Loading…
The website www.ivermectin4covid.com was selling unapproved and misbranded drug products claiming to treat, prevent, mitigate, diagnose, or cure COVID-19, violating sections 301(a), 301(d), and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company had not obtained FDA approval or authorization for these products, which posed inherent risks to consumers including potential contamination, counterfeiting, inconsistent active ingredient amounts, or undisclosed ingredient substitutions. The FDA issued this enforcement action during the declared public health emergency for COVID-19 to protect consumers from unapproved treatments being distributed over the internet.