FDA WARNING_LETTER - Seanjari Preeti Womb Healing, L.L.C. - May 05, 2020

On May 8, 2020, the FDA and FTC issued a Warning Letter to Seanjari Preeti Womb Healing LLC after reviewing their website, www.seanjaripreeti.com, and YouTube channel on April 23 and May 5, 2020. The letter states that the company offers a honey product for sale in the U.S. that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined this product is an unapproved new drug, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and a misbranded drug under section 502 of the FD&C Act (21 U.S.C. § 352). The introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The letter emphasizes that the FDA is taking urgent measures to protect consumers from unapproved products claiming to address COVID-19, given the public health and national emergencies declared. The company is required to immediately cease selling these unapproved and unauthorized products.

The company must email COVID-19-TASK-FORCE-CDER@fda.hhs.gov