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

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

July 16, 2013 — The New York Times has reported that federal prosecutors on behalf of the Justice Department and the U.S. Food and Drug Administration (FDA) have moved to seize dietary supplements containing the illegal stimulant drug DMAA. Prosecutors have requested legal authorization to seize 3,200 cases of the product from GNC warehouses in Pennsylvania and South Carolina.

It is extremely rare for the FDA to take forcible enforcement actions against a company. The FDA warned GNC that DMAA is an illegal and dangerous ingredient in dietary supplements, but the company continued to sell the products. After the FDA moved to forcibly seize the products from GNC warehouses, a spokesman for the company said that they intend to sell through the stock remaining on store shelves.

U.S. Attorney David Hickton has asked judges for permission to seize and destroy the products. GNC is the largest supplement retailer in the U.S. Their most popular DMAA products are Jack3D and OxyElite Pro, which are manufactured by USPLabs. GNC and USPLabs are the last major hold-outs to resist federal enforcement action against DMAA, which began in April 2012 when the FDA issued Warning Letters.

In June 2013, the FDA began taking stronger enforcement action against GNC. Inspectors visited a warehouse, halted operations, took pictures of the illegal supplements, collected physical samples, and seized shipping records. The officials also informed GNC that they were illegally storing adulterated supplements.

DMAA, also known as “1,3-dimethylamylamine” or “geranium oil,” is a synthetic drug that has mild stimulant effects. It has been marketed in dozens of weight-loss supplements and pre-workout energy boosters. It became controversial after it was linked to five deaths and 86 adverse events. Side effects include high blood pressure, increased heart rate, shortness of breath, chest tightness, psychiatric disorders, heart attacks, seizures, and more.

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