> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Santhigram Kerala Selling Unapproved Drugs: FDA
- URL: https://www.fdaweb.com/santhigram-kerala-selling-unapproved-drugs-fda/
- Published: 2022-05-24T12:00:00.000Z
- Updated: 2026-09-14T17:45:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151886

FDA says its review of a Web site and social media pages maintained by Santhigram Kerala Ayurvedic of U.S., Inc., North Brunswick, NJ, found that it is selling products whose uses establish that they are unapproved new drugs. A 5/19 [Notice of Violation](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/santhigram-kerala-ayurvedic-co-us-inc-625892-05192022?ref=fdaweb.com) also says the company describes two of its products as intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in people.

The letter presents some of the claims made for the products the agency considers to be unapproved new drugs. Santhigram Kerala was told to respond with a list of specific steps it has taken to address any violations and prevent their recurrence, with documentation of each step and a timetable for completing the work.