FDA Seeking to Outlaw IV Vitamin C, Other Nutrients
Rep. Ron Paul, MD: As an agency, FDA engages in “abuse of power…”
Action item: http://tinyurl.com/saveIVNutrients
Archive of Emergency Web Meeting of January 9, 2011 here:
March 9, 2011 – We Dissect a Response from the FDA! Click Here.
The FDA (the Food Destruction Agency) not content with its new power to control and industrialize our entire food supply, is, quite predictably, increasing its attacks on nutrients. Although the mis-named Food Safety [sic!] Modernization Act excludes nutrients, the FDA’s rampage against natural health is by no means limited to degrading our food supply.
DSHEA, the 1994 Dietary Supplements Health and Education Act, which protects dietary supplements does not protect nutrients unless they are delivered in oral form. That means that intravenous, transdermal, nasal, suppository or other forms of nutrition are vulnerable to FDA assault in a particularly worrisome way. This latest action by the FDA makes that point clearly.
On December 28, 2010 FDA ordered certain small manufacturers to stop making IV Vitamin C and several other injectable nutrients which are always used under a (holistic or Advanced health Care) physician’s supervision by classifying IV Vitamin C, Magnesium and certain B Vitamins as “New Drugs”.
The nutrients under attack, which form the basis of the popular “Myers Cocktail” and countless therapies for serious diseases, may be provided ONLY by compounding pharmacies under a specific prescription for a specific patient. This means that the cost of these nutrients will increase sharply.
It also means that the FDA, always hostile to compounding pharmacies and the independent use of nutrients, bio-identical hormones (now banned at the request of Wyeth/Pfizer, which manufactures dangerous synthetic hormones), the biologically active form of Vitamin B-6 (also banned at the request of a drug company) can pick off individual substances and attack compounding pharmacies at their leisure. This is a result of the power granted FDA in 2007 (section 301(11) of the Kennedy FDA Enabling Act) to ban interstate sale of any “food” ever studied for medical use, even if never so used.
Why, you ask, does FDA need authority to ban safe foods? Why does Congress think it has the power to grant such authority? Where in the Constitution does Congress have that power? And please, don’t say it’s in the “Commerce Clause” which grants the Federal Government the power to regulate Interstate Commerce. “Regulate” does not mean the power to forbid foods that people have always had the fundamental human right to grow, trade and use. It merely means to make commerce regular; to make fair and neutral “rules of the road” for Interstate Commerce. Under the 9th Amendment, the People have retained the right to grow and trade foods, including vitamins and minerals. As we Restore the Republic, that right must be respected again.
Manufacturing companies wishing to make and sell the now restricted injectible, inexpensive and life-saving nutrients will be forced to engage in full-scale drug approval testing for products that cannot be patented; this, the FDA knows, is economically impossible. The attack on Vitamin C comes on the heels of efforts by FDA to ban other nutrients, including forms of Vitamin B6 banned under the Kennedy Enabling Act.
If these restrictions stand, what nutrient will be next?
Please take the Action Item at this link, which tells the White House and FDA to leave our nutrients alone! http://tinyurl.com/saveIVNutrients
Blog entry originally published at: http://vitaminlawyerhealthfreedom.blogspot.com/2011/01/fda-seeking-to-outlaw-iv-vitamin-c.html
— On Wed, 3/9/11, CDER DRUG INFO
From: CDER DRUG INFO
Subject: RE: Leave our Nutrients Alone!
Date: Wednesday, March 9, 2011, 8:53 AM
Dear P… B…
Thank you for your e-mail expressing concerns about FDA’s December 28, 2010 warning letter to an individual manufacturer (McGuff Pharmaceuticals Inc.) of intravenous (IV) vitamin C along with other prescription drugs.
Unlike oral vitamin C-which could be a dietary supplement- these particular IV solutions are, by law, unapproved drugs. Moreover, the manufacturers neglected to follow current good manufacturing practices, potentially exposing users to unnecessary risks.
Such risks have occurred before. In the E-Ferol tragedy of 1983, premature babies received E-Ferol, an intravenous form of vitamin E. E-Ferol was associated with adverse reactions in 100 premature infants, forty of whom died. It is highly likely that this tragedy would have been prevented if the product had been reviewed and approved by the FDA before its introduction to the market.
Since FDA announced its Unapproved Drugs Initiative in June 2006, marketers of unapproved drugs have been on notice that addressing risks from unapproved drugs is a high priority for FDA, and that the Agency plans to systematically and responsibly ensure that all products on the U.S. prescription drug market become compliant with current FDA approval requirements for safety and efficacy.
The mission of FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that safe and effective drugs are available to the American public. Drugs that have not been approved by FDA may not be safe and effective, may have been manufactured under sub-standard conditions, may contain too much or too little (if any) active ingredients, and may not have necessary labeling information and warnings.
FDA’s drug approval process ensures that drugs are safe, effective, of a suitable quality and purity, and are properly labeled. The Agency remains committed to assisting all firms with meeting these standards.
Again, we thank you for your input and hope that we were able to address your concerns.
Division of Drug Information – JD
Center for Drug Evaluation and Research
Food and Drug Administration
For up-to-date drug information, follow the FDA’s Division of Drug Information on Twitter at FDA_Drug_Info
This communication is consistent with 21CFR10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
Please note: the above statement, in our humble opinion, misstates the law. The various laws passed by Congress over the decades continually adding to the FDA’s power all include “grandfather” clauses allowing products that existed when the various laws were adopted — IV nutrition has been used for a very long time. Andrew St Georgie received the Nobel Prize as one of the discoverers of Vitamin C in 1937. Frederick Klenner, M.D used IV Vitamin C in the 1940s. It was used IV well before the 1952 authorization by Congress giving FDA authority over the “safety and efficacy” of drugs (before that time, FDA only had authority over misbranded or adulterated drugs). rf
“From 1943 through 1947,” writes Robert Landwehr (3), “Dr. Klenner reported successful treatment of 41 more cases of viral pneumonia using massive doses of vitamin C. From these cases he learned what dosage and route of administration – intravenously, intramuscularly, or orally – was best for each patient. Dr. Klenner gave these details in a February 1948 paper published in the Journal of Southern Medicine and Surgery entitled ‘Virus Pneumonia and Its Treatment with Vitamin C.’ (4) This article was the first of Dr. Klenner’s twenty-eight (through 1974) scientific publications.”
It might be interesting to learn how poliomyelitis was treated in Reidsville, N.C., during the 1948 epidemic. In the past seven years, virus infections have been treated and cured in a period of seventy-two hours by the employment of massive frequent injections of ascorbic acid, or vitamin C. I believe that if vitamin C in these massive doses – 6,000 to 20,000 mg in a twenty-four hour period – is given to these patients with poliomyelitis none will be paralyzed and there will be no further maiming or epidemics of poliomyelitis.’ Levy concludes: “The four doctors who commented after Klenner did not have anything to say about his assertions.”
Klenner administered ascorbate by injection, and, as Lendon H. Smith describes in great detail in the Clinical Guide to the Use of Vitamin C: The Clinical Experiences of Frederick R. Klenner, M.D., Klenner found that “the most effective route was intravenous, but the intramuscular route was satisfactory. He gave at least 350 mg per kilogram of body weight.” That quantity per day is a dose of 25,000-30,000 mg or so for an adult. Yet, Smith adds, “With 350 mg per kilogram of body weight every two hours, he could stop measles and dry up chicken pox.”