FDA WARNING_LETTER - VarunKart Group LLC dba Organic Wellnesses - September 30, 2025

The FDA issued a Warning Letter to VarunKart Group LLC, operating as Organic Wellnesses, after a website review in September 2025. The agency identified several products, including "Lord"s L 143 Measles Drop" and "Himalaya Ophthacare Eye Drops," being illegally marketed as unapproved new drugs in the United States. These products are considered "drugs" under the Federal Food, Drug, and Cosmetic Act (FD&C Act) due to their intended use for disease treatment, mitigation, or prevention. Of particular concern are claims to cure or treat serious conditions like measles, syphilis, tuberculosis, cancer, and diabetes, which could lead consumers to delay or discontinue effective medical treatments. Ophthalmic products were also highlighted as posing a greater risk. The FDA emphasized that these products are "new drugs" not generally recognized as safe and effective (GRASE) for their labeled uses, lacking the required FDA approval. Introducing or delivering these unapproved new drugs into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act. VarunKart Group LLC is required to stop marketing and selling these products to comply with federal regulations.