Prairie Dawn Herbs and Griffo Botanicals received warning letters from the U.S. FDA asserting the illegality of promoting and selling products with unsubstantiated claims to improve the function of the immune system and to prevent or ameliorate symptoms associated with COVID-19.

The letters contain the statement "based on our review, products are an unapproved new drug under section 505 of the Federal Foods Drug and Cosmetic Act and furthermore products are misbranded drugs”.

There are no FDA-approved products to prevent or treat coronavirus infection.  Remdesivir is administered under emergency use authorization in hospitals under supervision of medical professionals.

Following receipt of the FDA letters the two companies concerned have modified their websites with respect to claims relating to COVID-19.