FDA WARNING_LETTER - Lakpura LLC - October 17, 2022

On October 24, 2022, the FDA and FTC issued a Warning Letter to Lakpura.com following website reviews on September 26 and October 17, 2022. The agencies found that Lakpura.com offers products like “Beam Suwa Dharani” and “Siddhalepa Lakpeyawa” for sale in the U.S., claiming they mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are deemed unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under section 502 (21 U.S.C. § 352). Their introduction into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The letter emphasizes the ongoing public health emergency due to COVID-19.

Lakpura.com must immediately cease selling all unapproved and unauthorized COVID-19 related products. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, including steps to prevent recurrence and supporting documentation. Failure to comply may lead to legal action, including seizure and injunction. The firm will be