Federal authorities have seized more than $2 million worth of dietary supplements from Hi-Tech Pharmaceuticals in Norcross, claiming the products are illegal because they contain the stimulant DMAA.
The seizure is the latest action by the U.S. Food and Drug Administration in the wake of an Atlanta Journal-Constitution investigation revealing that Hi-Tech has been selling products containing the amphetamine-like ingredient even as the FDA has been working to purge it from the market.
Hi-Tech CEO Jared Wheat declined to discuss the seizure with the AJC Tuesday. However, he was quoted in a trade publication last week as saying his company still has a sizable quantity of DMAA.
“They seized what was in my warehouse that day, but they didn’t seize what was in my warehouse the following day and the next day and the next day,” Wheat reportedly told Natural Products Insider.
An FDA spokeswoman declined to comment, citing a policy against publicly discussing pending litigation.
U.S. marshals seized more than 1,500 cases of finished goods and more than 1,200 pounds of raw materials at the Hi-Tech facility on Nov. 12, according to the FDA.
A federal government complaint filed in U.S. district court in Atlanta on Nov. 7 requested the seizure and condemnation of 19 products as well as all raw ingredients containing DMAA. The complaint alleged that the products were adulterated and asked that they be forfeited to the government.
Among the products that were seized was Fastin-XR, a weight loss product that the AJC found on the shelves at GNC, CVS and Kroger stores. CVS and Kroger pulled the product after learning from the newspaper that it was labeled as containing DMAA, but GNC declined to say whether it would do the same.
DMAA, used in supplements aimed at enhancing workouts or promoting weight loss, has been linked to dozens of serious medical conditions, including heart attacks and strokes. At least eight deaths in the U.S. have been tied to products containing the stimulant. None of the deaths or reports of serious medical problems have been linked to the Hi-Tech supplements.
Besides the health concerns, the FDA says DMAA can’t be sold as a dietary supplement because it’s not found in nature. Although some companies say the ingredient is derived from geraniums, the FDA disputes that claim.
The seizure of products at Hi-Tech followed a detention order issued by the FDA on Nov. 1 placing a temporary hold on them for at least 20 days. The order was issued after the FDA inspected the facility as a result of the AJC’s investigation.
In response to the seizure order, Hi-Tech filed a lawsuit in federal court in Washington, D.C., challenging the FDA’s authority to stop companies from stop selling DMAA. The lawsuit claims the FDA is engaging in a “campaign of intimidation” against individual companies instead of following its own procedures and formally banning DMAA.
The suit says DMAA is a natural component of the geranium plant, a claim, according to the pleading, that can be supported by at least four studies. It also states that Hi-Tech has sold over a million bottles of products containing DMAA without any adverse event reports.
In his interview with Natural Products Insider, Wheat said he plans to fight the FDA in court even though it could cost his company $1 million.
“My whole business model is to give consumers the product they want,” he said. “Just (throwing) in the towel is not how I was raised.”
Wheat’s company has twice before faced court actions aimed at stopping the sale of its products, including one found to contain an illegal erectile dysfunction drug, and he spent two years in federal prison after pleading guilty in 2008 to directing an enterprise that sold knock-off prescription drugs.
Wheat also has been targeted by the Federal Trade Commission, which in a 2008 obtained a judgment of nearly $16 million against him and other defendants for making unsubstantiated product claims. In that case, Wheat faces the possibility of more jail time for failing to abide by the 2008 order.
The FDA began sending letters to companies selling DMAA products more than a year ago, warning them that the stimulant cannot be used in supplements, but it did not include Hi-Tech among those companies.
One of the companies that received a warning letter, USPlabs of Dallas, initially declined to comply. But it later destroyed its stock of two popular DMAA supplements, Jack3d and OxyElite Pro, after the FDA seized 3,200 cases in GNC warehouses.