A Supplement Company Sued Over Research It Didn’t Like… And Lost
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 lettersto 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.
Read more here.