Nine days ago the UK media industry self-regulator, the Advertising Standards Authority (ASA), classified menopause as “a serious medical condition”.* This prepares the way for the prosecution of any seller or prescriber of food supplements or bioidentical hormone alternatives targeting this life stage of women.

This decision wasn’t made from thin air. It’s been in the making for several years.

Between February and June 2016, the UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) classified 3 food supplement products aimed at supporting menopause as unlicensed drugs.  The products, which included the herbs black cohosh or Agnus castus, had to be removed from the market so the manufacturers would avoid criminal prosecution.

One company in particular vigorously defended its right to sell the products as food supplements using the statutory procedure. Central to any defence is the notion that the menopause is a natural life stage that marks the end of menstruation in a woman. Dictionary definitions make this abundantly clear, as does the prime health authority guiding medical practice, NICE, the National Institute for Health and Care Excellence.

Then there’s the question of the activity of the herbs themselves. Here we see the testing of the central tenet of the EU definition of medicinal product which declares any product a medicine if it is either presented to treat or prevent disease, or if it’s function is to correct, modify or restore physiological functions by exerting a pharmacological, immunological function.

Screengrab from Advertising Standards Authority (ASA) website

As early as 2003, we had foreseen this type of problem with national regulators acting arbitrarily particularly where food supplements competed with drugs. The competition that doesn’t like these food supplements that have sold safely for years, is of course the drug companies selling HRT.

Cementing these decisions is the latest advisory issued on 18 September 2017 from the UK’s media industry self-regulator watchdog, the Advertising Standards Agency (ASA). The ASA has long been a controversial private entity that behaves more like a government regulator. In December 2016, ASA issued guidance that pre-empted the notion of menopause as a disease.

But now – the ASA has classified menopause as “a serious medical condition”. We’re not talking here of the treatment of, or reference to, symptoms, we’re talking about any reference to the term ‘menopause’ by an advertiser!

In effect, the ASA’s new edict means not only does the MHRA now have a media industry body doing its dirty work – and let’s not forget that the media is heavily funded by Big Pharma – Big Pharma has eliminated significant competition from any company selling a natural alterative to HRT.

ANH-Intl friend and supporter, Alyssa Burns-Hill, who has for some time been in the cross-hairs of the ASA, tells it straight in her latest blog.

Find out more about the ASA

Action plan initiated

This initiative is aimed fairly and squarely at those using bioidentical hormones and herbal products. Both have proven very popular among women of a certain age wishing to avoid the side effects of HRT which include an increased risk of cancer.

This is not something that we can sit and allow to happen. We are looking at various ways of effecting change – and stay tuned – because sitting on the sidelines is just not an option when it comes to government regulators and media industry self-regulators twisting rules for their own benefit, to the detriment of tens of thousands of older women who will soon have no option but to go their doctor’s and be prescribed HRT.

*Update 20/11/17 – The ASA have amended their wording as follows: “Whilst the menopause itself is obviously not a medical condition, the ASA is likely to consider the symptoms of the menopause to be conditions for which medical supervision should be sought. Claims to treat those symptoms are likely to discourage essential treatment, unless that treatment is carried out under the supervision of a suitably qualified health professional”

Comments

  1. Terrifying comment! Especially in the light of what I noticed a couple of years ago. I was having almost all the symptoms – night sweats I could just about swim in, mood swings, cycle whenever it felt like it, bloating and weight gain, cravings, can’t remember all of them – oh yes, poor memory… They all stopped when I realized just how much sugar I was consuming and stopped it! I’ve watched a number of TV programs about the dangers of sugar, most of them at least part in the UK and I now know just how hard it is to avoid sugar unless you’re almost completely OCD (or manage to live on a farm).
    My point is, How Many women are taking HRT because of all the sugar hidden in their diets??? Not because menopause is not a simple transition, but because we hide sugar in foods to make people buy more, much more than they need (then we tell them to send funds to famine-wracked Africa and have GMO crops to produce more food…) Says a lot for the professionalism of the medicos…

