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Were you aware of FDA’s New Sneak Attack on Supplements?

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?

 

http://www.anh-usa.org/fda-new-sneak-attack-on-supplements/  

7/5/11

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On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocolscontained in the Dietary Supplement Health and Education Act (DSHEA).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Now, seventeen years after the passage of DSHEA, the FDA has finally come out with draft guidance on NDIs—that is, on new supplements.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... 

 

 
agentwanda

Asked by agentwanda at 3:24 PM on Jul. 13, 2011 in Politics & Current Events

Level 35 (73,667 Credits)
This question is closed.
Answers (20)
  • No surprise at all. Haven't you noticed all the new warnings and the new old warnings even? They are warning people about things that have had warning labels on them forever. Things are being recalled just because they "might" be less than perfect.. This is just another way for Government to get their mitts into our lives. They don't care whose business it hurts or who it inconveniences. One more reason the FDA needs to be gone.
    itsmesteph11

    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....

    amazinggrace83

    Answer by amazinggrace83 at 3:30 PM on Jul. 13, 2011

  • Now supplements will be a gateway drug, sold only in the back rooms of head shops.
    Anonymous

    Answer by Anonymous at 3:35 PM on Jul. 13, 2011

  • I am all for it. There have been traces of lead and pharmaceuticals found in supplements, and many of them don't contain the strength that is on the bottle. Some companies have really good, clean product, but alot don't . . . and there is no way for the consumer to know which one is which.
    France is big on homeopathy, but they thoroughly test. So, it is a really safe and good alternative! here in the states, you never know when you are going to tox your kidney or liver!
    We actually need to regulation.

    BTW, I know someone who was permanantly disabled from unpure supplements, so it DOES happen
    ImaginationMama

    Answer by ImaginationMama at 3:36 PM on Jul. 13, 2011

  • I don't believe supplements, natural or not, are any safer than any other drugs. Lots of poisons are natural . Lots of supplements and natural cures (mercury is a huge one, used for ages in many cultures) are dangerous. And unfortunately, lots of vitamin and supplement makers have been caught making inferior or fake pills, some even with dangerous supplements or other drugs in them.

    Stupid of the supplement industry. They were basically unregulated, and proved to us they can't be trusted. (obviously, many can. But that's not good enough)

    The FDA can be annoying to both honest drug and herb makers (and even to citizens, because there are delays during the testing phase for new drugs!), but unfortunately, the alternative is even worse- there have always been "snake oils" and dishonest meds, useless and even dangerous, and there is no way for a consumer to know what she's getting if there is no regulation.
    Tracys2

    Answer by Tracys2 at 3:40 PM on Jul. 13, 2011

  • There should be truth in advertising regulations, and purity regulations, and GMP regulations. Beyond that, I don't want the FDA trying to test out supplements to decide if they work or not. They already have a pretty solid stance against them working, thus one of the reasons people have kept them out of the realm of testing. I worry that stuff may get pulled, because the FDA can't prove that they work.

    You need to consult a doctor, or do research to ensure you are taking the right supplements. Supplements do not need to be regulated to the point of requiring prescription.
    Candi1024

    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...  


    "The lack of oversight poses a major problem for Americans that are required to take medicine. U.S. officials do not have the proper number of inspectors or the time to inspect and test all drugs entering the U.S. market. Oftentimes, they must take the word of suppliers that the drugs have been properly tested."


    "Today, 80 percent of pharmaceuticals contain ingredients from China or India." 


    http://www.economyincrisis.org/content/chinese-made-pharmaceuticals-pose-risks


     

    agentwanda

    Comment by agentwanda (original poster) at 3:58 PM on Jul. 13, 2011

  • http://www.gaia-health.com/articles401/000412-poison-control-report-herb-vitamin-deaths.shtml


    Poison Control Reports: Not a Single US Death Caused by Supplements, Herbs, or Vitamins


    http://www.alternet.org/health/147318/100,000_americans_die_each_year_from_prescription_drugs,_while_pharma_


    companies_get_rich/


    "Prescription drugs taken as directed kill 100,000 Americans a year. That's one person every five minutes. How did we get here?"

    agentwanda

    Comment by agentwanda (original poster) at 4:11 PM on Jul. 13, 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.

    Candi1024

    Answer by Candi1024 at 4:13 PM on Jul. 13, 2011

  • IMO, none of them do the job they SHOULD. The pharma makes and pushes pills that kill and are sued constantly for it. The supplement cos lie, cheat and steal so..where are we really? You can't depend on anyone to really do the job as they should anymore. So the gov't gets involved and they are a bunch of lying cheats too. We are no better off either way IMO. It's just something else to squabble over.
    I take alot of supplements and do depend on them to keep myself healthy. I need to read up more on all of this to see how it's going to affect me and what I buy.
    KellyGirl_TX

    Answer by KellyGirl_TX at 5:39 PM on Jul. 13, 2011