Yourlawyer.com (DMAA Dietary Supplement News) http://www.yourlawyer.com/topics/overview/DMAA-Dietary-Supplement-Lawsuit-Heart-Attack Sat, 18 May 2013 21:38:36 -0400 pixel-app en FDA Warns Consumers, Retailers, Manufacturers to Stop Using DMAA Supplements http://www.yourlawyer.com/articles/read/19284 Tue, 01 Jan 2013 00:00:00 -0500 http://www.yourlawyer.com/articles/read/19284 Federal health officials are warning of the dangers of workout supplements that contain the additive dimethylamylamine (DMAA).

In a warning letter it issued last week, the FDA said it “is using all available tools” to make sure DMAA products are no longer available to consumers. The FDA has declared DMAA illegal and notes that it should no longer be sold in the U.S. Despite its warning, however, the FDA admits that its reach over the dietary supplement industry presents some challenges to eradicating DMAA products in the U.S. (these such products already have been eliminated in foreign markets).

DMAA has been implicated in a handful of deaths and dozens of other adverse health events recently. The U.S. Food and Drug Administration (FDA) has warned that products containing DMAA are dangerous, but manufacturers and retailers have argued against this stance, believing there is no evidence to support the regulator’s position.

According to a New York Times report in response to the FDA warning, retailer GNC said it will not remove products containing DMAA from its shelves. Popular products containing DMAA are marketed as Jack3d and OxyElite Pro, and are used primarily by people in workouts as a stimulant.

A New York Times report last week noted that while GNC continues to market products containing DMAA, another retailer, Vitamin Shoppe, has removed the products from its shelves.

The FDA feels compelled to act against products containing DMAA after receiving dozens of reports of adverse health events among people who were using these supplements. The agency said it has received 86 reports of illness or death associated with the supplements. The agency says some of the reports include effects to a person’s heart or nervous system but added that it could not conclusively determine that DMAA had caused these conditions.

Response to the FDA’s warning has largely been positive, but one specific manufacturer of DMAA products, USPLabs, has denied the allegations that the supplements it makes are dangerous. USPLabs even refutes the assertion that DMAA is dangerous, and submitted data back to the agency attempting to prove that DMAA is safe to use.

The FDA said in its warning statement last week that “after reviewing the studies provided by USPLabs, [we find] the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.”

Still, the FDA does not have full regulatory control over dietary supplements, so its warning is just that, for now. To completely remove products containing DMAA from shelves, the agency must complete more exhaustive legal steps. The FDA said it is continuing that process to ensure consumers do not have an opportunity to purchase products with DMAA.

Federal health officials are warning of the dangers of workout supplements that contain the additive dimethylamylamine (DMAA).

 

In a warning letter it issued last week, the FDA said it “is using all available tools” to make sure DMAA products are no longer available to consumers. The FDA has declared DMAA illegal and notes that it should no longer be sold in the U.S. Despite its warning, however, the FDA admits that its reach over the dietary supplement industry presents some challenges to eradicating DMAA products in the U.S. (these such products already have been eliminated in foreign markets).

 

DMAA has been implicated in a handful of deaths and dozens of other adverse health events recently. The U.S. Food and Drug Administration (FDA) has warned that products containing DMAA are dangerous, but manufacturers and retailers have argued against this stance, believing there is no evidence to support the regulator’s position.

 

According to a New York Times report in response to the FDA warning, retailer GNC said it will not remove products containing DMAA from its shelves. Popular products containing DMAA are marketed as Jack3d and OxyElite Pro, and are used primarily by people in workouts as a stimulant.

 

A New York Times report last week noted that while GNC continues to market products containing DMAA, another retailer, Vitamin Shoppe, has removed the products from its shelves.

 

The FDA feels compelled to act against products containing DMAA after receiving dozens of reports of adverse health events among people who were using these supplements. The agency said it has received 86 reports of illness or death associated with the supplements. The agency says some of the reports include effects to a person’s heart or nervous system but added that it could not conclusively determine that DMAA had caused these conditions.

 

Response to the FDA’s warning has largely been positive, but one specific manufacturer of DMAA products, USPLabs, has denied the allegations that the supplements it makes are dangerous. USPLabs even refutes the assertion that DMAA is dangerous, and submitted data back to the agency attempting to prove that DMAA is safe to use.

 

The FDA said in its warning statement last week that “after reviewing the studies provided by USPLabs, [we find] the information insufficient to defend the use of DMAA as an ingredient in dietary supplements.”

 

Still, the FDA does not have full regulatory control over dietary supplements, so its warning is just that, for now. To completely remove products containing DMAA from shelves, the agency must complete more exhaustive legal steps. The FDA said it is continuing that process to ensure consumers do not have an opportunity to purchase products with DMAA.

