FDA Warns: Potential Deadly Risks with Jack3d Use

This weeks’ news television show, Rock Center, reported about the frustration the U.S. Food and Drug Administration (FDA) faces regarding the supplement industry. The FDA has issued warnings about DMAA, the supplement present in the popular product called Jack3d.  Following the FDA’s advisory warning, the Council for Responsible Nutrition, the leading trade association for the dietary supplement industry, called for manufacturers to stop producing DMAA-containing products and for consumers to stop using them. Both the FDA’s advisory and the statement from the Council for Responsible Nutrition are discussed here:

In the past few years, a popular dietary supplement has accumulated a tremendous following of fitness buffs across the nation. From coast to coast, in most health food stores, as well as in gym bags, lockers and kitchen pantries, you can find a small, white jar of the pink powder called Jack3d.

Used as a weight-loss aid and work out booster, it contains a controversial substance called dimethylamyllamine or DMAA. It is said to give you that “edge” to push you to run that extra mile or lift more weight. But the FDA calls it “dangerous,” or potentially “deadly.”

The supplement, known as “Jack3d,” pronounced Jacked, contains an ingredient that makes it unique.  The ingredient 1,3 dimethylamylamine, or DMAA, is illegal, according to the FDA.

There have been 86 adverse event reports reported to the FDA, which are believed linked to DMAA. Some serious side effects that were 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 program at the FDA.

Fabricant’s message about DMAA was clear: “It is an illegal dietary supplement.”

It has been reported that DMAA is known to narrow the blood vessels and arteries, which can cause high blood pressure and possibly lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack.

Why is this supplement still being sold in the U.S.? This product is banned in Canada and in the UK.  Fabricant says, “banning it would be, you know…it’s difficult.”

The FDA has limited legal authority when it comes to supplements. In 1994, the U.S. government passed a law exempting dietary supplements 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 12th at 10pm/9 CDT on NBC’s Rock Center with Brian Williams.

So what can the FDA do?  On April 11, 2013, 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 the 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 markers 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. Peter Cohen, a Harvard professor and member of 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.” Dr. Cohen says that DMAA is produced in a factory.

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 states that there are similarities between DMAA and another supplement, which has been 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.

An official said manufacturers and distributors had “a responsibility under the law to provide evidence of the safety of their products.”

USP Labs in Texas, which made Jack3d and another DMAA-containing supplement called Oxy Elite Pro, went on the offensive. It threatened a lawsuit against a Max Muscle shop owner who described Jack3d as “an amphetamine-like compound” that “speeds up your heart rate.”

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

One of those soldiers was Private Michael Sparling. On a June 2011 morning, Sparling went for a training run on his base compound in Fort Bliss, Texas. It was only 70 degrees outside and the 3.5-mile circuit was easy for the young, fit soldier.

Later that morning, Michael’s mother Leanne received a phone call she will 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 be at her son’s bedside, Leanne called the hospital for an update on her son. “Ma’am, we’ve done everything we could to save him but at 11:17 this morning, he passed away.”

Michael Sparling was only 22-years-old. The Sparling family looked for answers to what could have caused their young, healthy son to die suddenly as they struggled with their grief.

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

It was determined that he had only been using the product for a month before his death.

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 U.S.

Keith Stewart is a 24-year-old marketing manager in New York City who used Jack3d almost every day as part of his fitness routine. After work, he heads to his lower Manhattan apartment, 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 the way of 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 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 also available over the counter at many local supplement stores, such as retail giant, GNC.

GNC declined our 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 are 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 stopping in to 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 Jack3d:’ 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.”

Last month, USP Labs agreed to settle a class action case in the U.S. regarding Jack3d and Oxy Elite Pro, settling aside $2 million to reimburse those who had purchased the products.

However, USP Labs has not admitted liability. It continues to maintain that DMAA is a synthetic copy of geranium extract, a matter debated by scientists.
It has created a reformulated version of Jack3d without DMAA called Jack3D Micro, but still sells the original version in the U.S.

Why is it that Canada, United Kingdom, Australia and six other countries have successfully banned this dangerous supplement but the U.S. agency that is supposed to protect consumers has failed to get this product off the shelves in our country?

Feel free to comment on this blog post. You can contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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