DMAA Banned by FDA?
Posted: May 7, 2012 in News
On April 27th 2012 – The U.S. Food and Drug Administration today issued warning letters to ten 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.
The letters as stated were warning letters not official cease and desist letters and focus on the rules for New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible for notifying the FDA of evidence to support their conclusion that their dietary supplements containing NDIs are safe.
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.
There has been no real direct link to problems from DMAA used in a responsible manner, especially considering deaths from many legal substances including alcohol, tobacco and pharmaceuticals. From the FDA release: “The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.” I doubt the evidence of the millions of doses of DMAA preworkouts taken with no ill effect will be sufficient evidence for the safety argument.
Is DMAA Banned by the FDA?
As of today the answer would technically be NO (although you would need and NDI to use it), but in the foreseeable future that will likely turn to a yes and DMAA will be the next ephedrine.