September 23, 2018

Despite FDA Warning About DMAA, One Company Continues Its Use

At least 86 incidents of illness or death associated with diet supplements containing the stimulant dimethylamylamine (DMAA) have been reported to the Food and Drug Administration (FDA). The illnesses reported include: heart problems, nervous system problems, and psychiatric disorders, according to the agency. Most of these reports have been voluntary from consumers and their health care providers, which does not necessarily establish a cause and effect relationship, the agency says.

Warning Recall SignDMAA is most commonly used in supplements that promise weight loss, muscle building and performance enhancement. It can elevate blood pressure, leading to cardiovascular problems, such as shortness of breath, tightening in the chest or heart attack. DMAA is particularly dangerous when used with caffeine.

The FDA has warned manufacturers that the ingredient is illegal. All but one company that received a warning letter about the dangers of the illegal drug agreed to quit using it. USPLabs, which sells products bis the Internet, responded to the FDA’s warning “by submitting published studies that purport to challenge FDA’s conclusions,” according to the agency. The FDA did not find the information provided sufficient to defend the ingredient’s use.

Dietary supplements are not subject to the same FDA rules as drugs and medical products. The agency “is required to undertake what are usually lengthy scientific and legal steps in order to force the removal of dietary supplements that may be unsafe or are otherwise illegal if companies don’t voluntarily comply.”  While that process continues for DMAA, the FDA urges consumers to check labels and avoid products containing DMAA.

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