]]>
DMAA Side Effects Prompt U.K. Ban http://www.yourlawyer.com/articles/read/18980 Wed, 05 Sep 2012 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18980 Health officials in England have ordered that all dietary and fitness supplements containing the stimulant DMAA (dimethylamylamine) should be pulled from store shelves because they put people at risk of suffering serious and life-threatening injuries.

According to a report from UK’s The Daily Mail, the ban includes the popular supplement Jack3d. Millions of units of Jack3d have been sold worldwide and in the U.K. it is no less popular. It is taken typically in combination with a workout regimen and is purported to benefit a person’s routine, helping them build muscle and cut fat.

As its popularity has increased exponentially in recent years, the notoriety has not always been positive. In recent months, supplements containing DMAA have been blamed on a growing number of adverse reactions suffered by people taking them, including the deaths of two U.S. soldiers who purchased a DMAA supplement at their base’s commissary shops.

Other reports show that supplements containing DMAA raise a person’s excitability and heart rate, many times to dangerous levels. In instituting the ban, the Medicines and Healthcare products Regulatory Agency in the U.K. (MHRA) noted that supplements containing DMAA increase a person’s heart rate and narrows their arteries. The agency said DMAA supplements can also cause high blood pressure, headaches, vomiting, and stroke.

 The Mail indicates that MHRA has already issued eight separate warnings to retailers who sell supplements containing the stimulant. These products are commonly found at nutritional stores like GNC (in the U.S.) and they’re also widely available for sale on the Web. 

 A spokesperson for MHRA told the source that retailers who continue to sell DMAA supplements will receiving a warning letter from the agency telling them to remove the products immediately. The previous eight warnings also told retail shops to stop selling DMAA supplements because they had been linked to dangerous side effects. 

 In the U.S., the Food and Drug Administration is engaged in its own fight with makers of supplements containing DMAA. Since they are not regulated entirely by the agency the way any other pharmaceutical product would be, the FDA has stopped short of ordering a recall on products but has warned retailers to stop selling the products. Many retailers have ignored the call for action and continued to sell the supplements, saying they would only remove the products once the FDA officially ordered a recall.

 DMAA supplements purportedly contain herbal ingredients not considered pharmaceuticals but the stimulant is listed as a banned substance for many sports agencies, including the U.S. and World Anti Doping agencies. The companies manufacturing these supplements have been ordered to submit documented evidence showing their products are safe and effective to the FDA in order for them to continue being available at the retail level here.

]]>
Health officials worldwide reacting to DMAA injuries, considering bans http://www.yourlawyer.com/articles/read/18852 Tue, 19 Jun 2012 00:00:00 -0400 http://www.yourlawyer.com/articles/read/18852 Health authorities in Australia have joined others around the world in warning the public about hte dangers of dietary and sports supplements containing the additive DMAA, or dimethylamylamine.

According to a report at NutraIngredients.com, the Food Standards Australia New Zealand (FSANZ) board has warned the public against using supplements often used in conjuction with bodybuilding or weight loss workout regimens. The additive DMAA is largely considered unsafe and puts people at unknown health risks but many reports suggest they increase the likelihood of heart attack and stroke.

In the U.S., the Food and Drug Administration has ordered the makers of these products to pull them from store shelves because they make false claims about their safety and effectiveness at aiding workouts. The FDA said no evidence exists to support the claims makers of DMAA supplements make and it considers the products adulterated and the claims false.

Making medical claims on a product in the U.S. requires the submission of scientific evidence that the product performs as advertised.

A growing number of adverse event reports involving DMAA brought these supplements into the focus of federal regulators and other health officials worldwide. This includes the death of two U.S. soliders following a workout. They had traces of DMAA in their system during an autopsy and were believed to be taking supplements sold at U.S. bases to soldiers that contained DMAA.

Officials in the U.S., Canada, Denmark, and now Australia and New Zealand have taken some stance on DMAA supplements. The substance has been placed on a banned substances list by Major League Baseball. It is also banned by the World Anti-Doping Agency and was reponsible for the most bans on athletes for doping, 123, in 2010.

The report indicates the Australian Federal Dept. of Health and Aging and the Advisory Committee on Medicines Scheduling are considering an outright ban on supplements containing DMAA by the end of July. FSANZ has identified at least 11 products containing DMAA that it is advising the public to avoid because they've received adverse event reports from people taking them: Noxpump, 3-D Explosion, Beta-Cret, PreSurge, 1 MR, Cyroshock, Jack3D, Mesomorph, Neurocore, Oxyelite Powder, and Hemo Rage Black.

In New Zealand, health officials there have labeled DMAA as a narcotic. 

