Rant about the FDA

I just need to get this off my chest. I have been trying to stay within the rules ever since I found out I needed injections eight years ago, but I find it increasingly difficult, expensive, and frustrating.

In the past eight years I have seen 10ml of cyanocobalamin increase from a price of $10 to $75. In that time there was also a massive shortage of supply. Both were a direct result of increased regulations on compounding pharmacies following the New England Compounding Pharmacy scandal, and more stringent inspection at the one and only manufacturer of cyanocobalamin in the US.

If it were just an increase in price and a temporary shortage of supply, I would chalk it up to unfortunate yet predictable cause and effect. However, I'm starting to suspect that the real goal is to severely limit availability of all forms of injectable B12 in the US. I don't know why anyone would think limiting a non-addictive, life-essential vitamin is a good idea, but it's the only explanation that makes any sense anymore.

Apparently the FDA is now beginning to enforce a requirement that only one month of injectable B12 be dispensed at a time. This increases the cost thanks to the extra cost of packaging the B12 in smaller vials. It also increases the inconvenience. It's a well known fact that the harder a medication is to obtain, the less likely the person who needs to take it will actually do so. So I guess the thinking at the FDA is, "Let's make a bunch of people who are too fatigued and brain foggy to think straight jump through a bunch of unnecessary hoops in order to get the vitamin that will keep them alive."

It's hard not to feel like there's a conspiracy going on when any sane person with common sense and knowledge about the effects of B12 deficiency would look at the current set of regulations and shake their head in amazement at how ludicrous the situation really is.

The next level of this particularly stinky onion is the fact that the supply shortage and cost increase of cyanocobalamin is what pushed me to agree to trying methylcobalamin instead. It's certainly not cheaper, but it's the go-to version of naturopaths since it is considered more bio-available. The trouble is that it is only available through one or two compounding pharmacies, the closest of which is hundreds of miles away from me. And that mandated health care I pay for? Yeah, it doesn't cover anything made by a compounding pharmacy. So there's that.

I am really tired of being jerked around by this system. I should not have to fight so hard for so long for access to an injectable that I need just to maintain the ability to function like a normal human being. I really don't understand why the FDA thinks a non-addictive vitamin that is impossible to overdose on needs to be so enthusiastically limited in availability. How can they all be so dense? What does it take to convince them to change the regulations?

I normally would not wish this condition on anyone, but in the context of educating the clearly under-informed regulators, I wish for them all to have B12 deficiency and for them all to have the same problems I've had getting proper treatment for it.

End of rant.

20 Replies

  • rant away - we have the same kind of gp blindness in the UK believe me

  • Sadly, the FDA is a federal agency that outranks individual GPs. They are the agency responsible for ensuring the safety and efficacy of the US drug supply. It seems like the real problem is that they've lumped injectable vitamins into the same category as much stronger, more dangerous, or actually addictive injectables.

    So we don't just have misinformed GPs in the US, we have an entire federal agency that needs to get their heads out of their backsides. They're painting all injectables with the same broad brush instead of using common sense. It makes me so angry.

    I can't help but wonder why the US government thinks all injectables should require a prescription when both Canada and Mexico are willing to sell injectable B12 over the counter. Are all Canadians and Mexicans so much more intelligent than Americans that we just can't be trusted to handle sharp, pointy syringes like they can? Clearly that is what the FDA thinks.

    Edited to add:

    Actually, the regulation on the injectable B12 is separate from the access to syringes issue. Although there is ridiculousness there also, I should probably stick to ranting about just the one topic at a time. :/

  • Galicia. This is just dreadful. My heart goes out to you. Treatment in the UK has its problems too! Many struggle to get adequate treatment and B12 injections. Medics are equally ill informed, rude and arrogant and regularly bully patients, certainly into ill health and potentially into an early death.

    But you're here...and probably know all this.

    Rant away whenever you like...at least it will save you from bursting.

    Have you thought about buying over the Internet from Europe. No prescription needed if we buy (at the moment). Not sure how / if this works between the USA and Europe.

    We can post details of suppliers if you want to give it a shot (excuse the pun).

    Take care xx

  • Foggyme, Please see my post below about Canadian source. Leilani

  • Thank you Leilanilea. Very useful indeed xx

  • Feel your frustration.

    Guess that other forms of potential supplementation are just as expensive as options in the US.

    Have you been in touch B12 awareness? b12awareness.org/

    Difficult in the face of ignorance, stupidity and the bloody mindedness of bureaucracy

  • Well said, Galixie!

