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FDA warns about dangerous dietary supplements ingredient

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Staff writer ▼ | April 15, 2013
The Food and Drug Administration (FDA) issued a warning about dietary supplements containing dimethylamylamine (DMAA) and recalled all lots from the market.
Food and Drug Administration (FDA)
Food and Drug Administration (FDA)The Food and Drug Administration (FDA) issued a warning about dietary supplements containing dimethylamylamine (DMAA) and recalled all lots from the market.


DMAA is most commonly used in supplements promising weight loss, muscle building and performance enhancement; it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine.

As of April 11, 2013, FDA had received 86 reports of illnesses and death associated with supplements containing DMAA. The majority are voluntary reports from consumers and healthcare practitioners. The illnesses reported include heart problems and nervous system or psychiatric disorders. Note, however, that a report is not proof that the product actually caused the problem.

FDA has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal. Such warnings offer the quickest way at FDA's disposal to halt the further distribution of dietary supplements containing DMAA in the marketplace. All but one of the companies sent a Warning Letter have agreed to stop using DMAA as an ingredient in their dietary supplements.

The one company that has yet to agree to such action, USPLabs, has responded to FDA's warning by submitting published studies that purport to challenge FDA's conclusions. After reviewing the studies provided by USPLabs, FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.

FDA is urging consumers to check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The alternatives are listed at FDA's DMAA web page.


 

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