Breaking News: We Win Major Concession on New Supplement Guidance

June 20, 2012
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herbal_supplementsFDA reverses itself—for now.

We have pointed out for months that the FDA’s NDI (new supplement) guidance threatens our access to supplements and indeed could destroy the industry, leaving drugs with a total monopoly.

After adamantly digging in its heels and refusing to reconsider, FDA has now at last agreed that the draft NDI guidance requires substantial revision. This follows a meeting between FDA Commissioner Margaret Hamburg and Mike Taylor, Deputy Commissioner of Foods, with Senators Harkin and Hatch, longtime champions of natural health.

According to our sources, the FDA stated in the meeting that the guidance would be revised to account for the numerous comments and concerns, and released in draft form once again, which will then be open for public comment. This is exactly what we asked for!

The FDA’s decision is a dramatic reversal of the position taken in an earlier meeting with the Senators’ representatives, in which they adamantly refused this very same request. While we may never know how or why the FDA changed their position, it is very likely that they were responding to our sustained public messages opposing the current NDI draft guidance.

ANH-USA has also been working closely with the Appropriations Committee that controls the FDA’s purse strings. We recently helped secure report language in the Appropriations Committee censuring the FDA for prematurely enforcing the NDI draft guidance while supposedly still in draft. The report goes on to further state: “The Committee urges FDA to withdraw the July 2011 NDI draft guidance and re-engage the dietary supplement community to develop a new guidance on what constitutes NDI.” This appears to be another reason the FDA is finally listening.

While the FDA has not yet agreed to a specific timeline for revising the guidance, nor indicated what exactly will be revised, they did commit to collaborating with the dietary supplement industry to create a list of agreed-upon “grandfathered” dietary ingredients (ie. supplements). A “grandfathered” dietary ingredient is an ingredient marketed before 1994 and therefore not considered an NDI (new). Grandfathered dietary ingredients are therefore not subject to the NDI guidance. Currently, there is no authoritative list of “grandfathered” dietary ingredients, leaving the legal status of many dietary supplements in limbo.

Although an authoritative list of “grandfathered” dietary ingredients could be useful to the supplement industry, we fear that the FDA will use this as an opportunity to knock out supplements that were indeed on the market before 1994 but may not meet the FDA’s idea of proof. This is precisely what happened to pyridoxamine, one of only three natural and bioavailable forms of vitamin B6. Although we know that pyridoxamine was on the market before 1994, the FDA determined that there was not enough of the right kind of evidence to conclusively prove so, and removed the ingredient from the market.

ANH-USA will participate in this process to try to ensure that the list of “grandfathered” dietary ingredients is inclusive in order to maintain your access to as many supplements as possible. We will also try to prevent the FDA from using the list as an excuse to delay indefinitely their promise to revise the draft guidance.

Our readers have sent hundreds of thousands of messages to the FDA regarding the NDI draft guidance issue. We have just won an important preliminary victory and it wouldn’t have happened without you! Now on to the next phase of the struggle. If we are patient and persistent, we will win.

70 Responses to “Breaking News: We Win Major Concession on New Supplement Guidance”

  1. Candy says:

    People that want to see less of their freedoms taken away had better start paying attention to which voting groups they want to aline themselves with. Less government control over ALL aspects of our lives is the only way to stop this power grabbing from those in office. And that crosses both parties. Pay close attention for those that want LESS government intrusion in your life and LESS government departments. And then VOTE for those people. Stop playing the “I always vote DEM/REP” game. Because it is just that. Time to wake up and smell the crap being fed to you.

       2 likes

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       0 likes

  3. Madeline Loder says:

    Thank you ANH-USA! We will continue to fight with you for our health and freedom.

       1 likes

  4. Jennifer Gaudet says:

    I do not understand how a free country (like the United States) can have an agency that wants to take the freedoms of its citizens away. What is even more disturbing to me is how many medical doctors from overseas have come to practice here, know about the benefits of supplements, yet are not allowed to use this knowledge within their practices because of the backlash they will get! My father had congestive heart problems and I asked his cardiologist when I saw him in the grocery store about coq10 to help out his condition. The doctor said it would be good to do if we were in another country, but he could not advise my father as his doctor in this country. Is this freedom? How those medical professionals must feel about themselves when their patients die before they needed to! This lack of freedom to discuss natural alternatives makes me and many others distrusting of the medical profession and that is a big shame for us all.

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  5. Shirley Heisey says:

    This is a basic freedom — One of the many — that the ELECTED LEADERSHIP(!) is trying to take from us. No wonder people are suspicious that there is a conspiracy under wraps!!! I have no doubt; how about you?

    Vote with our MONEY: MONEY TALKS! When the last body dies, the gold and silver will be meaningless. One of these days it will be their own families, there own body. Wonder when they will think of that.