    1. actually somebody told me as I’d been having night sweats and hot flashes as I had been going through my menopause to cut the sugar- and apart from the headaches and dizziness during the first week or so – which were similar to the ones I got when I dropped coffee, I do feel better for it and guess what — no more hot flashes or night sweats either

      1. I really don’t think women take HRT ‘because of all the sugar hidden in their diets’. I don’t take sugar, avoid it whenever possible, don’t drink coffee or any other fizzy drinks but still suffered from hot flushes, night sweats, urinary and vaginal problems all of which have been addressed by HRT. This campaign is pointing out the dangers of taking herbal remedies and unlicensed products sold as ‘cures’ for menopausal symptoms. All those women who have no problems during menopause are very lucky, but for those of us who do suffer then HRT is a lifeline.

        1. I don’t think anyone here would say don’t take HRT if that is what you want to do and if it helps you. However, I think what we would suggest is perhaps changing diet and supplementing where it might help, before taking the HRT… Glad it works for you, but I would rather not take it if I don’t have to as I’m sure a lot of women would…

        2. Dangers of taking herbal remedies? What are you smoking Barbara? There are no recorded deaths or serious side effects from these herbs, whilst HRT is known to increase cancer risk. You are more likely to die buying and over dosing on dispirin off the shelf. You are suffering from menopausal side effects and have clearly never even tried theses herbs and felt the wonderful benefits as I have. Don’t shout your mouth off before you have tried yourself. Boy, are you missing out! Your own fault you are not one of the ‘lucky ones’.

          1. I can’t believe the ignorance of the comments here. Most herbal remedies are unlicensed and untested and the few that are like black cohosh, which has been subject to a few clinical trials, can have serious side effects. I am not saying ban these products but list the contraindications and side effects. It’s every woman’s choice whether to take these products, but they should certainly be armed with the facts. There are many reported cases of serious illness from black cohosh.

          2. This is a response to points made on both sides.

            Herbs are NOT safe, natural is NOT safe. Some of the most toxic substances known to man are herbs that grow naturally. We derive the word toxin from the Latin word for yew- a herb.

            However, in many cases they have been used for centuries so to suggest they’re untested is untrue. It could be argued that they have been tested far more extensively than any pharmaceutical.

            Herbs do indeed have side effects, which for some reason are often ignored and are touted by ignorant shop assistants as ‘nice and safe’

            Scientific testing is often not as rigorous as it ought to be and in some cases expensive licensed drugs have been found to be less effective than a placebo. We know from thalydomide that drugs have been passed as fit for purpose that were not, with tragic consequences.

            Both herbs and drugs have side effects and what works well for one may make another quite unwell.

            The issue with this law is that it removes what may be the better option for some without proper investigation in a way that favours pharmaceuticals, despite their side effects.

            Better regulation of herb quality, strength and availability would have been a much better way forward. Pharmaceuticals will prevent that as an option because a herb cannot be patented. There is a clear objective within this that is not about quality of life for women.

        3. I have done all the menopause symptoms naturally, and herbs played a good part in it… there are great effects from herbs, they are natural and non dangerous… they are not man made, but nature grows them for good reason, HRT, is man made…. but if it helped you fantastic, HRT helped you, herbs helped another person… who’s right? surely if it helps a person then its good….

        4. The natural remedies are not sold as ‘cures’ even HRT is not a ‘cure’ because menopause is NOT a disease. The herbs etc are to help you manage the symptoms of this normal life stage. Just as having sex does

        5. Great if HRT is what you are happy with, but many women are not and I would be one of those. It will be a criminal act to deny women of choice and to push them down the pharmaceutical route (as we have been so many times before) and just look at the outcome! The human species (in my opinion) is no longer evolving, we are becoming weaker and sicker and as the world follows the Western lead menopause will spread like wild fire and once labelled a medical condition, will provide yet another income stream for BigPharma with no thought for the after affects to the woman. Ok some of the natural things don’t suit women (and you could be one of these), but generally speaking if the whole body is considered (holistically) then balance can return and will be no more. Menopause is a man-made issue, not a disease. A bit like type 2 diabetes and obesity (with a few exceptions of course). We humans need to clean up our whole act and that means our bodies and minds as well as the environment. Maybe then we would start to see a decrease in dis-ease.

