MHRA Double standards on vitamin B12 injections

Dec 31, 2020 | Petition | 32 comments

So far, B12 injections can’t be bought from a pharmacy in the UK by the general public, but can be bought from a hair or beauty salon or any one of the 2500 technicians, clinics or outlets in the UK at a cost of between £25 – £100 each.

Isn’t this odd?- And some would say ridiculous or even immoral.

Following on from my previous blog regarding the B12 OTC Petition and the future Westminster Hall debate which my MP Jane Hunt will apply for – some of you kind people have asked your MP to join Jane and also make supporting speeches. Some MP’s have said, “I would need some compelling evidence to agree to do this.” – As if being restricted to just 4 lifesaving, cheap, injections a year isn’t compelling enough?

Well, the following information may help your MP to act – but if it doesn’t, then goodness knows what will and I suggest you get yourself a new one as soon as possible!

Find your MP here: FindYourMP and perhaps send this blog post to them?

Now here’s the funny bit

The MHRA in responding to our petition stated:

“……Vitamin B12 could not legally be classified as a medicine that can be made available for sale without prescription in pharmacies because it is an injection and because the condition it is licensed to treat, pernicious anaemia, needs a clinician  to diagnose it, and monitor its treatment (see point IV above). The same applies to insulin injections and to the diagnosis and monitoring of treatment of diabetes.
Vitamin B12 injection is currently licensed for use in maintenance therapy for pernicious anaemia every 2 – 3 months depending on the type of pernicious anaemia. Even if the product could be reclassified to make it available for sale in pharmacies, it could not be used more frequently than every 2 – 3 months, so reclassification to a Pharmacy medicine would not help those who require more frequent injections.”

and then they also state:

“Our current advice to private clinics administering vitamin B12 injections which are not licensed medicinal products intravenously for non-medicinal purposes is that we do not regard these to be medicines and that they fall outside of the remit of the MHRA. It must be absolutely clear in the advertising of such products that they do not have a medical purpose.”

So the same B12 (hydroxocobalamin in this case), from the very same manufacturers, is at the very same time;

A licensed medicinal product and also a non-medicinal product.

Mad, maddening and hilarious all at the same time isn’t it?

Slaps on the wrist

Some enterprising B12 injection providers have been telling the general public the truth, that B12 injections help boost immunity, that they combat fatigue and they may therefore help against COVID but the MHRA’s ludicrous rules around non-medicinal products which are also POM’s mean these statements do not comply and in fact telling the truth is a BIG FAT NO NO.

The MHRA have spent time during COVID alongside the ASA (Advertising Standards Agency) warning people who sell B12 injections direct to the public through beauty salons and the like – that they absolutely must not tell those they advertise to, what B12 injections will do or what they can help with.

12th June 2020

The MHRA allows clinics and individuals to market B12 injections by using the words ‘wellness’ or ‘boost’ or ‘supplement’ but not ‘deficiency’, they absolutely cannot be marketed with medical claims, and this is the bit that makes NO SENSE whatsoever, because we with B12 deficiency keep being told they are a ‘Prescription Only Medicine’!!!!!!

Please see below;

In May, the MHRA and the ASA published an Enforcement Notice which makes clear to businesses which offer vitamin shots the nature of the rulings and directs them to remove any COVID-19 related claims from their websites and social media pages. 

The following sets out and details these most recent regulatory developments:

  •  Prescription-only medicines (POMs) cannot be advertised to the public. 
  • Injectable vitamin D and injectable vitamin B12, specifically, are prescription-only medicines 
  • Advertisers must not, directly or indirectly, promote POMs to the public. Targeted enforcement, with the aid of monitoring technology, to find problem ads for removal and sanction came into effect on 12 June 2020. It also states this applies to ads for all “vitamin shot” products, not just vitamin D or vitamin B12. 
  • Action against direct and indirect claims that vitamin shots could help treat or prevent COVID-19

B12 Clinics

Like anything in this world there is good and not so good practice. Some clinics and individuals selling B12 injections direct to the public are stringently trained and follow their company’s guidance to the letter, keeping good records.

If they find a potential client is severely B12 deficient but has not been diagnosed and needs to be referred to a GP, they will explain this without skewing chances of diagnosis by not giving a B12 injection. Others won’t, they simply may not know that diagnosing B12 deficiency for the person is key to being able to access B12 from their GP as there is usually a lifelong need and having regular B12 injections from a private clinic would may not be financially sustainable.

