals/eae10c6e-11f0-415f-948b-23f1b58845b3

> FDA WARNING_LETTER for Griffo Botanicals on October 01, 2020. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Griffo Botanicals
- Inspection Date: 2020-10-01
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On October 7, 2020, the FDA and FTC issued a Warning Letter to Griffo Botanicals regarding unapproved and misbranded herbal tincture products marketed for COVID-19. The agencies reviewed the company's websites (griffobotanicals.com, facebook.com/griffobotanicals, instagram.com/griffobotanicals) on September 15 and October 1, 2020.

The FDA determined that the products are unapproved new drugs under Section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) because they are intended to mitigate, prevent, treat, diagnose, or cure COVID-19. They are also 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 FTC found that claims of preventing, treating, or curing COVID-19 lack competent and reliable scientific evidence, violating the FTC Act (15 U.S.C. 41 et seq.).

Griffo Botanicals must immediately cease selling these unapproved products and remove all COVID-19-related claims. Within 48 hours,

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/griffo-botanicals/a527d2bf-cc93-49d7-927a-fef0e442ae5c

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