At the request of the U.S. FDA, U.S. Marshals seized dietary supplements manufactured and held by Hi-Tech Pharmaceuticals, Inc., located in Norcross, Ga., after FDA investigators found the products contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical equivalent. The retail value of the seized products is more than $2 million.
A complaint filed in the U.S. District Court for the Northern District of Georgia alleged that the products were adulterated according to the Federal Food, Drug, and Cosmetic Act because they contain DMAA, an unapproved food additive that is deemed unsafe under the law.
The FDA is urging consumers not to buy or use supplements containing DMAA, which can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine. Consumers should check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names.
During the FDA’s inspection of Hi-Tech Pharmaceuticals, Inc., which began in October, investigators identified eleven products that were labeled as containing DMAA or its chemical equivalent. These products included Black Widow, ECA XTREME, FASTIN, FASTIN-XR, Lipodrene, Lipodrene HARDCORE, Lipodrene XR, Lipodrene XTREME, LIPOTHERM, Stimerex-ES, and YELLOW SCORPION. The investigators also observed bulk DMAA raw ingredients at the facility.
To date, the FDA has received numerous reports of illnesses and death associated with supplements containing DMAA, including heart problems and nervous system or psychiatric disorders. Consumers can report an adverse event or illness they believe to be related to the use of a dietary supplement by calling 1-800-FDA-1088 or online. Your health care provider may also report this by calling the FDA’s MedWatch hotline at 1-800-FDA-1088.
Dietary supplements containing DMAA are illegal and the FDA is using all available tools at its disposal to remove these products from the market. In 2012, the FDA issued warning letters to companies notifying them that products containing DMAA need to be taken off the market or reformulated to remove this substance.
To learn more about DMAA and it’s medical effects, click here.