Despite checkered history, Norcross supplement maker avoids FDA crackdown

AJC investigation prompts retailers to remove products
Hi-Tech Pharmaceuticals president and CEO Jared Wheat at the company’s headquarters in Norcross, Georgia on Wednesday, December 5, 2007. The dietary supplement manufacturer is facing a variety of federal charges. PHOTO CREDIT: ERIK S. LESSER

Credit: Erik S. Lesser

Credit: Erik S. Lesser

Hi-Tech Pharmaceuticals president and CEO Jared Wheat at the company’s headquarters in Norcross, Georgia on Wednesday, December 5, 2007. The dietary supplement manufacturer is facing a variety of federal charges. PHOTO CREDIT: ERIK S. LESSER

1944 _ Dimethylamylamine, or DMAA, is patented under the name Forthane by Eli Lilly and Company for use in nasal spray.

1983 _ Eli Lilly withdraws Forthane from the market.

2006 _ Patrick Arnold, a chemist involved in the BALCO steroid scandal, introduces DMAA as a dietary supplement ingredient under the name Geranamine.

June 2011 _ Army Pvt. Michael Sparling, 22, collapses after a run at Fort Bliss in El Paso, Texas, and dies. Hypothermia is listed as the cause of death. Toxicology tests show DMAA and caffeine in his blood.

November 2011 _ A 31-year-old female soldier collapses while running. She dies six weeks later. The cause of her death is also listed as hypothermia, and toxicology tests also show caffeine and DMAA.

December 2011 _ The Department of Defense orders that all products containing DMAA be pulled from military exchanges.

April 2012 _ The FDA begins sending warning letters to companies selling products with DMAA, advising them that those products can’t legally be sold as dietary supplements.

January 2013 _ A coroner in Britain cites DMAA as a factor in the death of 30-year-old runner Claire Squires at the 2012 London Marathon.

February 2013 _ Sparling’s family files suit against USPlabs, the Dallas company that distributed the dietary supplement Jack3d, and GNC, the retailer that sold it, alleging they contributed to the Army private’s death.

April 2013 _ The FDA issues an alert to consumers stating that DMAA doesn’t qualify as a legal supplement and that it can dangerously elevate blood pressure.

May 2013 _ The House Energy and Commerce committee requests information on DMAA from the FDA, USPlabs and GNC.

June 2013 _ The Department of Defense releases a report on DMAA. It says no “direct causality” could be found between the deaths of four soldiers and their use of DMAA products. However, it recommends continuing the ban on the sale of DMAA products at military exchanges.

June-July 2013 _ In federal court, the FDA seeks to seize more than 3,200 cases of USPlabs DMAA products Jack3d and OxyElite Pro at GNC warehouses in Pennsylvania and South Carolina. GNC subsequently agrees to destroy the products.

July 2013 _ USPlabs destroys its inventory of Jack3d and OxyElite Pro.

1998 _ Hi-Tech Pharmaceuticals is incorporated in Georgia.

2000 _ The Atlanta field office of the Drug Enforcement Administration investigates Wheat’s role in the distribution of a substance called “Verve,” which allegedly includes the date-rape drug Gamma Hydroxybutyrate (GHB) and is labeled as “cleaning solution” to conceal its real purpose. Wheat wasn’t charged with a crime.

2003 _ Hi-Tech Pharmaceuticals agrees to destroy seven of its dietary supplements after the FDA seeks an injunction against the company for selling misbranded and unapproved new drugs. Some of the products had been subject to a public health advisory stating that they contained the erectile dysfunction drug tadalafil.

2004 _ The Federal Trade Commission files suit against Wheat, Hi-Tech Pharmaceuticals and others alleging that they made false advertising claims.

February 2006 _ The FDA seizes more than 200 cases of supplements valued at $3 million from Hi-Tech Pharmaceuticals because they contain the banned stimulant ephedra, linked to serious illnesses and deaths.

September 2006 _ A federal indictment alleges that Wheat masterminded a scheme in which Hi-Tech Pharmaceuticals used the Internet to sell knock-off prescription manufactured in Belize.

August 2008 _ Wheat pleads guilty to conspiracy to commit mail and wire fraud and to introduce and deliver unapproved new and unadulterated drugs into interstate commerce.

December 2008 _ U.S. District Judge Charles A. Pannell orders Wheat and other defendants in the FTC case to pay $15.9 million. The ruling also enjoins them from making false product claims in the future.

