Not in living and maintaining a healthy lifestyle.
Posted on 01/04/2012 3:19:18 PM PST by djf
Will it be enough to rein in FDA’s outrageous power grab?
ANH-USA, together with a number of supplement trade organizations, went to Capitol Hill to plead our case about the FDA’s profoundly flawed NDI (new supplement) draft guidance in the offices of two powerful senators and longtime friends of natural health, Sen. Tom Harkin (D-IA) and Sen. Orrin Hatch (R-UT). Our visit was preceded by all the letters you have been sending to Congress, which have immeasurably increased the visibility of this issue. As you know, if this draft guidance stands, it would allow FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years. Immediately after this meeting, Sens. Harkin and Hatch wrote to FDA Commissioner Margaret Hamburg and formally asked the FDA to withdraw its guidance document.
The senators urged FDA to begin work on a new draft that provides needed clarification on what constitutes a New Dietary Ingredient (NDI)—but, in their words, does not undermine Congress’s desire to provide consumers with access to safe, affordable dietary supplement products. Exactly!
These senators were uniquely qualified to make such a request, since they were the principal authors of DSHEA, the Dietary Supplement Health and Education Act of 1994. “When Congress included language in the Food Safety Modernization Act (FSMA) directing FDA to clarify when a dietary supplement ingredient is a new dietary ingredient, the expectation was that the guidance would be consistent with DSHEA,” they write. “Unfortunately, the draft guidance serves to undermine DSHEA in a number of important respects.”
They go on to outline the various arguments that we have been making in these pages for some time:
The requirement for a manufacturer to submit an NDI notification for every dietary supplement containing an NDI is directly contrary to the language of DSHEA, which requires notification only of the intent to use an NDI; This new requirement is burdensome and would impose substantial additional costs on manufacturers, would not provide additional safety benefits, and would undermine access to the safe, affordable nutritional supplements that DSHEA was designed to ensure; The NDI guidance’s assertion that synthetic copies of ingredients can never be a dietary ingredient is without any statutory basis, and is contrary to longstanding FDA policy; and This guidance is contrary to Congressional intent by grandfathering in only ingredients that were marketed before the enactment of DSHEA—such an argument is particularly specious since “the term dietary supplement wasn’t even defined prior to DSHEA”!
The senators requested that FDA meet with interested parties to work through all of the issues raised in our and others’ comments. Fortunately, FDA can’t just ignore the senators’ request, because the agency is required to work within legislative intent. Otherwise they would be creating new law—which legally they cannot do. This is one of the arguments we have been making all along—that FDA is in fact making new law with this draft guidance, and now Congress is calling them on it!
We would like to thank Senators Harkin and Hatch for being such stalwart champions of natural health, and for their leadership in this battle to prevent the FDA from usurping powers that they are not legally entitled to. We also want to thank every one of you for contacting Congress and the FDA and being such a vital part of this process.
We aren’t out of the woods yet—we’ll have another update soon with additional action items for you. The time may come for more specific legislative action, and we may find ourselves battling FDA in the courts as well. That’s why your continued support and activism is so terribly important. Together we can win this one, preserve your access to supplements, and keep supplements from costing as much as drugs.
PM
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Sorry, Place Marker. Just saving to read later.
Oh! OK!
Gotcha!
The FDA is messing up the market for Prescription drugs (shortages based upon their rulings/regs)...just think what they could do with Supplements!!!
The FDA complains about supplements, well supplements don’t kill people.
You would need a prescription for Celebrex for that!!
And YES!! it is STILL AVAILABLE, even after it has been proven to cause some deaths.
Will buy overseas if the FDA succeeds
From what I understand, big pharma wants control of dietary supplements. $$$$$$$$ Follow the money.
What we really need is a ban on selling any food or health product that contains any non-life source ingredient.
But we’d have to find something to re-train all the doctors to do, without any sick people for them to poison.
Must be too many healthy people running around not needing expensive pharmaceuticals. I think it’s all a patent scam anyway; create a new drug with marginal therapeutic effect, patent it, advertise the Hell out of it, and rape the sick by offering false hope.
>> “From what I understand, big pharma wants control of dietary supplements. $$$$$$$$ Follow the money.” <<
.
I hope you have a strong stomach, the trail you’ll follow goes straight to the mortuary.
>> “Will buy overseas if the FDA succeeds” <<
.
In your dreams.
Europe has already cut off access to supplements, and Australian companies will no longer sell to US addresses.
This is part of the cradle to grave feature of Obamacare, with emphasis on grave. No supplements. No pesky old people to deal with.
These brain dead slugs on the Federal payroll. They have nothing better to do than try to ruin parts of the private sector that do just OK without regulators interfering
Unfortunately, in many instances, big pharma is not our friend. Actually, many in the medical industry are not our friend or really too concerned with patient care. It really is all about the money. Next to oil companies, big pharma is a close second when it comes to revenues.
I’m sure getting sick of these FedMob criminals sticking their noses in every corner of our lives.
Bttt!
I know someone in med school right now, and it’s pretty much all about the money. They’re not even shy about it anymore.
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