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VarunKart Group LLC dba Organic Wellnesses was cited for offering nine unapproved new drug products for sale in the United States, including homeopathic remedies and herbal products, in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The products carried claims to cure, treat, or prevent serious conditions including measles, syphilis, tuberculosis, cancer, diabetes, and hepatitis—conditions for which approved, safe, and effective treatments exist—creating significant public health risk by potentially causing consumers to forgo or delay legitimate medical care. Additionally, two ophthalmic products (eye drops) posed heightened concern due to the inherent risks associated with direct eye administration of unapproved formulations.