FDA Moves to Seize DMAA, Jack3D, OxyElite From GNC Warehouses

July 16, 2013 — Federal prosecutors at the Justice Department, on behalf of the U.S. Food and Drug Administration (FDA), have requested judicial authorization to seize 3,200 cases of dietary supplements containing DMAA from warehouses operated by GNC, according to the New York Times.

The FDA has warned GNC that the products contain an ingredient that is illegal to use in dietary supplements, but GNC continued to sell their inventory. GNC spokesman stated that they intend to sell through their inventory of DMAA products remaining on store shelves.

U.S. Attorney David Hickton filed an action seeking the eventual destruction of products seized at the GNC warehouses, including Jack3D and OxyElite Pro, which are manufactured by USPLabs and also the most popular DMAA products. GNC and USPLabs are the last major companies that have resisted enforcement actions that began when the FDA sent Warning Letters to 10 manufacturers in April 2012.

It is very rare for the FDA to take forcible action to seize illegal dietary supplements. The enforcement against GNC began in June 2013. Inspectors visited two warehouses in Leetsdale, Pennsylvania, and Anderson, South Carolina. They took photographs, collected physical samples, and seized shipping records. Officials informed GNC that the products were adulterated and were being illegally held in the warehouses.

DMAA (also known as “geranium oil,” 1,3-dimethylamylamine, and other names) is a mild stimulant drug that is marketed as a pre-workout energy booster and weight-loss supplement. Unfortunately, it can also increase the risk of health problems, including high blood pressure, abnormal heart rhythm, shortness of breath, psychiatric disorders, heart attacks and seizures. Since 2008, the FDA has received at least 86 reports of serious side effects, including five deaths, in association with products containing DMAA.

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