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.

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

  1. carolyn says:

    what’s next? will they declare oranges and lemons drugs (after all they contain vitamin C and have been used to treat diseases)? will we be forced to eat twinkies and GMOs? will your mother get a warning for telling you to eat your vegetables? will popeye be criminalized for making health claims about spinach? when does this madness end?

       1 likes

  2. IV C Prof. says:

    This article and comments need to focus on the topic of quality. This FDA action involves one company/pharmacy and its products.

    I have experience involving IV C (& IV B-complex) for 20+ years. I haven’t heard much about Mcguff pharmacy since I’ve only dealt with pharmaceutical mfg IV C. There is still IVC available from at least 1 pharma company.

    Anything IV is considered a drug since once administered in the vein there’s no turning back. The pharma companies that make IV drugs are heavily scrutinized. Quality must be the highest priority since this is entering the bloodstream. After reading the FDA warning letter its clear that Mcguff was NOT performing acceptable quality practices.

    Pharma firms are reviewed from start to finish for quality (raw material to finished product). Starting out in the letter the FDA clearly says incoming raw material was not properly tested. A firm that doesn’t test the main ingredient of an intravenous product is not trustworthy. The letter goes on and on about serious quality issues (microbiology testing or equipment qualification). This company didn’t even perform the most basic pharma quality practices. Mcguff was visited in June 2010 and the letter is written Dec 2010. It seems the FDA worked with them for months to fix things and nothing seems to have happened.

    The FDA made sure this company/pharmacy stops and thanks to this letter they will not have any drugs approved or on the market whatsoever. This company doesn’t look like its getting any drugs approved at all

    I’ve called and they say they have no comment on any company or product and refer me to published info on FDA.gov. Pharma made IVC is still available. The vial says Merit Pharmaceutical.

    Hate the FDA as much as you want but it seems clear the FDA is looking out for the public interest -at least in this case.

    The letter is here
    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm238251.htm

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    • ANH-USA says:

      It is important to recognize that the letter has two distinct parts. The first part of the letter address cGMP issues, and the second part declares that IV Vitamin C is an “unapproved new drug”. The second part is independent of cGMP issues. Even if a manufacturer adhered to the letter of cGMP practices, according to the FDA’s declarations in this letter, IV Vitamin C is still an “unapproved new drug” that they are not permitted to manufacture. Remedying cGMP violations would not remedy the status of IV Vitamin C as an “unapproved new drug”.

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      • IV C Prof. says:

        ANH-USA you are not understanding the regulatory environment. Also, your statement “Even if a manufacturer adhered to the letter of cGMP practices, according to the FDA’s declarations in this letter,” is incorrect as this firm is clearly not cGMP in any way and NO product from this pharmacy/company will be approved -ever. This firm’s problems are so bad its clear the FDA threw the “(regulatory) book at them”. They are told to STOP/DISCONTINUE operations.

        This letter is specific to ONE company/pharmacy only. This firm is cited from the ground up – from incoming material on thru the facility and eventually finished pharmaceuticals. As you can determine from the letter their facility is unacceptable of getting anything approved whether Grandfather or not.

        When I was involved in R&D research in the past I learned about Grandfathered drugs (Mephobarbital & Methenamine mandelate, USP -both unapproved). All Grandfather drugs are unapproved because they pre-date the FDA. The FDA known term Grandfather status means the product is made without approval. Any firm who decides to manufacture Grandfathered drugs does so with the understanding they could provide FDA the information necessary to show a drug is Grandfathered. The risks are the product is not Grandfathered at all or the FDA determines the firm’s product information does not demonstrate the status.

        This firm appears to have not satisfied the information necessary or the quality process to manufacture or seek approval for ANY drugs.

           0 likes

        • ANH-USA says:

          As we noted in our article, we contacted the FDA personally and spoke to the Acting Director of the Center for Drug Evaluation and Research, who personally confirmed to our Executive Director that the FDA’s determination that IV vitamin C was an unapproved new drug was independent of the facility’s cGMP violations. IV vitamin C itself is an unapproved drug per the FDA, not only the particular IV vitamin C being manufactured by this firm. This means that any firm manufacturing IV vitamin C is guilty of the same violation. (As we note in our article, the same violation will not apply to prescription compounding, only to manufacturing.)

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          • IV C Prof. says:

            Please pardon my persistence but you are again incorrect. Your statement “This means that any firm manufacturing IV vitamin C is guilty of the same violation” is not necessarily true. Each company and its products are reviewed independently by FDA. While manufacturing may be separate from product status a firm’s ability to comply with cGMP directly influences that firm’s drugs. This pharmacy/company was not able to comply with the most basic cGMP so its likely they could not support the status of its 3 or 4 products.

            You may want to look into compounding further. A compounding pharmacy is supposed to customize products per prescription/patient, not mass produce or manufacturer batch scale drugs. It is unlikely a pharmacy could achieve cGMP without sufficient infrastructure -like Microbiology, Chemistry & Regulatory. There are many pharmacies, like the one in the warning letter (Mcguff), trying to be a manufacturer. They likely have little understanding of cGMP and the regulatory status of drug products. It is easy to see that this one is violating both cGMP & regulatory status by trying to be a manufacturer.

            Each pharma manufacturer is reviewed separately and its products status are reviewed separately. The current manufacturers of Grandfather drugs may NOT be in violation as another firm. For example, besides Ascorbic Acid USP Injection, the drugs I listed above, Mephobarbital & Methenamine mandelate, USP, and Forest & RLC Labs Thyroid products all remain available as Grandfather drugs that are not necessarily in violation.