    2. Yes, yes yes to the above – Clover. Many women reach their perimenopausal years exhausted, adrenals flat and sugar a huge issue. Then what I call the ‘bandwidth of tolerance’ narrows and bang… as she desribes. Yet sugar is allowed anywhere!

      Please tell me how I can get involved. I am still hopping with anger at this. I am a menopause mentor. I do not sell or recommend any products at all, but I often recommend a client visit a herbalist/kinesiologist/nutritionist. I feel the need to speak up and to protect this women’s natural cycle, to protect women’s choices about the care they receive and where they receive it from, and the planet, which will ultimately suffer from the ingestion of HRT.

      It all seems so flawed. Unless, of course, you are a pharmacorp or a government that grants costly licences to enable trading. Talk about restrictive practice.

      First of all, menopause is only one day – a one time event. Their language is, strictly, inaccurate. Secondly, to go against NICE really shows us the true arrogance and power of this body. If NICE don’t support it, then women are in a double bind. They cannot get absence from work, for illness, with this ‘serious medical condition’ because no doctor would support the classification (although they might get time off for symptoms anyway, I can see that) but neither will they the option of trying other products such as Black Cohosh, or Agnus Castis from a broader range of companies.

      It is condescending, in the extreme, and I couldn’t look someone with say – cancer – in the eye and tell them that I too, have a ‘serious medical condition’. How come the ASA get to say that for me? Is that decent, legal, honest or truthful?

      At it’s heart, it’s taking women (and society’s view of them) back to the days of ‘hysteria’ when womb removal (“hysterectomy”) was the ‘answer’ . It is removing personal power – power to choose, even to choose incorrectly – and in terms of harm to the planet, and bodies, I cannot imagine how much faux estrogen is going into the water table.

    1. Exactly our point Amanda. This decision potentially takes away a woman’s freedom of choice over how to manage the symptoms that can be associated with this natural life transition and puts her in a position of live with it or accept treatment that poses risks to many.

      Warm Regards
      Melissa

    1. Dear Caroline, thanks for your comment. Unfortunately we can’t speak for other bodies like BANT, but we’re sure BANT will be looking closely at this and will formulate a position for its members. This is of course not a rule but advice about interpretation of a rule. The challenge is that ASA has adopted a view that mirrors that of the medicines regulator, the MHRA, so to effect change it is necessary to help influence the MHRA’s position- something that will be tough given its seeming desire to protect conventional HRT over bio-identical hormones, herbal/nutrient combinations and other non-pharmaceutical approaches. We have been closely involved in this particular issue for some time, and have helped contest a number of ASA complaints and positions. Coming back to your question, we suggest you get a response directly from the bodies who represent your interests. We obviously are not an enforcer of any rules, so we are able to challenge views by regulators that we consider to be incompatible with the principles of natural health and natural justice.
      With kind regards
      The ANH Team

  2. We need for everyone to lobby their MP and see if we can find a friendly on the case lawyer who will challenge it legally
    We can all chip in with the cost
    It’s a matter of personal choice and saving cost to nhs

  3. I am confounded by the ASA categorising the menopause as a “serious medical condition” when it is a naturally occurring function in women’s lives. It would be laughable if it wasn’t so damaging to people such as Alyssa. Can this all be exposed in a radio or television programme, or taken up by investigative journalists in other media?

