Jared Wheat, the controversial CEO of Hi-Tech Pharmaceuticals, believes his company, seen as a rogue player by many stakeholders in the industry, is using some of its considerable profits to hem in regulatory overreach.
“I see us as being one of the few companies that stands up to the FTC and FDA,” Wheat told NutraIngredients-USA. “They have gone and started legislating by warning letter instead of going to Congress to get ingredients off the market the way they should.
“When they took mahuang (ephedra) off the market, we fought the ban and were unsuccessful but they did it the right way within their mandate,” he said.
Legal wrangle over DMAA
Wheat, who has spent time in prison on a number of charges, and his company are locked in a legal wrangle with FDA over the use of the stimulant ingredient 1,3-dimethylamylamine (DMAA). FDA in 2013 ruled on several grounds that was not a legal dietary ingredient after reports that the stimulant was implicated in the deaths of several soldiers. But while the case makes its way through the courts, Hi-Tech has been free to operate. The case, which has gone on for several years, pits FDA’s mandate to protect public health against the concept of due process before the government takes action against an individual or firm. Hi-Tech has argued that FDA’s use of its power of administrative detention to get DMAA off the market without conducting studies to provide scientific proof on the ingredient’s dangers violates this concept. Wheat says the military’s own assessment of the soldier’s death exonerates DMAA, though the ingredient remains illegal to sell at base commissaries.
“With [ephedra] they did things the right way. They chose not to do so with DMAA. Just because the government writes a warning does not mean they’re right. And a warning letter is not a final agency action. A warning letter starts a dialogue between the company and FDA,” Wheat said.
“When FDA sent out its 12 warning letters on DMAA we continued to sell it and we still do. We have a number of products containing DMAA on the market. We believe it is a constituent of geranium, and we don’t believe it makes a difference if we chemically synthesize that constituent,” Wheat claimed.
Hi-Tech does a considerable amount of contract manufacturing at its plants in Georgia and Pennsylvania and also supplies ingredients. The company claims a annual capacity of 35 billion tablets and 10 billion capsules. If other brand holders are using DMAA or are thinking about doing so, they aree not getting it from him, Wheat claimed. The only DMAA-containing products the company makes have its own labels on the bottles, he said.
“I’ve spent $3 million fighting the FDA on DMAA. I have to fight my own battles,” Wheat said.
Lawsuit vs Pieter Cohen
Wheat has also gotten into significant legal wrangles over another controversial ingredient, beta-methylphenethylamine, or BMPEA, which he claims can be derived from the botanical Acacia rigidula. Prominent industry critic Dr Pieter Cohen of Harvard Medical School had publicly urged FDA to take action on products containing this stimulant-like ingredient, citing serious safety concerns. Wheat’s response was to sue Cohen for defamation, a suit that Cohen ultimately won in November. But Wheat believes he made his point.
“We had been selling the product for 12 years with no serious adverse events,” Wheat said.
Cohen was contacted for comment but said he could not discuss the case further. Other observers say that Wheat’s purpose was to intimdate, a charge Wheat has not denied.
DMAA remains illegal
As for the DMAA case against FDA, the agency’s stance is clear. In response to a request for comment, the agency issued this statement:
“DMAA-containing dietary supplements are illegal and their marketing violates the law. DMAA can be a health risk to consumers and the FDA advises consumers not to purchase or use any dietary supplement containing DMAA. The FDA will continue working to remove dietary supplements containing DMAA from the marketplace.”
And as for Wheat’s claim to wave a free speech and due process flag for the industry, stakeholders within the business are less sanguine. The United Natural Products Alliance has a requirement that no member company will market products containing DMAA. And Michael McGuffin, president of the American Herbal Products Association, which has a number of sports nutrition companies as members, had this to say:
“The Food and Drug Administration has declared since at least 2013 that ‘dietary supplements containing DMAA are illegal.’ As far as AHPA is aware the agency has not changed its position on this ingredient.”