            You’re misunderstanding/misinterpreting and providing misleading information. Ascorbic Acid USP Inj is available from cGMP compliant pharmaceutical manufacturers who may not be in violation like the pharmacy/company trying to manufacture who was not cGMP at all.

            However, at anytime the FDA could take action against any/all Grandfather status products should there be reason (public health) to do so.

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  3. I just got another intravenous ascorbate infusion today with no problem. The Riordan Clinic in Wichita is the third provider of IV vitamin C in Kansas to assure me that the therapy was not going away. There are many suppliers out there. If these providers are wrong, maybe the ANC needs to get them involved too. If McGuff is without fault, they should sue the FDA.

    Writing letters to the FDA is like sending a note telling the wolf to leave the chickens he is guarding alone. Better to knock on the farmer’s door and tell him that his guard dog is a wolf. Demand Congress reform the FDA and remove the undue influence of Pharma.

       0 likes

    • TRUTHANDLIGHT says:

      Sure, it’s available, from compounding pharmacies, and possibly companies that haven’t gotten “letters” yet. I called ANH and since they spoke directly with FDA Acting Director*, it is definite that Vitamin C IV is considered an “unapproved drug” by the FDA. Their evil intent is clear. They are not concerned about the health of the recipients of IV Vitamin – and many desperately need it.
      (*Note how ironic, “acting” director, what role are we playing? )

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  4. George Kotsiris says:

    Well, we all know that the FDA is in bed with the drug companies and by regulating injectable or IV Vitamin C will put money in the pockets of these two large entites. Vitamin C is a non toxic water solube vitamin that has benefits and very little side effects, except for gastro-intestinal upset at high doese. I presume the injectable or IV vitamin C bypasses this issue and simply provide all the benefits. The drug companies can’t patent Vitamin C, but I’m sure this will give them another source of revenue from the ever increasing rise in sales and use of alternative medicine….

       1 likes

  5. So, when a letter is sent….what happens then. Is there a way to respond or is court or what.

       0 likes

  6. Geminga says:

    I have read folks asking what to do about this. CALL YOUR CONGRESSMAN 202-224-3121 right now…just ask for your Senator…speak to them then ask for your representitive. Let them know what you think of the FDA. Second CALL THE WHITEHOUSE 202-456-1111. Let the President know how you feel about the corporate controlled FDA under his watch and he needs to fix it.
    If they get so many calls on one day one one topic…it must be brought to the attention of the congressmen. The FDA belongs to the people. We need to call Congress often and let them know how we the people want the agency run….not how Merck et.al. wants it run!! Do this often and you along with thousands of others will make a huge impact.

       0 likes

  7. Alice Moriarty says:

    I am mystified. Why would we (the people thru our congresspersons) give the FDA the authority to control vitamins and supplements with no record of injury or death, when they (FDA) are unable or unwilling to do the job they are hired for. That is, control patented medicine/prescription drugs? Presumably the pharmaceutical companies had FDA approval for their prescription drugs before they were marketed. Also, presumably, the drugs had been tested according to FDA regulations before being approved for sale. Why then to we hear, AFTER the drugs were put on the market, of death and serious injury from those drugs? The ONLY answer is that the FDA is not doing its’ job. I repeat, why are we offering them an additional oversight job?

       1 likes

  8. Dr. Gordon says:

    The letter sent to McGuff creates a scary legal precedence that will affect anyone producing or clinically using any IV vitamin. No matter what, the price of IV nutritional therapies is going to become much more expensive form here on out.
    Does our ultimate goal as a society include making all forms of medicine as expensive and profitable as possible and making anything that goes against this system unattainable? This is our growing reality.
    This is just wrong and will ultimately destroy this (sad) country.
    We the People no longer matter, outside of being tools and pawns in bigger games.
    What do we do?
    Time to outsmart the weasels
    Truth and logic must prevail.
    Truth and logic will prevail.

       1 likes

    • Steve M. says:

      As “Joe” mentioned above in a comment, thanks to the FDA for letting the cat out of the bag for everyone that IV C is an extremely effective therapy!
      Now, to outsmart those weasels who seem to think they have oversight on what nutrients we consume. I suggest any company that receives letters from the FDA to simply play a little paperwork game of their own. Stop producing the product, but create a new company to make the product. Really, no logistical changes are necessary, but on paper change the name of the company. Then wait until the FDA finds them again, and repeat the process. All natural products companies should do this, effectively ignoring any perceived power of the FDA!

      Also make it difficult for the FDA to make contact with them: publish a phone number that goes to voice mail, stating that their call is very important, so please leave a message and we will get back to you as soon as possible; then have a message that the inbox is full.

      The other possible approach is to simply respond to the FDA’s letter stating that the FDA’s interpretation of “The Act” is incorrect since this regards nutrients, not drugs, and if they have any further concerns to please contact. Eventually force the FDA into court. With hundreds or thousands of court cases like this, the FDA will be too consumed to challenge anyone else.

         0 likes

  9. Neighbor says:

    The evidence is becoming quite clear in that everything that is bad for the public the FDA approves. Everything that is good they disapprove. They are not for us.

       1 likes

  10. CAWS says:

    If the FDA persues this track then by law they will have to stop fluoridation of all water systems [mass medication without oversite or consent] . The FDA classifys Fluoride as a drug but it has never been “approved” by FDA. I have a letter from them that says so.

       1 likes

    • Neighbor says:

      Good case in point. They simply will not because it is a good way to get rid of it while lying that it is good for our teeth.

         1 likes

  11. John says:

    People need to be aware that the FDA no longer represents their best interest, They represent the interest of the large drug companies. We need to start demanding that our elected officials stop this age of corporate appeasement and start taking care of the interest of this nation and its citizens.

