The Army has halted sales of DMAA products on Army bases while it conducts a safety review. The concern comes after two soldiers died from heart attacks after fitness exercises and DMAA was found in their systems. The Army also reports receiving reports of liver failure, kidney failure, seizures, loss of consciousness and rapid heartbeat from soldiers who have taken DMAA containing products.

1. Is DMAA Dangerous?
DMAA, or dimethylamylamine, is an active ingredient in products such
as OxyElite Pro and Jack3d. In the United States, these products are
marketed to athletes and fitness buffs as supplements that increase
energy, concentration and metabolism.
The safety of these supplements has recently been called into question
and here is what the following sources have to say about it:
 FDA. The FDA is Investigating Causes of Deaths and Injuries Linked
to Jack3d and OxyELITE Pro
 United States Army. The Army has halted sales of DMAA products on
Army bases while it conducts a safety review. The concern comes after
two soldiers died from heart attacks after fitness exercises and DMAA
was found in their systems. The Army also reports receiving reports of
liver failure, kidney failure, seizures, loss of consciousness and rapid
heartbeat from soldiers who have taken DMAA containing products.
 USPlabs, the manufacturer of Jack3d and OxyElite Pro. USPlabs
stands by the safety of its product and claims that there is no medical
evidence to suggest danger when used as directed.
Consumer Alert: FDA Investigates
Causes of Deaths and Injuries
Linked to Jack3d and OxyELITE Pro
The line between “dietary supplement” and “drug” is a fine one. Drugs
For more information contact: are subject to FDA approval and regulations; dietary supplements are not.
Anapol Schwartz P .C. That’s an important distinction when it comes to the health and safety of
(866) 735-2792 individuals who opt to take a given substance. And it’s a distinction that
Thomas R. Anapol, Esquire or often is blurred when it comes to performance enhancing substances that
Michael H. Monheit, Esquire are so appealing to athletes or anyone trying to get in shape. Two of those
substances—Jack3d and OxyELITE Pro—have recently come under close
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scrutiny, bringing to light the inadequacy of the Dietary Supplement Health
and Education Act (DSHEA) as well as FDA oversight.
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2. According to an article in the New York Times, on Feb 3, 2012 the United
States Army is investigating whether these types of “dietary supplements”
played a role in the death of two soldiers last year. Both died from heart
attacks and toxicology reports reveal the presence of dimethylamylamine
(DMAA)—the active ingredient in these products—in their blood. Aside
from those two deaths, there are also reports of liver and kidney failures,
seizures, loss of consciousness and rapid heartbeat from users of
DMAA. The evaluation is still ongoing, but In the meantime, the Defense
Department has removed all products containing DMAA from stores on
military bases. And the FDA is now launching an investigation into both
Jack3d and OxyELITE Pro.
Whether DMAA is a supplement or a drug is a debate with manufacturers
and retailers on one side and safety advocates on the other. The maker of
USPlabs describes the products as supplements derived from naturally-
occurring compounds found in plants, producing an effect similar to
caffeine. At the same time, organizations like the World Anti-Doping
Authority which regulates drug use by Olympic athletes, and several
professional sports leagues list DMAA as a banned stimulant. Health
experts as well describe DMAA as a powerful stimulant drug similar to
amphetamines.
The take-away lesson from all of this is that until the regulatory agencies
get their act together, consumers of these products need to be on alert. For
now, safety in using DMAA-containing products unfortunately falls on the
shoulders of the consumer.
OxyELITE Pro, Jack3d – harmful
dietary supplements
Is the FDA doing enough to protect the weight-conscious
and body-builder public against allegedly harmful dietary
supplements like OxyELITE Pro and Jack3d dangers?
Under United States law, dietary supplements are defined as products
containing only supplemental dietary ingredients, like vitamins or minerals,
and do not need FDA approval before they are sold. A dietary supplement
is a product taken orally which contains a dietary ingredient intended to
supplement the diet. Dietary ingredients can include vitamins, minerals,
herbs or other botanicals, amino acids, and substances such as enzymes,
organ tissues, glandulars, and metabolites.
Dietary supplements are not considered food nor prescription drugs nor
over the counter drugs and are not monitored as closely.
Under the Dietary Supplement Health and Education Act of 1994 (DSHEA),
the dietary supplement or dietary ingredient manufacturer is responsible
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Read more information online at www.anapolschwartz.com.
.C. Jack3d and Oxylite ||