A lifeline

These clinics and technicians provide an essential lifeline for so many who are dragging themselves around trying to survive on one injection every three months whilst trying to function, keep their mental health on track, look after a family, hold down a job and who may have had to home school on top of everything else during this years lockdowns.

They also provide a lifeline to the many patients who are B12 deficient but remain untreated due to a within range result on a serum B12 test. Too many GP’s do not understand the limitations of the test and that the clinical picture of B12 deficiency is of utmost importance. Some are unwilling to budge and allow treatment even when faced with a tearful patient on their knees begging for treatment.

Although my remit with my website is to keep people under the care of their GP when possible, I have referred people to the services of B12 clinics and technicians. This has occured when people are desperately ill and haven’t the strength or the inclination to battle with their GP for correct treatment. This has meant that these trusted sources can give the first injection and also teach the patient to self inject prior to purchasing their own supplies from pharmacies in other countries for around 60p per ampoule.

BREXIT

The awful truth is that the opportunity to buy from abroad has narrowed with BREXIT so now the situation is even more URGENT. We need B12 injections to be made available OTC from pharmacies in the UK so that when there is no help from the GP and where costly private injections are not an option, that people can access vital treatment.

Let’s not forget that the BSH sent out harmful Guidance stopping essential B12 injections which they then had to amend. Some GP’s Practices proudly report they are moving more and more patients onto tiny and useless 50mcg cyanocobalamin tablets unless they have a diagnosis of pernicious anaemia. This ludicrously harmful practice needs to be reversed. It needs to be shouted from the roof tops that PA is JUST ONE OF MANY CAUSES of B12 deficiency. It is NOT more serious than any other cause and apart from a deficiency caused by a proven dietary lack, treatment by injection is required for the swiftest recovery.

MHRA Threat to clinics

In communication with the MHRA, they also stated:

“However, we do have concerns about the level of clinical oversight present in IV vitamin therapy and injection services in general and the appropriacy of such services is currently under review.”

This ‘review’, if deciding on stopping treatment of B12 injections by clinics who do comply with the ridiculous rules of the MHRA, would not only negatively impact the companies and individuals who give B12 injections, but also to the people who rely on them to keep functioning both physically and mentally.

Don’t want to self inject?

There will always be people who do not wish to give themselves B12 injections and I for one hope that pharmacies would offer a service to people afraid of self administration.
Since embarking on the petition to make B12 OTC, some have commented that they fear that GP’s might stop giving B12 altogether if successful. I feel this fear is unfounded, doctors in countries who do allow OTC still prescribe and administer B12 injections to patients who need them. It would remain the responsibility of Primary Care to diagnose and treat B12 deficient patients but they would have to choose to.

Why do we need B12 to be made OTC?

Because so many people are restricted to just one lifesaving B12 injection once every three months. Some people say they can cope on this regime but many of us can’t, myself included. Each of us is differently affected and require a different frequency of B12 injections.

Whilst many GP’s will not treat patients according to individual need (or feel their hands are tied), then it is essential to allow patients the ability to look after themselves.

Please, if you feel strongly on this issue, ask your MP to get involved.

When rules are harmful, discriminating and ridiculous they need to be changed. Surely the MHRA can make vital lifesaving B12 injections available over the counter if they want to?

Wishing you the very best for 2021.

I hope that together we can reach this joint goal, along with freedom, togetherness and peace.

Tracey x
www.www.b12deficiency.info

If I’ve helped please consider buying me a coffee/leaving a virtual tip.
Doing this helps me to offer this free website to you and others around the world.
Thank you, I really do appreciate it.

32 Comments

  1. anyonefort

    The BNF states:

    Initially 1 mg once daily on alternate days until no further improvement, then 1 mg every 2 months.

    So at the first fence they are making a conflicting claim. They are careful to use the word “maintenance” – which they consider lets them completely ignore that the B12 guidance expressly allows alternate day dosing at least during the loading period.

    Does it take too much imagination to consider that someone who has actually gone downhill is in a position exactly like a new patient? They need RE-loading doses – which can (surely?) be every other day.