February 2009 _ Wheat is sentenced to 50 months in prison, followed by three years of supervised released.

March 2011 _ Wheat is released from prison.

August 2013 _ Pannell rules that Wheat and other defendants in the FTC case violated the 2008 court order by continuing to make false product claims.

September 2013 _ In a court filing, the FTC says it believes “coercive incarceration” is the only way to compel compliance with the judge’s order.

About this story

To check on the availability of products labeled as containing dimethylamylamine, or DMAA, The Atlanta Journal-Constitution purchased products from the websites of both Hi-Tech Pharmaceuticals and APS Nutrition. The newspaper also found a Hi-Tech product with DMAA, Fastin XR, being sold at GNC, CVS and Kroger stores in the Atlanta metro and the Dallas-Fort Worth areas.

Material on the deaths and health issues relating to DMAA and the FDA’s response was gathered from FDA documents, lawsuits and a report compiled by the Department of Defense, as well as interviews with industry experts. The AJC used the federal Freedom of Information Act to obtain a compilation of the adverse health events reported to the FDA.

To gain an understanding of how many supplement companies are still selling DMAA products, the AJC reviewed a database of DMAA products maintained by a federal program that studies health issues affecting soldiers.

Background on Jared Wheat was gleaned from criminal and civil court records dating back 10 years.

For more than a decade, federal authorities have had their eyes on Jared Wheat.

Wheat and his Norcross dietary supplement company, Hi-Tech Pharmaceuticals, have been forced to destroy products spiked with an erectile dysfunction drug, accused of selling a concoction containing a date-rape drug and and hit with a judgment of nearly $16 million for making false claims.

When federal prosecutors built a case against Wheat in 2009 for directing a scheme that sold knock-off prescription drugs through the Internet, they called him “a dangerous drug dealer.” He went to prison for two years. He and his company were required to forfeit $3 million.

Now Wheat and Hi-Tech Pharmaceuticals have found another niche. In this case, his products have names like Yellow Scorpion, Black Widow, White Lightning and Lipodrene Hardcore. And, according to their labels, they contain an amphetamine-like stimulant that the U.S. Food and Drug Administration says is illegal.

The stimulant, dimethylamylamine, or DMAA, also has been linked to dozens of serious health problems, including heart attacks and strokes. At least eight people in the U.S. have died in the last three years after using DMAA products, according to lawsuits, military records and adverse event reports compiled by the FDA. Four were soldiers who used the products to get through physical training.

For more than a year, the FDA has been attempting to crack down on companies selling DMAA products, which are promoted largely as improving energy for workouts and aiding in weight loss.

But Wheat’s companies, Hi-Tech Pharmaceuticals and a subsidiary, APS Nutrition, are among dozens that have continued to sell DMAA products in stores and online, The Atlanta Journal-Constitution found.

The AJC found a Hi-Tech Pharmaceuticals product labeled as containing DMAA on the shelves at GNC, as well as at CVS and Kroger stores. That supplement, Fastin-XR, is a weight-loss product that "seriously pumps up the stimulant activity" through DMAA and other ingredients, according to the Hi-Tech web site.

Inquiries from the AJC about the product caused both CVS and Kroger to recall it.

“We were not aware that Fastin-XR contained DMAA,” said Keith Dailey, a spokesman for Kroger Co. “We’re aware of it now.”

GNC, a defendant in two wrongful death suits over DMAA, said it is no longer purchasing the products. But the Pittsburgh-based health and fitness giant would not say whether it would remove existing stock from its shelves.

In an interview with the AJC, the FDA’s top supplement official, Dan Fabricant, acknowledged that the FDA was “familiar” with Wheat but wasn’t aware his companies were selling DMAA products until informed by the newspaper.

None of the nearly 90 adverse event reports the agency has collected related to DMAA links Wheat’s products to the medical problems. The majority cite supplements distributed by a Dallas company, USPlabs.

The FDA has sent letters to a handful of companies warning them that DMAA cannot be used in dietary supplements, and USPlabs agreed to destroy its stock of two popular products, Jack3d and OxyElite Pro, after the agency went to court to seize more than 3,200 cases in GNC warehouses.

Those actions aren’t insignificant, Fabricant said.

“We’ve got a marketplace of 85,000 products out there,” he said. “That’s enormous. I think our actions against USPlabs, the biggest seller of this particular product … shows we don’t take these matters lightly.”

