Hey, You Got Steroids in My Supplement!
Earlier this month, I briefly referenced a distant, equally sketchy relative of economic adulteration--spiked product adulteration. FDA commissioner Margaret Hamburg made a big deal about this late last year, after a rash of pharmaceutical ingredients were found in supplements promoted for sexual performance, body building, and weight loss.
Well, it looks one company didn't read the letter she sent to supplement manufacturers…From the website of Natural Products INSIDER, our sister publication, on May 9:
BOISE, Idaho—A federal court has sentenced the Arizona-based Tribravus Enterprises, which also does business as IForce Nutrition in California, to a fine and probation for marketing products as dietary supplements, but which actually were unapproved drugs due to being adulterated with steroids. Chief U.S. District Judge B. Lynn Winmill sentenced Tribravus to three years probation and a $125,000 fine, (payable in installments, in addition to a $400 special assessment) and ordered future financial disclosures and a monitoring and testing protocol that includes testing of all products distributed by Tribravus /IForce for banned steroids.
Where to begin?
First, steroids!
Second, I find it comical that part of Tribravus's punishment is to establish "monitoring and testing protocol" that is an ordinary aspect of business for most companies.
Third, and most unfortunate, is that this news item feeds into a public image that was developed during the ephedra controversy seven or eight years ago—that "natural products" is another term for jittery, unnatural performance-enhancing drugs. That misconception is another subcategory of the ill-developed premise that the natural products industry teems with hucksters and conmen.
And we have this development: This is not Tribravus's first brush with FDA and the Food, Drug, and Cosmetic Act. Last fall, FDA deemed that the company's Reversitol product contained an aromatase inhibitor that was not in line with the definition of a dietary supplement.
"A felony conviction is certainly appropriate, though in this case it was limited to a corporate plea," noted industry attorney Marc Ullman wrote to me in an e-mail. "I believe it would have been appropriate to require an individual plea as well."
I'll take his word on it—my only legal experience is reading "The Firm" when I was 14. But what galls me is that there's no procedure—I asked Ullman about this—where FDA can say to Tribravus (or any other repeat offender), "OK, that's two strikes. One more and you can no longer represent the natural products marketplace in any capacity whatsoever."
Think about it this way. If you keep wreaking havoc at your job, you're reprimanded and, eventually, fired. Lawyers can be disbarred. Professional athletes like Pete Rose can be banned from their sport. Maybe I'm building a rickety tower of nonsense, but there must be some way that the federal government and industry heavyweights can form a tribunal that can utter the final word in cases like these—and enforce it.
Help me out here: Is what I'm proposing as realistic as getting all the world's children together and having them hold hands and sing? Supplement companies: Is this is a story you've been through 100 times before or is your blood boiling?
Is spiked product adulteration, like economic adulteration, a way of business life? Can something be done?
(Note: I e-mailed and called iForce/Tribravus Enterprises seeking comment. As soon as I hear something from a company represenative, I'll share it.)
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