Dietary stimulants containing the stimulant DMAA have got to go, warned the Food and Drug Administration (FDA) in a press release on Friday.
In all, the agency says it had received nearly 90 reports at the time the statement was released of illnesses and death associated with the chemical, though, the FDA notes "a report is not proof that the product actually caused the problem."
Side effects of DMAA, the agency says, include cardiovascular problems, shortness of breath, tightening of chest and heart attacks.
Thus far, the FDA has warned all known companies carrying the stimulant that it is illegal. In response all but one have agreed to halt further distribution of their products.
The company that has not complied, USPLabs, responded by submitting published studies that allege the FDA is wrong and that the chemical is safe. At this point, it plans to continue the sale of Oxy Elite Pro and Jack3D though the FDA says it's currently working on responding to the situation as quickly as possible and that the studies were "insufficient to defend the use of DMAA" as an ingredient.
The challenge, the press release explains, is working through a system that, unlike prescription medicine, favors businesses over buyers.
"Consumers may mistakenly look at a capsule and think that [the] FDA has signed off on that product as safe and effective prior to that product appearing on the market, as we do with drugs and other medical products," explained Daniel Fabricant, the director of the FDA's Division of Dietary Supplement Program. "In contrast, with dietary supplements, there is no pre-market approval, and once a product is on the market, the burden is on the FDA to prove that a product is unsafe."
This process, in turn, can be a lengthy one as the agency must then undertake both legal and scientific steps before the harmful product can be removed.
For this reason, the FDA is urging consumers to check labels for DMAA and has listed alternatives on its website.
Anyone who experiences a problem related to the chemical is asked to report it here, and to always consult with health care professionals before using a supplement.