FDA WARNING_LETTER - Santhigram Kerala Ayurvedic Co. of U.S., Inc. - May 24, 2022

The FDA issued a Warning Letter to Santhigram, LLC, following a March 2022 review of their website (santhigram.us) and social media (Facebook, Instagram). The FDA observed that Santhigram takes orders for various ayurvedic products, including "Smokers Kit/Respiratory Care Kit," "Immunocare Kit," "Dadimadi Ghrutham," "Dasamoolarishtam," "Maha Tiktaka Ghrutham," "Padoladi Ghrutha," "Ashwagandha," "Triphala," "Garlic," "Eladi Taila," "Jathyadi Ghrutham," and "Jatyadi Keram."

The "Smokers Kit/Respiratory Care Kit" and "Immunocare Kit" are specifically cited for claims intended to mitigate, prevent, treat, diagnose, or cure COVID-19. The FDA determined that claims on Santhigram's websites establish these products as unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)). The products are considered "drugs" under section 201(g)(1) (21 U.S.C. 321(g)(1)) due to their intended use in disease diagnosis,