A New NDI Bill: It’s a Step in the Right Direction, but There’s Still a Long Way to Go

November 14, 2011
Category: Uncategorized

long-road
FDA’s disastrous supplement guidance, which threatens thousands of supplements, would be greatly improved by a new bill in the House. But it isn’t enough.


Rep. Dan Burton (R-IN), a champion of health freedom who has repeatedly demonstrated a willingness to stand up for consumer choice about supplements, has introduced new legislation that would change the definition of New Dietary Ingredients (NDIs—that is, according to the FDA, new supplements).

Currently, all supplements containing new dietary ingredients introduced into the marketplace after Congress passed DSHEA in 1994 are considered NDIs by the FDA, and their manufacturers are required to notify the FDA when they are introduced. But, as we have reported extensively, FDA is attempting to contravene congressional intent by creating a pre-approval process modeled on what the pharmaceutical industry must go through before marketing its often lethal drugs, a change that could mean the loss of thousands of supplements.

To prove that a product is not an NDI, and thus exempt from these burdensome requirements, extensive evidence is required to show that the product was marketed before 1994. Rep. Burton’s bill would change that date to 2007. His creative approach would directly address one of the major difficulties with NDIs. Evidentiary documentation is much more accessible (especially with greater Internet data) for newer products than for products that are seventeen years old.

A good example is pyridoxamine, a natural and critically important form of vitamin B-6 which we discussed previously. Even though the ingredient was marketed before 1994, manufacturers could not provide sufficient documentation to prove it.

Unfortunately, Rep. Burton’s bill is not perfect. It doesn’t address a number key NDI concerns:

  • FDA can still claim, without basis, that a grandfathered ingredient is “chemically altered”—and that would require a new NDI notification.
  • FDA would not be stopped from moving its standard for NDI “notifications” closer to the food additive or pharmaceutical drug standard. This will continue to crush future innovation.
  • FDA expects a different notification for the same ingredient for every different version of the supplement it is in. Contrary to Congress’s original intention—that each new dietary ingredient would provide notification—FDA seeks to apply their guidance to each supplement that contains an NDI. This means that a new magnesium formulation found in twenty different supplements would have to go through the expensive and burdensome process twenty times—once for each supplement.  Additionally, the same ingredient at a higher concentration would need a separate notification/approval.
  • Worst of all, there is always the risk that this bill will give Congress the illusion that the NDI issue is being adequately addressed.


So we need further strengthening of this otherwise excellent bill.

Congress traditionally doesn’t like intervention in a regulatory process until it is complete. At this stage, FDA is still theoretically reviewing all of our comments and deciding what their final guidance will look like. Only after the FDA’s final guidance on NDI provisions can we analyze the best legislative solutions. But rest assured that we’ve been having in-depth strategy sessions for an approach that will comprehensively address the mess FDA is attempting to create with its NDI guidance.

Clearly FDA and Congress are listening to you! Rep. Burton and others are encouraged to take action by YOUR grassroots activism. But the clock is ticking—we only have a few weeks left before FDA shuts down the comment period! Now more than ever, we need you to keep up the great work and continue to send your messages on the NDI regulatory guidelines. If you have not already done so, please take action now!

19 responses to “A New NDI Bill: It’s a Step in the Right Direction, but There’s Still a Long Way to Go”

  1. Suzanne says:

    As the note above says, there needs to be a new bill that answers the following:
    FDA can still claim, without basis, that a grandfathered ingredient is “chemically altered”—and that would require a new NDI notification.
    FDA would not be stopped from moving its standard for NDI “notifications” closer to the food additive or pharmaceutical drug standard. This will continue to crush future innovation.
    FDA expects a different notification for the same ingredient for every different version of the supplement it is in. Contrary to Congress’s original intention—that each new dietary ingredient would provide notification—FDA seeks to apply their guidance to each supplement that contains an NDI. This means that a new magnesium formulation found in twenty different supplements would have to go through the expensive and burdensome process twenty times—once for each supplement. Additionally, the same ingredient at a higher concentration would need a separate notification/approval.
    Worst of all, there is always the risk that this bill will give Congress the illusion that the NDI issue is being adequately addressed.

    • Marcus Evans says:

      The American people should have the right to choose what they put into their own bodies. We do not need a Father government telling us what to choose. For God’s sake let us make our own choices!

  2. Alice Ahern says:

    Leave our supplements alone.