    I am in the U.S. also. I have to go outside of my health care system which I pay for and pay more money to a naturopath to get enough B12. At least she prescribes it and I get it from a compounding pharmacy & inject it at home which is much cheaper than having her do it at her clinic. It still adds up to $22 a week for me since i need to inject every 2 days (1 vial holds four doses) not counting syringes and needles. Which is about a hundred bucks a month. That's a lot of money on a fixed low income!

    I haven't heard of the new FDA policy but I'm sure I will. Thanks for the heads up. Just another source of stress!

  • Hello Ndodge. Have you seen Leilanilea's reply (in this string) about buying B12 and needles from Canadian Pharmacy? Would this help you reduce costs?

  • Thanks Foggyme! I use methyl because Cyano did not work for me at all and I know methyl is more expensive. But, I'll check out their site and see if they have methyl. That would be awesome if I could get it for less money. Again thanks so much for bringing this to my attention! xx

  • Ah ha. Just looked at the site, and not available to buy in the UK. Also - prescription required - and this is what we struggle to get from our GP's!!!

    Methyl's not easy to get, is it.

    If I come across additional suppliers of Methylcobalamin, in my many internet rambles, I'll whizz details over to you.

    Take care xx

  • Thanks for checking that out, foggyme. I'm in the U.S., so thats not a problem. Needing an Rx is a real road block!

    I doubt my naturopath would be comfortable with me going the internet route instead of the compounding pharmacy that she likes to use, but I could always ask. Nothing to lose and much to gain! You're a pal indeed for looking out for my best interests! :-)

  • Hi Ndodge. Just repaying like with like. And a pleasure to do so 😀

    Hugs xxx

  • Galaxie,

    Thank you for voicing what so many of us think and feel. I'm in the U.S. and have absolutely no compunctions about buying my cyano- from Canadian pharmacy which has excellent and professional customer service and fast, trackable delivery. buy-otc.com

    Here is summary of my bill. This is a multi-dose vial containing 10ml. I haven't compared prices on syringes/needles with other sites.

    B12 Vitamin Injectable 1000 mcg/ml - 10 ml$15.99 [cyanobobalamin, Cytex]

    Needles (PrecisionGlide) 3 ml x 10 - 1inch$9.99 [BD]


    USA Canada Post Expedited 4-8 business days incl. tracking$13.00

    Grand Total$38.98 USD



  • Thanks for posting that info, Leilani. I'm going to check them out! :-)

  • In UK media sources, there has been a suggestion that B12 became a "boutique" substance - with numerous gliterati and media-aware people going for regular shots. Seems it became a fashionable thing to do with feeling more awake and brighter being the sorts of goal quoted.

    That caused a US-wide shortage, inevitably spilling outside the borders and affecting world supplies. In turn, that prompted the whole supply chain to up their prices.

    Whether the FDA is responding to this type of usage by enforcing their requirement, or not, is not known to me. Still very bad news for those who need more frequent injections.

  • Maybe that explains why doctors are so reluctant to prescribe!

    Thanks for that interesting info-

  • Just out of interest, it isn't just the USA that has people who ask for B12 injections. Margaret Thatcher, our former prime minister, used to get them:


  • I bet she had no trouble getting all the B12 shots she needed! :-)

  • "..it is only going to help if you are deficient. If you're not, it's just quackery.."

    First "prove" you are deficient!

  • It wasn't celebrities causing the shortage in the US. There were health code violations found at the only US manufacturer. Those had to be corrected, so there was about a year of time when they weren't producing any B12 at all. When they did resume, they were dealing with stiffer regulations and they took all their products except for the 1ml vial off the market. The cost increase for the additional batch testing and extra packaging pushed up the cost. Also, in the midst of this, there was a mine collapse in South America. The survivors needed hydroxocobalamin to recover from cyanide exposure. This caused an increased demand on hydroxo (which is the less available form on this side of the globe). That caused an immediate shortage of hydroxo and some people who had been taking hydroxo had to switch to the remaining supplies of cyano - which depleted that supply even more quickly than it was already running out.

    It's fun to blame celebrities for things, but the actual sequence of events is one that really couldn't have been forseen and really is not the fault of celebrities alone.

    In fact, if every celebrity in the US suddenly demanded to get regular B12 injections, it might cause enough demand to 1. Prompt competition in manufacturing so that we're not relying on just one manufacturer. 2. Put pressure on the FDA to recognize that this substance is safe enough to dispense without a prescription. and 3. Prompt doctors to actually become knowledgeable about the signs and symptoms of B12 deficiency.

    The fact that such a small percentage of the population needs B12 injections actually puts us at a disadvantage as far as changing the system at all IMHO.

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