Some say the supplement industry can’t be easily policed because, unlike drugs, supplements do not require FDA approval before they can be sold.

Still, the fact that Wheat’s companies have avoided the FDA’s crackdown raises new concerns about the agency’s ability to purge an ever-burgeoning market of products that can cause harm, some industry experts said.

Dr. Pieter Cohen, an assistant professor at Harvard Medical School who has closely studied DMAA and its effects, said it’s “just shocking” that, given Wheat’s history, the FDA didn’t immediately notice his companies were selling supplements with the stimulant.

Wheat, 41, declined a request to be interviewed for this story through his attorney, Art Leach.

“We certainly have a perspective on all that,” Leach said, referring to the DMAA issue. “But this is not the best time to engage in that conversation.”

Legal problems mount

Wheat started Hi-Tech Pharmaceuticals in the late 1990s, shortly after he completed a federal prison sentence for selling Ecstasy in his native Alabama.

Because he didn’t finish college and had a felony conviction, Wheat believed he would be shut out of a more traditional business career, according to a bio that appeared on his company’s web site.

“It was during a period of time I was (imprisoned) I basically formulated the idea of Hi-Tech and I came up with the name and started the company out of my parents’ house in Birmingham,” he was quoted as saying.

Wheat’s business history has since played out against a backdrop of thousands of pages of court documents, some containing salacious allegations, as a variety of federal agencies have pursued him and his companies.

In 2003, Hi-Tech agreed to destroy seven of its products after the federal government sought an injunction against it for selling unapproved and misbranded drugs. Some of those products had been the subject of an earlier public health advisory stating they contained tadalafil, an erectile dysfunction drug that had yet to be approved in the U.S.

In the knock-off prescription drug case, the government portrayed Wheat as the mastermind of an enterprise that purported to sell cheap, generic drugs from Canada when in fact they were manufactured under unsanitary conditions in Belize.

Wheat was arrested at his Alpharetta home in 2006, and authorities seized two expensive sports cars _ a 2006 Maserati Quattroporte Q and a 2000 Ferrari 360 Modena F _ in addition to computers and more than $100,000 in cash.

Perhaps the most compelling part of the case were allegations put forth by the government in an effort to detain Wheat prior to trial.

Describing Wheat as "a dangerous drug dealer who has perhaps squirreled away millions of dollars and is a significant flight risk," authorities quoted a witness who said he'd buried hundreds of thousands of dollars behind Wheat's house at Wheat's request. It also was alleged that Wheat and others had discussed hiring a private detective to blackmail an assistant U.S. attorney and obtaining a gun and silencer to attack an FDA agent.

In a 2008 interview with MSNBC, Wheat denied having knowledge of the alleged plots.

“I’ve never been in as much as a fistfight since I was a 10-year-old kid,” he said. “I’m not a violent person and Hi-Tech is not that kind of company.”

Wheat ultimately pleaded guilty to conspiracy to commit mail and wire fraud and selling unapproved and adulterated drugs and was sentenced to 50 months in prison. He remains on supervised release as part of his sentence.

Four of Wheat’s co-conspirators also received prison terms.

“We are extremely fortunate that no one was sickened or killed by these drugs,” said David Nahmias, then the U.S. attorney for the northern district of Georgia.

Wheat and his companies have also been embroiled in a lawsuit filed by the Federal Trade Commission seeking sanctions against them for making false and unsubstantiated product claims.

The lawsuit, filed in 2004, led to a 2008 judgment requiring that Wheat and other defendants pay $15.9 million and refrain from making certain product claims. But the case remains unresolved, with Wheat facing the possibility of jail time for contempt.

The FTC alleges that Wheat and his companies have continued to make false claims, causing consumers to lose at least $36 million. "Only coercive incarceration" will compel them to comply with the court's order, the FTC said in a September court filing.

U.S. District Judge Charles A. Pannell will consider the matter at a hearing that has yet to be scheduled, according to court documents.

Among the documents filed by the FTC are emails indicating that, even while incarcerated, Wheat directed Hi-Tech, often with an eye to making sure the company’s products would be sold by GNC and other national retail outlets.

“The only way to pay down the FTC debt is to hit a home run,” Wheat wrote in an email to his associates. “I have done well over the years with base hits but now I have to swing for the fence.”

