Showing posts with label USPlabs. Show all posts
Showing posts with label USPlabs. Show all posts

Tuesday, December 1, 2015

GNC and Military Base Exchanges stop selling USPlabs products

GNC has ordered its 5,000 retail stores, including those located on military bases, to stop selling products made by USPlabs after the Dallas-based company’s executives were charged with allegedly lying to government regulators and the public about ingredients of at least two products.

GNC officials said Nov. 19 that while the criminal charges are not related to current products on the market, they were suspending sales of all products made by UPSlabs “in the best interest of our customers."

“While ... we have no reason to believe there are any health and safety issues with respect to any USPlabs products currently sold by GNC, it is in our best interest … to suspend the sale of the company’s products pending further review,” Michael Archbold, CEO of GNC, said in a news release.

After GNC made the announcement, the Marine Corps Exchange stopped selling a reformulated version of the workout booster Jack3d, according to a spokesman from the Marine Corps Non-Appropriated Funds Business and Support Services Division.

The Army and Air Force Exchange Service, which carries the USPlabs workout supplement Jack3d Micro, is “evaluating the situation and will decide soon on whether the product will continue to be stocked," a spokeswoman said.

Navy Exchange spokeswoman Kristine Sturkie said USPlabs products were carried by GNC stores and not sold in the service's exchanges.

USPlabs and its top executives face criminal charges following a Justice Department investigation that alleges key ingredients in workout boosters such as Jack3d and OxyElite Pro are synthetic stimulants rather than natural ingredients as claimed.

An 11-count indictment handed down in the U.S. District Court for the Northern District of Texas in mid-November charges USPlabs, S.K. Laboratory and five company executives with unlawful sale of dietary supplements, conspiracy to commit money laundering, obstructing an FDA proceeding, wire fraud and food mislabeling.

The supplements Jack3d and OxyElite Pro contained 1,3 dimethylamylamine, or DMAA, or other ingredients the company claimed were naturally derived from plants, including geraniums or bael, a fruit common in India.

But the Justice Department said the two companies conspired with Chinese manufacturers to create a paper trail claiming the ingredients were natural in an effort to ensure U.S. retailers would sell the products, while the substances actually were synthesized chemical compounds.

The Defense Department removed products containing DMAA, including Jack3d, from base stores and on-base GNCs in 2013 after the supplements were implicated in the deaths of at least two soldiers who suffered heart attacks during physical training.

A follow-on investigation found insufficient evidence to prove the supplements caused the deaths, but investigators still decided that the ingredient posed enough of a health risk to keep it off the shelves of military stores.

In 2012, the FDA told companies selling products containing DMAA to stop using the ingredient.

USPlabs voluntarily destroyed $8 million worth of Jack3d and OxyElite Pro after the FDA move, but then reformulated the products, which made their way back to store shelves.v According court documents, the reformulated OxyElite Pro contained aegeline, which the company claimed was a natural extract but investigators allege is also a synthetic stimulant.

The company also added another ingredient, labeled as cynanchum auriculatum root extract, to OxyElite Pro to promote weight loss.

When the new formula went on the market in October 2013, more than 50 residents of Hawaii, including some military family members, developed acute hepatitis and liver failure. At least one person died and three required liver transplants.

According to the Justice Department, four defendants were arrested Nov. 17 and two agreed to self-surrender.

Article from Military Times

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Tuesday, October 28, 2014

Military Exchange stores again pull fitness supplements

This article came out on 27 October 2014 from Stars and Stripes News. Exchange stores at military bases around the world again pulled fitness supplements from shelves earlier this month after concerns they contained a potentially dangerous and untested stimulant.

The recalls might be triggering déjà vu among troops. Nearly three years ago, the same stores removed a variety of other supplements containing the previously obscure stimulant DMAA after reports of soldier deaths. The families of two soldiers who died after taking the products in 2011 have sued and those cases are heading toward trial.

Now, a study published Oct. 8 found the substance causing the latest military recalls, DMBA, closely mirrors the effects of DMAA as well as its name. The familiar spate of new product recalls and published research shows the military’s struggles with potentially dangerous fitness supplements may be far from over.

