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Dr. Paul's Lab sold an unapproved new drug called "COVID-Aid Tincture" that claimed to mitigate, prevent, treat, diagnose, or cure COVID-19 in people, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act. The product was also misbranded under section 502 of the FD&C Act and was distributed into interstate commerce through multiple websites including Dr. Sarah's Essentials. The FDA took this enforcement action during the global COVID-19 public health emergency to protect consumers from unauthorized products making disease claims without FDA approval.