    1. Linda I’m now 71 and had almost zero menopausal symptoms at all. In fact I used to listen to women talking about it and wonder when I would get those symptoms. I was using Herbalife’s Tang Kuei for muscle relaxation and, of course, in China, it is used (perhaps not as much in modern China) for thousands of years from the time a girl hits puberty until end of menopause. Very safe, the only thing you need to work out is the quantity for you, and your Herbalife supplier can help you with that. I’m still using TK and it’s great at keeping me supple, especially after a day in the garden! 🙂

  4. Im 55 and sailed through menopause so far. I eat clean i take juice plus and use wellsprings serenity cream and rhodiola occasionally. Menopause is part of the natural cycle of life not a medical conditition. Some women suffer badly so let them access nhs stuff if they want but let us get what we want to free up the system.

    1. I’m 59 started the menopause about 2006, was plagued by hot flashes and night sweats which, as I tended to be dehydrated at the time, were dreadful I doubt I could have HRT as when I was younger they gave me one of those coils with artificial hormones which I reacted to, putting on 7 lb and losing it every month with my cycle and having such a variation with my flow I didn’t know from day to day or month to month what to expect so the doc had to remove it I was advised to cut sugar out of my diet or at least cut it down and the flashes and sweats disappeared, although since then I do get sweat rash should I sweat

  5. How dare the ASA
    Government and big Pharma strike again.
    All about money nothing about health.
    I will continue on and not be forced in be direction of HRT!

  6. This is an absolutely ridiculous situation. I’m not saying ‘menopause’ was the most fun I’ve ever had in my life, as I had a full emergency hysterectomy at age 38 and dived headlong into Menopause.
    It took a while to get a suitable HRT ~ ended up with an old pharmaceutical medication, which didn’t do me a lot of good ~ I persisted with it for 5 years, then discovered I felt a bit better off of it (I’ve other medical conditions).
    I was introduced to “Cat’s Claw”, and found that very satisfactory, and it made the Menopause manageable, while causing me no undesirable side effects.
    “Serious Medical Condition”, my “A for bottom” ~ it’s a natural progression in every woman’s life. Some have more ‘tropical moments’ than others, that’s for sure, but what about a woman’s “choice” in how she manages this “Serious Medical Condition” ~ without the Pharmaceutical Companies making a mint out of it, and then causing women unwanted, horrific, side-effects into the bargain.
    I am disgusted with this “announcement” ~ which only has one winner, and that’s not the women of the UK, that’s for sure!

  7. I’m totally thankful that I didn’t have problems finding a remedy for menopause. I’ve used black cohosh over the years, and never had a problem since starting this wonderful supplement. I’m seventy and feeling like I did when I was half this age… except without the discomfort of having a menstrual cycle. I only have one comment about the UK and this outrageous determination for a condition that is a natural part of any woman’s life… Who decided this? … a group of men and a bunch of their twenty-something female supporters? Who else could, or would ever make such a totally absurd diagnosis… If I were standing in front of them, I would burst out in laughter at their half witted, mindless rhetoric! (I’m old, I can say those things!)

  8. Serious medical condition – on what grounds and what legal right do they have to stipulate this. Am outraged – this is taking away a woman’s right to choose. People who know or what are in contact with female MP’s need to start lobbying now.

  9. Thinking about it. Does this potentially have wider conertations? If I apply for a job do I have to tick the box for “Any serious medical conditions?”. Would this then affect an over 50 woman from getting jobs, is this another difficulty for the older woman?

    1. You make a very good point. What does this actually mean – anything or nothing? After all, it’s not a NICE or WHO declaration. But, do not be mislead, it is political and economic as Rob Verkerk says.

      Margot James MP, as a Minister for Business, has come out in full support of the ASA. Something other MPs and Lords have their reservations about. I think we need the Government to issue a statement regarding this, don’t you? If anyone can help to spread the word on this we may be able to achieve that.

      1. Hi Alyssa

        I have been wondering (as a former business advisor) that IF women were to approach their employer and ask for absence from work due to their ‘serious medical condition’ we would meet a wall, because NICE do not agree – their GP could not sign them off. However, if the 2 million women (or the % of them that are interested enough) were to ask for this – how would the Minister for Business answer to that?The 2010 Equality Act already provides for non-discrimination on grounds of health – and that ‘reasonable adjustments’ must be made if an employee needs them … also, after 26 weeks an employee can request flexible working patterns, which may help a woman who needs to nap, or not work her usual hours. I mentor women through perimenopause – I do not sell, or recommend, any products. I have used them and support any one’s right to use safe products however they are derived.