    Reply
    • Marlene Helen Flores

      I’m looking to buy B12 injectables for my diabetes and tingling of my feet that are peeling hurting terribly yet no Dr will help me. Where can l buy the methlobalamin type of B12 for home admistration bc I’m disabled. Thank you for any info you can share about purchasing this online or getting a prescription online. Thank you

      Reply
      • Simon

        Hi Marlene. This may not be helpful depending on your situation… I went to turkey and did a total health overhaul at Memorial hospitals group. Outstanding. It was £700 for the full body package but will be less for a localised consolation. I was diagnosed with a severe B12 deficiency. I was immediately prescribed 20 1000mg ampules of Dodex (B12) with syringes for alternate day injections. I feel brilliant. Such a brilliant change. No pins and needles, reduced balance issues, great sleep, big change in my depressive moods. I’m shocked by the difference. If you can manage the trip, do it!! All the best to you!

        Reply
      • Jane Williams

        You can buy Hydroxocobalamin in German pharmacies online

        Reply
    • Eleanor Caputo US

      Hello Tracey, thank you so much for all you do too fight this fight. I’m in the US. And it is extremely difficult to find any kind of support or logical help out here. Everything I find has to do with the UK. I can’t even sign this petition because I’m not in the UK, but I sure would like to. I don’t know what to do to change this or how I can help. But I find it maddening that a health spa can charge $90 for a B12 injection 58 days out of a 90-day period and I’m only allowed one injection a month in the US. I of course SI everyday with cyano, and I actually have some hydroxo ordered and on the way so I’m anxious to try that to see if it helps me more. Anyway, I don’t understand why our doctors are under a different standard than a health spa when they are both pushing the exact same supplement. Why is it being considered a drug with the doctors and not with the health spas. Is it because very wealthy people pay for these injections from health spas and there’s a lot of money to be made? And there’s not a lot of money to be made in the medical realm? I would really like to help somehow. Do something about this but I don’t know where to start. Or what I can do. And like I said I’m in the US. But I’m a graphic designer and if there’s anything I can do to help you, I would donate my time to design whatever you need. I just need to do something to change this ridiculous double standard. I don’t understand where this disconnect happened. Since 1850 B12 has been being used to maintain pernicious anemia. Way back then patients were allowed to have whatever it took to make them better. Doctors went by symptoms. Why isn’t this happening anymore? And if they’re so worried that we’re going to OD on B12 why are health spas allowed to dole out 58 injections in a 90-day period? There’s nobody there monitoring them? Just because they’re changing the wording in their advertisement that makes it okay? I don’t understand this. We aren’t stupid. But they treat us like we are. I don’t know where to go to voice my opinion. But I have a lot to say about this and I’d like to know where I can go and who I have to write to. Why can’t everybody suffering from pernicious anemia write a letter and send it to the FDA or the CDC or whoever we’re supposed to send it to to stop this ludicrous double standard. This is our lives. And to compare us to insulin… insulin can kill you and B12 can’t. That’s the only significance in that comparison. They give people a syringe and a bottle of insulin that could easily kill anybody with a slight overdose yet they won’t give us a syringe and a B12 ampule to save our own lives. This can’t keep on going on. I’m not going to live the rest of my life like this. Who do I write to what can I do? How do I make a difference? Thank you so much for what you do I’ve read about you. People talk about you in forums. They’ve posted this petition in forms for people to sign. However, I can’t sign it because I’m in the US. What can I do from here? Thank you so much!

      Reply
      • Tracey Witty

        Dear Eleanor,

        Thank you so much for your very kind comment. I agree wholeheartedly with everything you say!
        I have suggested this before Eleanor and no one has done this to my Knowledge- but why not start your own petition to make injectable B12 available OTC in the US? You can use the text from my petition and address it to who is best in your country. I will happily share this for you!

        I would perhaps – if you can – find another platform than Change.org as they badger signers for money all the time. They like the signer to think the money is going to the organisation or person who authors the petition but it doesn’t, it goes straight into their pocket.

        I did a secondary petition to my initial Change.org one via the UK Government and it still lies with them following a Westminster Hall debate. This superseded the first and so far we are no further forward – just waiting for cogs to turn. It’s depressing to think they may never turn at all.

        It is a ridiculous situation we find ourselves in for all the reasons you state. The restriction of B12 injections has nothing to do with our safety, but appears to have everything to do with money.