       0 likes

  12. BonnieB says:

    Dear ANH,

    What can we do about this? I have been signing your petitions and calling my Congressmen. When I call, all I get is smart remarks from their aids and receive form letters that tell me how fabulous the FDA is and how their process is so thorough and makes everything safe. I get so livid because I do not have the time to keep calling or writing letters and never get to speak directly to the representative. My father has had 3 cancers, has had one return but now has osteonecrosis of the jaw because they have been shooting him up with Zometa and not telling him the consequences! ONJ has no cure and no treatment and he did not need Zometa to beat any cancer – he just needed magnesium, potassium, calcium, high levels of D3 and Vitamin K to strengthen his bones – but they never gave him that option! It’s horrible to see him have to go through surgeries to remove pieces of his jawbone! The last one left a hole in his nasal cavity.

       1 likes

  13. D Adams says:

    Do hope things get straightened out with the Vitamin C issue. Also read about issues concerning Vitamin D. It seems as though the FDA and doctors are walking hand in hand. There are a lot of dangerous prescription drugs on the market. I know doctors do not like it when a patient refuses to take a drug because of the bad side effects. I was once on a lot of prescription drugs and nearly died.
    the only thing I take now is Synthryoid and I have to have this. It concerns me that doctors are so quick to pull out their prescription pads when many times health issues can be taken care of naturally. I do know doctors get kick-backs from the pharmceutical companies for prescribing their drugs. Why all of a sudden is the FDA picking on vitamins. Suppose the next target will be herbs. I do not know about anyone else, but the direction this is taking is frightening as Americans are heading farther and farther away from being a democracy and this is a part of the “taking away our rights”. Go after the new drugs! I have yet to hear of anyone going into renal failure do to an injection of Vitamin C!!

       1 likes

  14. Joe says:

    Who said “There is no good publicity or bad publicity, only publicity! Just make sure the name of the product is written properly” So I’m tempted to say thanks to the FDA for freely advertizing about IV C.

       0 likes

  15. Joe L'Amarca says:

    The problem with people that try to help with the fda is that they do not have to do anything that the voters want them to do and they aint going to help you at all!!!
    The only help that the federal mob will help you with is to take the rest of your wealth and blood that they mist of taking it in the first place .
    If anyone wants to understand about the federal mob how unconstitutional they really are 11th amend. is the federal const. Article three Section two is the U S Constitution gues wich one supersccede ?

       0 likes

  16. Garten Man says:

    So, what is the number I have to call for the FDA to tell them my story? I cannot find any info on their website.

       0 likes

  17. Garten Man says:

    IV C saved my life. I was on various chemicals to combat unknown masses moving through my body. I was wasting away from the masses and the chemicals prescribed to fight them for 2.5 years. Pharmaceutical companies made lots of money off me when docs pumped the expensive, patented meds into me but I had little to no success to show for all the effort and bills. Finally, I was told another surgery was required. My fiance put her foot down and vowed to find an alternative.

    She did find an alternative, in the form of IV C. I was dubious of it, but for her I did it. The masses retreated and I grew stronger. I am finally off all chemicals and I have the IV C to thank for it. I was en route to the grave but now I am recently married and we are planning to start our family once all traces of the chemicals are gone. No patents required to do the job.

    I am a person emerged from the morass of the institutional medical system with a life renewed due to God’s wonderful gift of vitamin C made injectable by man. Are you listening? IV C saved my life.

       1 likes

  18. It is indeed a sad point in the history of our great nation which prides itself above all in democracy and freedom that the process has begun of FDA removal of access to nutrients, the first of which are being used intravenously. The process of attacking one or a few nutrients at a time, or one company at a time, will not arouse a great public outcry. Only when we are left with very few or no therapeutic nutrients will everyone realize that our government agency, in the name of protecting us, has done us a great harm.

    It is very sobering to contemplate that in the name of health, at a time when health costs are out of control and drug costs are skyrocketing, that efficient manufacture of therapeutic nutrients is being branded as a criminal activity. Of all the issues that attention and redress in this nation by our government, preventing people from getting better by the method of their choice should not be a cause for being hunted down and threatened by the government of a Free Nation. If progressive restriction continues to occur, we should wonder the purpose of such prevention of ability of Americans to use nutrients to get healthy. It stretches the foundations of my belief in our democracy to imagine that this is our country’s first step in the FDA campaign to restrict natural healing, not for safety reasons, but for some unspoken agenda.

    I hope that the nation does not respond like the proverbial frog in the pot water on the stove, relaxing while the temperature gets warmer, until it finds itself boiled.

    I have used, been treated with, and seen colleagues use IV vitamin C with clinical benefit, from McGuff and other companies, and think that removing it poses a threat to health.

       1 likes

  19. Carol Walters says:

    I totally agree. If the FDA weren’t in bed with big Pharma, then they wouldn’t care about nutritional supplements. Just because foodstuffs can’t be patented to make millions of dollars from, this agency wants it banned along with other vitamins. You know, VITAL AMINES which is what vitamin c and b and others are, VITAL to our health. They talk a good story about controlling costs in Washington, but when it comes to people taking charge of their own health by trying to remain healthy, they want their foot in the door to say NO. Sounds like they want people to die off for lack of care, even sane sensible care for ourselves. Who needs Obamacare death squads when they want us to allow ourselves to die purely from neglect. What’s next?……arrest a doctor for recommending an apple a day would keep him away? Careful…..that apple is an unapproved drug! We will have to destroy it and arrest you….for your own good of course.

