Following FDA Actions, GNC Voluntarily Destroys All Products Containing Unsafe Food Additive

General Nutrition Centers Inc. (GNC) agreed to destroy all of its products containing 1,3-dimethylamylamine (DMAA), an unsafe amphetamine derivative, in response to seizure actions filed by the Department of Justice (DOJ) in Pennsylvania, Arizona, and South Carolina. Selling DMAA is illegal, and the FDA urges consumers to avoid any dietary supplements containing the product, which may be listed on a product label under multiple names, including methylhexanamine and geranium extract.

DMAA

DMAA is an amphetamine-like stimulant that has been linked to serious health problems, including at least 86 reports of illnesses and death. The substance narrows blood vessels and arteries, which can elevate blood pressure and lead to cardiovascular problems including heart attack, arrhythmias, shortness of breath, and tightening in the chest. Although DMAA was approved for use as a nasal decongestant in 1948, the approval was withdrawn in 1983 and today no medical use of the stimulant is recognized. DMAA is most commonly an ingredient in weight loss, muscle building, and performance enhancement supplements, and is often touted as a “natural” stimulant. Based on information reviewed by the FDA, there is no reliable science indicating that DMAA exists naturally in plants, and it cannot be considered a dietary ingredient.

FDA Action

In 2012, the FDA issued warning letters to 11 known DMAA providers and manufacturers. Because the FDA does not perform pre-market safety and effectiveness tests on dietary supplements, warning letters are the quickest way to stop distribution and sales of unsafe products in the marketplace. Following receipt of warning letters, 10 companies agreed to stop using DMAA. One additional company, USPLabs, responded to the warning letter with studies that it claimed defended the use of DMAA as a dietary supplement. The FDA found USPLabs’ studies insufficient, and used its administrative detention authority to seize the company’s DMAA-containing products. USPLabs voluntarily destroyed its products, and agreed to stop manufacturing dietary supplements containing DMAA.

In June, the U.S. Attorney’s Office and the DOJ worked with the FDA to file actions against GNC in three states where the company stored DMAA-containing products. After the cases to seize and condemn the goods were filed, GNC agreed to destroy all DMAA products in its warehouses. FDA personnel witnessed the destruction of the products in two warehouses and have made arrangements to witness product destruction in the third. All three seizure actions have been dismissed because of GNC’s cooperation. The FDA is following up to ensure companies uphold their agreements to stop production and sale of DMAA products, and will continue to look for DMAA in the marketplace and act to ensure its removal.