As I first explained here, I have been trying to find out what the laws are regarding the sale and manufacture of colloidal silver products in the UK and how they may be implemented.
As I said in my last post, colloidal silver has never been licensed as a medicine, nor is it permitted in food supplements. I have since had further correspondence with the MHRA, the Advertising Standards Authority and my local Trading Standards office which I feel is worthy of note. I also feel I need to answer critics by explaining the reasons for my concern about colloidal silver and my recent actions.
My response to critics
I have been accused of being a government parasite in the pay of mainstream medical companies. I have been asked why I am so concerned about the safety of colloidal silver (and to provide linked details of side effects of antibiotics recorded in clinical trials). I have also been informed that ‘properly manufactured Colloidal Silver cannot cause any harm to anyone when taking the suggested amounts’ and been accused of swallowing whatever lies the goverment spits out.
I wish to respond to criticism of this nature by pointing out that I am not receiving money from pharmaceutical companies or the government, nor do I ‘worship regulation’. The reason for my action is that I am concerned that vulnerable members of the public are being misled, with potentially harmful consequences. My concern is the unregulated sale of colloidal silver products which are promoted as being of medical benefit. It is possible to walk into a health food shop and buy a bottle of colloidal silver with the understanding that it can prevent or treat disease. Although this is illegal, people are not generally aware of this.
I do not believe there is sufficient robust scientific evidence that colloidal silver products are effective for what they are advertised to treat. I personally have little idea how safe they are (or what a safe dose would be). As well as argyria, according to NCCAM, side effects may include neurological problems (such as seizures), kidney damage, stomach distress, headaches, fatigue, and skin irritation. Colloidal silver may also interfere with the body’s absorption of some drugs.
Medicines and Healthcare products Regulatory Agency
Thankfully it isn’t up to members of the public (such as me, my critics or indeed the people who make colloidal silver at home) to weigh up potential risks and benefits of a medicine and decide whether it should be allowed to go on sale. For good reason, we have regulatory bodies such as the MHRA to make such decisions.
I wrote back to the MHRA, pointing out that the Department of Health had informed me that colloidal silver is not permitted in food supplements, that colloidal silver products are marketed with the understanding that they are to be used to treat or prevent disease and that the MHRA and the Advertising Standards Authority have previously described colloidal silver products as unlicensed medicines.
Their reply indicates that colloidal silver products would have to be assessed on an individual basis:
The medicines legislation with which the Medicines Borderline Section is concerned, relates to the classification of individual products as medicinal products (or not) rather than to substances in general (thus certain substances may be sold as both food and medicine). It is not therefore accurate to say that the Agency has previously classified “colloidal silver” as a medicine; the determination you have cited related to that one specific product. It is not possible for me to comment on the particular case
The Medicines Borderline Section does not have the authority to say that any specific product “is a food” but where a product is determined not to be a medicinal product and when that product is for oral consumption, it generally falls to be regulated as food by default. Food supplements are only one type of food and are subject to specific regulations as I understand it.
The prohibition against the use of medicinal claims which exists in Food Safety legislation (specifically the Food Labelling & Advertising Regulations) is there to cover products which might legally be sold as foods, having no pharmacological, metabolic or immunological effect. It cannot be the case that simply making a medicinal claim makes everything a medicinal product otherwise there would have been no need to have this prohibition on medicinal claims in food law.
All cases referred to the Classifiers in the Medicines Borderline Section are subject to a risk assessment which takes into account factors such as public health risk, previous compliance history and parliamentary and press interest, and may not necessarily be investigated. The Trading Standards Service operates locally on the “home authority” principle and no doubt cases are also subject to a risk assessment.
My local Trading Standards office have been in touch recently to say that they are looking into this from a ‘food standards perspective’ and planning the best way to deal with it, suggesting they may trawl the internet and contact other local authorities with a view to them checking the selling and advertising of these products in their area. They may alternatively use their professional forum to flag the issue up, perhaps providing some background information so that others are aware of all the problems. I was warned that it may take some considerable time before the situation is regularised.
Advertising Standards Authority
As I have already pointed out, there is already one ASA adjudication regarding colloidal silver. I personally made two complaints in May about the advertising of colloidal silver products, both of which were ‘informally resolved’ (here and here) when the companies agreed to amend their advertising.
Since then, I made a further twelve complaints about websites advertising colloidal silver, all of which I believed were making unsubstantiated claims of medical efficacy about an unlicensed product and some of which were, in my opinion, in breach of Medicines (Advertising) Regulations 1994. My local Trading Standards office were also informed of this.
I received a letter this week stating that the ASA ‘cannot justify allocating resources to this therapy at this time’ since they are currently dealing with a disproportionately high number of ongoing alternative therapy cases. They do not feel that this warrants the same priority as some of the more mainstream therapies and believe that the potential for consumer detriment is much lower for this therapy in comparison with others.
I understand that the ASA are very busy at the moment and do not intend to challenge this decision at the moment. I also intend to give Trading Standards more time to deal with this and will report back if there are any further developments.