Robert DiMaggio
Ironmag Labs
1860 Whitney Mesa Dr.
Ste 120
Henderson , NV 89014
United States
cs@ironmaglabs.comFEI 3011020174Issued May 4, 2022Center 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 3011020174.
Violations2
Issue DateMay 4, 2022
Product TypeDietary Supplements
StatusOpen
Letter Details
Firm
Ironmag Labs
Location
Robert DiMaggio
Ironmag Labs
1860 Whitney Mesa Dr.
Ste 120
Henderson , NV 89014
United States
cs@ironmaglabs.com
FEI Number
3011020174
Country
United States
Issue Date
May 04, 2022
Issuing Office
Center for Food Safety and Applied Nutrition (CFSAN)
Product Type
Dietary Supplements
Status
Open
Summary
Ironmag Labs was cited for marketing four dietary supplement products (CBD Gummies, Ephedra Stack, Lean Fuel V2, and Stimulate) that violated the Federal Food, Drug, and Cosmetic Act. The company failed to comply with new dietary ingredient (NDI) requirements by marketing products containing higenamine and hordenine—both classified as new dietary ingredients requiring pre-market notification to FDA—without proper regulatory authorization. Additionally, the CBD-containing product was found to be an unapproved new drug sold in violation of FDA approval requirements and was misbranded for lacking required labeling.