Regenaca, a division of VivaCeuticals Inc., has recalled lots of its RegeneSlim dietary supplement after FDA confirmed the presence of DMAA, also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. FDA warns that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
Safe, or unsafe?
Not everyone agrees with FDA’s take on DMAA, although all of the major players who were manufacturing or marketing supplements containing the ingredient have gone along with FDA and have removed the ingredient from the market. Major supplements retailer GNC had a lengthy back-and-forth with FDA over DMAA-containing products on its shelves that culminated with FDA seizing some remaining inventory from a GNC warehouse in New Jersey in late June 2013. Later that summer the Department of Defense concluded a review of the ingredient that was sparked by the deaths of two soldiers who died after ingesting DMAA and then exercising. The review concluded that there was low risk in the use of DMAA in accordance with label instructions and there was no conclusive link between the use of the ingredient and the soldiers’ deaths.
“GNC is delighted that the military’s review of DMAA products validated what we already knew; namely, that products containing DMAA do not cause adverse medical events,” said GNC CEO Joseph Fortunato at the time of the release of the review.
“DMAA is not technically illegal. There is no law that says it is illegal,” attorney Justin Prochnow of the firm Greenberg Traurig told NutraIngredients-USA. “FDA has taken the position that DMAA is not a permissible dietary ingredient because it is a synthetic constituent of a botanical. It is certainly FDA’s opinion that using it in a supplement is illegal.
“It is a little different than ephedra where there is a specific regulation (banning its use),” he said.
RegeneSlim is distributed though an independent sales force in the US and Puerto Rico and also through online sales. The company did not respond to a request for comment on the recall.