A Supplement Company Sued Over Research It Didn’t Like… And Lost

Image courtesy of Karen Chappell

Unlike FDA-approved medications, makers of dietary supplements are not required to demonstrate that their products are safe or effective. That shouldn’t stop independent researchers from doing their own tests to find out if a product works or is dangerous, but when one Harvard professor tried to do just that, supplement makers tried to shut him up..

STATnews has an in-depth profile of Dr. Pieter Cohen, a researcher and industry watchdog who has been digging into dietary supplements and so-called “all natural” ingredients for years.

That includes an amphetamine-like substance called beta-methylphenethylamine (BMPEA) that has been found to “send blood pressure and heart rate soaring in dogs and cats,” notes STAT, pointing out that the chemical has been linked to at least one stroke, and that Canadian officials have called BMPEA a “serious health risk.”

In 2014, Food and Drug Administration scientists found BMPEA in nine purportedly all-natural supplements instead of the Acacia rigidula plant listed on the label. However, the FDA stayed mum as to the products named or the manufacturers that made them.

That prompted Cohen and his colleagues to try to replicate those findings and publicize the specific brands using BMPEA. In the resulting study published in the scientific journal Drug Testing and Analysis in April 2015, his team says they chemically analyzed 21 popular supplements, made by various manufacturers, all labeled as containing Acacia rigidula. Eleven of those were positive for BMPEA, in some cases at potentially dangerous levels.

“Consumers of Acacia rigidula supplements may be exposed to pharmacological dosages of an amphetamine isomer that lacks evidence of safety in humans,” concluded the 2015 paper, noting that the data strongly suggested this BMPEA was not naturally occurring, but was being added to spike the final product.

The same month that report was released, the FDA issued warning letters to makers of dietary supplements, including a company called Hi-Tech, whose products had accounted for a majority of the supplements that tested positive for BMPEA in Cohen’s study.

“BMPEA is a substance that does not meet the statutory definition of a dietary ingredient,” the agency notes. “The Federal Food, Drug, and Cosmetic Act defines a dietary ingredient as a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances. BMPEA is none of these, rendering misbranded any products that declare BMPEA as a dietary supplement.

A few days later, the FDA continued the crackdown, notifying the makers of products to stop sales.

On that same day, April 28, Hi-Tech filed a lawsuit [PDF] in U.S. District Court in the company’s home state of Georgia against Cohen and the study’s three co-authors for $200 million. Cohen says he didn’t know he was being sued until he came across a report of the lawsuit in a supplement industry trade publication.

Hi-Tech’s owner and CEO Jared Wheat blamed Cohen for costing the company an immediate $14 million in lost business. Wheat says he received “hundreds” of supportive calls and emails in relation to the lawsuit, from people “hoping that we were able to silence this guy.”

A judge in Georgia dismissed that lawsuit in the spring of 2016, however, because Cohen didn’t do any of his work in that state.

“Nothing in Plaintiff’s allegations would show that Defendant Cohen wrote the article or made any additional statements with the purpose of directing them at Hi-Tech, the Georgia Plaintiff,” the judge wrote in that decision. “The alleged offending article relates only to β-methylphenylethylamine (‘BMPEA’) and whether it is a substance that occurs naturally in Acacia rigidula.”

Hi-Tech then refiled the lawsuit [PDF] in Massachusetts, dropping the study’s co-authors as defendants and nixing the demand for $200 million in damages.

Last summer, a federal judge ruled that Hi-Tech had a 7th Amendment right to a jury trial. That required Cohen to turn over hundreds of pages of his notes, peer-review feedback, and his written correspondences with the journal, coauthors, and journalists.

At the trial, which started in October, Hi-Tech accused Cohen of ignoring “fundamental canons and methods of scientific investigation,” and of making allegedly false statements about BMPEA. The company maintained that the BMPEA in its products occurred naturally, counter to Cohen’s contentions.

In the end, the jury wasn’t buying it. On Nov. 1, 2016 they ruled in Cohen’s favor, putting an end to this legal ordeal for the researcher.

He is now back to work: Days after he won the trial, he submitted a new study for publication, and has three new projects in motion this year. In his view, the arrival of the Trump administration means it’s more important than ever to hold the FDA responsible for enforcing the law.

“My experience 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,” Cohen says, adding that if one research paper could lead to an exhausting trial, it could have a chilling effect on others in his line of work.

Wheat, the CEO of Hi-Tech, hopes that’s the case, he tells STAT.

“I spent a lot of money, but hopefully it will deter others from going out there and making baseless allegations,” Wheat said. His advice to other academics: “Think twice and do better research, knowing you can get sued if you do this.”

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