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UPSY LLC sold unapproved CBD products on its website with claims that they could mitigate, prevent, treat, diagnose, or cure COVID-19, violating the Federal Food, Drug, and Cosmetic Act by marketing unapproved new drugs and misbranded products without FDA authorization. The company's products constituted prohibited introduction or delivery of unapproved drugs into interstate commerce under sections 301(a) and (d) of the FD&C Act. The FDA took enforcement action during the COVID-19 public health emergency to protect consumers from unauthorized products making disease claims without regulatory approval.