A Systematic Review of Probiotic Interventions for Gastrointestinal Symptoms and Irritable Bowel Syndrome in CFS/ME (2018) Marshall-Gradisnik et al

https://www.ncbi.nlm.nih.gov/pubmed/29464501
https://link.springer.com/article/10.1007/s12602-018-9397-8

 

And the press release from Griffiths will be along the lines of "Griffiths researchers find that probiotics hold the key to curing ME, Ebola and death itself!"

 

European consumer probiotics are still not permitted to have any health claims associated with them, since none of the research to date is deemed to be compelling enough to have the health claim ban lifted. (Claims were ordered removed from consumer products as misleading a few years ago from all food products including probiotic drinks and yoghurts). So far companies such as Yakult etc have failed to convince the panel that they have sufficient evidence that their products have any effect at all.

This seems to contradict the findings from this paper that states that the evidence is of excellent quality?

 

I'm not sure it does - AFAIK the reason companies like Yakult can't add health claims are two-fold:

• There's little evidence that probiotics are useful for the general population who doesn't have IBS. This is why companies like Yakult, Activia etc have to be careful about making health claims.
• Even if the companies have good evidence that it does work for IBS, they have to tread a very fine line between being a health supplement and being a medicine, so they'd steer clear of making such claims generally.

I'm not saying that probiotics necessarily work - though I believe there is some evidence for certain probiotic mixes that are not the same as one would find in the supermarket, especially for repopulating the gut after the use of wide-spectrum antibiotics. Just that the fact that supermarket probiotics not being able to make health claims doesn't contradict the use of other probiotics in all circumstances.

 

I also can't say whether probiotics work or not only the opinion of legislation for food, which is reasonably robust.

Regarding the reasons why Yakult don't claim...it's because they don't have a valid claim to make any more. Don't forget that there were claims permitted before for probiotics and these were withdrawn due to a massive review and tightening up of the clinical evidence. Probiotics were just one of many casualties where the evidence was deemed insufficient. General fibre claims were also hard hit.

Yakut and similar companies problems are more to do with how the system is structured rather than a fine line they need to balance. It's pretty cut and dry actually, rather than open to interpretation when you look at what's permitted.

The law works based on a health claim by product type, but also the active component is linked directly to a range of claims...so magnesium for example could have many permitted health claims to do with its action on different parts of the body (I think it has about 10 different claims). They also do specify the target population that the claim pertains to (e.g children, adults, etc)

So the legislation first specifies quantities required (eg a good source of ) which is determined by a threshold quantity found per 100g or similar. This varies by component. You can only make a claim if it is a "good source of" which is determined by rda's and other criteria that set the quantity as having a meaningful action. This also allows trading standards to test product for compliance and prosecute if false claims are made etc.

I think the claim for probiotics were along the lines of "maintains a healthy digestive system" or something of that order. A bit like fibre claims were (I would need to check the wording ).

You are right, no health claims on food products or supplements are linked directly to health conditions, but rather the action they take on a human body. So IBS is immaterial because it is a health condition. The legislation is very clear that foods are not medicines for conditions.

yakult etc have tried to present evidence several times I believe which has been reviewed and rejected as insufficient. This has been in the form of lobbying rather than formal submissions.

They are currently stumbling over the first hurdle...that is proving the quantity that is required to have a meaningful effect. I think they have submitted several times on this. Fundamentally though ...there is no hard and fast evidence for what a healthy human gut should look like in terms of healthy microflora when it comes to species.

Even if they prove quantity, they then have to have evidence to show how it maintains or improves health....via a plausible action ...they are miles away from either apparently.

Here is the latest ruling from 2011

http://www.efsa.europa.eu/en/press/news/110728

As a light aside, prunes have relatively recently been given their own health claim after about 25 years of lobbying and rejected submissions by the Californian prune board (sounds a fun place to be)

http://www.efsa.europa.eu/en/efsajournal/pub/2712

 

Highlights from 2nd Annual Microbiome
9 Oct 2018

"Shahram Lavansani of ImmuneBiotech, spoke about GutMagnificTM, a lactobacilli probiotic food supplement. Primarily for management of IBS, it also has implications for Leaky Gut Syndrome, a potential contributing factor in multiple sclerosis, as well as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome."

https://www.fiosgenomics.com/microbiome-cdx-immuno-oncology-2018/

 

I have not read the full paper but I would be surprised if the evidence for probiotics being useful in IBS was 'excellent'.