       1 likes

  20. Fletcher Millmore says:

    I am appalled, angry, and frightened by the FDA and its cronies, nothing new there. I was nearly in the same state regarding ANH after the Jan 4 notice. It was yet another example of the same crappy journalism, bad science, and rumor mongering of which we have way too much already.

    Contrary to the opening statements of today’s Jan 11 notice – “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 Jan 4 headline was “Now the FDA Is Going After Vitamin C!”, followed by “The FDA has just notified one pharmacy that it will no longer be allowed to manufacture or distribute injectable vitamin C…” The references “With this pharmacy, the FDA also banned injectable magnesium chloride and injectable vitamin B-complex 100. etc.” complete the factual references to this action.

    The letter was not published or linked, and McGuff was not mentioned. No details, including the date of the letter, were supplied. If you want people to act on your alerts, then you had best supply us with some real facts. I found the letter on another site, after several hours searching, with nothing to go on but “FDA warning letter”. Any confusion resulting is entirely on your heads.

    I expect better, and we must have better info to fight this evil amalgam of vested interest, profit motive, and fear mongering.

    I will note that I have no medical coverage except my nutritional resources, of which ascorbate is primary. Frankly, I think I am better off without medical coverage. Two years ago I got to watch my wife (pancreatic), my oldest friend (ovarian), and my oldest friend (pancreatic) in the local area die from cancer. 120 person years of the most important people in my life. No doctor would even discuss alternatives, but they sure were amazed at how well my wife healed after their surgery, and how few side effects she had from their poisons. She lost heart to battle authority, and her decline was in direct proportion to how much she abandoned her nutritional procedure. They would not even read the published studies I supplied. At the end of her life, my friend with ovarian cancer was diagnosed as being catastrophically low on vitamin D, as I had predicted, but that was a year and two surgeries and a lot of chemo too late. These people are criminals, and to the extent that they know or should know what they are doing are guilty of manslaughter if not murder. It is illegal here to do IV yourself, but if my time comes I will do whatever “battlefield medicine” it may take.

    FRM

       1 likes

  21. Brenda McAfee says:

    May I suggest everyone read “Curing the Incurable” by Dr.Thomas Levy from LivOn Books http://www.LivOnBooks.com or 1-866-790-2107, detailing the power of IV Vitamin C with no adverse side effects. What the FDA is doing is criminal. Let’s all do all we can to bring this issue to the public and generate grass roots opposition to this!

       1 likes

  22. R. Bowman says:

    This is unconscionable and it is ludicrious that we let the FDA get away with it. Tell us what we can do to stop such nonsense right now. People across this entire nation should absolutely be raising absolute hell over this. It is high time we did something serious about the FDA. We need to demand (en masse.. meaning in very large numbers across this entire country) that our Congress persons do something right now about reigning in the abuse of power by the FDA and to keep their damn hands off natural foodstuffs and that includes injectable vitamin C. If all you are good for is sending us alerts then you are mostly just wasting our time. You should ban together with any and every other organization you can find and finally DO something serious about this. Stir up enough people to petition our Government to directly rescind this situation and eliminate further power grabs of this nature that affect the health of the people of this great country. I do NOT want Big Pharma, its lapdog the FDA or its partner in crime the AMA to decide what I can and cannot have access to as regards natural type products to sustain or improve my health. All this bitching to each other on a forum basis is a waste. We need to organize and take action in a big way! Aren’t the rest of you tired of having your freedoms stolen regularly one by one???

       1 likes

    • TRUTHANDLIGHT says:

      YES I am in 100% agreement with you! I am but one concerned citizen, but multiply that by a few million, or more…..WHAT ARE THE NEXT STEPS? I’ve written to the FDA, and my representatives in Congress. Supposedly, one letter equals 1000 votes, because most people simply don’t get up from the couch and write….unless it affects them directly. So how to rally the “troops”?

         1 likes

  23. Gracie says:

    The FDA is on the whole, a despicable agency, a tool of the AMA, ADA, “big pharma” and other industries and their lobbyists. They don’t care if they kill people with their extreme bias and constant attack on alternative health care, it’s practitioners and natural supplements. They are sneaky and underhanded in their dealings, and can’t be trusted. Unfortunately, I doubt this will ever change, but I pray it does.

       1 likes

  24. Frank Kentin says:

    I think that if anyone who wishes to have their doctor administer IV C to treat cancer, where all other treatments have failed, should not be denied by the bureacrats in FDA. Furthermore, I think that if there should be a death where such denial by FDA has been involved, FDA should be sued.

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  25. i agree that vit c with the other nutrients are not drugs, they are non toxic and the FDA better stay out of nutrution. i do extensive researching and in the past they have said herbs were unsafe, but i found out they are using astragulas extract and finding it is the fountain of youth. .
    they have now gotten their own doctors who charge huge prices to do the therapy, in florida and new york and in calif. the elite are paying up to 7000 and more for a six months supply and are being tested by these doctors and are finding it is changing the RNA, to the advantage of people. it is renewing our damaged cells, from pharma drugs, and is being hailed as the fountain of youth. how dare them comdemn herbs and vitamins, if you do research, you will find cures for all illnesses – our people have to educate themselves and start to do their own investigations, as to why the government wants to shut down all the natural supplements.

       1 likes

  26. Heather Koehler says:

    FDA has big Pharm in their pocket. Part of the Beast. This is one step towards controlling vitamins.

