What does a dietary supplement company with a shady past do when reputable researchers find that six of the dietary supplements it sells contain an illegal, potentially dangerous drug in them?
That’s what happened to Pieter Cohen, an assistant professor of medicine at the Harvard Medical School, who tests dietary supplements for the presence of illegal ingredients.
The first detailed look at this legal clash was published this week by STAT, a health and medicine news website. (You can find a link to STAT’s full story at the end of this post.)
Finding an illegal ingredient
Pieter Cohen and his colleagues in 2015 published the results of a laboratory analysis of 21 supplements that found an illegal amphetamine-like drug called BMPEA in 11 of them. The study’s details appeared in the scientific journal Drug Testing and Analysis. Canadian health officials have called BMPEA a “serious health risk.”
Within two weeks, the Food and Drug Administration (FDA) ordered the manufacturers to recall the products.
A dietary supplement company looks to “silence this guy”
Six of the tainted supplements were manufactured by Hi-Tech Pharmaceuticals of Norcross, Georgia, a company that sells $100 million of supplements a year. Twice before, HiTech has gotten into trouble with the FDA for selling illegal supplements. The company’s founder and CEO, Jared Wheat, has also served two prison terms for selling illegal drugs.
All six of the Hi-Tech products were marketed as weight-loss pills. Wheat claims he lost $14 million worth of business because of Cohen’s analysis.
Wheat also said he got “hundreds” of supportive calls and emails from people “hoping that we were able to silence this guy.”
The $300,000 to $400,000 lawsuit
Hi-Tech Pharmaceuticals sued Pieter Cohen and his research team in Georgia for $200 million. When that case was dismissed, Wheat re-filed it in Massachusetts where Cohen works.
A seven-day trial took place last October. Hi-Tech didn’t deny the presence of BMPEA in its products. Instead, it claimed that the substance was a legal dietary supplement ingredient, but offered no evidence to prove that.
The jury quickly declared Cohen not guilty.
Although the lawsuit cost his company $300,000 to $400,000, Wheat said it was worth it. “Hopefully, this will deter others,” he told STAT.
The year-long ordeal was, indeed, grueling for Cohen. Fortunately, he had the backing of Harvard University.
And he was not deterred. A few days after the verdict, Cohen submitted for publication a new study of dietary supplements.
“My experience,” he told STAT, “has really reinforced to me why it is so important to not only continue the research we’re doing but to be very aggressive about speaking out about it.”
Meanwhile, the six tainted supplements from Hi-Tech are still on the market. Wheat has refused to recall them. Instead, he said he made minor modifications to some of the formulas in order to placate his distributors.
Here’s the original study that provoked the lawsuit: An amphetamine isomer whose efficacy and safety in humans has never been studied, β-methylphenylethylamine (BMPEA), is found in multiple dietary supplements.
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