3. for ensuring that a dietary supplement or ingredient is safe before it is
marketed. Can dietary supplement makers police themselves?
FDA is responsible for taking action against any unsafe dietary supplement
product after it reaches the market. Generally, manufacturers do not need
to register their products with FDA nor get FDA approval before producing
or selling dietary supplements.
The FDA is responsible to oversee product information, such as labeling,
claims, package inserts, and accompanying literature; however, the
Federal Trade Commission (FTC) regulates dietary supplement advertising.
Packaging and advertising might say: This product has not been evaluated
by the FDA.
Is the FDA doing enough to protect the weight-conscious public against
allegedly harmful dietary supplements like Jack3d and OxyELITE Pro?
Jack3d negative side effects
The Army removed Jack3d (pronounced jacked) and OxyELITE Pro
and other products containing the same active ingredient – DMAA
– from all military bases. DMAA (dimethylamylamine) is promoted to
increase workout energy and efficiency. DMAA has been banned by
numerous sports organizations, including the international body that
regulates Olympic athletes and several professional sports.
DMAA / Jack3d negative side effects include:
 Death
 Heart attack
 Seizure
 Kidney failure
 Liver failure
 Loss of consciousness
 Heart palpitations
USP Labs, LLC a small Texas company, claims the two dietary
supplements are safe when taken as directed. Jack3d and OxyELITE Pro
are sold online and through GNC vitamin stores and other retail.
Our more restrictive neighbors to the north classified DMAA as a drug.
According to Canada’s governmental health agency (Public Health Agency
of Canada), companies cannot sell products containing DMAA as a dietary
supplement.
While USP Labs try to stake claim for Jack3d and OxyELITE Pro as
dietary supplements, medical experts in the United States want to classify
these products as drugs with more FDA oversight because of the Jack3d
negative side effects.
Copyright © 2012 All rights reserved. Anapol Schwartz P
Read more information online at www.anapolschwartz.com.
.C. Jack3d and Oxylite ||

4. Jack3d pulled from shelves
DMAA is marketed as a dietary supplement. DMAA is the active
ingredient in Jack3d and OxyELITE Pro. DMAA was first used as nasal
decongestant in the 1940s then taken off the market and reborn as an active
ingredient in dietary supplements in 2006 after the ephedrine (Fen Fen) ban.
According to the Jack3d website “1,3-Dimethylamylamine HCl is safe in small
doses. Never exceed recommended dosage and follow directions. Although
there are no long-term studies on its usage, it has a long history of safe use.
We will stay on the lookout for more information on geranamine. Geranium
has been safely used as an herbal supplement for centuries, though.”
DMAA is frequently combined with caffeine and other ingredients and
used as an over the counter fat burner or general purpose stimulant. The
only structural difference between DMAA and amphetamine is that DMAA
lacks phenyl or benzene. DMAA’s safety and toxicology profile hasn’t been
established in humans.
In New Zealand, DMAA is an emerging active ingredient of party pills. Side
effects of headache, nausea, and stroke have been reported in recreational
users.
In 2009, the World Anti-Doping Agency added DMAA to the 2010
prohibited list. Numerous athletes in a variety of sports -- cycling, track,
football, rugby, tennis, basketball and more -- have been disqualified from
participating or stripped of medals after testing positive for DMAA.
In 2011, two U.S. soldiers who collapsed during physical training were
both found to have DMAA in their systems. Jack3d was pulled from the
shelves on base stores.
The World Anti Doping Agency considers DMAA a drug while the FDA
considers DMAA a dietary supplement. The U.S. Army considers DMAA
harmful and Jack3d was pulled from shelves in base stores while your
local GNC vitamin store can still make the sale.
Have you or a family member who tried to increase stamina and/or burn
body fat been harmed by Jack3d or similar products with DMAA? If the
answer is yes – then contact us about a possible unsafe Jack3d lawsuit.
Copyright © 2012 All rights reserved. Anapol Schwartz P
Read more information online at www.anapolschwartz.com.
.C. Jack3d and Oxylite ||