       1 likes

  27. jerod jewell says:

    I am healthcare provider, a simple guy from the country with many years of experience in hem/onc. The greatest “threat” to our great nation in my opinion, next to the our DEBT, is our health not the cost, but the lost of it. Because if you lose your health, it is hard to get it back. How can you defend yourself if you are PHYSICALLY WEAKER than your adversary. We are increasingly feeling the ranks of our “elite forces” in the military with nationalized citizens. Why?………….. When we responded to the 9-11 bombing, I witnessed many statements from the men & women of our military who engaged the enemy upon return back HERE, statements of………. “how physically strong and great endurance they possess”….. Look, the FDA is controlled by BIG PHARMA, which is controlled by WALL STREET, which is controlled by the FEDERAL RESERVE(which is private collection of us citizens and foreigners), which is linked to the IMF, which controls WTO, which controls WHO, which governs the CODEX committee. We got problems big problems and the FDA IS A PUPPET. Just my opinion………………………………………………….

       1 likes

    • Shepherd says:

      amen and amen.
      it has already been a long war, which most people are only now becoming aware of.
      so it’s not really that big of a problem when you already know who wins.

      wake up. God is in control. always has been, always will be.

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  28. Dennis Oberholtzer says:

    As someone who rarely gets sick, and has never taken an IV dose except when I had my kidney stones, I am not aware of intravenous vitamins. I do see the value in it, and believe the FDA is far too powerfull. But if pharmaceutical doctors are already prescribing it, there is no reason whatsoever that the FDA should stick there controlling bigotry into their business. It is not like a person can prescribe it to themselves.

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  29. Leslie Johnson says:

    I think all the Pharma lobby money is going to the Senators and Representatives in charge of FDA programs and budgets. Where can we find out who they are?

       0 likes

    • Sally G says:

      I would start with opensecrets.org & Public Citizen. VoteSmart is good for finding out which legislator is on what committee; they also have information on how each votes. ProPublica may be helpful, also.

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  30. Frank says:

    What do we the people need to do to get control of the FDA, an out-of-control agency?

       0 likes

    • Neighbor says:

      We need to organize in numbers first and sign a petition of sorts stating that “we the citizens” are tired of Big Pharma and its enforcing thug, the FDA telling us what is best for us. Who gives them, FDA, such power? Follow the money. IF and when they will not listen then we have to be willing to have one person, a delegate, from each State, smybolically march to their respective State Capitols and then on from there up to our Nation’s Capitol, with smybolic rubber pitchforks and trudgeons, to get their attention, if need be.
      This may sound a little harsh but it is gauranteed to work when nothing else wil.

         0 likes

  31. Jean Baugh says:

    I have the greatest contempt for a federal agency who operates as if they have no control and their unstated aim, is genocide by taking away everything that might help the health of people!

    Jean Baugh

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    • [email protected] says:

      I agree Jean. Healthy people are not profitable for drugs, doctors, or hospitals. These people don’t won’t to lose the money. I have always said that the Cancer industry doesn’t want a cure. Where would all the doctors and others that work at places like Sloan Kettering go.

      Jay

         1 likes

  32. TRUTHANDLIGHT says:

    I came across this article from Dr. Mercola’s site – please note the inherent bias of the FDA towards patented drugs, and against non toxic Iv therapies.:

    http://emf.mercola.com/sites/articles/archive/2005/01/22/hydrogen-peroxide-part-three.aspx

       0 likes

    • [email protected] says:

      There was a You Tube video at Mercola.com. I can’t locate it, of course. Anyway it was about a man that was on life support because of the swine flu. He almost died. After a legal battle the family was able to put him on intravenous vitamin c. Of course, he did not live in the US. Dr Fredrick Klenner used intravenous c. The FDA only wants to ban it because the pharmaceutical houses will lose money because it works. One can make one’s own injectable c, but not the intravenous. One of the many evil things about the FDA is there control all around the planet

      Jay

         1 likes

  33. snoodledoo says:

    I think the FDA should be sued for monopolistic behavior because of their consistent descrimination against anything not made by BIG PHARMA. I also think the FDA should not have jurisdiction over non-pharmaceuticals, including IV vitamins, because of their inherant conflicts of interest and consistant anti-nutritional stance.

       0 likes

  34. I personally witnessed a 34 year old lady in 1991 who was receiving injectable vit. c. This lady told me it was stage 4 at the MAYO cLINIC in Rochester, Mn. She got 100 cured when I saw her several years later. We were both at a clinic of natural healing in the twin cities. I had agent orange type poisoning with no help from any regular clinic. This clinic saved my life
    by using natural plant products and minerals.
    signed James Pelowski

       1 likes

  35. Leif Werner says:

    please go to http://www.hvhy.org for more information on the Kenites who rule this world with the four hidden dynasties: the economy, the education system, religion and politics…the pharmaceutical industry is just one example…ciao Leif

       1 likes

  36. Stan says:

    I have just read your previous alert on this, and understand that these 3 forms of nutrients are part of an injection. But there is a fundamental issue here. If nutrients are not to be allowed as nutrients – foodstuffs – when they are taken in more than RDA doses – therefore taken for ‘therapeutic’ reasons – that gives the FDA their foot in the door to disallow any strengths larger than the RDA. And that violates the spirit of the law that ALLOWS people to have access to food supplements at larger than RDA levels, because they are to be considered as just that – food supplements, not “drugs”. It’s a matter of definition. And we cannot be letting the FDA outlaw this sort of situation, or truthful health claims to be made for various foods, because that should be outwith their regulatory powers. What’s the ANH’s position on this matter?

