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Deadly workout supplement 'Jack3d' (which contains DMAA) outside FDA's reach

By Rob Cypher, Apr 13, 2013 | | |
Rating:
4/5,
  1. Rob Cypher
    Over the past few years, a popular dietary supplement has amassed a cult-like following of fitness enthusiasts across the country.

    From coast to coast, you can find small white canisters filled with a pink powder tucked into gym bags, stashed in lockers and sitting in kitchen cupboards.

    Devotees claim it gives them that extra edge they need to run that elusive last mile, or to lift that extra 10 pounds.

    But detractors call it potentially dangerous, perhaps even deadly.

    The supplement is called Jack3d (pronounced Jacked), but the ingredient that users say sets it apart from other pre-workout supplements is 1,3 dimethylamylamine - or DMAA. The U.S. Food and Drug Administration says DMAA is illegal.

    The FDA has received 86 adverse event reports believed to be linked to DMAA. Serious side effects reported to the FDA include depression, anxiety, vomiting, loss of consciousness, chest pain, and even death.

    NBC News Chief Medical Correspondent Dr. Nancy Snyderman sat down with Dr. Daniel Fabricant, director of the division of dietary supplements programs at the FDA.

    Fabricant's message about DMAA was clear: "It is an illegal dietary supplement."

    So why is it still being sold in the US? Fabricant says, “banning it would be, you know…it’s difficult.”

    The FDA has limited legal authority over supplements. In 1994, a law was passed by the U.S. government that declared dietary supplements exempt from pre-market FDA approval.

    “We don't have pre-market approval…we don't evaluate [dietary supplement] products for safety or efficacy prior to them going to market,” said Fabricant in an interview airing Friday, April 12 at 10pm/9CDT on NBC's Rock Center with Brian Williams.

    So what can the agency do? On April 11, the FDA issued a consumer advisory warning against the supplement. A day later, the Council for Responsible Nutrition, the trade association representing the dietary supplement industry called on the manufacturer and consumers to heed the FDA warning.

    “With this conclusion, CRN now calls on dietary supplement manufacturers to stop manufacturing these products and further advises consumers to stop using them,” said Steve Mister, president and CEO of the Council for Responsible Nutrition in a statement released today. “The safety and well-being of consumers is always our highest priority.”

    This warning is not the first time FDA raised concerns about DMAA’s safety. In 2012, the FDA sent warning letters to 11 manufacturers questioning DMAA’s safety and challenging their claims that the ingredient even qualifies as a dietary supplement. All of them voluntarily pulled their products - except for USP Labs, the makers of Jack3d.

    In a written statement to NBC News, Michael Petruzzello on behalf of USP Labs maintains that, “DMAA is a safe and lawful dietary ingredient. We stand by the scientific evidence presented and believe there is no reason to withdraw it from the market.”

    The company also points to “three published scientific papers [that] document that 1,3 DMAA can be extracted from [a] geranium found in particular areas of China,” meaning it is a natural substance, and is therefore not subject to the FDA’s drug approval process.

    Dr. Pieter Cohen, a Harvard professor and member of the Cambridge Health Alliance who studies supplement safety, disagrees with USP Labs that DMAA comes from a plant.

    “DMAA has nothing to do with nature … That's an absolute myth perpetuated by companies selling it,” he says. “DMAA is a drug that manufacturers are passing off as a plant product.”

    So if DMAA doesn’t come from the geranium plant, as USP Labs claims, where does it come from? Cohen says “DMAA is ... produced in a factory.”

    Debates over DMAA’s origins aside, Cohen thinks the ingredient should be removed from the market for another reason: “Could it increase the risk of death? Could it lead to the death of a young healthy man? Absolutely.”

    Dr. Cohen says DMAA behaves in the body like an amphetamine: “If you took a low dose of this, you might notice a slight tremor-- a little more alert, awakeness, your heart beating a little faster.”

    He also sees similarities between DMAA and another supplement that was famously banned years ago, Ephedra.

    “Now we're seeing situations in which people are taking this and experiencing adverse events that are completely consistent with those that we saw with Ephedra-- the heart attacks, the strokes, the deaths,” Cohen said.

    In response to questions about the safety of DMAA, USP Labs had this to say: “The company is unaware of a single corroborated serious adverse event [associated with DMAA] when used in accordance with labeled directions for use," and that there are "eight peer-review published clinical studies detailing the safety of DMAA."

    DMAA has been banned in the United Kingdom, Canada, Australia and six other countries. It is also prohibited for use by athletes by many sports organization in the United States, as well as the by the International Olympic Committee. The U.S. Military now prohibits the sale of DMAA on all bases, after two soldiers who used the product died.

