On Thursday at the Supply Side West trade show in Las Vegas, Dr Daniel Fabricant, director of dietary supplement programs at the Food and Drug Administration, said that some DMAA products are still on the market and that the agency is using all the tools it has to remove them from commerce.
“This ingredient has cost people their lives; it has cost them their jobs,” Fabricant said.
In the latest incident, a complaint was filed against the company based in Norcross, a suburb of Atlanta, in the U.S. District Court for the Northern District of Georgia alleging 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.
Finished goods, raw materials seized
The authorities 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 on Nov. 12. The products had been under administrative detention since the start of the month, when FDA inspectors identified them as containing DMAA during an inspection.
“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.
FDA said it has received a number of adverse event reports, including illnesses and death, associated with supplements containing DMAA. Illnesses reported included 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. Healthcare provides can report events on FDA's MedWatch hotline at 1-800-FDA-1088.
In 2012 FDA sent a series of warning letters to makers of DMAA-containing products. In those letters, FDA asserted that there is no evidence that DMAA was on the market before Oct. 15, 1994, meaning that the ingredient should have a NDI notification on file. As no DMAA manufacturer has submitted such a notification, FDA’s conclusion is that the ingredient is illegal, and the agency has further concluded that it is unsafe.
DMAA-containing products have been banned from the shelves of military commissaries for more than a year. A recent Department of Defense safety review of the ingredient concluded that the ingredient poses potential health risks but could not be causally linked to the deaths of four soldiers who died with the ingredient in their bloodstreams.