       0 likes

  37. Leif Werner says:

    thank God….representatives for the FDA of course understand that to completely shut down intravenous vitamin C would be stupid ….they may need it themselves if and when they get sick…but remember we have to be on guard and see what wicked stuff the Kenites come up with ….they rule this world with the four hidden dynasties: the economy, the education system, religion and politics…be a watch man ciao Leif

       0 likes

  38. MAAguilera says:

    Is it not true that since Vit C has been around for more tha 50yrs, it is exempt from the FDA control. There is some law that allows contunued use of products that have been around since before 1970.

    Can you please clarify?

    Thanks,

    MAA

       0 likes

  39. JadeQueen says:

    To pick on one manufacturer is discriminatory. I wonder if the Institute for Justice would be interested in a case like this? The company with the issue would have to take it to them.

       0 likes

  40. TRUTHANDLIGHT says:

    ALL the FDA has done is make IV Vitamin C less available, inconvenient for doctors to obtain, and ultimately, MORE expensive. THERE WERE NO ADVERSE EVENTS!!! NONE! THIS IS A WITCH HUNTwith trumped up charges, all with the intent to make Vitamin C – a NUTRIENT – either go through “drug approval” or be completely unavailable in the long run! Glad to hear my family members with cancer can still get IV C NOW, if their doctor gets it through a compounding pharmacy.. But the bigger picture IS VERY FRIGHTENING, calling it “an unapproved drug” and stating that it was “adulterated” because of some paperwork violations – ABSURD. Thank you ANH-USA for keeping tabs on this, and keeping us informed.

       1 likes

    • LindaN says:

      Once again, The reason the FDA can presently do this is because the injectable is being used to “treat” disease, and in the FDA’s eyes anything being used to treat disease, including water, is magically turned into a drug and must go through the drug approval process, because only “drugs” can treat disease. If it is advertised that eating walnuts can lower cholesterol, then magically walnuts become drugs, and any “drug” must go through the drug approval process. The catch here is that natural substances cannot be patented and the millions it would take to go through the FDA drug process cannot be recouped by whomsoever spent it to get walnuts approved as a drug. Of course all of this is just word games so that the FDA can squash any claims that anything but pharmaceutical drugs can treat disease. The way the game is set up it is just a win win situation for drug companies and the FDA (who get kick backs of a sort through PDUFA) and a lose lose situation for supplements and the health of the American Public. But the drug industry writes the laws for the most part. This was/is NOT stating that it was “adulterated” because of some paperwork violations.

         1 likes

  41. Charlene Yanchak says:

    We need to be aware of government actions against our vitamins and make sure
    they are never taken from us.

       0 likes

    • DeJay says:

      Things as they are will have to change if we are to remain free. Freedom has a price that the sheeple can’t seem to comphrehend. The sheeple don’t seem to realize that the FDA, the AMA and the pharmacuetical companies have not been with us very long. They were instituted by the monied people who even with 100’s of millions of dollars can’t seem to get enough. That should tell us something. They don’t care about us and would like to eliminate us thru the process of gradualism so we don’t notice what is happening. We got along much better before the FAD, the AMA and the drug companies came in to being. We have to get ridof them and the manufactures of processed foods. The answer could be self sufficiency but many in the cities would be unable to do so. There was hope in the newly elected Congress but now we find out that all the newbies put out lies like our Obummer did. Since the companies that manufacture the electronic voting machines are in cahoots with the powers that be (TPTB) the elections can easily be rigged. Our future looks very dismal.

         1 likes

  42. Hilery says:

    The evil of the FDA is well-known, but this is a new low. People are waking up to the fact that they can benefit from high dosages of a simple nutrient – vitamin C – that has been available without prescription and expense for decades. But the Medical Monopoly is not willing to continue to lose all those healthcare dollars to something they cannot control – so now Vitamin C is a dangerous unapproved drug.

    It’s criminal and it’s time for people to speak up and demand Freedom of Choice in their own healthcare!

       1 likes

  43. Suzanne says:

    I hope everybody listens to Dr. Tom Levy on Natural News Live on Thursday night (1/13). Here are the details:

    By now, you must have heard that
    the FDA wants to prevent YOU from
    having access to vitamin C.

    Yet, the scientific research is clear –
    Vitamin C is a valuable nutrient in the
    treatment of several health challenges,
    including cancer.

    Our next guest, Thomas Levy, M.D. is
    dedicated to the value of Vitamin C.

    You won’t want to miss what he has to say.

    Date: Thursday – Jan. 13, 2011

    Time: 6 pm (PST) / 9 pm (EST)

    You can sign up for your own link by sending Jonathan Landsman an email at

    NaturalNews LIVE [[email protected]]

       0 likes

  44. Corde' says:

    See attached on Vitamin C IV

       0 likes

  45. Stan says:

    I don’t understand – why are (IV) vitamin C, magnesium, and a form of B complex being considered “unapproved new drugs” – and why is the ANH okay with this? this is a terrible foot in the door. The public should be objecting strenuously at this interpretation. If not, why not??

       0 likes

    • ANH-USA says:

      Hi Stan, we at ANH are absolutely opposed to this classification of vitamin C as an unapproved new drugs – hence our action alert on the issue! We have long taken issue with the definition of a drug as “any product intended to treat disease”.

         0 likes

      • TRUTHANDLIGHT says:

        Is writing to the FDA making any impact at all?? They aren’t elected officials. I am aghast at the arrogance to classify nutrients as drugs, then suddenly decide they are not ‘grandfathered in” – although they were around prior to the FDA’s existence – and have NOT harmed anyone! Should we contact Congress? File a class action lawsuit? WHAT ELSE CAN WE DO?

