The U.S. Food and Drug Administration has issued an order that temporarily halts a Norcross company’s distribution of dietary supplements with an amphetamine-like stimulant that has been under the agency’s scrutiny for more than a year.
The company, Hi-Tech Pharmaceuticals, previously had dodged the FDA’s efforts to purge the market of products containing dimethylamylamine, or DMAA, an Atlanta Journal-Constitution investigation revealed. The detention order, issued as a result of that investigation, requires that shipments be detained for at least 20 days while the FDA contemplates further action.
But Hi-Tech has filed a lawsuit in U.S. district court in Washington, D.C. challenging the FDA’s action.
The company contends that the agency has overstepped its authority by cracking down on companies selling DMAA products without formally banning the ingredient. The suit asks that a judge set aside the detention order against Hi-Tech and stop the FDA from taking any type of enforcement action against the firm.
“In short, rather than meet its burden of proof and allow public comment on a rule-making procedure regarding DMAA, the FDA preferred to formally intimidate dietary supplement makers who marketed these products,” the suit alleges.
The suit says the FDA inspected Hi-Tech’s facilities on Nov. 1 and then issued the detention order. According to the suit, the FDA has demanded that the company cease making and marketing DMAA products and voluntarily destroy its existing stock.
Dan Fabricant, director of the FDA’s dietary supplement programs, said Wednesday he’s prevented by agency policy from commenting on pending litigation. However, he pointed out that the FDA can use a variety of tools, including detention orders, to remove products it believes are harmful.
“Our authority is to protect the public from misbranded or adulterated products,” Fabricant said. “When there’s scientific evidence that something is adulterated or misbranded, (the FDA) doesn’t have to go through a rule-making process.”
That’s particularly true for DMAA, which has been linked to at least eight deaths and dozens of serious medical conditions, including heart attacks and strokes, he said.
“I think, by and large, we don’t expect dietary supplements to cause people to have seizures, to have strokes, to have rapidly increased heart rates,” Fabricant said.
The FDA was given the power to obtain administrative detention orders for products it believes are adulterated or misbranded under the Food Safety Modernization Act, passed by Congress in 2010. Previously, to detain products the FDA had to show they presented a threat of serious health consequences.
Speaking generally, Fabricant said a detention order allows the agency to “hold products in place” until it decides how to proceed. That could mean court action to seize the products, he said.
The FDA campaign against DMAA started more than a year ago with a series of warning letters to about a dozen companies selling the products, aimed largely at enhancing workouts or promoting weight loss.
In addition to health concerns, the letters cited the FDA’s contention that, because DMAA isn’t found in nature, it can’t legally be sold as a dietary supplement. Although some companies have said DMAA can be produced from geraniums, the FDA says there’s no credible scientific evidence to support it.
USPlabs, a Dallas company linked to most of the serious health problems, voluntarily destroyed its stock of two popular products, Jack3d and OxyElite Pro, in July after the FDA obtained court orders for the seizure of more than 3,200 cases of those supplements at GNC warehouses.
However, until inquiries from the AJC, none of the agency’s actions were directed at Hi-Tech even though the company and its CEO, Jared Wheat, have a history that’s well known to federal authorities.
The FDA has twice taken legal action against Hi-Tech to get its supplements off the market _ once for selling products containing an erectile dysfunction drug and and another time for selling products with ephedra _ and Wheat spent two years in federal prison for directing a scheme that sold knock-off prescription drugs through the Internet.
In its lawsuit against the FDA over DMAA, Hi-Tech argues that the ingredient can indeed be found in geraniums and that “no less than four published, peer-reviewed scientific studies” have confirmed it. Hi-Tech has sold more than a million bottles of supplements with DMAA without any adverse event reports, according to the pleading.
The suit says Hi-Tech sells supplements at more than 100,000 retail locations, including GNC, CVS, Walgreens, Kroger and Kmart, and that the company “has an established and respected business reputation in the dietary supplement industry.”
Jack Wenik, a Newark, N.J., attorney representing Hi-Tech, said his client believes it has a strong case.
“I have no problem in saying my client believes this ingredient is safe and that the lawsuit has a good-faith basis to go forward,” he said.
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