    One of those soldiers was Private Michael Sparling. On a June morning in 2011, Sparling went for a training run on his base compound in Fort Bliss, Texas. It was comfortable 70 degree weather and the 3.5 mile circuit was nothing unusual for the young, fit soldier.

    Later that morning, Michael’s mother Leanne received a phone call she’ll never forget. It was the commander of the base hospital, calling to tell her that her son was in cardiac arrest. While preparing to fly to her son’s bedside in Texas, Leanne called the hospital for an update on his condition.

    "Ma'am, we've done everything we could to save him but at 11:17 this morning he passed away."

    Michael Sparling was 22 years old. Grief-stricken, the Sparling family looked for answers. What could have caused their young, seemingly healthy son to die so suddenly?

    During the autopsy, tests confirmed the presence of the substance DMAA in Michael Sparling’s blood. Army doctors told the Sparlings that the substance may have played a role in his death.

    He had only been using the product for a month before he died.

    But even tragic stories like that of Michael Sparling, and the threat of possible side effects like heart failure and cerebral hemorrhage aren’t enough to scare off many enthusiastic Jack3d users. In 2011, more than $100 million worth of DMAA-based products were sold in the United States.

    Keith Stewart is a 24 year-old marketing manager in New York City who uses Jack3d almost daily as a part of his fitness routine. After work, Stewart heads to his apartment in lower Manhattan, takes the recommended dose of Jack3d, and quickly heads to the gym. He’s got the timing of when he takes Jack3d down to a science, and won’t let anything get in between him and his work out.

    “Within 30 minutes, you feel this rush of energy in your body and you just have to move. You basically have to lift things, move things, get it out of your system … I take it, and I know 30 minutes later, if I'm not in the gym, I'm going to start to feel antsy.

    "Your body will start to tingle. Your skin starts to tingle, actually … you can feel it in your veins. You feel this rush of energy in your body and you just have to move,” says Stewart.

    “Once I took it actually and I couldn't get to the gym, and, uh, I just remember I had to run. I just started running down the street, um, and doing like a work out in my own park, so, it was, uh. That was when I noticed that, wow this stuff is really powerful.”

    Powerful and available over the counter at many local supplement stores, like retail giant GNC.

    GNC also declined our request for an interview, but had this to say: “GNC has no reason to believe that DMAA is unsafe. GNC, as a responsible retailer, does not sell products that contain substances banned by the FDA or that have been recalled by the FDA.”

    While it’s true that DMAA is not a banned substance, Cohen feels the company has a responsibility to protect its customers.

    “It’s shocking that GNC continues to support USP Labs in selling their wares,” Cohen said.

    The parents of Michael Sparling say they aren’t waiting for the FDA to ban DMAA, or for GNC to voluntarily pull Jack3d from its shelves. They are suing both USP Labs and GNC for causing their son’s death. USP Labs has moved to dismiss the lawsuit. Regarding the two military deaths, USP Labs says, "There is absolutely no evidence to support the assertion that 1,3 DMAA had anything to do with those unfortunate deaths."

    In a statement, GNC told Rock Center that the company relies on manufacturers to warrant “that the products are fully compliant with all applicable laws and…safe for human consumption.”

    And for the past two years, Michael’s mother has been dropping into supplement stores to find out if they’re still selling the product she believes killed her son. She told us about a conversation she had with a clerk a few months after Michael’s death:

    “I said, ‘Well, I'm interested in a product called Jack 3D, or Jacked?’ And he goes, ‘Oh yes.’ And he became very animated,” she said.

    Leanne says the clerk told her it was the store’s top seller. She asked him if he had heard of any adverse side effects from using the product. “And he goes, ‘No, it is 100% natural, it's totally safe…Are you buying it for your son?’”

    Leanne Sparling pointed to the dog tags around her neck and said, “Do you see the dog tags I wear…They were my son's … He died after taking this product."

    Janet Klein, Lauren Specter and Adrian Taylor
    NBC News
    Apr 11, 2013

    http://rockcenter.nbcnews.com/_news...out-supplement-jack3d-outside-fdas-reach?lite

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  1. Calliope
    [IMGL="white"]http://www.drugs-forum.com/forum/attachment.php?attachmentid=32224&stc=1&d=1365859679[/IMGL]F.D.A. Issues Warning on Workout Supplement

    Certain workout-booster and fat-burning products, sold in recent years by retailers like GNC and Vitamin Shoppe, are illegal and may present serious health hazards to consumers, federal health regulators have determined.