‘Jolt of extreme energy’

According to the Washington Post, a chemist, Patrick Arnold, introduced DMAA as a supplement ingredient in 2006, calling it “Geranamine.” Arnold had previously gained notoriety for his role developing substances for the Bay Area Laboratory Cooperative, or BALCO, the company famously exposed as a supplier of performance-enhancing drugs for athletes.

Hi-Tech Pharmaceuticals introduced its first DMAA products about the time Wheat was released from prison in March 2011 and added more in 2012, an Internet Archive search of the company’s website shows.

Around the same time, a series of deaths linked to USPlabs’ DMAA products started to call attention to the stimulant.

Michael Sparling collapsed during a run at Fort Bliss in El Paso, Texas, in June 2011. Before the exercise, the 22-year-old Army private from California used the USPlabs product Jack3d purchased at a GNC store on the base, according to a wrongful death suit filed by his family.

The death of a 24-year-old Abilene, Texas, woman while visiting friends in Austin in November 2011 occurred under similar circumstances, according to a lawsuit filed by her family. Jessica Davila died of malignant hyperthermia after using USPlabs' OxyElite Pro, also purchased at GNC, the suit says.

Mark Zamora, an Atlanta attorney who is representing Davila’s estate, called Davila “a fit young lady who took her health seriously.”

“She took the typical dosage and paid for it with her life,” he said.

The deaths of Sparling and another soldier prompted the Department of Defense to remove all DMAA products from military exchanges.

The FDA then got involved. It says DMAA is illegal because, even though some products label it “geranium extract,” it is a synthetic compound. That means it doesn’t qualify under federal regulations for use in dietary supplements because it is not a natural ingredient.

The FDA began sending out warning letters to companies selling DMAA in April 2012 and has since sent a total of 13. It's believed all have stopped selling the products, Fabricant said. Two other companies have voluntarily recalled their DMAA products.

However, a database of DMAA products maintained and updated monthly by the Human Performance Research Center, a federal program that studies health issues affecting soldiers, shows that 69 products distributed by 40 different companies remain available online.

Eight of those products are from Hi-Tech Pharmaceuticals or APS Nutrition. On the companies' websites, DMAA is plainly listed among the ingredients _ in some cases, boldly so.

“Millions of people have enjoyed the effects of … DMAA,” the description for one of the products proclaims. “… Now White Lightning takes extreme energy to another level! White Lightning will cause you to feel the jolt of extreme energy from the moment you take it and will stay all over you for hours!”

Spot checks by the AJC at retail outlets in two states also found one of Hi-Tech’s DMAA products, Fastin-XR, on the shelves at GNC, CVS and Kroger stores.

Mike DeAngelis, a spokesman for CVS Caremark, wrote in an email that, because no FDA warning letter had been sent to Hi-Tech Pharmaceuticals, CVS did not “have visibility to the DMAA issue” as it relates to Fastin-XR until contacted by the AJC.

Like Kroger, CVS ordered the product removed from its shelves.

GNC took a different stance when contacted by the newspaper.

In an email, company spokeswoman Laura Brophy said GNC “believes DMAA is safe and legal.” She cited a Department of Defense report that found no “direct causality” between the military deaths and DMAA.

Although Brophy said GNC is no longer purchasing products containing the stimulant, she said the company would not respond to the question of whether it would remove any existing products with DMAA from its shelves.

GNC CEO Joseph Fortunato, questioned about DMAA during the company’s first quarter earnings call in April, said the FDA had “pretty much” said the products are safe “just from the fact they haven’t pulled them from the shelves.”

Fabricant defended the FDA’s actions, saying the agency is doing its best with limited resources.

“One out of every four dollars in the country is spent on an FDA-regulated good,” he said. “It’s pretty clear we don’t command one out of every four dollars in the (federal) budget, nor is one out of every four people in the U.S. working for the FDA.”

Steve Mister, president of the Council for Responsible Nutrition, a trade group for supplement companies, said the FDA typically cracks down on market leaders and hopes smaller firms will comply on their own.

“They hope the little guys see that the big guy is facing a seizure and the destruction of product,” he said. “But if (the smaller firms) don’t get the message, then the FDA does need to go back and clean up the smaller players as well.”

The FDA has had the authority to issue mandatory recalls for supplements since Congress passed the Food Safety Modernization Act in 2010, but the agency has yet to use it.

Zamora said the FDA’s effort is failing, and it won’t become effective unless there’s a mandatory recall of all DMAA products.

“If there’s another death, it’s on the FDA and the product maker,” he said.