Here’s something so obvious that it should have been done years ago:
WASHINGTON — Unlike prescription drugmakers, manufacturers of vitamins, minerals and herbal remedies have no obligation to tell the Food and Drug Administration if consumers suffer serious side effects after taking their products.
That may soon change.
Legislation headed for a vote in the Senate would mandate for the first time that makers of dietary supplements and over-the-counter drugs inform the FDA when they learn of any serious adverse event linked to their products.
“The current reporting system is voluntary. It’s not adequate for detecting the number or prevalence of adverse events associated with a product,” said Sen. Dick Durbin (D-Ill.), a key backer of the bill.
The legislation defines a serious adverse event as a death, life-threatening experience, inpatient hospitalization, disability, birth defect or medical and surgical intervention.
The measure stems from concerns regarding the now-banned dietary supplement ephedra, which has been linked to dozens of deaths; from the dangers associated with the use of steroids and performance-enhancing substances by athletes; and from a variety of scientific reports raising doubts about numerous herbal products.
A group of the big players in the $23 billion-a-year industry, facing growing criticism and worried about the possibility of tougher controls, has signed off on the bipartisan legislation. The bill was approved in committee in late June, and could be voted on before the Senate begins its August recess later this week. It would then move to the House.
Steve Mister, the chief executive officer of the Council for Responsible Nutrition, a major industry trade group, said the reporting requirement for serious adverse events is “the right thing to do for consumers.”
“It will give FDA the ability to look for early trends or signals where there could be a problem,” Mister said.
But Mister said the industry will never back other legislative proposals that would require their products receive FDA approval for safety and efficacy before marketing.
One smaller trade group, the Nutritional Health Alliance, opposes the adverse-event bill, saying in a statement that it will “destroy health freedom and the nutritional supplement industry.”
“Health freedom”? Funny, these guys aren’t so forgiving about big pharma whenever there is are adverse reactions to conventional medications.
Of course, this never would have been necessary if Congress hadn’t passed a law exempting supplement manufacturers from FDA approval:
Congress in 1994 enacted the Dietary Supplement Health and Education Act, a measure that removed the requirement that manufacturers prove the safety of their products either before or after marketing.
Instead, it placed the burden on the FDA to prove a dietary supplement already on the market poses a significant and unreasonable risk to health before it can be recalled.
The supplement industry has driven a tank through this loophole by marketing all sorts of herbal remedies and compounds as “supplements,” making health claims with a wink-wink, nudge-nudge and an unconvincing disclaimer that their products are “not meant to diagnose or treat any disease.” The result:
In May, a National Institutes of Health scientific advisory panel concluded that this regulatory system makes it “difficult for the health of the American public to be adequately protected.”
“The FDA has insufficient resources and legislative authority to require specific safety data from dietary supplement manufacturers and distributors before or after their products are made available to the public,” the scientists said.
“This lack of regulation exists despite the fact that many of the ingredients of multivitamin/multimineral supplements would be subject to pre-market approval if they were marketed as food additives, and in some cases the ingredients possess biological activities similar, if not identical, to those found in medications,” said the NIH report.
A mandatory adverse-event reporting system was one of the scientists’ recommendations.
The FDA estimates there are 29,000 dietary supplements on the market today, up nearly 20 percent since Congress weakened the regulations. More than half of American adults take multivitamins or mineral supplements, according to recent surveys.
But a string of studies and reports have found companies making false and misleading claims about their products, adding ingredients that could be dangerous or failing to manufacture supplements properly to ensure purity and quality.
Tod Cooperman, president of Consumerslab.com, an independent dietary supplement-testing company, said in congressional testimony in March that “one out of four supplements has a quality problem.”
In addition, he said his organization has found products contaminated with heavy metals, in one case discovering a ginkgo biloba supplement containing more than 30 times the allowable limit of lead. He said he found fish oils and other oils that were “rancid, spoiled, that you would not want to be taking.”
I applaud Congress for finally taking a baby step to deal with this problem. It’s still too little, but it’s a start.
Anyone want to take a bet on how long it is before I start seeing rants on altie websites decrying this reasonable step towards reregulating the supplement industry as a conspiracy of big pharma to “suppress” alternative medicine? And, of course, the passage of this bill is nowhere near secure.
Big suppa (big supplement) is not without its own power to persuade Congress.
