This post has been adapted from an article in a vitamin and health supplies brochure I was sent in the mail. The EU is something I tend to keep an eye on, because of this body’s exorbitant cost to the taxpayer with its vast, wasteful bureaucracy, lack of accountability and excessive red tape. The continued availability of certain dietary supplements, and the quantities/strengths available in one purchase, has long been a concern of mine.
Note: I can’t comment on nootropics as I have never sought to purchase them for my own use, but if anyone knows of any UK/EU legislation affecting these, please feel free to comment!
There have been many changes over the last few years concerning vitamins, minerals and herbal products. These changes were brought about by legislation in the EU affecting all member states, with the stated purpose of increasing the safety of said supplements. There have been some scare stories in the press and some factual information, but generally a dearth of data for the consumer on what is happening and how it affects them, this article will hopefully enlighten and bring you up to date.
The EU authority for food supplements (as well as all foods) is EFSA, the European Food Safety Authority. It is an independent agency created in 2002, funded by the EU and is responsible for assessing the safety of all foodstuffs on sale within the EU. The Food Standards Agency (FSA) carries out enforcement locally in the UK.
EFSA have issued various Directives and subsequent Annexes which lay out specific rules and regulations regarding food supplements, including the setting of RDAs (Recommended Daily Allowances). The first one that caused a significant change came into force in 1009; this stated what vitamin and mineral compounds were permitted in supplements and what were not. For example, prior to 2009, certain mineral compounds could be used, like Chromium Polynicotinate, but after 2009 it was not approved and manufacturers had to switch to an approved source of Chromium, like Picolinate. The next step (Article 13.1) came into force mid-December 2012; this allows certain health claims on specific vitamins and minerals.
Thousands of claims were submitted to EFSA for consideration and many were rejected. The criteria for the submissions included a full dossier with supporting clinical evidence and trials for each individual vitamin or mineral. As you can imagine, this was a lengthy and costly process, one which only the “big guns” could realistically afford to undertake. Fortunately, the claims for generic vitamins and minerals are available to all manufacturers for use in promoting and selling their supplements.
What does this mean for the consumer? Its stated purpose is to protect the consumer from spurious and misleading claims, thus removing any ambiguity on what can and can’t be said and is intended to be a clear statement of its function. Which it is, sort of.
The problem that arises is, if you make a medical claim about a food supplement you are effectively saying it is a medicine and then you need a medicines licence in order to sell it. Further, you go beyond the remit of EFSA and the Food Standards Agency (FSA in the UK) and come into the domain of the MHRA (Medicines and Healthcare Products Regulatory Agency). So, all claims that are permitted on supplements are “general function” and contributory type claims, rather than curative or preventative ones.
As an example, Folic acid (Folate) has been studied and is known to be beneficial to pregnant women, the NHS website states, “Folic acid is important for pregnancy as it can help prevent birth defects known as neural tube defects, which can cause conditions such as spina bifida. You should take a 400 microgram folic acid tablet every day while you are trying to get pregnant and until you are 12 weeks pregnant.” Food supplement manufacturers are restricted to the following permitted statement: “Folate contributes to maternal tissue growth during pregnancy” and inexplicably, the RDA for Folic acid is set at 200 micrograms. There are other permitted claims for Folic acid, but this is the only one relating to pregnancy.
All anecdotal evidence, folklore and “granny says” type statements are effectively forbidden.
A medicinal product is defined as one that “treats or prevents disease” and “otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating, reducing or postponing, or increasing or accelerating the operation of that function or in any other way”, most nutritional deficiencies can cause disease therefore eating the right foods could prevent them, but a statement to that effect would be unacceptable. Centuries ago British sailors knew that eating limes prevented scurvy (hence the nickname Limeys for the British), this was down to the Vitamin C content. The proverb “an apple a day keeps the doctor away” may contain some truth, but would be seen as a borderline claim. Hippocrates, the father of medicine, said “Let food be thy medicine and medicine be thy food.” So where does that leave us [the vitamin suppliers]?
Well, we have a list of permitted claims which consumers will see appearing on labels and in marketing, but do we even need them? Most consumers of food supplements are fairly well educated on health products and the unlimited resources of the internet mean that information, good or bad, is a click away. Ultimately it may not alter the purchasing habits of most consumers, what it should do is weed out the ineffectual “snake oil” salesmen who do make outrageous and unsupported claims about various products.
Recently the THMPD (Traditional Herbal Medicinal Products Directive) came into force which placed restrictions on the sale of certain herbal products, unless manufacturers apply to the MHRA for a THR (Traditional Herbal Registration), which is effectively a medicines licence for a herb. You will no doubt see fewer herbal products on the market as smaller companies cannot afford the costs of obtaining a THR for each individual herbal product they manufacture. Obviously it is aimed at the fly-by-night dodgy dealers and will ensure safer herbal products, but it may be a double-edged sword. Traditional Chinese Medicines and Ayurvedic Medicines will also be hit by this legislation, so although simple remedies will exist such as one ingredient Echinacea but multi ingredient herbal remedies might disappear.
What of the future? The next major change will be the “maximum permitted dose” legislation, which will set a maximum upper limit for each vitamin and mineral in a tablet or capsule. Currently though there is no agreement between member states and the legislation has been continually delayed. Countries like Holland and the UK who have traditionally had quite relaxed views on supplements are up against countries like France and Germany where supplements have always been sold in pharmacies and subject to more restriction. Who knows when it will ever come to fruition.
Regarding dosages, it is worth mentioning that the RDA (recommended daily allowance) of vitamins and minerals is the barest minimum amount considered to prevent disease, not the amount a person should be consuming each day for optimum health. Many supplements already contain such small amounts of each vitamin that, unless you ignore the warnings not to take more than one or two a day, you may be effectively wasting your money.
If you are still wondering why this is all a big deal for bureaucrats and big business, consider this: vitamins and other natural substances cannot of course be patented. Protectionism at its very best.
SevenSigma Project 