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Borderline products – products with medicinal property

Borderline products are products that fall into categories somewhere in-between pharmaceuticals, foods and cosmetics. The number of such products sold over the Internet is increasing, and most of them are declared as dietary supplements. A Joint Expert Commission of the German Federal Office of Consumer Protection and Food Safety and the German Federal Institute for Drugs and Medical Devices has now been set up with the aim of shedding light onto borderline products and medicines.

Foods that provide additional health benefits are now fully integrated items on supermarket shelves. Probiotic yoghurts, phytosterol-enriched margarine and certain cereal varieties used in bread and muesli are only a few examples of the many products available. Foodstuffs like oat, amaranth, quinoa and other crops and pseudocrops that were placed on the European market prior to the Novel Food Regulation in May 1997, do not need to undergo retesting and reapproval. However, well-known foodstuffs with new additives or completely new products that have been placed on the European market subsequent to this date need to undergo special safety assessments. In Germany, such assessments are carried out by the Federal Institute for Risk Assessment (BfR) and the investigation offices of the German Länder, and in Europe, by the European Food Safety Agency (EFSA). The assessment involves the collection of biological and toxicological data, including information on a product’s potential toxicity and metabolism in humans, its carcinogenicity and reproductive toxicity. 

Novel foodstuffs are being tested

Margarine enriched with phytosterol esters was one of the first foods to receive marketing authorisation under the Novel Food Directive in 2000. Phytosterols are structural components of plant cell membranes, whose structure is closely related to that of human cholesterol. Phytosterol esters have been shown to reduce the intestinal uptake of cholesterol. Most cholesterol is made by our own body. Studies have shown that the consumption of 20 to 30 g margarine per day provides an 8-10% reduction in the plasma LDL cholesterol level (LDL, low density lipoprotein). However, the blood plasma beta-carotene level simultaneously decreases by 20%. In 2000, the responsible examining authority ruled that a total amount of phytosterol ester corresponding to eight percent free phytosterols can be added to human foodstuffs. However, due to the associated reduction of the beta carotene level, the EU’s Scientific Committee on Food advised consumers to restrict phytosterol intake to less than 1 - 3g/day. Moreover, in 2004, the EU Commission published a regulation concerning the labelling of foods and food ingredients with added phytosterols. For example, food labels with added phytosterols also include the advice to consume fruit and vegetables regularly to help maintain carotenoid levels. In the meantime, numerous foodstuffs with added phytosterol esters, including yoghurts, rye bread and milk-based fruit beverages have been placed on the market. 

The aforementioned phytosterols are produced from the oil of soy, sunflower, corn (maize) or rapeseed plants, which have long been used for human consumption in the European Union. However, an increasing number of foods containing substances that were previously only found in medicinal products has recently been emerging on the EU market. Such products are referred to as borderline products where medicines are not easily distinguishable from cosmetics or food supplements. A single product can only belong to a single product category, i.e. either food or drug, as the food definition explicitly excludes medicinal products. The classification of beverages containing medicinal plant extracts is proving particularly difficult. 

Experts that help to classify products

Food supplements are also sold as effervescent tablets. © Fotolia / Heike Rau

Due to the observation that so-called borderline products are increasingly sold on the Internet, scientists from the Investigative Office for Food Control and Animal Health (CVUA) in Karlsruhe conducted a study in 2008 to gain insights into the Internet marketing of borderline products with a specific focus on the analysis of anti-ageing and weight-loss products offered on the Internet. The scientists found that a major proportion of such products is sold through online shops and social networks. They also found that around 25% of a total of the 292 substances used in weight-loss products were active pharmaceutical ingredients, and must therefore not be used in dietary supplements. Amongst other ingredients, the researchers found alpha lipoic acid, an active pharmaceutical substance that is used for the treatment of liver diseases, as well as yohimbine, an α2 adrenoreceptor antagonist that is sold as prescription medicine for the treatment of sexual dysfunction. 

These substances can have considerable adverse effects and should in no circumstances be taken in the form of a dietary supplement. Most consumers are usually unaware of the substances contained in weight-loss products, and the scientists found that the dietary supplements commonly featured misleading claims, non-licensed additives and ingredients classified as novel food. The study also identified borderline products that fall into categories between pharmaceuticals and cosmetics. The weight-loss products contained non-licensed foods such as Hoodia gordonii, a succulent plant which works as an appetite suppressant, but is banned from sale in the European Union.

In order to be able to improve the classification of borderline products, the German Office of Consumer Protection and Food Safety (BVL) and the German Institute for Drugs and Medical Devices (BfArM) have established a Joint Expert Commission for the classification of borderline products that are placed on the market as food or food ingredient. This commission aims to draw up scientific opinions on individual substances and compile criteria catalogues that help in the classification of borderline products. These scientific opinions have the potential to provide food control authorities with reports that can be used as evidence in court where the majority of cases, regardless of whether a product is a food, drug or cosmetic product, is decided. The Joint Expert Commission specialists are active in the fields of toxicology, pharmacology, pharmaceutical biology, food technology, food and drug analytics, drug safety, nutritional medicine as well as in food and drug legislation. The first constituent meeting was held in Berlin in January 2013. It is to be hoped that the new Expert Commission will enable a better handling of borderline products, in particular those that fall in between pharmaceutical substances and food, thus increasing consumer safety in this area. 

Haller, D., Grune, T. und Rimbach, G. (Eds.), Biofunktionalität der Lebensmittelinhaltsstoffe, Springer Spektrum 2013
Löbell-Behrends et al., Borderlineprodukte: Kontrolle des Internethandels mit Anti-Aging und Schlankheitsmittel, Eine Pilot-Studie; Deutsche Lebensmittel-Rundschau, 104. Edition, Volume 6, 2008


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