        Why NOW? I am concerned for many reasons – as a consumer, a citizen of a free country, and – as one with 2 relatives battling cancer right now, and while they chose to use chemo, they also were grateful to know about IV nutrients to combat the chemo side effects! (Personally I’d never subject myself to chemo but I support them and their choices)

           0 likes

        • DeJay says:

          What Iread from doctors who only use prescribed medicines as a last resort is that an IV of hydrogen peroxide put more oxygen in the cells which target anerobic cells. Those are cells that annot survive in the presence of oxygen. Therefore it will cure cancer. Vitamin C is very important to the health of the body. Livon Labs claims that in tablet or capsule form, only 20% is absorbed whereas the lipospheric form delivers 98%. When a person goes to the ER with a heart attack, one of the things in the IV is magnesium. Magnesium is very important to heart health and most of us are deficient of it. Also vitamin B IV is normally used to give the body more energy. B vitamins are water solubable and do not linger in the body too long.

             1 likes

          • TRUTHANDLIGHT says:

            There is much science that supports IV Vitamin C. Oral forms are great addition, but nothing takes the place of IV administration. The body can tolerate much higher dosages in IV form without the one lone side effect of “too much” vitamin C – loose bowels.

               1 likes

  46. Rosemary Ennis, Ph.D says:

    Thank you for your fine work. Dr. Ennis

       0 likes

  47. Charles Tuesburg says:

    A possible substitute for IV C would be a new form of C called Lypo-Spheric by Livon Laboratories in Henderson, NV. Website is http://www.livonlabs.com. I hope this info is helpful.

       0 likes

  48. Jack B says:

    It is rediculus to think the FDA can treat vitamin C or any other natural occuring substance (inluding Marijuana for that matter) as a drug. The American people should wake up and and get them to protect us, not stay in bed with “big PHARMA”!!

       0 likes

    • LindaN says:

      The reason the FDA can presently do this is because the injectable is being used to “treat” disease, and in the FDA’s eyes anything being used to treat disease, including water, is magically turned into a drug and must go through the drug approval process, because only “drugs” can treat disease. If it is advertised that eating walnuts can lower cholesterol, then magically walnuts become drugs, and any “drug” must go through the drug approval process. The catch here is that natural substances cannot be patented and the millions it would take to go through the FDA drug process cannot be recouped by whomsoever spent it to get walnuts approved as a drug. Of course all of this is just word games so that the FDA can squash any claims that anything but pharmaceutical drugs can treat disease. The way the game is set up it is just a win win situation for drug companies and the FDA (who get kick backs of a sort through PDUFA) and a lose lose situation for supplements and the health of the American Public. But the drug industry writes the laws for the most part.

         0 likes

      • Nancy Anderson, MAHH says:

        Since the FDA is concerned with the compounding aspect, it may be different concerns than drug vs vitamin. I was a compounding IV Pharmacy tech for over 25 years, and after reading the articles and reviews I saw things a little differently. First, some referred to IV and some said injectable. These are two very different routes of administration. The IV method goes directly into the blood stream and bypasses the immune system. As a tech, we had to filter the magnesium and ascorbic acid carefully because they were dispensed in ampules. In the actual compounding, we were required to have a pharmacist verify every step of the process (from powder to diluent to final concentration) to ensure consistency of dose. If we used manufactured ampules, filtration and concentration were the main issues. Also, we had to be concerned with the quality assurance of the class 100 environment we prepared the injection in. Many recalls occur because the environment is contaminated, or the person giving the injection did not use asceptic technique and the patient had a staph infection because of the route. Cyanocobalamin *Vit. B12″ has two main dosages: 1000mcg and 100mcg. These are often mixed up and can harm when given to a patient through IV methods. Just thought I’d shed some light on a different aspect of this debate.

           0 likes

  49. I am a medical writer. I called McGuff yesterday, spoke with Bill, and got a different picture than what you paint here today:

    In late December, the FDA sent a warning letter to McGuff Pharmaceuticals that the company will no longer be allowed to manufacture injectable vitamin C, injectable magnesium chloride, and injectable vitamin B complex. You seem focused just on the vitamin C, but it is magnesium and B-complex as well. The key word here is “manufacture.”

    According to McGuff Pharmaceuticals, this is a continuation of the FDA’s policy announced about 2005 that there should be no more “grandfathered” drugs.

    The FDA’s warning letter means that these injectables can no longer be manufactured. They must now be compounded, meaning, made by hand at a compounding pharmacy rather than by streamlined manufacturing methods. The key word here is “compounded.”

    For doctors, this means those who ordered the injectable C, B-complex, and magnesium will need to order from McGuff’s compounding pharmacy – or at some other compounding pharmacy. It is readily available.

    For patients, it means that the quality used to be consistent because a manufacturing process is more consistent than what the numerous compounding pharmacies may do to produce it.

    We still need to talk to a company other than McGuff to find out what that perspective is.

    Respectfully,
    Mary Budinger
    Phoenix, AZ
    http://www.AlphabetOfGoodHealth.com

       0 likes

    • Love what your home page says-beautifully and simply expressed.
      http://www.BetterFoodForBetterKids.org

         0 likes

    • JFremin says:

      Good grief! Injectible Magnesium is about as main line as you can get. We’ve been using it in the hospital for decades! Makes me wonder who got paid off.

         1 likes

    • IV C Prof. says:

      The statement “This means that any firm manufacturing IV vitamin C is guilty of the same violation” is not necessarily true. Each company and its products are reviewed independently by FDA. While manufacturing may be separate from product status a firm’s ability to comply with cGMP directly influences that firm’s drugs. This pharmacy/company was not able to comply with the most basic cGMP so its likely they could not support the status of its 3 or 4 products.

