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Lakpura LLC sold multiple Ayurvedic and herbal products, including medicinal drinks, balms, oils, and cough syrups, that were marketed on their website to mitigate, prevent, treat, diagnose, or cure COVID-19 without FDA approval or authorization. These products violated section 505(a) of the FD&C Act by being unapproved new drugs and section 502 by being misbranded, with their introduction into interstate commerce prohibited under sections 301(a) and (d). The FDA took enforcement action during the COVID-19 public health emergency (declared January 31, 2020) as part of urgent measures to protect consumers from unauthorized products making disease claims.