        Why can Canadian’s buy B12 injections OTC and yet metres away American’s can’t? Nothing makes sense!

        If you want to email me Eleanor to discuss further, please do so at tracey@b12deficiency.info .

        Very best wishes
        Tracey

        Reply
  2. Dennis Holohan

    Hi Tracey, Brilliant info.

    I think that there could be a loophole provided by the NICE, whereby they have admitted that people over 65 cannot absorb Vit D from food, so can now get on prescription for the winter months, October to March. One then has to question that age is no barrier to a problem, and a simple test will prove. It is 2 of our top numbnuts who are americanising Britain, wanting us to pay.

    Reply
  3. LJ

    Am I right that you thoroughly researched the 2-3 month standard license and could not find any medical evidence or reasoning for this from anyone? In which case the statement: “Even if the product could be reclassified… it COULD NOT be used more frequently than every 2 – 3 months” would have no medical or any other rational basis.

    Reply
  4. Andrea MacArthur

    Tracey, can you not play the MHRA at their own game and say that pharmacies should then be permitted to sell injectable B12 so long as they don’t market it as a medicine? What’s the difference between that and beauty salons? Surely, if beauty salons are allowed to sell it, then there’s no reason why pharmacies can’t sell it too. They may argue that the person is being given their injection by someone ‘qualified’ but what is their qualification – a recognised medical one? I doubt it. And even so, if these injections are allowed to be given as a supplement then the people receiving them are not under medical supervision so what’s all the hysteria around that issue?

    Reply
    • Tracey Witty

      Hi Andrea, my experience of dealing with the MHRA has been like trying to catch an eel with bare hands. We need more people to help by getting their MP’s to speak up and just how show ridiculous this situation is so that we can make B12 OTC.

      Reply
  5. maria sobolewski

    It may be more accurate to label this B12 malabsorption as opposed to B12 deficiency. As we know, blood tests may show an abundance of B12 which nevertheless will not be absorbed.

    Reply
  6. Alyson Gilbert-Smith

    I haven’t investigated this thoroughly but what is to stop individuals registering as a Beauty Salon?!

    Reply
  7. LauraCoyle

    Hi, really informative, thank you.
    I came across this campaign back in Nov, I think it’s amazing what you’re doing. I was diagnosed with PA four years ago, aged 26. I’ve been getting injections as prescribed every 3 months at the doctors surgery. I was fortunate enough to receive my last jab in Dec and was telling the nurse about the campaign. She did say that one thing I can do at the moment (although it doesn’t change the ability for all to access the B12 injections) is to bring someone with me in March, when my next injection is due and she will teach me how to self inject, so I can cut out having to go to the doctors all the time, or I can be away when an injection is due and not worry about it.
    I’m based in Northern Ireland and maybe this something people have access to already. It was the first I knew I could do this, only for telling the nurse about the work you are doing.

    Reply
    • Elizabeth 5

      Brave, I self inject migraine meds but b12 is an uncomfortable one. I find if it’s injected too fast or I’m tensing my muscles in anticipation it makes it worse. Don’t think I’d be able to do it myself but it’s great thing if people can have that facility

      Reply
  8. Dawn Hughes

    Could you tell me please, ” how many people in the UK have been left in a wheelchair because of B12 deficiency

    Reply
    • Tracey Witty

      I am sorry Dawn, I have no way of knowing and so many people remain misdiagnosed.

      Best wishes Tracey

      Reply
  9. Jenny

    I’ve just been diagnosed 2 weeks ago should be having 3 injections a week but can only get 1.cant get drs nurses walk in appointments nobody listening very I’ll lost use of foot.are beauty salons safe?

    Reply
  10. Anonymous

    As a healthcare professional, I can vouch, that if people who are diagnosed to have a requirement for B12 which exceeds every three monthly, then they receive hydroxocobalamin more frequently than 4 times a year.
    Just because the MHRA have listed this as being the guidance, for the frequency of the medicine, it doesn’t mean a clinician cannot prescribe it “off-license.” And this is done often.

    Reply
    • Elizabeth Humphrey

      Hi, I have been having B12 injections every 6 weeks for over 20 years for PA. By week 5 my memory is affected, I get tingling in my hands, I’m more lethargic and my already chronic migraine condition is triggered.
      I’ve. Just joined a new GP practice who are forcing me to go for 8 weeks because they have to get a special license to allow for 6 weekly injections. I’ve never had a GP say this before, is it true and if so, is it really that hard to get this license?

