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Greg Webb
Greg Webb
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Jack3d, A Dietary Supplement-Untested, Unregulated and Potentially Lethal

2 comments

There are over 8000 unregulated dietary supplements on the market, untested and ostensibly safe for use. According to a 2011 study released by the FDA, more than half of U.S. adults used a dietary supplement between 2003 and 2006, compared to 40% between 1988 and 1994.

On April 11, 2013, the FDA issued a warning about supplements containing DMAA, dimethylamylamine, a stimulant. The warning came in advance of a story aired on NBC’s Rock City, about a young soldier who died of a heart attack as a result of using Jack3d, a product that contains DMAA.

DMAA is most commonly used in supplements promising weight loss, muscle building and performance enhancement; it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest.

DMAA provides ‘that little edge’ to make workouts better. The product in question, Jack3d (pronounced Jacked) is manufactured by USP Labs. There is no law prohibiting it and no legislation that gives the FDA authority to do more than issue a strong statement about the dangers of dietary supplements containing DMAA.

In a written statement to NBC News, Michael Petruzzello, on behalf of USP Labs, writes, “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.”

GNC is one of the nutritional stores that sells Jack3d. They do not feel responsible for ‘policing’ the items they sell. In a statement to Rock Center they said they rely on the manufacturers to make sure drugs are in compliance with the law and safe for humans to take.

A US law passed in 1994 declared dietary supplements exempt from pre-market FDA approval. The FDA’s warning last week stated, FDA's 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.”

For now, the FDA can only issue a warning. And GNC will keep Jack3d on its shelves because USP Labs says their product is safe. USP Labs and other manufacturers of dietary supplement remain free of the kind of scrutiny drug makers must go through. The burden rests on these businesses, the ones manufacturing and profiting from the production of these so-called ‘safe’ dietary supplements, to respond appropriately. In the absence of legal oversight, it’s left to businesses like GNC and USP Labs to weight the considerations of human life versus making a profit.

Bottom line: we have hundreds of manufacturers, supported by big box businesses like GNC, producing and selling unregulated dietary supplements to consumers. DMAA, the ingredient in Jack3d, is banned in nine countries across the world, including Canada. Yet, you or I can walk into a store and buy a product that has already been connected with the illness or death of 86 individuals.

There has to be a balance between neglect, overreaching government regulations and judicious oversight. We should, however, expect more when it comes to the safety of American citizens – our families, our friends, our loved ones.

For more on the hazards of DMAA, see a previous article this writer published a year ago at: http://charlottesville.legalexaminer.com/defective-and-dangerous-products/dmaawhat-is-it-and-why-hasnt-it-been-banned-in-the-us.aspx?googleid=300874 or visit http://www.michiehamlett.com.

2 Comments

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  1. Greg Webb says:
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    Joe,

    Thank you for your comments. I certainly did not intend to fear monger. My question is whether there is a sufficient and conspicuous warning on the product – enough to put users on notice of the real, potential dangers of use – dangers that may otherwise be latent. Your example comparing the dangers of “water” and “mother’s milk” is akin to comparing apples and donkeys in my opinion. People generally know of the primary hazard of water because it is obvious: drowning. People do not consume too much mother’s milk because nature will not allow mother to produce too much, and a child will throw up before consuming too much. Your analogies fall short for a variety of reasons. To be sure, I do not think DMAA should be outlawed; but I do think there are legitimate grounds for a discussion on regulating the product. Until such time, then the only checks and balances on this product will be through the tort system.

    Lastly, can you provide authority for your conclusion that DMAA is “one of the most studied dietary ingredients ever”? You may be correct, but I would like to see some evidence.

    Thank you for commenting. I mean it. I think this is an interesting issue to debate.

    Greg

  2. joe says:
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    Greg,
    The comment on mothers milk and water was sarcasm, in other words every person alive has had them and will inevitably die…more of a poke at the fact people complain about everything, that being said the dangers of water are apprently not obvious because you did not know that if you drink 4-5 gallons depending on your body weight…urinate and then go to bed….you won’t wake up.
    I’m good with a conversation on dangers of products, as long as they are all equal for example, snack food,fast food,guns,bottled water,cars,ect. Should all have basic common sense warnings and also then we can still hold people accountavle ubder misuse.
    I’m gonna sue McDonald’s because I gained a pound and then sue Hoover for my vacuum sucking up my ring,can you see how silly it is when people just dont use their brains.
    As for evidence the clinicals are out there,your a lawyer for god’s sake do some research,you should support the supplement companies,instead of the easy money of sueing them,defense of the underdog,is more b,enifical than the other way around.
    I have been using this companies products for years often slightly over dose, when taken correctly they are safe,when misused(like anything) they are dangerous,but we have not outlawed smoking or alcohol yet,which is responsible for many many more deaths than even the extreme misuse of dmaa,these are just the opinions of a guy who studies supplements and knows the safety and dangers of them and who is sick of them being taken away by ignorant people who have not even the first clue of what the products are used for