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USPlabs, makers of the dietary supplements OxyElite Pro and Jack3d, have agreed to remove a controversial ingredient, 1,3-dimethlyamylamine, or DMAA, from their best-selling products.
In an apparent course change in an ongoing battle with the Food and Drug Administration over the stimulant, the company emailed a statement to marketers April 16 saying it will tweak the products’ formulas and remove DMAA.
“USPlabs stands by the safety and legality of its products containing the dietary ingredient 1,3-DMAA. We disagree with FDA’s position. … The company has nevertheless concluded for business reasons to phase out products containing 1,3-DMAA,” according to the statement.
The FDA issued a consumer alert April 11 saying workout boosters and “fat burners” that contain DMAA are illegal and potentially dangerous. DMAA is known to known to elevate blood pressure and can cause health problems ranging from heart attacks to shortness of breath, the FDA said.
Last April, the agency warned manufacturers to stop marketing products containing DMAA. According to the FDA bulletin issued April 11, all but one — USPlabs — complied.
USPlabs instead sent the FDA copies of company-funded studies that they said proved their products were safe.
But USPlabs quietly notified supplement retailers of upcoming changes on April 16. The company did not respond to requests from Military Times for an interview.
Supplements that contain DMAA are still available online and at some dietary supplement stores, but consumers should not use them, the FDA advises.
As of April 11, the agency had received 86 reports of illnesses or death associated with the ingredient. Symptoms ranged from cardiovascular distress and heart attacks to anxiety and psychiatric disorders.
The reports indicate only that patients developed symptoms or died after or while using the product and do not mean the ingredient specifically caused the health problems.
The Army Public Health Command launched a study of the stimulant in 2012 after two soldiers, Pvt. Michael Sparling, 22, and Sgt. Demekia Cola, 31, died of heart failure during physical training in 2011 at Fort Bliss, Texas. The Army said DMAA use was a “contributing factor” in both deaths.
A third soldier, Pfc. David Artis, died in July 2012 of heat stroke; Army officials linked DMAA use to his death as well.
Sparling’s parents, Michael and Leanne Sparling of Rio Linda, Calif., have sued USPlabs and GNC for wrongful death, saying the side effects of Jack3d contributed to his death.
DoD in late 2011 removed all products containing DMAA from on-base store shelves while the Army launched a safety review and study.
DoD spokeswoman Cynthia Smith said April 16 that the study is complete and a draft is under review by military leaders.
“It would be premature to speculate on findings at this time. Once all leaders and stakeholders have had the opportunity to review and comment, the final report will be released publicly,” Smith said.
DoD urges service members to research all dietary supplements before taking them. The military’s Human Performance Resource Center maintains information on supplements, including DMAA, an ingredient that goes by at least 10 different names on ingredient lists.
The Center also maintains a list of products that still contain DMAA and may be available for sale.
The FDA urges consumers to check labels carefully and warns that any product containing DMAA is “particularly dangerous with caffeine.”
“Consumers are urged to report any problems associated with supplement use to the company or the agency, and to always consult with their health care professional before using a supplement,” according to the FDA statement.
DoD has started an education campaign warning troops and families about the potential health risks of consuming supplements.
“Operation Supplement Safety” aims to educate personnel about individual supplements and promote informed decision-making on a wide range of products.