Supplements need strong FDA medicine
When I read about the founder of Berkeley Premium Nutraceuticals being sentenced last week to 25 years in prison for defrauding customers with dubious herbal remedies, I asked myself yet again: Why doesn’t the government regulate this stuff?
Unlike conventional drugs, which must be approved by the Food and Drug Administration before hitting store shelves, dietary supplements are basically sold under the honor system. These products now constitute a $22-billion industry.
Supplement makers are required by a 1994 federal law to ensure that their products are safe before being marketed, although no one checks on the companies’ research, if any. The FDA steps in only after a product is marketed, usually if questions arise over whether a product is safe or effective.
By then, of course, it can be too late.
The most prominent supplement gone bad was ephedra, which tens of thousands of people ingested to try to lose weight. By the time it was finally banned by the FDA in 2004 -- after seven years of dithering by officials -- ephedra was linked to more than 100 deaths.
Last week, the Journal of the American Medical Assn. reported that about one-fifth of so-called ayurvedic herbal medicines used by thousands of Americans may contain dangerously high levels of lead, mercury and other toxic substances.
“It’s a real crapshoot for consumers,” said David Schardt, senior nutritionist at the Center for Science in the Public Interest. “There’s no authoritative body you can trust before a dietary supplement is sold.”
Take Airborne, for instance. For more than a decade, people have been plopping those fizzy tablets into water to help prevent colds. “Created by a school teacher!” Airborne’s packaging declared. “Helps support your immune system.”
Last month, Airborne Inc. agreed to pay $30 million to settle charges brought by the Federal Trade Commission that the company was making unsubstantiated claims about the product’s effectiveness.
“It’s like we’re back in the 19th century,” Schardt said. “Companies make these concoctions and sell them with all these wild claims.”
Berkeley Premium Nutraceuticals has sold a variety of herbal supplements, including Enzyte, which the Ohio company’s website says provides a “firmer, stronger, fuller-feeling” sensation to the anatomy of millions of men.
Perhaps you’ve seen Berkeley’s ads featuring a wide-mouthed fellow named Smiling Bob, who apparently enjoys the benefits of a steady regimen of Enzyte.
In February, Berkeley’s founder, Steve Warshak, 42, was convicted on 93 counts of fraud, conspiracy and money laundering for bilking customers out of $100 million. He was sentenced last week to 25 years in prison and ordered to pay $93,000 in fines.
Berkeley Premium Nutraceuticals and other defendants in the case were ordered to forfeit more than $500 million.
Smiling Bob’s enthusiasm notwithstanding, the court ruled that Enzyte doesn’t deliver as promised.
“Steven Warshak preyed on perceived sexual inadequacies of customers,” U.S. District Judge S. Arthur Spiegel said at the sentencing. “I don’t see any evidence of remorse or concern for anyone but himself.”
No one at Berkeley Premium Nutraceuticals returned my calls and e-mails seeking comment.
The supplement industry says a handful of bad apples such as Warshak unfairly tarnish the reputations of trustworthy companies. The industry also says Warshak’s sentencing shows that existing regulations are sufficient to protect consumers.
“A 25-year sentence is a pretty clear indication that regulations are being enforced and they’re pretty strong,” said Daniel Fabricant, vice president of scientific and regulatory affairs for the Natural Products Assn., the leading industry group for dietary supplements.
His message to supplement buyers: “You can feel extremely confident that you’re safe and that you’re not being hoodwinked.”
Michael Herndon, an FDA spokesman, said oversight of the supplement industry improved significantly last year with adoption of a requirement that manufacturers report any “serious adverse events” related to their products.
Such events are defined as involving death or a life-threatening experience, or a condition requiring “medical or surgical intervention” to keep you from keeling over.
Prior to the new rule, regulators typically wouldn’t know of any problems, serious or otherwise, until complaints from consumers piled up.
The new reporting requirement “should increase consumers’ confidence in the quality of the dietary supplement products that they purchase,” Herndon said.
I’m not so sure. The requirement may help stop another ephedra from killing a lot of people, but it would do nothing to address the seemingly exaggerated claims of an Airborne or Enzyte.
How’s this for a rule: If you put something in your mouth, and if that something is purported to improve your health or well-being in any way, then it needs regulatory approval before being marketed.
Fabricant at the Natural Products Assn. said this would be unreasonable for manufacturers and “would effectively remove many of these products from the market.”
No. Safe and effective products would still find their way to market and would no doubt be better for having met more stringent safety requirements.
What that means, though, is that we have to beef up a woefully underfunded, understaffed and underutilized FDA and give the agency the resources it needs to do its job -- keeping dangerous or ineffective medicines away from consumers.
The supplement market is awash in snake oil. If that’s not what we pay our regulators to protect us from, what is?
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