      You may want to look into compounding further. A compounding pharmacy is supposed to customize products per prescription/patient, not mass produce or manufacturer batch scale drugs. It is unlikely a pharmacy could achieve cGMP without sufficient infrastructure -like Microbiology, Chemistry & Regulatory. There are many pharmacies, like the one in the warning letter (Mcguff), trying to be a manufacturer. They likely have little understanding of cGMP and the regulatory status of drug products. It is easy to see that this one is violating both cGMP & regulatory status by trying to be a manufacturer.

      Each pharma manufacturer is reviewed separately and its products status are reviewed separately. The current manufacturers of Grandfather drugs may NOT be in violation as another firm. For example, besides Ascorbic Acid USP Injection, the unapproved/grandfathered drugs, Mephobarbital & Methenamine mandelate, USP, and Forest & RLC Labs Thyroid products all remain available as Grandfather drugs that are not necessarily in violation.

      You’re misunderstanding/misinterpreting and providing misleading information. Ascorbic Acid USP Inj is available from cGMP compliant pharmaceutical manufacturers who may not be in violation like the pharmacy/company trying to manufacture who was not cGMP at all.

      However, at anytime the FDA could take action against any/all Grandfather status products should there be reason (public health) to do so.

         0 likes

      • Truth and Light says:

        IV Prof, I’ve read all your posts, and ANH response. I am not a spokesperson for McGuff but I must defend the company, as I worked until 2009 for a company that worked with them and have been in touch since. I found them to be an upstanding company of imppecable integrity, honesty, and learned from contact with them at that time, thay they thought they had “good communication” with FDA officials who visited often, and were given free reign, even showing them private records beyond what is needed for a GMP inspection.- McGuff, according to their website is ISO 9000 certified, PCAB (Pharmacy Compounding Accreditation Board) and has passed all GMP FDA inspections with the exact Standard Operating Procedures in all previous years. The only difference was an interpretation – and the cGMPs are written so that the FDA can interpret and change them without warning. ANH is quite correct in referring to the obscure language FDA uses, including the word “adulterated’ in reference to a paperwork infraction. It could be punctuation on a report, if the FDA inspection official that day is so inclined! “FOLLOW THE MONEY” is my motto, when it comes to irrational things such as attempting to re-classify Ascorbic Acid – even IV – as an “unapproved drug”! Even the National Institute of Health is conducting clinical trials on IV C and Cancer – which proves they know it is safe! It is all about money, fees to the FDA, and possibly some pressure by an unknown company who is finaicially affected should IV C have the healing properties that Integrative Doctors, or informed patients, suspect it has….think “H1N1″ and “cancer” – both big money makers for Big Pharma…..

           1 likes

  50. Mark Kaylor says:

    Thank you for posting this clarifying piece.

       0 likes

    • George says:

      If injectable Vit.C becomes unavailable the lipolized form taken orally will get blood levels at or above those attainable thru injection. Just something to think about.

         1 likes

      • Medea says:

        George- What exactly is the “lipolized form” of Vit. C, and why is it different from regular oral Vit. C form (I guess, non-lipolized?)? I googled it and found no explanation other than lipolysis which concerns breakdown of fats. Can’t be just the buffered Vit. C form that has a neutral pH? Or L-ascorbic acid? This would concern the chirality or “handedness” (”the L-enantiomer of ascorbic acid is also known as vitamin C”, Wikipedia). Please explain?

           0 likes

        • deenie says:

          Maybe George is referring the palmitate form of C? ascorbyl palmitate. I take Durk Pearson & Sandy Shaw’s Dual C that is made up of two forms of C: calcium ascorbate and ascorbyl palmitate.

             0 likes

      • margie says:

        There are other issues. Oral Vitamin C actually inhibits cancer drugs, leaving the cancer cells able to continue multiplying. This is why cancer patients are told not to take Vitamin C. The IV Vitamin C does the opposite and acts like a cancer drug, targeting cancer cells, but without the side effects of the cancer drugs. For cancer patients they must have the IV vitamin C.

           1 likes

    • Any and all loop holes available to the FEDERAL DEATH ADMINISTRATION will be used to protect the profits of BIG PHARMA, and if we as citizens of any nation want to walk a different path in our quest for wellness, they will do their best to stamp it out.

         1 likes

    • Lori says:

      Will it still be possible for compounding pharmacies to make and use this iv c for alternative
      doctors to use since there are some of these type of doctors around? Why can’t the fda just have
      a alternative branch of medicine that uses these natural types of medicinal vitimins and so forth???
      They are slowly taking away our right to choose what type of medicine / vitamine we want to put into our bodies for the treatment of such illnesses. Little by little the greed grows more and more and we loose our freedom. Sad state! L R

         0 likes

      • jake says:

        They would not be able to control things that way

           0 likes

      • Viviane says:

        I had this IV C for my CSF and fibromyalgia. It save my health 20 years ago.

        It is enough that they took away Armour thyroid, which millions of Americans use it. The fda wanted 10 millions $ to let them continue the production. Unbelievable the greediness!!!!!!!!!!!!!!!!!!!

        Viviane

           1 likes

  51. ANH-USA says:

    Please refer to the article above. The information we received from the FDA directly contradicts the argument you put forth above. “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.” The NDA drug approval process is an entirely separate issue from the cGMP violations at McGuff’s manufacturing facility. Once they remedy their cGMP violations, the IV vitamin C will still be considered an unapproved new drug, as approval is not facility-specific but rather drug-specific. This information comes directly from the acting director of the FDA.

    In particular note that the FDA’s letter to McGuff specifically reads, “In addition to violating CGMPs, 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,” further clarifying that the cGMP violations and the unapproved status of IV vitamin C are independent of each other.

       0 likes

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