I return to this issue only once in a great while, so I hope you’ll forgive a brief (or maybe not so brief) tirade on an issue that doesn’t get a lot of attention.
A bipartisan pair of senators — Dick Durbin (D-Ill.) and George Voinovich (R-Ohio) — told the FDA yesterday that the federal system on regulating dietary supplements is wholly inadequate. If anything, the two were mild in their criticisms.
“If the object of this law is to protect American consumers, it fails,” Durbin told the director of the FDA’s Center for Food Safety and Applied Nutrition, Robert Brackett, who is responsible for enforcing the law. “How can you meet that responsibility when the law is so weak?”
In particular, Voinovich expressed concern about a 10-year commitment to set federal standards for manufacturing processes that would prevent contaminants such as bacteria and lead from appearing in these supplements. Yet, a decade later, the standards don’t exist.
That’s not good enough, Voinovich told Brackett. “I just cannot believe that it has taken that long after this law is passed,” the senator said. “It’s unacceptable that it takes 10 years to get something done.”
The regulations will be “done as soon as possible, that is our goal,” Brackett said.
This is more than just a problem with a slow-moving agency. The Dietary Supplement Health and Education Act (DSHEA) doesn’t work because it was designed not to.
If you see a “supplement” on the shelf at a grocery store or pharmacy, you’d probably assume that it’s safe. After all, the FDA wouldn’t allow stores to sell products unless they meet a minimum of safety and health regulations, right? Wrong.
It all comes back to the DSHEA, championed by Sen. Orrin Hatch (R-Utah) a decade ago. The law, as Stephanie Mencimer explained in the Washington Monthly a few years ago, “has left Americans ‘free’ to serve as guinea pigs for a multibillion-dollar industry, much of which is built on a foundation of fraudulent claims, pyramid schemes, and lousy manufacturing practices.”
If this were simply about customers being fooled into thinking some sugar pill will help them burn fat while watching TV, it would still be a multi-million dollar fraud on the public. Regrettably, it’s far, far worse.
Since DSHEA became law, substances as varied as paint stripper, bat shit, toad venom, and lamb placenta have all been imported from overseas, bottled up—often by people with no scientific or health backgrounds—and marketed as dietary supplements to unsuspecting American consumers. Many supplements have been tainted with salmonella, arsenic, lead, pesticides, unapproved foreign prescription drugs, as well as garden-variety carcinogens. And despite their New-Age health aura, a significant portion of these “natural supplements” are stimulants, depressants, and other mood-enhancers that some medical experts believe would be classified as drugs if they were synthetic. A surprising number of these products are addictive.
Thanks to Hatch, the U.S. now has standards as low as those in many Third World countries for the sale of many products with serious, pharmacological effects. The results have been deadly. Between 1993 and 1998, the FDA linked at least 184 deaths to dietary supplements, which are now suspected of contributing to the sudden deaths of three football players in August [2001].
Hatch’s DSHEA ties the government’s hands by shifting the burden of proof from manufacturers to regulators. In short, DSHEA doesn’t require manufacturers to prove their product is safe before putting the pills on store shelves, it requires the FDA to prove the product is unsafe. Worse, while drug manufacturers are required to record and report adverse reactions effecting consumers taking their medication, Hatch’s DSHEA frees makers of these supplements from this “burden,” so adverse and possibly dangerous reactions remain secret from consumers.
And yet, this treacherous law has esacped attention for the better part of 10 years. Maybe it has something to do with the fact that the supplement industry generates over $17 billion a year and lavishes generous campaign contributions on its political allies.
Sen. Durbin, to his credit, is the first lawmaker in years to express real concern by recommending a modest, common-sense first step in fixing this law.
Durbin, who requested the subcommittee hearing, is sponsoring a bill that would make manufacturers report serious adverse reactions such as hospitalizations, permanent injuries or deaths involving users of supplements. The bill also would let the government require manufacturers to prove a product is safe if FDA had received information that suggested adverse reactions from a supplement.
Does the president — that paragon of compassion — support Durbin’s move?
“The administration at this time has no plans to make any changes,” the FDA’s Burkett said.
One of these days, the curtain will be lifted on this scam and Americans will wonder why we didn’t do something sooner.