European Food Regulation and 'Intended Normal Use'
CategoriesWhat is a food and what is a medicine, is a question that has no easy answer. The grey line of demarcation between the two might seem unimportant to some, but if distinctions are arbitrarily set, they can destroy markets and prevent people from effectively taking care of their own health by adjusting the intake of certain nutrients in their diet. With diet and nutrition closely linked to the prevention of chronic diseases, the importance of the free availability of healthy foods is hard to overstate.
Food or medicine?
European Food legislation is evolving to recognize the existence of healthy foods specifically formulated to provide greater amounts of some of the nutrients also found in 'normal' foods. The concept has been enshrined in the food supplements directive, and more recently in the food fortification regulation. It is important that legislation in this area strike a delicate balance between protecting consumer health and allowing markets to form and expand unimpeded.Consumers expect foods and supplements to be safe, but within the confines of safety they definitely cherish their freedom to choose, even at times to 'exaggerate' with a good thing. Especially the users of supplements are vociferous in demanding that there be no undue restrictions that would deprive them of their favorite combination of nutrients.
Producers of healthy foods, on the other hand, value their access to a European market that has been deregulated, meaning that what can be sold in one country can - in theory - also be sold in all others. Meanwhile, some national authorities insist that "here, the situation is different" and they proceed to 'protect' their consumers from having too many choices.
The 'classification problem'Finding the correct dividing line between foods and medicines has been vexing legislators and health authorities since the day they decided to promote Europe-wide regulations for food supplements and 'fortified foods'. Pharmaceutical interests have been lobbying to keep the food-based competition at bay. They demand nutrient dosage restrictions and an absolute prohibition for foods to claim an ability to prevent or cure disease.
The eternal question of is: when is a nutrient a food and when does it turn into a medicine? The European Commission is eyeing 'safe upper levels' for vitamins and minerals in supplements to make that distinction, and there is talk to limit 'botanicals', meaning substances extracted from fruits and vegetables, with reference to 'therapeutic dosage' or 'pharmacological dosage'. This is discussed in "Use of botanicals in food supplements. Regulatory scope, scientific risk assessment and claim substantiation."
Intended Normal Use
Such developments will eventually carve up markets to favor certain cartels, says a recent paper published in Environmental Law and Management, because they introduce arbitrary - and unnecessary - criteria for distinction. See "The European regulation of food supplements and food fortification: Intended normal use - the ultimate tool in organising level playing field markets and regulations, or how to break the fairy ring around 'other substances'." As the title says, the authors concentrate on 'other substances', nutrients in a wide sense that are neither vitamins nor minerals and thus are not directly regulated by the food supplements directive. But the discussion of a product's 'intended normal use' as the guiding concept for distinguishing with certainty and in a way that is both market and consumer friendly, encompasses the whole field of food legislation. It is by no means limited to mushrooms, herbs or other 'botanicals' - and it shows a way out of legislative uncertainty that appears set to harm both producers and consumers.
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Of mushrooms and 'other substances'
Here are a few excerpts from the paper, which you may want to download as a PDF file and print out for easy reading and reference.
A 'fairy ring' is an open space in a forest marked by a circle of mushrooms. Fairy rings can also be found in meadows. Technically, the circle indicates the periphery of perennial underground mycelial growth. In autum, the mycelium forms mushrooms...
Mushrooms and 'other substances' are on the plate of the European regulators who are making efforts to organise and harmonise markets and regulate the large variety of today's food supplement products. Understandably, their efforts are made in the interest of public safety and the free movement of goods, two principles that are finely engraved in the minds of all EU regulators. In the case of 'other substances' (such as mushrooms), perceiving them as fairy rings obstructs and compromises the creation of a transparent and balanced legal framework that organises markets in an EU setting.
Intended normal use is a remarkably simple concept that, subject to its consistent and irrevocable execution and application, can serve to regulate products and organise and harmonise relevant markets. We suggest that intended normal use is at the core of food supplements legislation. We will focus here on 'other substances' within the field of food supplements and we will elaborate on the concept of intended normal use within that field of food supplements as a means to ground future regulation in a transparent and consistent manner.
In view of a number of papers published in the last few years, it seems that intended normal use tout court is difficult to embed into regulation. One of the reasons for this, we believe, is the idea that regulators, despite their prerogative not to regulate, inevitably will succumb to the compulsion to regulate, mostly for reasons of safety and security.
... it would appear that regulation and jurisprudence creates markets. Nothing is further from the truth. It seems therefore critical to reiterate the obvious: manufacturers make products and thereby create markets. However, it is worth stipulating the obvious, because users sometimes overlook or discard the manufacturer's original intention and the ensuing use he had in mind when he conceived, developed, tested, manufactured and brought his product to market. in our view, the manufacturer's intention, as expressed in the intended normal use of his product, is fundamental in classifying a product. The manufacturer's viewpoint, not the user's or for that matter the regulator's viewpoint, must be, indeed cannot [but] be, the guiding principle in classifying a product.
In the field of conventional, novel and fortified foods, and food supplements and medicines, applying the same principles to define and distinguish products and markets are of equal importance, because these products, and especially food supplements, are being used not only in their intended nutritional setting, but also in therapeutic and/or experimental ones. When a nutritionally oriented medical doctor advises a patient to take a food supplement to effectuate an improvement of that patient's physical or mental condition, that does not change the basic intended normal use given to that food supplement by its manufacturer. Equally, when in scientific research a food supplement is applied in dosages that far exceed those recommended for the product's intended normal use, these scientific activities cannot alter the basic intended normal use designed for and explicitly mentioned on the packaging of that product by its manufacturer. Abnormal use should not alter or replace intended normal use.
Read the whole paper:
See also related:US and EU agree 'single market'
The United States and the European Union have signed up to a new transatlantic economic partnership at a summit in Washington. The pact is designed to boost trade and investment by harmonising regulatory standards, laying the basis for a US-EU single market. The two sides agreed to set up an "economic council" to push ahead with regulatory convergence in nearly 40 areas, including intellectual property, financial services, business takeovers and the motor industry. The aim is to increase trade and lower costs. Some reports suggest that incompatible regulations in the world's two richest regions add 10% to the cost of developing and producing new cars.
A little-reported development that could have implications for the health food area as well as for the larger industries...
posted by Sepp Hasslberger on Friday May 4 2007
updated on Monday May 14 2007
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