    With names like Jack3d and OxyElite Pro, the popular products contain a stimulant known as dimethylamylamine, or DMAA for short. In a public warning late Thursday, the Food and Drug Administration said that the stimulant did not qualify as a legal dietary supplement ingredient and that it could raise blood pressure, potentially causing heart attacks and other health problems.

    Since early 2008, the agency has received reports of 86 health problems, including at least five deaths, in consumers who used DMAA products. Although such reports do not prove that the stimulant directly caused the health problems, agency officials warned people not to consume the ingredient.

    “We are very concerned,” Daniel Fabricant, the director of F.D.A.’s division of dietary supplements programs, said in a phone interview Friday. “We think consumers should stay away from products containing DMAA.”

    Steve Mister, president of the Council for Responsible Nutrition, a trade group, said on Friday that the dietary supplement industry should honor the agency’s warning.

    “The F.D.A. has spoken,” Mr. Mister said. “We are urging the industry not to manufacture products with DMAA. Retailers should heed the advisory as well.”

    A lawyer for USPlabs, the Dallas company that markets Jack3d and OxyElite Pro, said his client disagreed with the F.D.A.’s position.

    “USPlabs continues to believe that DMAA is legal, or otherwise they would not be selling it,” said the lawyer, Peter B. Hutt of Covington & Burling in Washington.

    As of Friday afternoon, GNC was still selling Jack3d (pronounced “Jacked”) on its Web site as a “hot buy.” A company spokesman did not return requests for comment.

    Vitamin Shoppe appears no longer to be stocking Jack3d, and now offers only Jack3d Micro, a newly formulated product that does not contain DMAA.

    The F.D.A. warning comes as the agency faces mounting pressure from medical researchers, sports organizations and investigations in the news media to take action on the stimulant.

    In late 2011, the Defense Department pulled products containing DMAA from stores on military bases, pending an investigation into the deaths of two soldiers who died after they used the stimulant. Last month, an article in The New York Times described the death of one of those soldiers, Michael Sparling, who collapsed during a training run with his unit in 2011 after taking Jack3d and died soon after. The Sparling family has filed a lawsuit against GNC, where he bought the product, and USPlabs.

    On Friday night, the NBC News program “Rock Center With Brian Williams” was scheduled to broadcast a segment on Mr. Sparling and DMAA products.

    Mr. Hutt, the USPlabs lawyer, said the F.D.A. made its announcement to get out in front of the NBC report and shield itself from being criticized for lax enforcement.

    “This is the agency’s customary attempt to protect itself,” Mr. Hutt said. “These reports rely on a plaintiff’s unsubstantiated allegations. There is no evidence that the soldier’s death was caused by DMAA.”

    Although health regulators in at least seven countries, including Canada, have effectively banned supplements containing DMAA, the products have remained widely available at supplement stores in the United States. Some medical researchers say federal health regulators should have warned American consumers much earlier.

    “We’ve had hundreds of millions of dollars spent on products that should have never been on the marketplace to begin with,” says Dr. Pieter Cohen, an assistant professor at Harvard Medical School who studies dietary supplements. “There’s no reason the F.D.A. should have waited to warn the public of the dangers of consuming the ingredient.”

    A year ago, the F.D.A. issued letters to 10 companies that marketed DMAA products, saying the stimulant did not fit the legal definition of a supplement as a vitamin, mineral, herbal or botanical ingredient used to supplement the diet. The stimulant was originally developed in the 1940s by Eli Lilly, the pharmaceutical company, as a nasal decongestant called Forthane, but the drug maker officially withdrew the medicine from the market in the 1980s.

    Among the companies that received the federal warning letters last year, all but USPlabs agreed to stop marketing DMAA products, according to the F.D.A. advisory. USPlabs submitted published studies on the ingredient in an effort to challenge the F.D.A.’s position, the advisory said, but the agency found the information “insufficient to defend the use of DMAA as an ingredient in dietary supplements.”

    Mr. Fabricant said the F.D.A. intended to take further steps to remove the stimulant from the market. Although he declined to comment specifically on USPlabs, the agency’s options in such cases generally include asking a supplement maker for a voluntary recall of potentially hazardous products, seizing such products or instituting a mandatory recall.

    “We are going to use all of the tools available to us to get this out of distribution,” Mr. Fabricant said.

    By NATASHA SINGER and PETER LATTMAN
    NYTimes
    http://www.nytimes.com/2013/04/13/business/fda-issues-warning-on-workout-booster.html
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