I am not sure that a company making a probiotic derived from food sources would have any problem with making claims if it had done trials and had evidence because of an overlap with drugs. At least in the UK something derived from a foodstuff without chemical synthesis is not subject to the licensing requirements for a drug - simply because it is a 'foodstuff'. That is a crazy anomaly but it remains in place as far as I know. The same anomaly applies to radioactive isotopes (or did a few years back at least) because they are not synthesised drugs - they are called 'devices' and do not require proof of efficacy in the way drugs do.

 

There are no probiotic health claims permitted for any foodstuffs of any sort sold in the EU by law. This has been the case since 2011. Any health related claims made by any food probiotics sold in the UK or EU would be subject to prosecution fines/imprisonment.

There seems to be confusion with suppliers of supplements sold on the Internet thinking the food regulations don’t apply to them, unfortunately I don’t believe that is the case.

Basically there is a list of permitted health claims...probiotics have been removed from the list. This is because there is a lack of scientific evidence that they have any health benefit at all.

To get a permitted health claim on the list there needs to be a lot of scientific evidence for efficacy and this tends to be more rigorous than the drug industry ...mainly because it’s got an established fraud prosecution history...adulteration of food and misleading sales of food is as old as the hills law wise.

 

That's interesting. So it is easier to sell foods than drugs (at least in terms of safety testing) but maybe harder to make positive claims about them.

 

Yes for health and nutritional (good source of etc) claims, which are enforced via local trading standards officers.

For food manufacturing there are also food safety laws and training in hygiene/allergen control etc to ensure the manufacturing/food preparation processes don’t kill people or make them sick. This is enforced via local environmental health officers who have the power to shuit down premises (I.e. stop the business trading). When incidents occur they have to be recorded and the food standards agency notified.

The retailers also have another layer of oversight for own label products, which also involves fines and monitoring of consumer complaints and FSA notifications/site audits etc. They also cover off the legality of claims and set their own policies that tend to be more about corporate social responsibility etc.

 

At least while we are still in the EU, after Brexit, does anybody know? I assume that the current rules will continue for the time being?

 

One of many questions I have. I heard that they would migrate the current rules, but not how they plan to replace the expert panel that reviews the scientific side of things for future amendments etc.

 

Except certain E numbers - not used in food , but commonplace in medicine . The common side effects of many drugs ( itching, rashes, etc) not be the drug itself, but the colouring.

Edit spelling

 

All things in moderation. This article peaked my interest pointing out that for those who are taking high levels of probiotics they may be causing as many problems as they solve.

https://www.sciencedaily.com/releases/2018/08/180806095213.htm

From the article: "Probiotic use can result in a significant accumulation of bacteria in the small intestine that can result in disorienting brain fogginess as well as rapid, significant belly bloating, investigators report."

"Probiotics are supposed to work in the colon and not the small intestines or stomach, Rao says, so motility issues can result in problems with probiotic bacteria reaching the proper place. A wide variety of problems, from conditions like diabetes to drugs like antidepressants and minerals like iron, can slow movement and increase the possibility that probiotics will remain too long in the upper gut where they can cause harm, he says."

Getting probiotics via food seems like a common sense approach.

 

Artificial colours are permitted for food use. Some, azo dyes known as the ‘Southampton six’ (tartrazine etc) do have to carry a warning for hyperactivity in children, but no permitted dyes have been shown to cause significant itching or rashes to warrant a warning.

Some artificial colours have been widely permitted in the past and are no longer permitted or have had their use limited for one reason or another.