      Reply
  11. Curious

    Do beauticians check blood levels first? What’s to stop people going to multiple places and getting huge amounts of B12 injections?

    Reply
    • Nic

      There isn’t… I’m a nurse and aesthetics practitioner. In my aesthetics clinic if someone wanted b12 Injections you wouldn’t check blood levels. You would ask questions such as… have they got a diagnosis of b12 deficiency/had b12 for medical purposes before/have any symptoms of b12 deficiency. In which case you would refer them to their GP… however in training we was taught that will GP consent (confirmed by the practitioner by phone call/letter/email) it could be given by you. All the questions would be included in consultation/consent form and we just have to take client’s word for it… but there we are obviously covered legally and by insurance if the client has lied on they’re consent form and has signed it. Also b12 injections come in 2 forms, prescription and not prescription… prescription wise each client’s history and symptoms are checked by the prescribed and if they think they need to see a GP instead they will advise the practitioner and not prescribe the injection.

      Reply
  12. Barrie Jones

    Where are we up to now on getting Vitamin B12 injections over the counter or has it all gone quiet.
    I used to buy mine OTC in Lanzarote but have recently been dismayed to discover that they now require a prescription.

    Reply
    • Tracey Witty

      Dear Barrie

      We still await any movement I’m afraid. I will let people know as soon as we have more news. Here is the latest blog on the situation:https://www.b12info.com/eight-long-years/
      Best wishes Tracey

      Reply
  13. joan appleton

    Hair dressers and beauticians in my town are advertising vit B12 injections. I have no idea what condition they think they are treating. I doubt any tests are done first or diagnosis made. The two ladies I’m thinking of, say they are fully trained and insured ! As a retired nurse, I am horrified

    Reply
    • Becca

      If the Dr say you need them every 2-3 months why are salons saying every 10 days for the 1st 3 then once a month to stay topped up? Iv only had one say 2-3 months

      Reply
  14. David

    Is there a list of reputable suppliers for buying ampules.
    I have low vitamin B12 anxiety and psoriasis. I can tell when my B12 is low because I suffer with fatigue crashes and my anxiety and psoriasis get worse.
    But because my GP conducts a blood test which is a couple of points above the lower limit. Will not proscribe them. Although I was on them for about 7yrs straight 8n the past.
    So I would like to purchase my B12. But don’t have enough info on where is best to go. What amount to buy. Or administering kit to use

    Reply
  15. Kerri

    Living in Australia means I have access to over the counter low cost B12 ampules. What a blessing as I self inject regularly. I have been doing this for over two years now and am on injections for life so cannot imagine the hardship, physically, mentally and financially, it would cause if I didn’t have this option. All the best .

    Reply
  16. Kristiina

    I find seeing GP/health professional is like preparation for a battle. I have multiple health issues and taking multiple medications for them, but never have I been alerted for possible vitamin/mineral deficiency issues that could come with their long term use. So I have resulted to ‘self medicate’ while problem solving the reason for various symptoms. And yes, after getting some B12 injections from abroad and treating myself….over last few months I have started be like different person again..physically and mentally. I truly wish I could talk to nurse/doctor about this rather than having to talk to unhearing ‘brick wall’ and I hope one day I could go to my local pharmacy and buy the needed meds there without prescription. Seems like doctors will gladly write prescription for any medication that come with leaflets containing long list of warnings…but something ‘easy’ like B12? No chance!

    Reply
  17. Bren W

    My partner has extreme B12 symptoms but normal serum results, a MMA of 0.29 and Homocysteine of 11.4. The consultant said that if Homocysteine had been higher he could have had B12 injections. Does anybody here think it still could be a B12 deficiency? We’re tearing our hair out about this as it has been going on for so long and no one can find out what is wrong with him. Thank you in advance.

    Reply
    • Tracey Witty

      Dear Bren, If the clinical signs and symptoms point towards B12 deficiency and they ‘can’t find out what’s wrong” then this should be taken seriously and treated regardless of numbers on paper. The optimal level for homocysteine is 6. Surely the consultant could prescribe B12 to see if this eases symptoms and confirms a need? If you need my help please see: https://www.b12info.com/contact-me/
      Very best wishes Tracey

      Reply

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