FDA Comes Down on DMAA Manufacturers, Distributors

May 2, 2012

The agency contends that DMAA is not backed by safety studies or a relevant history of use and so DMAA is unqualified for use as a New Dietary ingredient.

FDA recently issued warning letters to 10 manufacturers and distributors of dimethylamylamine (DMAA), an ingredient often used in weight loss and bodybuilding dietary supplements. The agency contends that DMAA is not backed by safety studies or a relevant history of use and so DMAA is unqualified for use as a New Dietary ingredient.

DMAA is most commonly used as a thermogenic and a general stimulant. It is often touted as a “natural” stimulant, due to unreliable claims that it is derived from geranium oil. On January 13, 2012, the American Herbal Products Association (Silver Spring, MD) notified all of its members that they should not market DMAA as “geranium oil” or as being any part of the plant.

“There are no known-published reports indicating that [DMAA] is a natural product,” said AHPA chief scientific officer Steven Dentali, PhD. “Any labeling stating that it is naturally occurring in geranium, or any other natural source, would need appropriate scientific evidence to support it.”

FDA’s warning letters note that DMAA is known to narrow the blood vessels and arteries, which can increase one’s risk of serious cardiovascular events. The letter adds that the agency has received 42 adverse event reports from consumers of DMAA products.

Companies that received warning letters have 15 business days to respond to FDA with an outline of how they will address the issues disclosed in the warning letters.

UPDATE, May 3: Attorney Justin Prochnow of Greenberg Traurig LLP (Denver) has notified us of the fact that class action lawsuits have now been filed against 9 of the recipients of FDA DMAA warning letters; the 10th company, USP, had already been sued in February of this year. The class actions were brought by lawfirm Kirtland & Packard LLP (El Segundo, CA). Additionally, Prochnow says, four actions have also been brought against companies that did not receive FDA warning letters but that market DMAA products.