Medical Mikes, Inc. Warning Letter Details

Summary

Medical Mikes, Inc. was cited for selling unapproved CBD products on its website that claimed to mitigate, prevent, treat, diagnose, or cure COVID-19, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act by marketing unapproved new drugs. The products were also found to be misbranded under section 502 of the FD&C Act, and their introduction into interstate commerce violated sections 301(a) and (d) of the Act. The FDA took action during the declared public health emergency and national emergency related to COVID-19 to protect consumers from unauthorized products making disease claims without FDA approval.