A Norcross dietary supplement maker is once again under federal scrutiny, warned this time to immediately stop sales of products with an ingredient that may not be safe.
The U.S. Food and Drug Administration says Hi-Tech Pharmaceuticals shouldn’t be selling products containing the stimulant DMHA.
But a defiant company owner Jared Wheat vows to continue to provide his customers with the pre-workout powders and diet aids until a court orders him to stop. Wheat – no stranger to battling with federal authorities – says the FDA’s recent warning is toothless.
“We are not only going to respond but sue the agency. They’re just basically trying to scare you into submission,” he told the Atlanta Journal-Constitution.
Wheat is already fighting federal criminal charges accusing him of wire fraud and money laundering, and of introducing misbranded drugs and products that contain anabolic steroids into interstate commerce.
Wheat has been trying to get the criminal charges thrown out, telling the court that he was being singled out for prosecution in retaliation for speaking out against the FDA. He also argued that the products in question didn't contain enough anabolic steroids to warrant criminal charges.
Earlier this month, a federal magistrate rejected both arguments.
Wheat is also battling a $40 million civil penalty ordered by a federal judge in a lawsuit the Federal Trade Commission filed years ago. In that case, the judge ruled that Wheat violated a permanent injunction against making unsubstantiated claims for purported weight-loss products.
Many of Wheat’s battles have been over the legality of the ingredients in his dietary supplements, including a long fight over products with the amphetamine-like stimulant DMAA. That stimulant was blamed for the deaths of two U.S. soldiers in 2011.
When Wheat continued to sell DMAA products despite an FDA ban, federal authorities seized millions of dollars worth of product inventory at his Norcross headquarters.
He’s gone to federal prison twice. In 2006, he was accused of illegally importing prescription drugs from a manufacturing center in Belize and served two years in prison after pleading guilty. He was sent to prison in 2014 for failing to carry out a product recall but released after two months when the recall was completed.
His latest run-in came when the FDA told Wheat, as well as seven other dietary supplement makers, that they were violating the law by selling products that contain DMHA. Warning letters to the companies were recently posted on the FDA website.
“There is inadequate information to provide reasonable assurance that such ingredient (DMHA) does not present a significant or unreasonable risk of illness or injury,” the FDA letter states.
It continued: “To the best of the FDA’s knowledge, there is no history of use or other evidence of safety establishing that DMHA will reasonably be expected to be safe when used as a dietary ingredient.”
According to the FDA, Hi-Tech products Ultimate Orange, HydroxyElite, Lipodrene Elite and Synadrene are labeled as containing DMHA. Hi-Tech’s website promotes Ultimate Orange as a pre-workout powder that supports increased muscle mass and strength and the other products as capsules that can help with weight loss.
The FDA warning letter gave Wheat 15 working days to provide documentation that detailed the specific steps he had taken to correct and prevent a recurrence of the violations.
In a news release, Hi-Tech said that the FDA letter was a "bullying tactic" to quasi ban a product by issuing a warning. The proper means by which the agency should deem whether a product is safe is by its standard procedure of rule-setting, and the FDA did not adhere to that, the post says.
The federal agency, which is chiefly responsible for ensuring that drugs are safe and effective, regulates dietary supplements as foods. But unlike, drugs, supplements don’t have to be proven safe and effective before they are sold. That’s because supplements are supposed to either contain only natural ingredients or ingredients that were lawfully marketed for dietary products before 1994.
FDA claims that DMHA does not meet either test. Wheat asserts that DMHA is commonly found in natural foods, so it is legal.
“In this particular case, DMHA is found in walnuts, so therefore walnuts have clearly been in the food supply since 1994 so our position is that you know this is an ingredient within the walnut and so therefore it is a lawful dietary supplement,” he said.
Similarly, in his battle with FDA over DMAA, Wheat had argued that stimulant was a natural ingredient because it is found in geraniums, an argument that the courts rejected.
Andrew Shao, a spokesman for the supplement industry’s leading trade association, said it’s not uncommon for companies to disagree with the FDA over its product interpretations.
However, when there is a safety concern, he said the industry always sides with the regulator.
Hi-Tech is “not really representative of the mainstream, responsible industry,” said Shao, who is senior vice president for scientific and regulatory affairs at the Council for Responsible Nutrition, based in Washington, D.C.
Dietary supplements are a growing industry in the U.S. More than 170 million Americans take them daily, studies show.
A recent survey by the council reported that 75% of U.S. adults use supplements, compared with 65% a decade ago. Most adults take multivitamins and minerals. About 29% take sports nutrition boosters, such as protein powders, while 19% use weight management supplements.
Staff writer Danny Robbins contributed to this report.
FDA wants to overhaul regulatory process for supplements
As more new products flood the market, the FDA is working on efforts to modernize its approach to regulating dietary supplements, industry officials say.
The agency has been pushing for companies to undergo a notification process before they introduce new products to the marketplace. That process would require them to provide FDA with a dossier on the product ingredients along with safety data.
Now, dietary supplements don’t have to have pre-market approval from the FDA. But companies must address any FDA concerns about the products’ safety and compliance with federal law.
“Our members represent the responsible players in this industry so they do comply with this requirement,” said Andrew Shao, spokesman for the Washington, D.C.-based Council for Responsible Nutrition, which represents more than 150 dietary supplement companies.
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