Risks of DMAA Detailed By The FDA

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Spurred on by a wave of reports alleging injurious circumstances in conjunction with a substance known as DMAA (or dimethylamylamine), the Food and Drug Administration has issued a warning to consumers about the stimulant.  They’re also attempting to use this particular incident as a means to explain the difficulties of overseeing the safety of dietary supplements.

As of yesterday, the FDA had received 86 notices of a death or an injury linked with a supplement that uses DMAA as an ingredient.  Among the side effects reported were things like psychiatric problems, nervous system issues, and heart problems.  The FDA worries that consumers exposed to DMAA could be susceptible to heightened blood pressure that can lead to breathing difficulties or a heart attack.

Because DMAA is most commonly found in dietary supplements, the way the FDA reacts to this type of situation is different from how the agency would approach a potentially hazardous drug.  Dietary supplements do not have to go through a pre-market approval process, and thus consumers shouldn’t automatically think that an item being on sale automatically means the FDA has put it through the rigors.  Instead, the FDA must prove a lack of safety after an item has already been released and potentially made its way into the hands of consumers.  The FDA is usually able to step in once an active drug ingredient has been found in a dietary supplement.

In this instance, the FDA has asked makers of dietary supplements that use DMAA to cease including the ingredient.  Only one firm has failed to comply with this request, and the FDA is in the midst of putting together an appropriate response to that company.