Showing posts with label dmaa lawyer. Show all posts
Showing posts with label dmaa lawyer. Show all posts

Saturday, September 21, 2013

GE Pharma Announces Recall of Creafuse Powder

Ge Pharma, LLC of North Haven, CT is recalling Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, packaged in a white, 600 gram container with an expiration date of 2/2015 because it contains 1,3 dimethylamylamine (DMAA).
DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. The Food and Drug Administration (FDA) has warned that DMAA is potentially dangerous to health. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems. A number of adverse effects associated with DMAA containing dietary supplements have been reported to the FDA. The FDA has also warned that DMAA is not a dietary ingredient and thus, is not Dietary Supplement Health and Education Act (DSHEA) compliant.
The product was distributed nationwide and was sold via telephone and email. There have been no reports of adverse events associated with these products to date.
No other products distributed by Ge Pharma LLC are subject to recall.

Wednesday, September 26, 2012

September, 2012 DMAA News

The US Food and Drug Administration (FDA) has issued another warning letter for DMAA, with Irvine, CA-based Regeneca receiving the letter for its RegeneSlim product.

Tuesday, May 08, 2012

DMAA News for May 8, 2012: GNC, Vitamin Shoppe Keep DMAA Products in Stores

From CNBC:

Ten days after the FDA sent warning letters to manufacturers of supplements with DMAA in it, the nation’s largest supplement retailers still have the product on the shelves

 Although companies have insisted that DMAA is a product that exists in nature (from the geranium plant), the FDA has challenged that assertion. Since DMAA wasn’t previously approved as a supplement, it would technically be considered a drug and therefore be subjected to more stringent oversight. Dietary supplements do not have to be approved before hitting the market. Those that are considered drugs cannot be sold before receiving FDA approval. While the FDA said in its warning letters that the safety record of DMAA is not clear, Vitamin Shoppe and GNC seem to be making the bet that DMAA is in fact safe. 

The two retailers could potentially get their money back from the manufacturers, but if DMAA is proven to be dangerous, the companies would still have legal exposure

Tuesday, May 01, 2012

May 1, 2012 DMAA News: FDA challenges marketing of DMAA products for lack of safety evidence

The U.S. Food and Drug Administration today issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.
Also referred to as 1,3-dimethylamylamine, methylhexanamine, or geranium extract, the ingredient is in dietary supplements and is often touted as a "natural" stimulant.  
The companies receiving warning letters and their product names are:
 Company Product(s)
 Exclusive SupplementsBiorhythm SSIN Juice
 Fahrenheit NutritionLean Efx
 Gaspari NutritionSpirodex
 iSatori Global Technologies, LLCPWR
 Muscle Warfare, Inc.Napalm
 MuscleMeds Performance TechnologiesCode Red
 Nutrex ResearchHemo Rage Black
Lipo-6 Black Ultra Concentrate
Lipo-6 Black
Lipo-6 Black Hers Ultra Concentrate
Lipo-6 Black Hers 
 SEI PharmaceuticalsMethylHex 4,2 
 SNI LLCNitric Blast
 USP Labs, LLCOxy Elite Pro
"Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated," said Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program.

Specifically, the warning letters cite the companies for marketing products for which a notification had not been submitted for the use of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible for notifying the FDA of evidence to support their conclusion that their dietary supplements containing NDIs are safe. Manufacturers or distributors must submit notification at least 75 days before marketing their products. The companies warned today were marketing products for which this requirement had not been met.
The FDA warning letters also advised the companies that the agency is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible for ensuring that they are marketing a safe product.
The FDA letters noted that 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. The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.
The agency additionally warned the companies that synthetically-produced DMAA is not a “dietary ingredient” and, therefore, is not eligible to be used as an active ingredient in a dietary supplement. DSHEA defines a dietary ingredient as a vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of these substances.

Thursday, March 08, 2012

3/7/2012 DMAA News

Lead plaintiff Stephen Rush has sued Nutrex Research in Federal Court. This is the next lawsuit regarding DMAA.

