Position paper of the Society for Phytotherapy on the differentiation of herbal medicinal products and food supplements
Detmar Jobst (1), Andreas Hensel (2), Karin Kraft (3)
(1) Rhein. Friedrich-Wilhelm-Universität Bonn, Teaching assignment naturopathy, Germany
(2) University of Münster, Institute for Pharmaceutical Biology and Phytochemistry, Germany
(3) University Medicine Center Rostock, Chair of Naturopathy, Germany
1. Introduction: The Society for Phytotherapy (GPT) pleads for a clear distinction of food supplements from medicinal products
Food supplements (FS ) had a market volume of over two billion euros in Germany in 2019. The respective sales increased in Germany in the past by about 5.8 % annually, recently even by 7.2 % (Statista). FS are therefore economically successful - not only in Germany, but throughout Europe. However, there is by no means always a benefit for consumers. In many cases, food supplements can harbor risks, e.g. due to poor quality and incorrect declaration (apotheke adhoc; Schwingshackl et al., 2017; Weißenborn et al., 2018). The safety of use can negatively be influenced by misleading advertisement (14th BfR Consumer Protection Forum "Food Supplements" on October 10 and 11, 2012; Verbraucherzentrale NRW e.V.; Wheatley and Spink, 2013). This is particularly the case for food supplements with distinct health claims  (see pt. 3) which have not yet been approved for many such preparations. A so-called Community List relevant for this is the responsibility of the EFSA (European Food and Safety Authority).
In the interest of consumers, the German Society for Phytotherapy / Gesellschaft für Phytotherapie (GPT) pleads for a clear distinction between FS and drugs. This applies in particular to products containing herbal preparations, the so-called botanicals . The GPT as a scientific professional organization therefore advocates the consistent implementation and control of the existing legal framework for FS at national and European level, in particular the application of the European Health Claims Regulation (EC No. 1924/2006), which has been pending for years. It also suggests possible solutions to the problems outlined below, as the regulatory target set by the EU since 2006 has not been achieved at all so far. This long-known shortcoming has again been evidenced by a recent evaluation, published in 2020 (European Commission, 2020).
2. Food supplements mostly look like medicinal products
At present, the marketed food supplements look very similar to drugs due to their presentation. Thus it is often difficult for consumers and even experts to distinguish botanical FS from approved or registered herbal medicinal products. The GPT calls for FS to be more clearly recognizable as food products by modifying the German Food Supplements Regulation (FSR). This order stipulates that FS "are marketed in the form of capsules, pastilles, tablets, pills and other similar dosage forms, powder sachets, liquid ampoules, bottles with dropper inserts and similar dosage forms" (FSR, §1, para. 3). In the perception of the GPT, this can lead to relevant misinterpretations of the performance of food supplements and to confusion with medications.
One of the legal bases for the GPT's demand to put consumer safety first is Article 7 of EU Regulation 1169/2011 (Fairness of Information Practice), which clearly states:
"Food information shall not be misleading. This also applies to the presentation of foods, in particular their shape, appearance or packaging, the packaging materials used, the way they are arranged and the setting in which they are presented."
The consumption of FS is intended only for healthy humans and for people interested in maintaining their health. All FS should therefore be clearly identifiable as foods in their external form, including the respective primary packaging, and should not have the appearance of drugs. The labeling as food on each package of FS should clearly indicate that the product is not a drug. That label should also be given special prominence because, to date, existing labels as a FS are often lost in other package labels (Raynor et al., 2011).
3. Health claims are not sufficiently substantiated scientifically
According to the European Health Claims Regulation (EC) No. 1924/2006 (HCVR), health claims or claims referring to the reduction of a disease risk must only be used after official approval by the European Commission. The respective health claims must also be distinguished from nutritional claims. The so-called Community List as an annex of the HCVR counts about 500 substances with approved health claims, predominantly vitamins and minerals. For details see BVL (Federal Office of Consumer Protection and Food Safety). The European regulation requires scientific evidence for such health claims. They can be derived from known data. For new ingredients, such as plant extracts, they can be provided by use of scientific investigations. In vitro tests are generally not sufficient. Meaningful in vivo studies and tests on healthy humans are also required. The respective product manufacturers are responsible to perform these studies.
