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FDA Warns Consumers, Retailers, Manufacturers to Stop Using DMAA Supplements

Jan 1, 2013

7Federal health officials are warning of the dangers of workout supplements that contain the additive dimethylamylamine (DMAA).

In a warning letter it issued last week, the FDA said it “is using all available tools” to make sure DMAA products are no longer available to consumers. The FDA has declared DMAA illegal and notes that it should no longer be sold in the U.S. Despite its warning, however, the FDA admits that its reach over the dietary supplement industry presents some challenges to eradicating DMAA products in the U.S. (these such products already have been eliminated in foreign markets).

DMAA has been implicated in a handful of deaths and dozens of other adverse health events recently. The U.S. Food and Drug Administration (FDA) has warned that products containing DMAA are dangerous, but manufacturers and retailers have argued against this stance, believing there is no evidence to support the regulator’s position.

According to a New York Times report in response to the FDA warning, retailer GNC said it will not remove products containing DMAA from its shelves. Popular products containing DMAA are marketed as Jack3d and OxyElite Pro, and are used primarily by people in workouts as a stimulant.

A New York Times report last week noted that while GNC continues to market products containing DMAA, another retailer, Vitamin Shoppe, has removed the products from its shelves.

The FDA feels compelled to act against products containing DMAA after receiving dozens of reports of adverse health events among people who were using these supplements. The agency said it has received 86 reports of illness or death associated with the supplements. The agency says some of the reports include effects to a person’s heart or nervous system but added that it could not conclusively determine that DMAA had caused these conditions.

Response to the FDA’s warning has largely been positive, but one specific manufacturer of DMAA products, USPLabs, has denied the allegations that the supplements it makes are dangerous. USPLabs even refutes the assertion that DMAA is dangerous, and submitted data back to the agency attempting to prove that DMAA is safe to use.

The FDA said in its warning statement last week that “after reviewing the studies provided by USPLabs, [we find] the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.”

Still, the FDA does not have full regulatory control over dietary supplements, so its warning is just that, for now. To completely remove products containing DMAA from shelves, the agency must complete more exhaustive legal steps. The FDA said it is continuing that process to ensure consumers do not have an opportunity to purchase products with DMAA.

Federal health officials are warning of the dangers of workout supplements that contain the additive dimethylamylamine (DMAA).

 

In a warning letter it issued last week, the FDA said it “is using all available tools” to make sure DMAA products are no longer available to consumers. The FDA has declared DMAA illegal and notes that it should no longer be sold in the U.S. Despite its warning, however, the FDA admits that its reach over the dietary supplement industry presents some challenges to eradicating DMAA products in the U.S. (these such products already have been eliminated in foreign markets).

 

DMAA has been implicated in a handful of deaths and dozens of other adverse health events recently. The U.S. Food and Drug Administration (FDA) has warned that products containing DMAA are dangerous, but manufacturers and retailers have argued against this stance, believing there is no evidence to support the regulator’s position.

 

According to a New York Times report in response to the FDA warning, retailer GNC said it will not remove products containing DMAA from its shelves. Popular products containing DMAA are marketed as Jack3d and OxyElite Pro, and are used primarily by people in workouts as a stimulant.

 

A New York Times report last week noted that while GNC continues to market products containing DMAA, another retailer, Vitamin Shoppe, has removed the products from its shelves.

 

The FDA feels compelled to act against products containing DMAA after receiving dozens of reports of adverse health events among people who were using these supplements. The agency said it has received 86 reports of illness or death associated with the supplements. The agency says some of the reports include effects to a person’s heart or nervous system but added that it could not conclusively determine that DMAA had caused these conditions.

 

Response to the FDA’s warning has largely been positive, but one specific manufacturer of DMAA products, USPLabs, has denied the allegations that the supplements it makes are dangerous. USPLabs even refutes the assertion that DMAA is dangerous, and submitted data back to the agency attempting to prove that DMAA is safe to use.

 

The FDA said in its warning statement last week that “after reviewing the studies provided by USPLabs, [we find] the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.”

 

Still, the FDA does not have full regulatory control over dietary supplements, so its warning is just that, for now. To completely remove products containing DMAA from shelves, the agency must complete more exhaustive legal steps. The FDA said it is continuing that process to ensure consumers do not have an opportunity to purchase products with DMAA.


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