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

Source: https://www.globalkeysolutions.net/records/warning_letter/santhigram-kerala-ayurvedic-co-of-us-inc/602f67c7-b654-4859-b3a8-328acabde8d1

> FDA WARNING_LETTER for Santhigram Kerala Ayurvedic Co. of U.S., Inc. on May 24, 2022. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Santhigram Kerala Ayurvedic Co. of U.S., Inc.
- Inspection Date: 2022-05-24
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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,

## Related Officers

- [Carolyn E. Becker](https://www.globalkeysolutions.net/people/carolyn-e-becker/ad2daae5-dda1-4b9c-a69a-775997e7b60b)

Company: https://www.globalkeysolutions.net/companies/santhigram-kerala-ayurvedic-co-of-us-inc/b23a97d3-dce8-41cc-b0cb-9a9952353cc6

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