FDA WARNING_LETTER - Swift Digital Group LLC dba Swadesii - September 30, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Swift Digital Group LLC, operating as Swadesii, on November 17, 2025. This action followed a September 2025 review of the company"s website, swadesii.com, which revealed the sale of numerous drug products lacking FDA approval. The primary violation involves marketing and selling unapproved new drugs in the United States, including products like “Deekshant Thyroid Tablet,” “Hepatina Syrup,” and “Elaneer Kuzhambu,” among others. These products are explicitly promoted with claims to treat, cure, or prevent serious and life-threatening conditions such as thyroid disorders, liver problems, measles, autoimmune diseases, stroke, Alzheimer"s, and various eye conditions. Under the Federal Food, Drug, and Cosmetic Act, these products are considered unapproved new drugs because their intended uses demonstrate they are meant to diagnose, treat, or prevent disease, or affect bodily functions, without undergoing the necessary FDA review for safety and effectiveness. The FDA expressed significant public health concerns, emphasizing that claims for such serious ailments could lead consumers to delay or forgo conventional, proven medical treatments. The ophthalmic product, "Elaneer Kuzhambu," poses an elevated risk due to its direct administration into the eyes, bypassing natural defenses. Swift Digital Group LLC is required to cease introducing these unapproved drugs into interstate commerce to comply with federal law.