Ron Elul
CEO
Radhanite, LLC d/b/a Curalife Ltd
208 Paterson Plank Rd.
Union City , NJ 07087-2826
United StatesFEI 3015337160Issued Sep 7, 2021Center for Food Safety and Applied Nutrition (CFSAN)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3015337160.
Violations1
Issue DateSep 7, 2021
Product TypeDrugs
StatusClosed
Closeout LetterMar 23, 2022
Letter Details
Firm
Radhanite, LLC d/b/a Curalife Ltd
Location
Ron Elul
CEO
Radhanite, LLC d/b/a Curalife Ltd
208 Paterson Plank Rd.
Union City , NJ 07087-2826
United States
FEI Number
3015337160
Country
United States
Issue Date
September 07, 2021
Issuing Office
Center for Food Safety and Applied Nutrition (CFSAN)
Product Type
Drugs
Status
Closed
Closeout Letter
March 23, 2022
Summary
Radhanite, LLC d/b/a Curalife Ltd was cited for marketing CuraLin, a dietary supplement product, as an unapproved drug through disease treatment claims made on their website and social media platforms. The company's marketing materials made numerous claims that the product promotes healthy glucose levels, supports insulin sensitivity, and helps people with diabetes maintain glucose control—statements that establish the product's intended use as a drug for treating or mitigating disease under federal law. These drug claims rendered the product misbranded and introduced it into interstate commerce without FDA approval, violating the Federal Food, Drug, and Cosmetic Act. The FDA and Federal Trade Commission jointly reviewed the company's online marketing channels in August 2021 and identified the violations.
Radhanite, LLC d/b/a Curalife Ltd FDA Warning Letter, September 7, 2021