An Important Update on IV Vitamin C

January 11, 2011
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After our Action Alert on the FDA’s move against intravenous vitamin C, a number of rumors have sprung up. Today we want to sort through the confusion.

As we reported to you last week, the US Food and Drug Administration recently sent a warning letter to McGuff Pharmaceuticals, ordering it to stop manufacturing and distributing intravenous vitamin C. The warning letter lists several issues, but the issue of concern falls under the subheading Unapproved New Drug and Misbranding Violations. The FDA letter tells the firm, “You manufacture and market unapproved new drugs in violation of sections 505(a) and 502(f)(1) [21 U.S.C. §§ 355(a) and 352(f)(1)] of the Act”—that is, the Federal Food, Drug, and Cosmetic Act, or FD&C.

The letter goes on to specify which “unapproved new drugs” are being targeted: various formulations of injectable (intravenous) vitamin C, magnesium chloride, and B complex 100.

In our discussions with the acting director of the Compliance Branch of the FDA, ANH-USA confirmed that the FDA’s determination of intravenous vitamin C as an unapproved drug is completely unrelated to other issues raised in the warning letter. We mention this because widespread rumors are circulating that this particular firm was targeted for reasons that would not relate to other firms, and that other manufacturers of IV C would not be affected. This is simply not true. According to the acting director, the FDA has gone through an internal process whereby they determined injectable vitamin C to be an unapproved drug.

Further, because McGuff was unable to show (a) that this form of vitamin C was exempt because it had been grandfathered in under the FD&C, or (b) that they were in compliance with new drug approval protocols, the FDA ordered them to discontinue manufacturing and distributing intravenous vitamin C immediately.

What we still don’t know is the extent to which FDA is targeting IV C. The acting director told ANH-USA that any other company unable to show an exemption or prove that it has taken IV C through the drug approval protocols would be subject to a similar order to cease production and distribution. What she would not tell us was when or whether they intend to move on other manufacturers and distributors. We know that FDA has a history of targeting specific products, such as estriol and natural desiccated thyroid. Sometimes they begin with one company in an effort to scare other companies into shifting business practices, and sometimes they send letters to multiple companies at once. At other times, they speak to companies behind the scenes without issuing official warning letters of public record.

The good news is that so far, it appears FDA has gone no further than this initial firm. It’s possible that FDA merely intended to test the waters with this first company, and that public reprisal via your messages has them rethinking their strategy. It’s also possible that FDA intended to target this one company alone, although we should reiterate that the language in the warning letter would apply to all other companies currently making or distributing IV C.

There is some more potentially helpful news. Injectable vitamin C is both manufactured by companies in bulk and on an individual prescription basis by compounding pharmacies. It appears that FDA may have targeted the manufacturing end of things, rather than the compounding pharmacies. Although IV C alone has not been approved as a new drug, it is a component of other drugs which have already been approved and which have USP monographs. This is important, because it means that intravenous C can arguably continue to be made by compounding pharmacies even if the FDA targets the remaining manufacturers of IV C.

It would be devastating to lose widespread access to IV C, but ANH-USA does not believe it will disappear completely, because compounding pharmacies could still make it. So it’s not time to stockpile intravenous vitamin C just yet! We must, however, remain vigilant.

ANH-USA is continuing to receive information about IV C daily. We will continue to monitor FDA’s actions, and as always, we will update you as we learn more.

112 Responses to “An Important Update on IV Vitamin C”

  1. John says:

    I am currently taking intavenous Vit C at a local doctor in Northeast FL but the cost ($70 to $120 per infusion) is too expensive for me to continue. I have written to the vitamincfoundation @ att.net to find out if there is a way (like our Ecuadorian friend) to get it via a compounding pharmacist with a doctor’s prescription (actually it appears in Ecuador you don’t even need the prescription).

       2 likes

  2. Denise Redmore says:

    I love the fact that I know about this… we have been so suppressed and kept in the dark about the positive effects of this vitamin. Does anyone know if there is a place close to Indiana that does this treatment? 2 hours away from Chicago and 4 hours north of Indy.. My sister in law has had Hep C for close to 20 years now, they have put her thru so many trial drugs and now I find out that all drug testing for this condition has been halted on all levels because the trial drugs are killing the patients.. wow.. how shocking is that… not shocking at all considering that most drugs from the FDA does that eventually. Please help…

    Thanks in advance…

       2 likes

  3. lisa says:

    my son is fighting 4th stage hodgekin lymphoma cancer, he is 26. the cancer docs to any of the cancer treatment centers he has been to have not even mentioned anything about I.V.C or any other supplements, i guess they would be afraid of losing money for treating the disease instead of encouraging alternitive treatments to possibly save a life. i found I.V.c is used at some holistic places

       1 likes

  4. I have to say that for the past couple of hours i have been hooked by the impressive articles on this blog. Keep up the good work.

       1 likes

  5. Fred says:

    We live in Ecuador and you can get IV C in the mall administered by a nurse .The cost is under $25. I am so glad we have moved out of the States. I started this search looking for the different kinds of IV vitamin C.

