IV vitamin C “Action Alert” needs to be substantiated (updated)

If you Google “intravenous vitamin c fda” for the last 24 hours, you’ll see that an “action alert” from the Alliance for Natural Health has spawned dozens of copy cat “reports” on blogs and websites across the Internet in less than a day.

Strategically, this may be a great way to put the FDA on alert to not even think about regulating IV vitamin C… just in case they were thinking about doing so. Unfortunately, the more I look into this, the more it feels like another consumer protection organization is capitalizing on the fact that too many of us are “sheeple”. I include myself, because I not only responded to their online form, I promoted it to others on my Facebook news feed.

It also shows the power of the Internet to spread information very quickly that has not yet been vetted. The blogosphere is just as vulnerable to manipulation and abuses as the mainstream media is.

The action alert does not provide a copy of the FDA’s letter, or even a single snippet of the content of the letter or letters.  Any concerns about revealing the pharmacies involved could easily be addressed by blocking out identifiable information, but scanning the letter on official letterhead and posting it for the rest of us to read.  There wasn’t even any reporting of the name(s) of the FDA officials who signed the letter, making it impossible to hold anyone accountable.

We are all expected to take this report at face value, based on the word of a nameless reporter for the ANH.

I regret now that I didn’t do my own due diligence before jumping onto the bandwagon. I’m counting on my own IV vitamin C therapy to help me improve my immune health and reading that that option was being threatened triggered an emotional response. How can I not believe that isn’t exactly what ANH was attempting to do with their “action alert”?

Note to ANH and other organizations:  I don’t like being manipulated by a public service organization anymore than I want to be abused by a criminally corrupt government agency like the FDA.

The pharmacy that is preparing my vitamin C infusion for tomorrow is still open and doing business. They have not received any notices from the FDA. A second local compounding pharmacist just told me the same thing and further, informed me that the FDA does not even have the authority to prohibit the production of intravenous vitamin C by compounding pharmacies. Any such order can be successfully fought, if not simply ignored.

I repeat: the agency does not have the authority to do what the ANH is suggesting happened. Yet bloggers and health oriented websites across the blogosphere are parroting this story before anyone else has even seen a single document from the FDA produced by the originators. Not even an excerpt or the name of a single FDA official.

The FDA does, however, have the authority to order a pharmacy to stop producing compounded formulations if they fail to meet safety and health standards. In fact, the pharmacist I talked to sounded almost proud as she claimed that they and other compounders are responsible for stepped up inspections and enforcement by the FDA. They are trying to protect their own business by insuring that safety and quality standards are defined and enforced.

It sounds like there could be some internal battling for market share among compounding pharmacies going on to me, but I won’t argue against safety oversight of compounded drugs, and that’s what proponents of IV vitamin C argue it is: a drug. If I’m going to have a needle stuck in my arm and attached to a plastic bag of clear liquid dripping into my veins, I want some assurance that it contains what it’s claimed to have and that the pharmacy that prepared it was clean and sanitary.

I am still waiting to see if the FDA responds to my request for a comment, but I did hear from David G. Miller, R.Ph., Executive Vice President and CEO of the International Academy of Compounding Pharmacists.

 

I received a copy of [ANH’s] action alert this morning and upon further investigation, have been unable to verify any such communication from the FDA to the pharmacy community at large.  We have researched whether this was a warning letter to a particular pharmacy or if, indeed, there is broader action in place.  So far, we have been unable to find anything specifically addressing an FDA action against injectable vitamin C nor have any of our more than 2,000 member pharmacists informed us of such a communication.
What is particularly interesting is the use of the term “manufacture” in this action alert.  Indeed, the FDA does have the authority to order a cease and desist to any pharmacy or other entity who is engaged in the manufacturing of an unapproved drug.  It does not, however, have the ability to do so for a legitimately prescribed compounded medication.  That responsibility lies within the jurisdictional authority of the individual state Boards of Pharmacy who are responsible for licensure and enforcement of practice laws and regulations.

 

The ANH’s action alert, urging concerned consumers like me to “contact the FDA, and tell them to take their job of protecting our health seriously—by allowing injectable vitamin C, magnesium chloride, and vitamin B-complex 100 to continue being manufactured and sold!” falls short. They need to add the word “safely” to the end of that statement.

Until we can all see the contents of the FDA’s letter, we have no way of knowing why the agency took action against some “small pharmacies”. As unbelievable as it may seem to most of us who have come to distrust the FDA, there just might have been good reason for shutting some shops down.

I have no problem with confronting the FDA about their internal corruption and the fact that they have sold their souls to Big Pharma.  What I take issue with is being manipulated with hyperbole from the very groups charged with doing that.

I’m from Missouri.   Show me the FDA letter. I would love nothing more than to owe ANH an apology.

UPDATE:

More from David G. Miller:

Here’s some additional information.  The FDA issued a warning letter to McGuff Pharmaceuticals – a manufacturer — on 28 December 2010 regarding safety and quality issues in that company’s preparation of various injectables including ascorbic acid.  This letter is in follow-up to an FDA inspection of the McGuff facility in May of 2010.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm238251.htm

That is the only such warning letter and it does pertain strictly to issues of manufacturing and distribution at one facility.

This letter may be the smoking gun that ANH is referring to.  If so, it took most of my day to track it down.

I was unable to find a website for McGuff Pharmaceutical, but there is a small compounding pharmacy named McGuff Medical Products at the same address as that on the FDA’s warning letter.  It appears to be primarily a compounding pharmacy, so I’m a bit confused about the difference between “manufacturing” and “compounding”.

Based on my read of the warning letter it does indeed appear that the FDA may be overstepping their bounds and needs to be slapped down for harassing a small business.  It looks like they are nitpicking by trying to assert that ascorbic acid (vitamin C) is a “new” drug, solely due to some differences in packaging.  The other concerns cited in the warning letter concerning sterility are of greater concern to me.

(Read followup report here)