# FDA WARNING_LETTER - agroterra, ltd.  - May 05, 2020

Source: https://www.keypedia.com/records/warning_letter/agroterra-ltd/35ff0ed2-fe10-4bc0-8629-29e5a3f40310

> FDA WARNING_LETTER for agroterra, ltd.  on May 05, 2020. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: agroterra, ltd. 
- Inspection Date: 2020-05-05
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On May 7, 2020, the FDA and FTC issued a Warning Letter to 209 McConnell Ct. Lyons, CO 80540, regarding unapproved and misbranded products related to COVID-19. The FDA reviewed www.patriotcbd.org on May 1, 2020, and observed the sale of CBD products with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act, violating sections 301(a) and (d).

Additionally, the company participates in the Amazon Associates program, promoting products like silver, iodine, and vitamins with similar COVID-19 claims. These "Amazon associate products" are also considered unapproved new drugs and misbranded drugs, with their introduction into interstate commerce prohibited under sections 301(a) and (d), and 301(k) of the FD&C Act.

The FDA is taking urgent measures due to the COVID-19 public health emergency. The company must immediately cease selling these unapproved and unauthorized products. Within 48 hours, an email must be sent to COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, including documentation and recurrence prevention. Failure to comply

## 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/agroterra-ltd/61d82bf6-f114-4a88-a499-e27c47a1b72a

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