In Australia, according to the report, DMAA is blamed with causing hyperactivity in a growing number of residents, especially younger people. Parents report their children acting hyper-active and focused, it adds. DMAA supplements are blamed for causing an increased heart rate and hyperactivity in a recently filed U.S. lawsuit by a man and woman who were taking them as part of their workout regimen. 

]]>
Dimethylamylamine ( DMAA ) Injury Lawsuit | Dimethylamylamine ( DMAA ) Injury Lawsuit | Heart Attack, Heart Problems, Cardiac Problems, Irregular heartbeat, Seizures, Heart attack, Stroke, Liver damage or liver failure, Kidney damage or kidney failure, Psychiatric side effects, Elevated blood pressure, Sudden cardiac death | Lawsuits, Lawyer, Attorney http://www.yourlawyer.com/topics/overview/DMAA-Dietary-Supplement-Lawsuit-Heart-Attack Tue, 19 Jun 2012 00:00:00 -0400 http://www.yourlawyer.com/topics/overview/DMAA-Dietary-Supplement-Lawsuit-Heart-Attack Dimethylamylamine ( DMAA ) Injury Lawsuit

Dimethylamylamine ( DMAA ) Injury Lawsuit | Heart Attack, Heart Problems, Cardiac Problems, Irregular Heartbeat, Seizures, Heart Attack, Stroke, Liver Damage, Liver Failure, Kidney Damage, Kidney Failure, Psychiatric Side Effects, Elevated Blood Pressure, Sudden Cardiac Death | Lawsuits, Lawyer, Attorney

Did you suffer a heart attack or other heart problem while using a DMAA (dimethylamylamine) dietary supplement? Also known as "workout boosters," DMAA supplements sold under the names Lean Efx, Napalm, Nitric Blast and others have been the subject of Food & Drug Administration (FDA) warnings. DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest, to heart attack, according to the agency. In December 2011, the U.S. Department of Defense pulled dozens of DMAA products from U.S. military bases after two soldiers who died during or shortly after physical activity were found to have DMAA in their bloodstreams.

The defective drug lawyers at Parker Waichman LLP are currently investigating DMAA supplement side effects, including:

  • Irregular heartbeat
  • Seizures
  • Heart attack
  • Stroke
  • Liver damage or liver failure
  • Kidney damage or kidney failure
  • Psychiatric side effects
  • Elevated blood pressure
  • Sudden cardiac death

If you or a loved one used a DMAA workout booster and suffered one of these serious side effects, we want to hear from you today. Our DMAA injury lawyers are offering free lawsuit evaluations to anyone injured by one of these products. To learn more about the legal remedies available to you, please contact our DMAA injury lawyers today.

DMAA Supplements

DMAA dietary supplements have been marketed by certain companies as a dietary supplement in combination with caffeine and other ingredients. DMAA supplements contain a synthetic drug ingredient that has a stimulant effect that is similar to ephedrine, though not as strong. Though DMAA supplements are marketed as "natural," most experts agree there is no credible evidence linking DMAA to a natural source, and it is actually a synthetic drug.

DMAA may be listed on supplement labeling as

  • 1,3-dimethylamylamine
  • Methylhexanamine
  • geranium extract (or any part of the geranium)
  • 4-methyl-2-hexanamine
  • 2-amino-4-methylhexane

In December 2011, DMAA workout boosters were banned from on-site stores at U.S. military installations after the deaths of two soldiers were linked to such products. In the summer of 2011, a 22 year-old soldier collapsed and died at an Army base in the Southwest during a training run. That fall, another solider at the same base collapsed after a physical fitness test. The 32-year-old died in the hospital just a month later. Both soldiers were found to have DMAA in their blood.

FDA DMAA Warning Letters

In April 2012, the FDA issued warning letters to 10 DMAA supplement makers and distributors for marketing products for which evidence of the safety of the product had not been submitted to FDA.

DMAA supplements named in the FDA letters included:

  • Biorhythm SSIN Juice
  • Lean Efx
  • Spirodex
  • PWR
  • Napalm
  • Code Red
  • Hemo Rage Black
  • Lipo-6 Black Ultra Concentrate
  • Lipo-6 Black
  • Lipo-6 Black Hers Ultra Concentrate
  • Lipo-6 Black Hers
  • MethylHex 4,2 
  • Nitric Blast
  • Oxy Elite Pro
  • Jack3D 

According to the FDA, it has received 42 reports of side effects in patients who took supplements that contain DMAA. They included heart and nervous system problems, psychiatric disorders, and death.

Legal Help for Victims of DMAA Supplements

If you or a loved one suffered a heart attack, stroke or other serious health problem while using a DMAA supplement product, you may have valuable legal rights. To discuss your case with one of our DMAA injury lawyers, please fill out our online form, or call 1 800 LAW INFO (1-800-529-4636) today.

]]>