November 20, 2013
Although federal authorities recently seized more than $2 million in dietary supplements from Hi-Tech Pharmaceuticals Inc., the company is continuing to make products that contain the controversial stimulant 1, 3-Dimethylamylamine (DMAA) as it gears up for a long and costly legal battle with FDA.
"They seized what was in my warehouse that day," Hi-Tech Pharmaceuticals president Jared Wheat told Natural Products Insider Tuesday, "but they didn't seize what was in my warehouse the following day and the next day and the next day."
Hi-Tech Pharmaceuticals and FDA have sued each other in Georgia and the nation's capital.
On Oct. 24, FDA showed up for an inspection to review the company's compliance with current GMPs (good manufacturing practices). During the days-long inspection that ended on Nov. 3, FDA didn't directly ask about DMAA, Wheat said.
"They asked about it in an indirect way when they were asking for certain documents," he said.
Wheat said FDA didn't find violations of cGMPs, meaning it didn't issue a Form 483. Instead, the agency took more drastic action.
On Nov. 1, FDA invoked its administrative detention authority under the nearly 3-year-old Food Safety Modernization Act (FSMA). Wheat noted the agency stuck tape around his products, preventing the company from shipping them out of its warehouse. FDA has authority to detain products for up to 30 days without involving the courts.
"When you go arrest a cocaine dealer, do you leave the stuff at his house?" Wheat said. "Why would you leave it at our warehouse if it's so bad?"
Four days later, Hi-Tech Pharmaceuticals filed a lawsuit in Washington, against FDA and the U.S. Department of Health and Human Services. Hi-Tech Pharmaceuticals claimed FDA unlawfully failed to engage in a rule-making procedure before banning DMAA from the market. According to the lawsuit, the agency has violated the Administrative Procedure Act and the Dietary Supplement Health and Education Act of 1994 (DSHEA).
"By its own admission, the FDA has declined to engage in the rule-making process necessary to formally ban DMAA. Thus, there has been no public discussion or comment regarding the scientific evidence regarding DMAA and its safety," New Jersey lawyer Jack Wenik wrote in the complaint on behalf of Hi-Tech Pharmaceuticals. "DMAA has existed in the food supply for many years. Hi-Tech has sold over a million bottles of dietary supplement products containing this ingredient without any adverse event reports."
During a presentation at SupplySide West last week, Daniel Fabricant, Ph.D., FDA's Director of the agency's Division of Dietary Supplement Programs, argued that FDA does not need to follow the rule-making process to remove DMAA products from the market. He said DMAA is not a dietary ingredient, so supplements that contain it are not legal to sell in the United States.
FDA hasn't formally responded yet to the lawsuit. However, it alleged in a separate complaint filed in Georgia that Hi-Tech Pharmaceuticals' products are adulterated under the Federal Food, Drug and Cosmetic Act because they contain an unapproved food additive. The agency on Monday announced that U.S. Marshals seized more than $2 million in products from the company's warehouse.
The supplements found to contain DMAA or its equivalent included: Black Widow, ECA XTREME, FASTIN, FASTIN-XR, Lipodrene, Lipodrene HARDCORE, Lipodrene XR, Lipodrene XTREME, LIPOTHERM, Stimerex-ES and YELLOW SCORPION.
It was more than 18 months ago that FDA sent a warning letter to 10 supplement firms. In the letters, FDA declared that DMAA was unsafe and illegally on the market. Although Hi-Tech Pharmaceuticals made products with DMAA, it didn't receive a warning letter from FDA.
FDA said it received several reports of death and illnesses associated with DMAA-containing supplements, including heart problems and nervous system or psychiatric disorders. The agency warned that the substance can heighten blood pressure and could lead to such cardiovascular problems as shortness of breath, tightening of the chest and heart attack.
One of the companies that received a warning letter was USPlabs LLC. Earlier this year, in the face of legal action, the sports supplement manufacturer agreed to destroy products worth roughly $8.5 million, Fabricant wrote in a blog. The other companies that received warning letters removed DMAA from their products, according to the lawsuit Hi-Tech Pharmaceuticals filed against FDA.
Hi-Tech Pharmaceuticals plans to fight FDA in both lawsuits even though Wheat said it could cost the company $1 million and take at least a year to be resolved. According to the company's lawsuit, the retail giant GNC sold more than "440 million doses of DMAA with only a single adverse event report (AER)."
"My whole business model is to give consumers the product they want," Wheat said. "Just [throwing] in the towel is not how I was raised."
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