Santhigram Kerala Ayurvedic Co. of U.S., Inc.

Warning LetterOpen

Gopinathan Nair Santhigram Kerala Ayurvedic Co. of U.S., Inc. 1503 Finnegans Lane North Brunswick , NJ 08902 United States contact@santhigram.us santhigram@gmail.comFEI 3014227710Issued May 19, 2022Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3014227710.

Violations0

Issue DateMay 19, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Santhigram Kerala Ayurvedic Co. of U.S., Inc.
Location: Gopinathan Nair Santhigram Kerala Ayurvedic Co. of U.S., Inc. 1503 Finnegans Lane North Brunswick , NJ 08902 United States contact@santhigram.us santhigram@gmail.com
FEI Number: 3014227710
Country: United States
Issue Date: May 19, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

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.

Santhigram Kerala Ayurvedic Co. of U.S., Inc. FDA Warning Letter, May 19, 2022