Supplements & functional foods in Europe: what a difference a decade makes in the EU.
Manufacturers placing new products in the marketplace needed to decide where they wanted to go--to the liberal markets in the U.K. or the Netherlands (where their products were regulated as supplements, with low investment but equally low proceeds). or to the more strictly regulated markets of Germany or France (where more investment was needed, but the products were regulated as drugs, prescribed by physicians and reimbursed by the health insurance system, and thus could be sold at a higher price).
As for functional foods in those days, the category was still in its infancy. Orange juices fortified with calcium were among the first functional products appearing on store shelves carrying all sorts of claims.
Supplements were mostly just that--products such as vitamins and minerals that supplemented any deficiency in the diet. And they were certainly not meant to improve appearance or increase well-being. Science had ling since recognized the importance of healthy food, but consumers still believ illness is something that inevitably happens from time to time. And when that time comes, consumers are most inclined to go to their doctor to get a prescription.
As for cosmeceuticals, except for almost unrecognized pioneers such as Germany's Merz Spezialdragees, they did not yet exist a decade ago and continue to represent a very small market with impressive growth projections.
The Harmonization Heard Round the World
The diversified European situation was finally addressed in 2002. In an attempt to harmonize regulations throughout the EU, the market as a whole became more stringent. The new European Supplement Directive 2002/46/EC, implemented in 2004, stipulates that vitamins and minerals and a list of other well-defined ingredients be regulated as supplements--herbal products are not part of that existing legislation. The Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC came into effect and was implemented in October 2005 by individual member states. Herbal products that have been on the market for at least 15 years, with an additional 15 years outside of Europe. are regulated under this directive. They require a drug registration file with a complete quality dossier, including analytics, stability testing, GMP production, etc. While there is no requirement to prove efficacy, safety and tradition have to be documented on a literature basis.
In addition to a complete restructuring of the natural products and vitamin and mineral markets in Europe, the claims for food products and, accordingly, food supplements were harmonized based on the newly agreed upon Food Labeling Directive 2000/13/EC. Basically, the directive states that all claims need to be scientifically proven in well-controlled peer-reviewed published studies. As a consequence, the various interpretations of supplement claims in Europe will be harmonized on a very stringent level, demanding clinical trials for the exact product or formulation that intends to make the respective claim.
These regulatory changes slowed market growth as some manufacturers adopted a wait-and-see attitude. Still, others forged ahead to secure the advantage of proprietary claims. The full consequences of the changes have yet to materialize, but one thing can be said already: where manufacturers before had to apply to each EU market separately if they wanted to market their products, now one application is valid EU-wide. This makes Europe as a marketplace much more attractive to global players.
Apart from changing regulations, the past 10 years have produced many herbal highlights, as functional food evolved into a thriving category and cosmeceuticals and beauty foods appeared on the scene. Green tea is just one of the star ingredients that has grown into a multi-purpose ingredient for use in weight loss products and cosmeceuticals. Its constituent polyphenols, such as epigallocatechin gallate (EGCG) have been proven in randomized, double-blind, placebo-controlled studies to reduce weight and waist circumference in moderately obese men. EGCG also affects safety and glucose production in the liver, making it a promising anti-obesity agent.
Superfruits are everywhere, from supermarket shelves to supplements, even in Europe. Their much-touted high antioxidant activity makes them attractive, both as a healthy food ingredient, and as beauty food.
And, even though not an herbal, it looks like science has yet to find a health benefit that is not offered by omega 3 fatty acids.
There are other good examples of food ingredients backed by solid scientific proof that continue to grow considerably in market value. For example, the recently proven health benefits of cocoa flavanols and catechins have given the functional confectionery industry a new "healthy" story, so much so that EGCG, the main catechin contained in cocoa, is being talked about as a potential new vitamin.
Cinnamon's blood sugar lowering effect, too, benefits from solid scientific evidence. Several well-controlled clinical trials prove the postprandial lowering of glucose response that is the spice's main health benefit and makes cinnamon-cocoa mixes and attractive combination for functional beverages. There are also indications that cinnamon could aid in the treatment of metabolic syndrome.
In the past, clinical trials were instrumental in establishing food ingredients on the market. The carotenoid lycopene, for instance, responsible for the red color of tomatoes, pink grapefruit and watermelon, was first linked to human health in the mid-1990s, when epidemiological studies found properties useful in the prevention of cardiovascular disease and cancers of the prostate and gastrointestinal tract. At the time, lycopene's antioxidant properties were also known, but the lack of controlled clinical studies meant that these results were merely "strongly suggestive" for
Nutraceuticals World 10th Anniversary these health benefits. This changed when the first clinically derived data demonstrated that lycopene might not only prevent prostate cancer, but also have therapeutic effects.
As recently as 2007, a review of all clinical trials on the health benefits of lycopene, published in the European Journal of Clinical Nutrition, came to the conclusion that consumption of processed tomato products-containing lycopene--is of significant health benefit and can be attributed to a combination of naturally occurring nutrients in tomatoes, and that lycopene, the main tomato carotenoid, contributes to this effect, but that its role per se warrants further investigation.
Changing regulations demand more science behind the claim, but this means the claims that are made have the full force of scientific evidence behind them. This, in turn, increases consumer confidence at a time when the market still feels the effect of generous promises made in the past, which have created skepticism among consumers.
Despite this, changing consumer attitudes are certainly helping herbals at the moment. Health-conscious consumers are realizing that healthy eating is part of preventive medicine, and they are listening when the industry tells them about the health benefits of a given herb or plant. They are also listening when informed about negative effects of some artificial additives, or of synthetic drugs. All of this is driving consumers toward gentler alternative medicines and natural food and beverages, even as it drives the health industry toward developing natural alternatives.
The past 10 years have been full of interesting changes and developments in the supplement and functional food industries in Europe. It will be even more interesting to see how the regulatory changes affect market development in the long run, and where we will be in another 10 years.
It seems safe to say, however, that the efforts of harmonizing the European markets will have positive consequences for the industry in the next two to three years. For one, there will be clarity on what is a supplement, and what is a medicine--unlike previous situations where the same product could be one or the other, depending on where in Europe the product was registered. For another, a product registration in one European country will be valid for all of the EU, not just for that individual country. And the claims on its labels, too, will be applicable to the entire EU. This is a good starting position for new products, and a great position for the European market as a whole.
By Joerg Gruenwald, "Eurotrends" Columnist
Joerg Gruenwald is president of analyze & realize AG, a specialized product development, research and consulting company for nutraceuticals, herbal medicines and functional food. He is also the author of the PDR for Herbal Medicines.