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  6. Gertrude Lamb says:

    Point one: We won NOTHING. Everyone please notice that the FDA still has the 1994 “grandfather” provision in place. Ask why. Why the 1994 date? Because most prescription drugs, from what I have read, have not been substantially altered since then, may be one reason. It would cost them almost nothing to duplicate any pseudo-”new” drugs they have come up with since then.
    Why now? Because a lot of Big Pharma’s patents are due to expire pretty quick. And there is only so much they can do to label them as “new” by scratching an extra cut-line on tablets.
    Point two–In Nazi Germany, the pogroms began with requiring Jews to simply “register.” Now FDA wants to make it mandatory for supplements to simply “register.” With whom? With FDA!
    Point three–No supplement can possibly pass FDA’s required “protocols”, for 1,000 times normal dosage–of each ingredient or compound separately. Think of plain drinking water–no one could survive drinking 1,000 glasses of water a day every day for a year. Think of many supplements which, like whole foods, can NOT provide broken-apart individual segments and still get the same results. As one supplement maker pointed out recently, when you separate the ingredients in the natural product, all you get is a sticky mess! Further–FDA uses the “1,000X dosage” protocol for nefarious ends. When one FDA-favored commercial product came under fire for health risks–FDA’s answer was, eh, you’d have to drink a thousand of them a day to come to harm. And the dangerous product was allowed to remain on the market, for that reason. Despite evidence that even reasonable consumption levels had led to noticeable harm–and to the outcry.
    Last point–which should be the FIRST point–It is NOT and never has been FDA’s responsibility to oversee, regulate, or otherwise govern in any way over nutrient supplements. We need to work toward laws to back off FDA from ANY such “Guidelines” –not just cheer because FDA agreed to wait a little longer to hammer down. From what I gather other places, FDA tried this same stunt twice already, and got shut down on it by Congress. This time FDA may succeed.
    Congress–please shut FDA down on this new attempt to cut out competition from Big Pharma.
    OKAY–the really last point–We can impeach presidents, but there is zero consequence for a government agency, such as FDA. FDA even wrote an applicant’s application for them, concerning GMO salmon–which the President of Consumers’ Union…

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    • ANH-USA says:

      Gertrude, thank you for your comment. We agree with many of your points, but would like to respond to your mention of the 1994 date. The reason the date is set in 1994 is because this is when Congress passed the 1994 Dietary Supplement Health Education Act. In DSHEA, Congress declared that all existing supplements were considered untouchable unless a safety issue arose, and that any new dietary ingredients that would be introduced to the market after the passage of DSHEA should submit notification to the FDA along with evidence to support their safety. (Note that the bill required notification, not application for approval.) The legislation directed the FDA to work out the specifics of how companies should submit notices, and FDA waited 17 years to get around to it! The 1994 date and the NDI guidance both apply only to dietary supplements, not prescription drugs.

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  7. Peggy G. says:

    Thank God for the ANH!! You make it possible to know what is going on in our huge federal government. Thank you, and keep up the great work!

       1 likes

  8. Lisa M. says:

    I called the offices of Senators Hatch and Harkin today to thank them for their tireless work to stop the FDA from taking away our right to buy supplements. Both staffers I talked with thanked ME for calling and said they rarely hear positive comments, and that they would definitely pass on my message to the Senator.

    So I urge others here to call also. They deserve our thanks for standing up for our rights, and supporters of natural health in Washington are few and far between. I told the staffers I’m not even a constituent of either of them but just wanted to say thanks.

    Senator Orrin Hatch: (202) 224-5251
    Senator Tom Harkin: (202) 224-3254

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  9. Lisa M. says:

    One thing that concerns me is that Senators Hatch and Harkin, who seem to be the main Senators who fight for our right to have free access to supplements, are both getting older, and Senator Hatch is in the fight of his life to keep his Senate seat in Utah. If either or both of them leave the Senate, I’m afraid there will be no more champions of natural health in Washington to help us fight the FDA.

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  10. I’m so pleased that the FDA appears to be “coming around” regarding our right to take the medicine of our choice. Natural remedies and therapies have been around for thousands of years, so I’m not sure why they are discussing grandfathering supplements since 1994…why not supplements prior to that? There are many good, reputable and helpful supplements that have been around a lot longer than that.

    As always, consumers need to have their right to pick and choose what they will and won’t put in their body. As a Naturopath, people come to be on purpose so that I will recommend something healthy and natural for their body and their various symptoms. It should ALWAYS be an individuals right and choice if they choose to NOT take pharmaceuticals and instead, to take nutritional supplements.

    Too many organizations like Monsanto, are pulling the purse strings with our government and our choices. This must stop. Thank you to your organization for helping to win this current battle!

       0 likes

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