FDA WARNING_LETTER - Handelnine Global, LLC dba Navafresh - September 30, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Handelnine Global, LLC, operating as Navafresh, on November 17, 2025. This action followed a September 2025 review of the company"s website and the sampling of its "Rheumacare Capsules" product. The FDA determined that Navafresh is illegally selling several products in the U.S., including "Dr. Patels Measles Tablets," "Mans-Pachak Vati," and "Tri-Origin Ayurveda Diabetic Tablets," which are considered unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Additionally, "Rheumacare Capsules" was found to be a misbranded drug under section 502 of the FD&C Act. Laboratory testing of "Rheumacare Capsules" revealed the presence of lead, rendering it an adulterated drug under section 501(a)(2)(B) due to safety concerns and non-compliance with current Good Manufacturing Practice (CGMP) requirements. The FDA highlighted significant public health risks, particularly from products claiming to treat serious conditions like cancer, diabetes, and measles, potentially leading consumers to delay or forgo effective medical care. Ophthalmic products were also noted as posing increased harm. Navafresh must cease marketing these unapproved, misbranded, and adulterated products to comply with federal law.