Opportunity For Some As DMAA Supplements Troubles Deepen
Some saw the writing on the wall, so to speak, and changed their ways or formulae to be more precise. Others were not so quick, and are now beginning to pick up the pieces. We are talking about pre-workout and weight loss supplements containing the stimulant DMAA (Dimethylamylamine) whose sale was stopped by the FDA.
That dietary supplements are not regulated by the FDA is a false notion one that even this blog has previously been in error about. The FDA usually only steps in after serious safety issues have been raised as the present situation with DMAA. But dietary supplements are regulated:
FDA regulates both finished dietary supplement products and dietary ingredients under a different set of regulations than those covering “conventional” foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement or dietary ingredient manufacturer is responsible for ensuring that a dietary supplement or ingredient is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. (Emphasis mine) FDA
As stocks of supplement companies fell following the negative news about the popular stimulant, giant supplements chain store GNC issued a statement asserting that the agency had not cited medical or scientific evidence to show that indeed DMAA was unsafe.
One popular pre-workout supplement, C4 Extreme, had faced a lawsuit for containing DMAA but by then the manufacturer had since removed the compound from the supplement, perhaps seeing the writing on wall. C4 Extreme is still popular even without the stimulant.
Other pre-workout supplements makers that previously did not have this compound in their product saw opportunity:
MusclePharm Corporation, a nutritional supplement company focusing on all categories of an active lifestyle, today said that, in light of yesterday’s FDA ban on the substance DMAA, which is not used in MusclePharm products, it expects to capture a wider market share, particularly for the company’s pre-workout supplement Assault(TM), which is the only pre-workout product on the market that is certified by both NSF International and Informed Choice as free of banned substances. Yesterday, the United States Food and Drug Administration (FDA) imposed a ban on the supplement 1,3-Dimethylamine (DMAA), an ingredient used by many supplement companies MusclePharm competes with, citing its potentially fatal side effects. See original story
It is now a scramble to reformulate their products for some of those caught by the DMAA ban, while others simply stopped making and/or selling it and may have to move on without it. In our previous post (See Another Popular Supplement Pulled) I had said that this compound may join ephedra in the list of banned stimulants and thermogenics. As it appears, I was right.