Generally the practice in the food industry is to avoid artificial colours if you can, mainly because of consumer concern (a lot of it rumour mill rather than based on facts ) and to allow for the no artificial colours or flavourings claim which is motivating for consumers. Similarly the gluten free and dairy free claims are coming to the fore, not because of a fact based reason or a safety issue....just to appeal to consumers perceived needs (to sell more)

Sometimes you have to use artificial colours because the natural alternatives don’t work in the product (e.g. extremes of temperatures or the natural colour interacts with the drug active agent. I don’t think the “no artificial colour” is as motivating a claim in Pharma, which might be a reason they are used more?

https://www.food.gov.uk/safety-hygiene/food-additives

 

I had an interesting conversation with ER doctor after they had consulted the on duty pharmacist.
My daughter has reacted to different medicines - the reaction in both cases was attributed by the pharmacist ( and one ER doctor) to the colouring in the capsule. Both were E104, which is ( i am told) salicylate based.

The pharmacist advised that itching and rashes were more likely to be the colourant. Whether this is based upon any science i don' t know. I can only assume that they have seen it play out on more than one occasion .

Interestingly it does seem to be the salicylate based colours Iron oxide is fine.

Previous skin rashes when younger were found to be caused by any food that had been bleached- this is commonly benzoates, which are so similar to salicylates that the body may not be able to differentiate.


This may point to issues with detox pathways in liver. Interestingly, skin was problematic after chickenpox.

Skin was horrendous when endocrinologist tried hydrocortisone too. ..

Note. Edit to add Some E numbers ( some of Southampton six) are banned in food in other countries , but not here.

 

Yes most of the rules at play in the EU come from close scrutiny of the scientific evidence and I believe there are plenty of studies to draw upon for food colouring agents, so I don’t believe it’s an absence of evidence thing. That doesn’t proclude an allergic reaction ever happening, just what is likely. I do know there was a lot of hype about food colourants about 10 years ago, most of it a bit misleading from memory with the usual food tampering insinuations, and the EU did review it’s legislation around this time. I suspect if it were a major problem the complaints capture process would flush it out...all food products sold have a route to the fsa to identify trends etc (mostly microbiological, but also includes allergen), so it’s probably not a big issue in terms of numbers. The recent pret case came about from 2 incidents I believe.

So far the weight of evidence isn’t with this theory but I appreciate the concern.

Regarding salicylate, I would need to dust off my organic chemistry but from memory salicylate is a rather common component found in plant extracts and tinctures (fruit flavour aromas from memory) and you find variants of this phenol ring around chemicals in nature all over the place so I’m not sure that it being that general constitutes an allergen per se, not that I’m aware of in food anyway. I’m pretty sure quinolone yellow is more complicated than salicylate (has multiple phenol rings), but I would need a clear head and a bit of time to give you something more specific on this.

 

In the US this is the situation....

"The United States Food and Drug Administration’s (FDA) regulation of products containing probiotics is complex and largely depends on the claims that are made for the product. For example, they can be regulated as foods, dietary supplements, cosmetics, or drugs/biologics (a class of drugs which are extracted from or derivatives of living organisms)."

"Another concern about probiotics is that they're considered dietary supplements, not drugs. As a result, the FDA doesn't monitor the manufacture of probiotics. "It's not clear if probiotics that can be bought at pharmacies and health food stores are high-quality products. It's even possible that some lower-quality products may not even contain the probiotic bacteria that are listed on the label," says Dr. Hibberd." (from a Harvard Medical School article)

"Dietary supplements are considered safe until proven unsafe. In 1994, the Dietary Supplement Health and Education Act (DSHEA) defined dietary supplements as a category of food, which put them under different regulations than drugs. They are considered safe until proven otherwise."

 

After a strong morning coffee i have revisited this.
I think this reaction may be tied to specific groups of man made chemicals.
As the vit D treatment was part of a course to treat deficiency , the prescription was changed for the next dose with no E104, and there was still a reaction, albeit it smaller. The product contained synthetic vit E ( subsequent skincare products have confirmed this sensitivity) .
The final product was a liquid .

Interestingly, the skin affected was limited to face and backs of hands ( in a very defined area) . These areas are combined and expressed during PEM
So benzoates were right eyelid and upper lip. Vit D and E were eyelids, temples and side cheeks, hands, and hydrocortisone was sides of mouth and chin , eyelids and temples and karger hand area.
In PEM flares skin is a mess as geberally it us all expressed.

To me this suggests issues with detoxibg specific chemical groups.