agroterra, ltd. – FDA Warning Letter, May 5, 2020

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