The US Food and Drug Administration has issued warning letters to 10 manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.
Daniel Fabricant, PhD, director of FDA’s Dietary Supplement Programme, said: “Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated.”
The FDA warning letters also advised the companies that the agency is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible for ensuring that they are marketing a safe product.
The latest battle in supplement safety wars
The FDA has noted that the health risks associated with narrowing of the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack.
The agency additionally warned the companies that synthetically-produced DMAA is not a ‘dietary ingredient’ and, therefore, is not eligible to be used as an active ingredient in a dietary supplement.
It has been reported that revellers as young as 17 are taking the supplements, which have names such as Napalm and Code Red, to give them an energy rush similar to those induced by amphetamines.
But the lack of regulation of the supplements, and the ease with which they can be obtained and abused, has raised concerns among health experts.
Discussions are now underway, and investigations are being carried out. But how many more deaths will be reported before the matter is closed?
The effects and ‘rush’ experienced from taking ‘Napalm’ and ‘Code Red’ will travel fast. The ‘discussions’ will have to move faster than the speed of social media.
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