        Last point: as we all know the term menopause is: a) a description of only one day/point in time and b) a description in itself of a life stage. It is a word that simply describes a particular physical occurrence – there are many wrangles in the RCM about what is a ‘condition’ in many other fields of health, there is no debate with them about this one.

        How can I help – I have a network of women who are willing to listen to a balanced message. The rule in the ASA network – 2:12 actually states that the ASA are “likely… to classify M as a serious medical condition”. This is slippery language – the place to go to, IMHO (as a former insider in committee world!) is to the committee and the code – who was on the committee, how they are qualified or not to make this statement and so on? Where next?

        Debs de Vries

  10. ASA’s naming the menopause as ‘ a serious medical condition’ thereby preventing advertising of alternative products to big pharma HRT is insidious bullying towards herbal and other product wholesalers/ producers in favour of big pharma and money making HRT. It also treats women as stupid and removes informed choice.

  11. I must have been mad to think I could open up a serious discussion here about herbal remedies and HRT. All on here are so blinkered when it comes to so called ‘natural’ products. Natural doesn’t always mean safe. All medicines should be thoroughly tested and all products sold as so called miracle cures for menopausal symptoms should be thoroughly vetted as well.

    1. Well said Barbara. Does anyone actually realize that “Big Pharma” actually produce herbal & vitamin supplements as well!!!! Apparently “ignorance is bliss”

  12. I have started using Black Cohosh root for symptoms and find they lesson, plus no Coffee or Tea, alcohol tends to bring it on, so less of that and I find drinking more water helps. My GP wanted me to take anti- depressants for mood swings and that was not satisfactory for me so tried St Johns Wort instead, this helped considerably, HRT was not offered as I hadn’t long been menopausal, this was a relief. Whatever works for the individual. It’s a natural condition with a trial and error, find what’s right for you. Apparently Flax seed in food and Omega 3 helps. We will get through it. 🙂

  13. What about those who have a genetic issue with processing estrogen? I have just had my genetics done and have a couple of mutations regarding detoxification of estrogen. Admittedly this is a relatively new field, I’m no expert and will need to delve deeper into my results with a professional, but from what I’ve read so far from my reports is that taking HRT with this kind of genetic mutation can further increase risk of breast cancer

  14. May I just ask for some additional clarification. As I understand it, a Traditional Herbal Registration is currently required to have a herbal product on the market that treats a ‘minor illness’. So by means of the ASA shifting the goal posts, the companies that bring products like Agnus Castus to the market, have now to go the Marketing Registration route. (massively different in costs and time taken).

    OK, I am with the plot so far.. but surely, if something already contravenes the ASA or even sale of goods guidelines (an insubstantiated claim for instance, or failure of a product to meet what it is sold for) they can already sue and force them to take down adverts. Is that correct? And is it the advertising rather than the product that is subject to their (the ASAs) regulation? Can for example, Black Cohosh continue to be sold as long as no claims are made for what it does?

    I have spoken to medical professionals btw who are horrified at this classification. They agree that menopause is: a: just a one time event (12 months after the lmp) and b: not a condition, simply a stage ,and cannot be classed as a condition. Menopause is a ‘description’ of a natural stage in life.

    So if anyone can help – are we saying these products will disappear or are we saying their advertising will have to change if they want to specify that they are to help menopause symptoms.

    Thanks

    Debs

  15. I don’t understand. Black cohosh and Agnus castus are still for sale in the UK. Is it about making claims for their efficacy?

  16. Well, I thought I couldn’t be surprised any more but menopause as a serious medical condition really is ludicrous especially when we know this is only concocted because certain industries do not want any competition. I don’t criticise anyone for taking the route that suits them best but I want a choice to be available to me.. once access to these herbs has gone we’ll never get it back.

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