I didn't see where there was a post about this on 7/5, if there was, sorry to repeat...
This is health related but imo, it's just another "political control"power grab... Do you agree?
Just before the July 4 holiday weekend, hoping to limit media attention, the FDA dropped a bomb on dietary supplements. Don’t let them get away with it! A new Action Alert.
On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocolscontained in the Dietary Supplement Health and Education Act (DSHEA). Ever since DSHEA was enacted in 1994, supplement manufacturers have had very little guidance on what counts as an NDI and when or how to send an NDI notification. The government has arbitrarily ignored or enforced this section of DSHEA, doing as it liked, without spelling out the rules.
Why does this matter? Because when you hear New Dietary Ingredient (NDI), substitute “New Supplement” in your mind. What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements—and if so, under what rules.
Now, seventeen years after the passage of DSHEA, the FDA has finally come out with draft guidance on NDIs—that is, on new supplements. They had to do this because it was mandated by the recent Food Safety Modernization Act.
We have reviewed the very complicated new regulations in detail. In the hands of an agency charged with regulating supplements fairly—one not hostile to supplements the way FDA is—they might be made to work. But in the hands of the FDA, which wants everything, supplements and drugs alike, to go through the vastly expensive new drug approval process, we fear the new rules will be used to forbid the development or sale of any new supplements—where “new” means anything after 1994, when DSHEA was passed.
Please note that many important supplements sold today were developed after 1994. Others the FDA will say were developed after 1994, even though they are just variants of what was “grandfathered” by DSHEA. For example, the FDA has already banned a critical form of vitamin B6, pyridoxamine, because that particular form of B6 couldn’t be shown to have been sold prior to 1994, even though B6 in general was certainly sold prior to 1994.
There are many other important new supplements that could be banned depending on how the NDI process is run. We won’t mention the names because to do so would be to put a target on their back. But we can assure you they are important and many of you are taking them.
The FDA already has the power to pull from the market any supplement, whether “grandfathered” or not, if they are unsafe, do not comply with Good Manufacturing Practices, etc. The oft-repeated claim that the supplements market is unregulated or “the Wild West” is patently false. But the FDA cannot pull a grandfathered supplement arbitrarily. They must show cause. What we don’t want is for the FDA to have the power to ban all new supplements arbitrarily. We fear that they will use this power to ban any supplement innovation unless the supplement is turned into a drug and brought through the drug approval process.
The draft guidance clearly outlines the conditions under which an ingredient is considered an NDI (a new supplement) and when it is considered grandfathered. Further, it details the circumstances under which it is necessary to submit a notification for an NDI and when it is not. Not surprisingly, the FDA has applied a very narrow definition of grandfathered dietary ingredients, and so by extension a very broad definition of NDI.
Please see the above link for the remainder of this article...
Answer by itsmesteph11 at 8:18 PM on Jul. 13, 2011
I think all that is going on is going to make me an active member in the black market....
Answer by amazinggrace83 at 3:30 PM on Jul. 13, 2011
Answer by Anonymous at 3:35 PM on Jul. 13, 2011
Answer by ImaginationMama at 3:36 PM on Jul. 13, 2011
Answer by Tracys2 at 3:40 PM on Jul. 13, 2011
Answer by Candi1024 at 9:12 AM on Jul. 14, 2011
FDA controls pharmaceuticals and imo, they are not protecting us, they just make drug co's tell you that their medication might kill you, if you take it, it's your funeral...
Working in the industry, I can assure you the FDA does a lot more than just requiring warnings. For every piece of SMALL equipment used, there are about (4) 3-inch binders full of required paperwork from the manufacture of that equipment, and that is just the beginning.
Answer by Candi1024 at 4:13 PM on Jul. 13, 2011
Answer by KellyGirl_TX at 5:39 PM on Jul. 13, 2011