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Waxman Says FDA Dropped the Ball on Lead Contamination Investigation
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ShareApril 06, 2007 11:50 AM
The Food and Drug Administration is under fire for failing to take "even basic first steps" to investigate elevated levels of lead in a popular women's vitamin supplement.
Lead poisoning can cause permanent brain damage, hypertension, organ failure and death, according to the Centers for Disease Control and the Agency for Toxic Substances and Disease Registry.
In January, an independent testing company reported it had found high levels of lead in The Vitamin Shoppe-brand Multivitamins Especially for Women. The supplements contained 15.3 micrograms of lead, according to the company New York-based Consumerlab.com. According to the FDA, pregnant women should not ingest more than 25 micrograms daily of lead; small children should not have more than six micrograms.
"Given the potential public health hazard posed by this product, I was disturbed to learn that your agency had taken no meaningful steps to investigate these allegations," Rep. Henry Waxman, D-Calif., chairman of the House Oversight and Investigations Subcommittee, said in a recent letter to FDA Chairman Andrew von Eschenbach.
The Vitamin Shoppe company has questioned the accuracy of the Consumerlab.com report in press reports but immediately recalled the Multivitamins Especially for Women when the report was issued.
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Waxman says he was "disturbed" to find the FDA had taken no steps to investigate the matter when he met with FDA officials two weeks ago, even though the Consumerlab.com report was publicized on MSNBC in January.
An FDA spokeswoman said the administration's practice is to follow up on reports of contaminated products, however, "such activity can take some time and two plus weeks since the briefing with the congressman is not usually enough time to complete a follow-up."
Despite the scare, The Vitamin Shoppe insists it manufactures its drugs "in compliance with the Food and Drug Administration's Good Manufacturing Practices for food and highest industry standards," as its CEO stated in a recent press release.
But that may be the problem, say medical watchdog groups, who say those guidelines are weak and rarely enforced. The FDA is not permitted regular oversight of vitamins and dietary supplements, and industry standards aren't hard to meet, according to the groups.
Under current law, manufacturers do not need to register their products with FDA or get FDA approval before producing or selling dietary supplements.
Medical watchdogs have called for new laws to require more regulation.
"This is a problem here," said Christine Stencel of the Institute of Medicine of the National Academies, a national non-profit organization for science-based advice on matters of biomedical science, medicine and health. "Dietary supplements need to be held to the same basic standards that conventional therapies are."
But lobbyists for the nutritional supplements industry say more regulation would destroy the business for vitamin manufacturers and providers. "We're talking about a $50 or $60 billion industry. Now that the Democrats have control of Congress, we're worried more regulation will kill the industry," said Boyd Landry, executive director of the Coalition for Natural Health, a legislative advocacy group for natural health providers.
April 6, 2007 | Permalink | User Comments (12)
wait a second.... more regulation? isn't that what the FDA is supposed to do? regulate and enforce... so.... what are they doing? how are they held accountable for their actions or inactions as the case may be.
Posted by: craig | Apr 6, 2007 1:53:39 PM
the medical watchdog groups are looking out for their own intrest... with more regulations, consumers would have to get prescriptons from doctors to buy vitamins... thats absurd
Posted by: george | Apr 6, 2007 1:56:33 PM
so how does lead get into a multivitamin? accidentally?... thats like accidentally adding sand to cookie recipie..... who is funds Consumerlab? I would not be surprised if it is the same medical watchdog group that is encouraging more regulations.
Posted by: tony | Apr 6, 2007 2:02:19 PM
US condemns Iranian treatment of Britons...
ABC And the MSM do not...
Whose side are they on?
Posted by: JelloBiafra | Apr 6, 2007 6:16:51 PM
there is no reason the vitamin industry shouldn't be required to prove in a substantial fashion that what they claim is in the product actually is and nothing else. if you're buying a multi vitamin, all of those vitamins in the quanities described should be there. we do need to be a verifiable standard. in this case it should be fairly straight forward and certainly not require a perscription to insure reliable standards of production
Posted by: jim | Apr 6, 2007 9:18:25 PM
I agree with George. How does lead "accidentally" get into a multi-vitamin or any pill for that matter?
Posted by: Essential Minerals | Apr 7, 2007 11:41:15 AM
don't ya just love it when someone suggests that dangerous business practices be allowed to continue, on the basis of the money generated? On that basis, lets legalize heroin and crack...
It's kind of like Bush saying that the necessary steps to mitigate global warming would hurt the economy...
Posted by: brian | Apr 8, 2007 4:54:58 AM
"verifiable standard"?..... so what exactly is the FDA doing?... if I went to work and didnt do my job, I would be terminated... the company wouldnt hire someone else to do it for me and continue to pay me.... more regulations on supplements isnt an answer... hows about doing something to make sure that the FDA does its job
Posted by: george | Apr 8, 2007 2:51:27 PM
Who watches the watchdog?
Prescription vitamins isn't absurd-there are people who would die if a vitamin were mislabeled or contaminated because of other medicines they are on. Based on the amount of "miracle" vitamin scams, I'd say that visiting a doctor before taking a vitamin is a good idea. You can get a blood test to see if you are deficient-more isn't better. Would you put in a mystery substance into your car engine that might be motor oil or maybe something else without knowing if your car even needs it?
Posted by: Joe | Apr 10, 2007 8:22:32 AM
George the "Decider" is the worst President this country has ever had. He should not ever been the President in the first place. He pull off the biggest scam the world has ever known with the support and aid of these so-called "Free Traders", Capitalism, no new taxes bull crap
Posted by: william | Apr 11, 2007 11:47:41 PM
As someone in the Vitamin Industry, I believe we should be held to a high standard and be able to verify through testing that "the stuff" that is in the product is actually in there. But so called "watch dog" groups like ConsumerLabs are completely bogus. They charge manufacturers to test products and if the tests are not positive, they protect them and don't publish the results. In addition, in most cases, they don't use the correct testing methodologies. What this country needs is the FDA to enforce laws that are already in place like DSHEA of 1994 and get things cleaned up so consumers can start taking products and feel comfortable. Lastly, don't ever ask and MD for advice on supplements. That isn't part of the curriculum in Med school. Most would much rather write you a script than give you a vitamin. (big $$$ in that biz) In the end, its all about the $$$ not your health. So take charge of it yourself. Read and educate, that is the answer!!!
Posted by: Ed | Apr 12, 2007 3:23:03 AM
Why do you always jump to the wrong conclusions force fed to you by these media clowns. You don't need more regulation. What you need is for the FDA to test supplements. That's it. If it finds something, then it should take action. No new regulations are necessary. Just do the job which they are supposed to do right now. We don't need to give more government power over our lives.
Posted by: knowledge | Jan 12, 2008 3:36:33 AM
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