A U.S. District Court judge has ordered a permanent injunction against Hood River businessman James Cole, who has been accused by the federal government of selling “adulterated” and “unapproved” dietary supplements under his company Maxam Nutraceutics.
The injunction was entered by Judge Michael Simon in U.S. District Court in Portland on Feb. 5, which prevents Cole and his former general manager, Julie Graves, from manufacturing or distributing their products until they come into compliance with federal law, as first reported by the Hood River Biz Buzz.
According to Cole’s attorney John Markham, the injunction has resulted in the closure of Cole’s business located at 1020D Wasco Street.
“He’s obviously very sad that he had to shut down and can no longer supply his customers with his products,” Markham said, speaking on behalf of his client after the News made multiple attempts to contact Cole via both the local and toll-free phone numbers for Maxam Nutraceutics.
The injunction is one of several actions the federal government has taken against Cole over the past five years. According to News archives, in 2010 the Food and Drug Administration issued a warning letter to Cole and his company Maxam Nutraceutics, threatening legal action unless he corrected “unsubstantiated claims” involving his products’ health benefits, which offered treatments for everything from autism to Alzheimer’s and other afflictions.
In 2011, federal agents raided Cole’s home on the Heights as well as his business’ offices on Wasco Street and the Big Gym on West Cascade Avenue, which Cole owned at the time and is now known as the Power Station gym and the site of Cross Fit Hood River. Agents confiscated documents, computers and over a half a million dollars in cash and gold from Cole.
In 2013, Cole pled not guilty to a federal case brought against him that alleged he had filed false tax returns. That same year, a jury ruled against Cole in another case, allowing the federal government to keep the assets it seized in the 2011 Hood River raids.
The most recent case stated that Maxam’s supplements were unapproved by the FDA and were considered “misbranded drugs because the products failed to bear adequate directions for use for the purposes for which the drugs were intended” according to a news release from the U.S. Department of Justice. The court also found that the dietary supplements were “adulterated” because they had not been “produced in compliance with federal good manufacturing practice regulations,” and noted that “defendants did not have specifications for the ingredients in their products and did not conduct appropriate tests on incoming shipments of components used in the manufacture of their products to determine the identity, strength, purity and composition of each component.”
Markham says his client continued to stand by his products, despite continued scrutiny from the FDA, and is bolstered by positive customer testimonials regarding the efficacy of Cole’s supplements.
“In the 15 years he’s been selling these products, despite the FDA looking high and low, there has not been one illness, injury or bad reaction,” Markham noted.
Cole also challenged the federal government’s tactics used in their investigations. A website called “Maxam vs. FDA” makes references to the “tyranny” of the FDA and linked to a legal defense fund for Cole, as well as providing updates regarding the court cases. A message on the website that appears to have been signed by Cole states that over $600,000 had been spent on legal fees over the last five years and that the injunction was “the final straw.”
“They have us in a checkmate situation where we can’t possibly survive or ever comply,” the message states, adding that “we are being forced to close Maxam in contemplation of bankruptcy.”
Markham was not able to confirm the veracity of the message or whether Cole was considering bankruptcy. He said Cole was working to comply with the terms of the injunction in an attempt to get his business up and running again.
“He is determined to find a lawful way to sell these products,” Markham said.
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