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SafaLab, Inc. was cited for selling an unapproved new drug called "The Prevention 12 Pak" (also marketed as the "Coronavirus Prevention 12 Pak"), a combination product containing 12 ingredients including vitamins, minerals, and supplements, which violated section 505(a) of the Federal Food, Drug, and Cosmetic Act by lacking FDA approval. The company made disease claims on its websites (safalab.com and weeksmd.com) that the product could mitigate, prevent, treat, diagnose, or cure COVID-19, rendering it both an unapproved drug and a misbranded drug under section 502 of the FD&C Act. The FDA took action during the COVID-19 public health emergency period to prevent distribution of the unapproved product into interstate commerce in violation of sections 301(a) and (d) of the FD&C Act.