Santhigram Kerala Ayurvedic Co. of U.S., Inc. Warning Letter Details

Summary

Santhigram Kerala Ayurvedic Co. of U.S., Inc. was cited for distributing unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act, specifically sections 505(a) and 301(d). The company marketed various ayurvedic products including "Smokers Kit/Respiratory Care Kit," "Immunocare Kit," and other herbal formulations through its website and social media channels (Facebook and Instagram) with claims intended to diagnose, treat, prevent, or cure disease—including COVID-19. The FDA determined that these products met the definition of drugs based on their intended use to diagnose, treat, mitigate, or prevent disease or affect body structure and function, but lacked required FDA approval for marketing.