  3. Brian Lewis says:

    Rep. Burton’s bill is a start in the right direction but the FDA
    1. must NOT to be allowed to claim, without basis of substantial, provable, evidence that a grandfathered ingredient is chemically altered.
    2. must be stopped from moving the standard for NDI notifications closer to food additive or pharmaceutical drug standard
    3. must be stopped from changing the intent of “notification of a new dietary ingredient” to mean that every supplement that uses it or every difference in the amount used must undergo the requirements for notification again. This is absurd and blatently against what was approved by congress.
    4. Congress MUST understand that passing Burton;s bill as it is will continue to allow the FDA to disregard congress’s original intent and to rape the public. They are on an all out vendeta to do just that and its past time that congress stepped up and investigated the FDA and the connections they have and investigate many of the FDA top employees to the point of checking for offshore accounts and what high paying jobs or consultant contracts they get after they leave the FDA.

  4. Russ Lemon says:

    Several years ago I was asked if I believed in Contrails. I said yes, they are just condensed water vapor behind jet aircraft in flight. This year [2011], information has been published on the web about Chemtrails, the massive spraying of aluminum and barium all over the United States [including Hawaii]. Officially, there are no chemtrails. Unofficially, aluminum and barium are be sprayed in our upper atmosphere to reflect sunlight to counter Global Warming. What is not said, is that aluminum and barium are very toxic. When they eventually fall to ground, they poison the soil so any plant the depends on metal nutrients from the soil will die. Of course, crops from Monsanto that are “Round-Up Ready” grow without metal nutrients and will therefore grow in soil contaminated by glyphosate [main ingredient in Round-Up], 2,4-D [active ingredient in Agent Orange], aluminum, barium or uranium. Note that the corn, soy, cotton-seed, canola, papaya, sugar beet and alfalfa being grown that are ‘Round-Up Ready’ will not sustain life. Animals, including humans, absolutely need metal nutrients [copper, chrome, iron, zinc, magnesium, manganese, molybdenum, etc.] for a healthy immune system and a healthy body. Thus if this agenda to prevent growing of all non-GMO and organic crops and trees succeeds, and if supplements containing these metals are not available, there will be massive disease and even death.
    If this all sounds like insanity, it is. But before you condemn me to an asylum, I ask to review a very small portion of the documentation I have read over the last five years.
    Required Reading / Viewing:
    Do read the book “Seeds of Deception” by Jeffrey Smith or view the video made from it called “The World According to Monsanto” by Marie-Monique Robins.
    DVD ISBN: 978-0-9729665-9-7 Currently it is not on-line.
    Bt-toxin
    from Bacillus Thuringiensis is now being made by Bt-corn, Bt-soy, Bt-cottonseed, etc:
    http://naturalnews.tv/v.asp?v=647A592F2CBEA8D7FAD3DA5C474703FC
    AG CHEMICAL AND CROP NUTRIENT INTERACTIONS – CURRENT UPDATE
    Don M. Huber, Emeritus Professor, Purdue University
    http://www.geertsonseedfarms.com/pdfs/agchemicalandcropnutrientinteractions.pdf
    “Glyphosate is a strong, broad-spectrum nutrient chelator that inhibits plant enzymes responsible for disease resistance so that plants succumb from pathogenic attack. This also predisposes RoundUp Ready and non-RoundUp Ready plants to other pathogens. The introduction of such an intense mineral chelator as glyphosate into the food chain through accumulation in feed, forage, and food, and root exudation into ground water, could pose significant health concerns for animals and humans and needs further evaluation. Chelation immobilization of such essential elements as CA (bone), Fe (blood), Mn, Zn (liver, kidney), Cu, Mg (brain) could directly inhibit vital functions and predispose to disease. The lower mineral nutrient content of feeds and forage from a glyphosate-supplementation.”
    Chemtrails: What in the World Are They Spraying? (Full Length)
    http://www.youtube.com/watch?feature=player_embedded&v=7C5TFTkblKQ
    —Russ

  5. Michael Jones says:

    What happened to the people’s voice of less government intervention.
    why now do they feel the need to control supplements in such an oppressive and obvious ploy to favor the drug industry.

  6. Marion gura says:

    The FDA is creating a mess with it’s ndi guidance.stay out of the supplement business.no one has been harmed. Stick you nose in prescription drugs that have caused plenty of harm.

