Editor's Note: Acting on an FDA request, U.S. Marshals seized an estimated $2 million in dietary supplements manufactured by Hi-Tech Pharmaceuticals, Inc. after FDA investigators found the products contained DMAA (1, 3-Dimethylamylamine HCl) or its chemical equivalent. The seizure comes after Hi-Tech sued FDA on November 5 claiming that the administration improperly issued a detention order on products that contain DMAA before conducting a formal rule-making process.
Food and Drug Administration
U.S. Marshals seize more than $2 million in adulterated dietary supplements from Georgia company
FDA acts to prevent distribution of products containing unapproved food additive
At the request of the U.S. Food and Drug Administration, 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. The FDA has warned consumers about the health risks of DMAA on its web site.
On Nov. 12, 2013, U.S. Marshals seized more than 1,500 cases of finished goods and more than 1,200 pounds of in-process/raw material goods from the Hi-Tech Pharmaceuticals, Inc. facility.
"This company has a responsibility to ensure its products are safe for distribution and human consumption," said Melinda K. Plaisier, the FDA's associate commissioner for regulatory affairs. "We have taken action to protect consumers and demonstrate our commitment to their safety by keeping these products from entering the distribution system."
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. Prior to the seizure, on Nov. 1, 2013, the FDA issued an administrative detention, temporarily holding the products until they were seized. ...