“We are seeing the same style [as with DMAA] … multiple companies are introducing these brand new stimulants that have never been tested,” said Pieter Cohen, a doctor and assistant professor of medicine at Harvard University who has studied the stimulants extensively.

At least a dozen supplement products were found to contain the new synthetic stimulant, which has unknown effects and could pose significant health risks, according to a study co-authored by Cohen and published in the Journal of Drug Testing and Analysis.

The Army and Air Force Exchange Service said it pulled the weight-loss supplement MD2 Meltdown on Oct. 14 and Marine Corps exchanges reported removing it a day later due to concerns over DMBA.

Supplement giant GNC, which operates outlets on many military bases, removed that product and two others called Redline White Heat and OxyTHERM Pro this month, the exchange services said.

The Navy Exchange said it does not sell any of the products that tested positive for DMBA.

Companies have sought out new stimulants after the Food and Drug Administration pressed for the DMAA products to be eliminated following a rash of health problems beginning with the soldier deaths in 2011, Cohen said.

The military services and their exchange stores have struggled in the past to keep up with the variety of potentially dangerous substances that have hit the market in recent years. Supplements are largely unregulated by the FDA and ingredients are self-reported. Recalls typically occur only after reports of health problems from the public.

Bodybuilding and weight-loss supplements are highly popular among troops who are often under intense pressure to stay fit — on-post retail sales ring in at about $190 million per year and about 250,000 servicemembers use products considered to be high risk for side effects.

Last year, a supplement containing a designer drug similar to methamphetamine was not recalled from military shelves until months after initial reports of the dangers.

In the case of DMBA, it appears the services moved more quickly.

The stakes can be high and fallout from potentially dangerous supplements can stretch out for years.

Retailer GNC and a maker of DMAA products, USPlabs, recently settled a class-action lawsuit in Florida, reportedly paying out $2 million to consumers.

But the families of Pvt. Michael Sparling and Sgt. Demekia Cola, who both died at Fort Bliss, Texas, after taking the supplements in 2011, are still waiting for their day in court.

“We’re just really racing toward trial. The Sparlings are really looking forward to telling their story in court,” said Anne Andrews, a California attorney who also represents Cola’s family. “They want the world to know a young soldier died because of a dangerous product sold at GNC.”

Sparling, 22, took the bodybuilding and weight-loss supplement Jack3d just before a 3½-mile run with his new unit in summer 2011. He collapsed, lost consciousness and began foaming at the mouth.

He was pronounced dead several hours later at a nearby hospital.

His parents believe DMAA directly contributed to their son’s death and that it could kill or seriously injure some users even at recommended doses. They sued GNC and USPlabs and created a foundation in their son’s name to educate the public on the dangers of supplements.

Their case is set to be heard in a Texas court in June.

A lawsuit against the companies was also filed by Cola’s mother. The sergeant experienced muscle breakdown and heatstroke in late 2011 after taking a DMAA product. She suffered with complications for more than a month and died while waiting for a liver transplant, according to the court filing.

Both GNC and USPlabs declined to comment on the lawsuits.

They have repeatedly denied DMAA products pose a health risk.

A spokesman for USPlabs referred Stars and Stripes to a Department of Defense safety review two years ago that could not determine DMAA caused four reported soldier deaths but did find the substance might have endangered thousands of troops.

A GNC spokesman issued a statement saying, “GNC fully complies with all federal, state, and local laws and regulations with respect to the sale of dietary supplements, including those governing ingredients.”

MyAchingKnees Comment: Well, there you go. How many articles have to be published about the dangers of toxins or just poor manufacturing control of food grade supplements? With GNC stating that they comply with all law and regulations concerning supplements and ingredients, the logical question is "what laws and regulations might those be?" I am not trying to make light over this latest fiasco concerning off the shelf supplements, as I too was in the Army and the pressure to be as fit and physical as you could be prompted almost everyone I knew to take supplements. I was a GNC customer for years. Until 9 1/2 years ago, when I began to get educated. Not just in the need for supplementation, but the choices one has with quality or choosing the monetary savings you get with non-quality products.

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