       3 likes

    • JV says:

      CAn you help me with a address, phone number or email of a clinic that sales IV C. I need it for my wife who has little to live. I want to try it and see what happens.

         0 likes

  6. Sandy says:

    What would happen if one of the family members of the FDA was in hospital dying from pneumonia, would they let the person dye or go for the Vitamin C treatment?

       1 likes

  7. Richard says:

    The pharmaceutical cartel/fox is running the FDA/henhouse and our benevolent and protective government stands by and does nothing to end the abuses. The level of corruption in the agency and the injury to the innocent victim of disease that it exercises is tantamount to criminal negligence at the very least. Perhaps, if some of the personnel sitting the board of the FDA were tried and convicted of wrongful death, the remaining members might reconsider how they do business.

       5 likes

  8. Debra Ross says:

    I am seeking someone who can give me the lV C in High Point, NC. I requested it from a doctor at the Baptist Hospital in Winston Salem, NC and she practically smirked at the idea. Just because it was never taught in Medical School, you would think that all that reading and studying, the doctors should know something so obvious.
    If someone know where I can get the lV C close to High Point, NC please email: [email protected] Thank you in advance.

       0 likes

  9. Ted Langs Sr. says:

    Some times our government fails to control or inspect their own system. The FDA is one of them. what the government does not realize is that the drug Industry runs the FDA and it due to the amount of money passed over to the FDA by the drug industry under the guise of grants. With drug prescriptions the cause of over 160,000 death a year wouldn’t you think that their would be a upraising over that?
    One of the main killers in hospitals is pneumonia which attacks patients in a weakened condition and usually they will pass away in a few days.even if they give shots to the patients. Vitamin C via IV would save countless lives and the FDA is trying to stop it’s manufacture. If it were your love one that was the one dying of pneumonia would you want some thing that would cure them? Vitamin C via IV.

       1 likes

  10. Julie Greenwood says:

    I personally think that as individuals we have to put our powerful thought energy into what we want to see rather than what we fear will be. Just thinking that “their system will prevail” gives added energy to “their system”. Change our thoughts, send our letters, share the info and keep our vision on the future as we would like to see it.

       1 likes

  11. Charles Thomas says:

    Big pharma and Monsanto controlled FDA will continue to destroy all sources of true, inexpensive, cures to protect the high profit death system currently in place. So long as our leaders are in their pockets and no one goes to prison their system will prevail.

       3 likes

  12. Robert Paggen says:

    As usual the FDA [ For drugs Always] is protecting the Drug companies profits rather than the general publics health. We need to start prosecuting the indviduals at these agencies personally for corruption. By gradualy banning real, effective natural treatments we will be less healthy and forced to use their toxic drugs. More profit for the drug companies. How do these people sleep at night.

       1 likes

  13. dez says:

    The Vit. C genie is out of the Bottle. I have never taken a prescription drug in my 79 years. Have taken a limited amount of vitamin c and supplements for over 40 years. Last year I read Dr Klenners vitamin c papers on the internet. I have increased my vitamin C intake to 3 to 15 grams a day and many more supplements of all kinds for the last year. My mental and physical well being, week by week has improved dramatically. How many people at 79 go out with a chain saw and cut up logging size trees. Dr Klenner saved many lives by having Vitamin c ready for injections at all times.

       1 likes

  14. Richard Waggy says:

    Can the FDA be sued for personal injury? The single case of the person the doctors deemed unable to survive, and attempted to kill by unplugging life support, should be enough proof for holding the FDA liable for damages caused by denying public access to vit C, which has been used longer than the FDA has existed.

    The date of this or other incidents should be recorded, notifying the employees of the FDA that they could be criminally prosecuted for reckless endangerment, etc. for territory grabbing that results in the death of fellow citizens.

    Hold gov’t criminals responsible for their actions.

       4 likes

    • Ted Langs Sr. says:

      Believe me, the Government will cover their deeds so you can never indict or sue them. After all they work for the Drug companies not the ones that employ them.

         0 likes

  15. Shoshannah says:

    If the FDA is going after the intravenous C, it means that the alternative medicine world is succeeding and the medical mofia is feeling greatly threatened that the money is going somewhere else. Just think how rediculous it is to make an issue of vitamin C!

       0 likes

    • Marianne D. says:

      Yes, the alternative medicine world is succeeding and medical professionals are feeling extremely threatened by the independent decisions made by people looking to get and stay well. If more people would use their doctors as just another sounding board, instead of the end all decision makers, more people would get and stay healthy.

         2 likes

  16. Kelli says:

    So they make it illegal to use a IV nutrient that has the potential to save millions of live then they have the nerve to call supplements “dangerous”? CONventional medicine is the biggest quackery there ever was with all their toxic drugs and barbaric surgeries. Yet they have the nerve to criticize life-saving non-invasive treatments…why did western medical science not make it a priority to find non-invasive treatments long ago?

       0 likes

    • Marianne D. says:

      I agree with you. Someone should sue the CONventional medicine people and the FDA. Elizabeth Edwards is dead and Suzanne Somers is alive.

         0 likes

    • Barry says:

      Big pharma and the fda are in this together to keep people sick. I think they (big p) create some of these diseases for population control.

         0 likes

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