FDA warns Formulife to remove DMAA supplements

Such products containing DMAA as Muscle Marinade Fresh Fruit and XR Thermolipolytic are "adulterated" under federal law because DMAA is an unapproved food additive, an FDA official, Reynaldo Rodriguez, stated in a warning letter dated June 17, 2013.

FDA could take enforcement against Formulife if it fails to "immediately cease" distributing the products containing DMAA, Rodriguez warned.

A number of companies have withdrawn DMAA products from the market after FDA issued similar warning letters in April 2012.

Tamara Ward, a spokesperson for FDA, declined to comment on the Formulife warning letter, citing "open compliance issues".

Natural Products Insider couldn't immediately determine whether Formulife has removed DMAA from its products. Brandon Smith, president and owner of Formulife, did not return a phone call Friday.

In a consumer advisory, FDA warns that DMAA narrows arteries and blood vessels and may lead to cardiovascular problems as well as seizures and other neurological and psychological conditions. The agency has received reports linking the stimulant to psychiatric disorders, heart problems, nervous system disorders and death.

But companies who have sold DMAA maintain the ingredient is safe. And a safety review panel formed by the U.S. Army and Department of Defense recently concluded DMAA did not cause the death of four servicemen.

"The existing evidence does not conclusively establish that DMAA-containing substances are causally-associated with adverse medical events," the panel wrote.