Dear Grace,
Thank you for your message. I hope you will forgive me for not being able to recall the particular conversation.
Your attachment shows a standard section from a letter sent by the MHRA's Borderline Section. This would normally appear in a letter, either replying to a request for advice on a product's status in the UK, or one sent as an initial contact following a complaint about a suspected unlicensed product which has already been placed on the market. It is a list intended to offer guidance as to what kind of marketing material is likely to be regarded as unacceptable if used to promote a product which does not have a Marketing Authorisation (product licence).
The system for classifying products is complex, and because it relates largely to the legal interpretation of both national laws and European Directives, there tend to be very few black and white areas to simplify matters.
I am not completely sure if your concerns relate to the marketing of specific products or in relation to the publishing of generic information. There is a difference. Generic information; that is to say where there is no intention to promote or recommend the sale or use of any specific proprietary products for human use, is free from regulatory controls as far as medicines legislation is concerned. When information is product related, it is no longer considered as generic.
Products for human use are, and must be subject to regulatory controls for public safety reasons. These can be regulations for medicines, medical devices, foods, biocides, cosmetics etc. Medicines regulations generally sit at the top of the tree since medicinal products have the greater potential for significant effects and thereby, safety concerns. Other products’ regulations contain a section which dis-applies from their remit, any product that falls within the definition of a medicine.
That definition is:
"Any substance or combination of substances presented as having properties for treating or preventing disease in human beings. (and/or)
"Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis”
The definition is very wide and open to interpretation. The approach adopted by the UK has been consistent for many years and developed in the light of case law, (especially European Court Judgements) and scientific advancements. Applying the law is rarely as straightforward as most people would like and this is especially true of medicines legislation. Persons and companies placing unlicensed products on the UK market are able to do so under a self-regulating system. This places the onus on them to ensure regulatory compliance but does provide a mandatory pre-vetting system. This makes it possible for the naive, the ignorant and the dishonest to place products on the market unlawfully, and that gives rise to a need for regulators to "police" the market and deal with breaches of law as they come to light. Subsequently, it is necessary to apply the regulations fairly and consistently, without favouring certain groups because they may be able to display what appears to be better quality scientific evidence.
The law is quite clear about products for human use. If they contain ingredients that are capable of significant physiological effects that would not otherwise occur in normal life, and would be deliberately used by consumers to elicit such effects, or they make claims of being capable of preventing or treating some form of adverse condition, then they are likely to be classified as medicines and require proper authorisation.
European law has established the principal that medicinal claims can be made by implication alone. As a result, regulators are required to give greater consideration to the message conveyed with a product, rather than just the actual wording or graphics used to promote it.
In a perfect world, regulators would have an easier task if not having to deal with those who place members of the public at risk by promoting products that are designed to do little more than generate profit, or which are based upon bad, unsubstantiated or contested science.
The rights of those who wish to extol the benefits of unproven remedies has to be balanced against the rights of the consumer to be protected. Even seemingly harmless products can present a danger if used against or instead of informed professional advice. There can also be hidden dangers from poor standards of manufacture, such as contamination or lack of dosage level consistency.
Therefore, there is to my mind a compelling need for a uniform system which places the same requirements on all. I do not believe that there is such a thing as a “perfect” system. However the current Marketing Authorisation structure operating in the EU provides a sound and trusted mechanism for helping to ensure that products are judged and assessed on grounds of safety, quality and efficacy to the same standards.
Classifiers on the Borderline Section see a wide variety of unlicensed products on a day to day basis. We also come across a wide variety of individuals and companies selling unlicensed products. Some appear to be well qualified in their respective fields and many seem genuinely well intentioned and concerned about public health. The rest are motivated by profit margins and as a Classifier, I can assure you that it is normally impossible to discern between these. We are therefore left with no alternative but to apply the same rules to all.
In my view, information and recommendations about what is or may be good for you should come from an independent and expert source. For preference this should be a qualified health professional who is familiar with your individual medical history. (An apple a day won’t keep the doctor away from someone that is Pectin intolerant). (! - GF) If health advice is obtained by self-research from a generic source, then it is open to the individual to cross check with other sources or seek a second or professional opinion. It is not correct that someone with a specific interest should be permitted to offer persuasive arguments.
This is why there is a prohibition on making or implying medicinal claims for unlicensed products which have not been expertly evaluated for their safety, quality and efficacy. There are also strict limitations on what can be claimed and advertised by licensed medicines.
An enforced licensing system has been in operation in the UK since the late 60’s following the Thalidomide tragedy. It was conceived by scientists, lawyers and politicians and has been monitored, developed and enhanced using the same level of recognised expertise. It may not be perfect, but I believe that it is the best option available.
I think I have already answered most of your question 1. To summarise and clarify, if a product is not licensed as a medicine, it may not be presented with any information, that makes claims for medicinal use, either directly or by implication such as publishing third party testimonials which say that a product had a medicinal effect.
With regard to question 2, I need to point out that the products sold by a greengrocers, beekeepers and ironmongers do not normally fall within the remit of the MHRA. These are the regulatory responsibility of Trading Standards under Food Law (door knobs excepted). However there are, by necessity, similar prohibitions on making medicinal claims in other product legislation.
My response in general terms is dependent on whether you are actually, and only talking about claims to kill germs in a broad sense and in an environmental capacity. (As an example using lemon juice to clean your bathroom taps). This, I do not believe would pose a problem, but it would be for a Trading Standards Officer to confirm and he/she would probably require some scientific evidence.
Conversely, if you are thinking more in terms of expanding claims to include health benefits of eating certain foods, then the question takes on a new complexion. There are in fact regulations under food law which govern what claims may be made for food products. These generally fall short of medicinal claims and concentrate more on possible long-term benefits.
Were a greengrocer to claim that a particular fruit or vegetable could prevent or treat specific diseases, should he not also say how much should be consumed on a daily basis and how often? Should he also not advise on possible contra-indications and warn about interactions with medications etc? What would the humble greengrocer do when someone threatened to sue him because his vegetables didn’t work? Overall, I think there are many very sensible reasons for not permitting unsubstantiated claims.
Conclusion:
It would be very nice for all concerned, including regulators, if the rules could be simplified further. However, rules tend to be adopted in response to their needs, and in a world of innovation, enterprise and those who seek to bend or push the boundaries, there is a constant need to update them.
It is not possible to have one set of allowable claims applicable to all. If there was it would be restrictive on commerce and competition, not to mention innovation. Therefore you cannot operate a system with strict taboos. Instead it is necessary to judge each case on its own merits and consider each claim within the context in which it is used, and as a part of a product as a whole. Our normal advice to companies is, if you intend consumers to gain the impression that your unlicensed product can be used for a medicinal purpose, then we will probably interpret it in the same way. Without a Market Authorisation, you have no lawful right to make medicinal claims. In exactly the same way, if you have no right to drive on a public road unless you have a driving licence – even if your name is Lewis Hamilton.
I must decline your request to appear on camera. This is not solely due to my personal perceived lack of photogenicity.
For additional information I have attached a copy of our Guidance Note 8 – “A Guide to What is a Medicinal Product. You may be interested in Appendix 1 which gives some examples of claims that are likely to be deemed inappropriate, but none of which are prohibited.
I hope that I have managed to answer your questions successfully and that you have found my reply informative, if not quite what you may have been hoping for.
Simon Parker
Classifier
Medicines Borderline Section
Inspection, Enforcement & Standards Division
MHRA
