FDA acts to prevent distribution of products containing unapproved food additive
Silver Spring, Maryland—(ENEWSPF)—November 18, 2013. 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.
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.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The FDA also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.