Dietary Supplements such as Jacked (aka Jack3d) and OxyElite Pro can be dangerous because they contain DMAA (dimethylamylamine). The Food and Drug Administration has received 42 adverse event reports on products containing DMAA, products containing DMAA have been banned from US Army bases, and Canada has banned DMAA products. Yet products containing DMAA are still apparently available at stores in the USA. Therefore, we are warning our friends, family and clients not to use any dietary supplements containing DMAA.
The FDA is currently investigating the safety of DMAA (dimethylamylamine). There are concerns that DMAA products may be linked to liver failure, heart attacks, loss of consciousness, rapid heartbeat and even death. The products containing DMAA are generally marketed as "dietary supplements" and are therefore not regulated or pre-approved by the FDA.
In April 2012 the FDA issued warning letters to 10 manufacturers and distributors of products containing DMAA (sample warning letter). The FDA position is that before products containing DMAA are marketed to the public, the companies that make the products must provide evidence of safety to the FDA which they apparently had not done. Unfortunately, Federal Law is a bit murky in this area and it gives the makers of OxyELITE and Jack3d and other supplements wiggle room. The applicable law is the Dietary Supplement Health and Education Act of 1994 (DSHEA). The FDA position is that synthetically produced DMAA is not a "dietary ingredient." and therefore the manufacturers/marketers must establish that it is safe. Some of the products referenced in the FDA DMAA warning letters are: Biorhythm SSIN Juice, Lean Efx, SPirodex, PWR, Napalm, Code Red, Hemo Rage Black, Lipo-6, MethylHex 4, Nitric Blast, Oxy Elite Pro, and Jack3D.
In an Article on WebMD, Pieter Cohen, MD, an internist and Harvard Medical School Professor, says "It is more potent than ephedra, and ephedra is already removed from the market......At best DMAA is a waste of money and at worst it can damage your health."
The bottom line is that weightlifters, gym rats, and athletes should not use products containing DMAA. If you or anyone you know is injured as a result of using a dietary supplement please contact us at (301) 589-2999. We are investigating product liability, negligence and wrongful death claims resulting from the use of dietary supplements containing DMAA.