  7. Please stop maligning natural supplements. We need them. This country is becoming very sick
    and we need all we can to make us healthy in a natural way. I am hoping that this is not a push
    by the big drug companies. Why are you requiring such a rigorous process for something that
    is not lethal. Please reconsider the process you are contemplating for supplements.
    Thank You,
    Katherine Wuthrich

  8. Janice Riopelle says:

    The FDA is working for the pharmaceutical giants at the expense of the American people’s health and the economy. This bill will destroy almost all supplements along with jobs, herb farms and right livelihood businesses. More people are choosing preventive over drugs with side effects. Is this why the new guidelines on supplements that have a stellar track record are under attack?

  9. It is a dusgusting shame that the U.S. government , big pharma, a.m.a. & the doctors are all trying to make the American people sick so they can make money.
    Thank you for your efforts to change this..

  10. Jonni Vann says:

    Vitamin supplements are not drugs and they need to be overseen as food…I am grateful for all of the people that woke up for this and have let their thoughts be known.

  11. ronald reeb says:

    BIG PHARMA needs to stay away from the natural supplement business account they actually help people without all the nasty side effects.the FDA is in bed with BIG PHARMA and anyone with a lick of sense can see it,just follow the money!!!!

  12. Sue A. Blanton, DC says:

    I think we are encouraged to be way too polite to the medical monopoly and their hacks in government who are making/breaking rules/laws that have been/are being made that interfere with public health. Since most of these rules/laws are designed for medical monopoly profit, not public health, I think we need to be wide open to calling it like it is. One of these days there will be a genocide trial just like the one at Nuremburg, and we need to have placed ourselves plainly where we stand, both scientifically and ethically in this movement. Neither science nor ethics is any part of what the medical monopoly uses today, and if we don’t bring it back, who will?

  13. Barbara tenWolde says:

    I would like to support an FDA that is truly concerned about the health of our nation. It has been appearing that the FDA is concerned about the financial gain of a few, chemically backed. Please note that natural supplements are NOT in the same category as toxic poisons, and the regulation of such should run on two separate, appropriate tracks. Please know that we are better informed and concerned than ever before, and watching your track record.

  14. Richard Bernal says:

    I want to make a comment, I do not believe the FDA should be allowed to influence or have any intervention over the supplement industry. This whole issue centers around who the FDA is protecting. The FDA is not protecting the public’s right to choose, the FDA is protecting Big Pharma. Big Pharma is threatened because the supplement industry has proven products to improve health and Big Pharma doesn’t and the public is choosing with their wallets. So, Big Pharma sends out the FDA to police the supplement industry, essentially to put many companies out of business. I find it interesting, capitalism, free markets, free enterprise is what the public is taught and now you want to violate these ideals under some fallacious excuse that the supplement industries products (new ones) are not safe. The supplement industry does’t have blood on their hands, Big Pharma does (chemo drugs, radiation, drugs for symptoms, etc.). Stop this harrassment now.

  15. m m pribula says:

    All suplements currently in use or already in the market should be grandfathered into approved status, no exceptions, and generally recognized as safe to use, as are food ingredients and most foods prior. The FDA is **not** omniscient, nor even impartial and unbiased, just power hungry and eager to serve its industrial masters. Let us limit the FDA authorities to their pre-2001 arena, at least until they truly understand they are our servants, and never our master.

  16. Marybeth Rose says:

    please allow supplement companies to continue to make quality products available for the consumers. this bill needs more work!

  17. Sally Savin says:

    Our family has been gifted with great health & the information given to us by my sister. She was a nurse for 30 years, and has been far in advance, regarding Natural Health Remedies. We are stating our needs & our ideas regarding Natural remedies vs. mainstream Western medicine.
    I have had seizures & other Central Nervous System problems, making the simplest duties in life, extremely difficult. Acupuncture, Massage, and supplements have helped reclaim my body, as my Nervous System is now co-operating with my mind & body. I am writing o let all those concerned, that mediation, Yoga, Positive Thought Systems & a strong desire to treat my body, with Natural Remedies. After many years of having a body, with a mind of it’s own, I can now say, ” Natural remedies have allowed me to work, speak without stuttering, eat, bathe, and express my love & gratitude, for all. Please endorse, natural remedies & put an end to “sometimes” lethal side effects. My daughter almost died & lost her sense of self, after being prescribed a drug for excessive nerve damage, radiated from her Nerve damage in the skull. Thanks for keeping up the great work & we have far to go.

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