 Rush claims that Nutrex's leading products, including "Hemo Black Rage," "Hemo Black Rage Ultra Concentrate," "Lipo Black 6 Ultra Concentrate," "Lipo Black 6 Hers" and "Lipo Black 6 Hers Ultra-Concentrate" contain dangerous levels of the stimulant DMAA, also known as 1,3, dimethylamylamine, and as methylhexanamine, and as geranamine.

DMAA, whose 1944 patent claims to be derived from the oil of the geranium plant, is a dangerous central nervous system stimulant that is on the World Anti-Doping Agency and Major League Baseball lists of banned substances, according to the 37-page complaint. "DMAA is totally banned in Canada and New Zealand. Recently, DMAA has gained popularity with young people as a designer drug used in 'party pills,'" according to the complaint.

DMAA was developed by Eli Lilly and marketed as a nasal decongestant in the 1970s under the trade name Forthane, the complaint states.

Rush claims that the DMAA in Nutrex's products is purely synthetic. "Significantly, recent studies have also concluded that there is no DMAA in geranium oil at all, that DMAA cannot be extracted from geranium oil, and that all DMAA on the market is synthetic," the complaint states.

Monday, February 27, 2012

2/27/12 DMAA news:

Another lawsuit over DMAA. The compound is  1,3-dimethylamylamine, also known as DMAA, is "illegal and dangerous," court filings said. in another case The lawsuit also claimed that "experts in the industry have become concerned that this potent stimulant drug will lead to serious health issues and even death."

The suit was filed by Lynette Bates, who last summer bought a pre-exercise drink powder called C4 Extreme, which promises "explosive workouts."

Bates sued retailer GNC and Cellucor Sports Nutrition, which manufactures, distributes and markets the supplement, for "making false and unsubstantiated representations concerning the efficacy, safety and legality of C4 Extreme," among other claims. Cellucor's parent company, Woodbolt International, is also named in the suit.

C4 Extreme is no longer manufactured with DMAA. But the substance can still be found in a variety of dietary supplements aimed at boosting physical performance or weight loss, such as Jack3d (pronounced "jacked") and OxyELITE Pro, which are sold online and at retail stores.
Advertised as "legal cocaine" on some websites, the powder is also sold in packets or pill form. Medical experts say there are potential health risks from consuming DMAA.

Tuesday, February 07, 2012

News: DMAA – Jack3d and OxyELITE Pro News February 2012

English: Logo of the .
Image via Wikipedia

The United States Army is investigating DMAA dietary supplements – Jack3d and OxyELITE Pro – after two U.S. soldiers died from heart attacks during fitness exercises. The Defense Department removed these products and any products containing the same active ingredient – DMAA – from all military bases. It is unclear at this point what action the FDA will take.
The active ingredient DMAA (dimethylamylamine) is promoted to increase workout energy and efficiency. However, DMAA, found naturally in Asian geraniums, is a dangerous additive. Medical literature from the 1950s discovered the toxicity of DMAA.
DMAA has been banned by numerous sports organizations, including the international body that regulates Olympic athletes and several professional sports.
Already, one lawsuit has been filed against BPISports. A class action claims Florida-based BPI Sports’ bodybuilding and dietary supplements “contain a dangerous amphetamine-like ingredient that poses a serious health risk and has potentially life-threatening side effects.”
BPI’s products include ’1.M.R’ powder and tablets, ‘RoxyLean ECA’ and ‘Rx6.’ These products are purported dietary supplements which are marketed for use as bodybuilding and weight loss supplements. 1.M.R is marketed as a pre-workout bodybuilding supplement. RoxyLean and Rx6 are marketed as ‘fat burning’ weight loss supplements.
The Most Serious Jack3d or OxyELITE Pro Side Effects Include:
Heart Attack
Cardiac Arrest
Heat Stroke
Kidney Failure
Liver Failure
Loss of consciousness
Heart palpitations
Talk with us if you believe that you or someone you care about took a DMAA product and was hurt by it.

Enhanced by Zemanta