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Archive for May 16th, 2013

FDA v. Jack3d: Round 2

Jack3d is a dietary supplement manufactured by USPlabs and promoted by the giant supplement retailer GNC as producing “ultra-intense muscle-gorging strength, energy, power and endurance.” A key ingredient is DMAA, which the FDA doesn’t think is a proper dietary supplement ingredient at all and wants Jack3d and other products containing it removed from the shelves and the web. The FDA also questions its safety.

As discussed in a previous post on the subject, both USPlabs and GNC maintain Jack3d (pronounced “jacked”) is safe when properly used. Apparently few agree with them on this point: not the FDA, not the U.S. military, not the countries and athletic associations which have banned DMAA. And certainly not the parents of Michael Lee Sparling, a 22-year-old Army private. The Sparlings filed a lawsuit alleging Jack3d caused the death of their son, who went into cardiac arrest and died after using it.

Here is where we left off the last time we looked at DMAA:

Last April [2012], the FDA sent warning letters to several supplement manufacturers saying it had no evidence DMAA is a legitimate dietary ingredient and citing its risks. (Health regulators in other countries, such as Sweden and Denmark, have actually banned DMAA-containing supplements.) Heart attacks, heart failure, kidney failure and liver failure were among the health problems reported to the FDA, as well as 5 deaths. GNC responded that it was “completely opposed to this unilateral, factually and legally unfounded action by the FDA.”

Now to Round 2.
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Posted in: Herbs & Supplements, Legal, Politics and Regulation

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