FDA Issues Warning On DMAA Workout Supplements


Posted on 13th April 2013 by gjohnson in Uncategorized

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The Food and Drug Administration (FDA) how lowered the boom on the controversial workout boosters Jack3d and OxyElite Pro, issuing a warning last Wednesday that the stimulant they contain – dimethylamylamine, or DMAA – is illegal.


The FDA said that it was using all the tools at its disposal to ensure that dietary supplements containing DMAA are no longer distributed and available for sale to consumers in the marketplace. GNC and Vitamin Shoppe have been selling the products for years.

I blogged on this topic when The New York Times did an investigative piece about the dangers of DMAA.DMAA is most commonly used in supplements promising weight loss, muscle building and performance enhancement. According to the FDA, 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,” the FDA said. In its warning, the FDA reported that it had received 86 reports of illnesses and deaths associated with supplements containing DMAA.

“The majority are voluntary reports from consumers and healthcare practitioners,” the warning said. “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.”

The FDA said that is has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal. It said that such warnings offer the quickest way for the FDA to halt the further distribution of dietary supplements containing DMAA in the marketplace.

All but one of the companies sent an FDA warning letter have agreed to stop using DMAA as an ingredient in their dietary supplements, according to the agency.

The company that hasn’t agreed, USPLabs, has responded to FDA’s warning by submitting published studies that purport to challenge FDA’s conclusions.

“However, 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,” the FDA said.

“FDA is finalizing a formal response to the firm to reflect its findings, according to Daniel Fabricant, director of FDA’s Division of Dietary Supplement Program.

The FDA said that its authority over dietary supplements is very different from its authority over drugs and other medical products. FDA 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.

The FDA said that as it continues the process needed to get DMAA off the market, it 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 agency said that its response to the use of DMAA “illustrates the challenges that the agency faces in addressing incidents involving potentially dangerous dietary supplements.”

That effort is increasingly important as the use of dietary supplements increases worldwide, the FDA said. A 2011 study found that more than half of U.S. adults used a dietary supplement between 2003 and 2006, compared to 40 percent between 1988 and 1994.

In recent years, the FDA has alerted consumers to hundreds of tainted products marketed as dietary supplements. Consumers should be aware that dietary supplements are subject to different oversight than drugs and other medical products.

“Consumers may mistakenly look at a capsule and think that FDA has signed off on that product as safe and effective prior to that product appearing on the market, as we do with drugs and other medical products,” Fabricant said. “In contrast, with dietary supplements, there is no pre-market approval, and once a product is on the market, the burden is on the FDA to prove that a product is unsafe.”

The FDA’s role in overseeing dietary supplements is laid out in a 1994 law and subsequent amendments, and its enforcement capabilities range from issuing warning letters seeking voluntary cooperation bringing criminal charges.

In recent years, FDA enforcement actions involving dietary supplements have included banning products, executing injunctions, working with U.S. marshals to seize products, and issuing safety alerts and consent decrees—which are agreements approved and enforced by a federal court, the agency said.

In many cases, the FDA has acted when dietary supplements were found to contain ingredients approved for use in prescription drugs. DMAA was approved in 1948 for use as a nasal decongestant, but the approval was withdrawn in 1983, according to the agency.

The products cited in the warning letter to USPLabs are Oxy Elite Pro and Jack3d. These products claim, among other things, to be fat-burning and performance-enhancing supplements, respectively.

While action in that case in pending, the FDA said it is following up to ensure that other companies which promised to cease using DMAA as an ingredient in their dietary supplements are actually doing so.

The agency is also looking to see if there are other dietary supplement products containing DMAA in the marketplace, and will continue to act to ensure that such products, when identified, are no longer distributed and available for sale to consumers.

Energy-Supplement Dangers Put Under Microscope


Posted on 18th March 2013 by gjohnson in Uncategorized

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Energy boosters and other performance supplements appear to fall through the cracks of federal safety regulators, leaving products like Jack3d on retail shelves, according to the Sunday New York Times.


The Times did a lengthy story outlining the legal issues raised by the sale Jack3d — or “jacked,” as in “jacked up” — a supplement that Leanne Sparling blames for the death of her son Michael, who was in the Army. After taking the workout supplement, he collapsed and later died of cardiac arrest while running in a military drill.

Sparling, a private, bought his Jack3d, which contains the stimulant dimethylamylamine, or DMAA, at a GNC shop. Last month his parents filed a wrongful death suit against the maker of Jack3d, Dallas-based USPlabs, and GNC, The Times reported.

GNC maintains that the supplement is safe, and it certainly is legal: The Food and Drug Administration (FDA) hasn’t pulled the supplement from the market. But it’s raised enough safety concerns that the Defense Department took all products that contain DMAA from stores on military bases in 2011, The Times reported. And seven countries have banned supplements containing DMAA.

After filing a Freedom of Information Act request, The Times learned that from January 2009 to present the FDA received 80 reports of people having health problems after taking DMAA supplements, including five deaths.

Amidst this all, GNC defended the safety of Jack3d and argued that it should not be liable for selling a product that is legal, according to The Times.

Mother Leanne Sparling disagrees.