Pharmaceutical

FDA warns against using dietary supplements containing DMAA

fda logo FDA warns against using dietary supplements containing DMAAThe Food and Drug Administration (FDA) is warning consumers that dietary supplements promising weight loss, muscle building and performance enhancement containing dimethylamylamine (DMAA) can be dangerous and even deadly and should be avoided at all costs. The agency is working hard to remove all DMAA-containing supplements from the marketplace, however some companies continue to sell the products illegally.

DMAA can elevate blood pressure and could lead to cardiovascular problems including heart attacks, shortness of breath, and tightening in the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine.

As of April 11, 2013, the FDA has received 88 reports of illnesses and deaths associated with dietary supplements containing DMAA. Incident reports include heart problems and nervous system or psychiatric disorders.

The FDA has cracked down on companies that make supplements with DMAA and has sent warning letters informing them that selling these products is illegal and must stop immediately. All but one company agreed to stop using DMAA in their products. USPLabs responded to the FDA’s warning by submitting published studies that challenge the agency’s conclusions. Upon review, the FDA found the studies to be insufficient.

The FDA’s guidance of dietary supplements is much different than with drugs and medical devices. In order to force removal of dietary supplements by companies who do not voluntarily agree to remove the products the FDA believes are unsafe, the agency must undergo lengthy scientific and legal steps. As part of this measure, the FDA is urging consumers to check the labels of dietary supplements and avoid ones that contain DMAA.

Unfortunately, DMAA may be referred to by 10 different names including 1,3-dimethylamylamine, methylhexanamine or geranium extract.

Any side effects with supplements containing DMAA should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA