FDA WARNING_LETTER - Radhanite, LLC d/b/a Curalife Ltd - September 09, 2021

The FDA issued a Warning Letter to CuraLife regarding their CuraLin product, based on a review of their website and social media in August 2021. The FDA determined that CuraLin is marketed as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) due to claims indicating its intent for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

Examples of violative claims include: "promote healthy glycemic response," "maintaining healthy glucose levels," "89% would recommend CuraLin to a diabetic friend," and claims about ingredients like Turmeric, Bitter Melon, Fenugreek, and Picrorhiza Kurroa supporting glucose and insulin levels. Testimonials on Instagram and Facebook also suggested disease treatment, such as "#beatingdiabetes" and "managing your Type 2 Diabetes naturally!"

CuraLin is considered a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for its claimed uses, and lacks prior FDA approval, violating sections 301(d) and 505(a). Furthermore, the product is misbranded under section 502(f)(1) as it lacks adequate directions for use by a layperson, given that the diseases it targets are not amenable to self-diagnosis or treatment without professional supervision. This misbranding violates section