As a result of the fact that scientific assessments have been suspended since 2010 due to inactivity of the European Commission, the regulation has been circumvented for years with the help of the so-called On-Hold List. Thus, unauthorized health-related advertising claims for many FS, especially botanicals, remain unchallenged in limbo. Nevertheless, they clearly contradict the spirit of the HCVR. Therefore, the German Bundesrat has requested the Federal Government in February 2021 to end this situation in the European Commission (Bundesrat of the Federal Republic of Germany).
Tests that correspond to the current state of science have hardly been carried out for botanicals so far. The HCVR has not been consistently implemented here for many years either. (Bilia and Costa, 2021). The GPT demands that food supplements may only claim health benefits when this claim was positively assessed by the EFSA and based on substantial scientific data (Armbrüster, 2020; Kraft, 2016).
4. The quality of food supplements is problematic in many cases
Analytical studies indicate major quality problems of FS in many cases. Product- and batch-related routine testing of FS by use of meaningful and validated analytical methods is currently the responsibility of the respective manufacturers - as is common in food law. The methods and results are not published. However, on the basis of our own investigations (Gaspar et al., 2021; Lechtenberg and Hensel, 2019), publications of the food monitoring authorities (Bavarian State Office for Health and Food Safety; Federal Office of Consumer Protection and Food Safety) and other sources (Costa et al., 2019; Meins et al., 2016; Sogame et al., 2019), the results of broader quality testings are in many cases worryingly poor. It can be assumed that in practice such product analyses are carried out with little care by some manufacturers or negative results are not taken into account. Although the European Federation of Association of Health Products Manufacturers (EHPM) developed the first Pan-European quality guideline as early as 2007 (updated in the 2nd edition in 2014 (European Federation of Association of Health Products Manufacturers), the very many quality deficiencies range from incorrect content values or contamination up to ingredients that are not detectable although declared on the label (Meins et al., 2016). The GPT therefore calls for more transparent and significantly intensified quality testing of FS on the market by national food monitoring authorities (Armbrüster, 2020) or state-authorized Notified Bodies analogous to the Medical Devices Act (Federal Institute for Drugs and Medical Devices) in order to protect consumers. In addition, verifiable analyses using validated procedures should ensure that quality controls are routinely carried out by manufacturers on a batch-by-batch basis, thus providing a secure data basis for product quality. Food supplements which, after inspection, show the above-mentioned deficiencies may no longer be placed in the market!
5. Additional measures improve quality and safety of use of food supplements
If, despite of a more strictly monitoring of analytical quality testing and systematic as well as random monitoring of the FSs on the market, no substantial improvements occur within a reasonable period of time, the GPT recommends more intensive measures towards the producers or distributors.
These could include:
- Creation of a publicly accessible register of the FS quality test results prior to distribution, obtained by independent test laboratories. As before, the costs of testing should be covered by the manufacturers, plus the expenses for the register;
- Mandatory licensing of food supplements, e.g. in accordance with European Regulation 2015/2283 on novel foods (European Union, 2015);
- Prohibition of the sale of products or even of entire product lines in cases were manufacturers repeatedly place problematic food supplements on the market;
- Application of a so-called Nutrivigilance according to the French Agence Nationale de Securité Nationale Sanitaire d'Alimentation (Republique Francaise - ANSES, 2021).
The GPT intends that with these regulations the similarity of medicinal products and NEM used by the market will soon be over. FS with health claims will be precisely declared as health-promoting foods and will therefore be more easily recognizable. Clear quality criteria for identity, purity and content of active ingredients and declared contents will be controlled. Approved or registered medicinal products, especially herbal medicines, will again be more clearly distinguished from FS. Problems such as advertising-related misconceptions, malnutrition, overdoses or interactions with medicines (European Scientific Cooperative on Phytotherapy, 2021) will occur less frequently in connection with food supplements in the future.
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 Food supplements are concentrated sources of nutrients (i.e. mineral and vitamins) or other substances with a nutritional or physiological effect
 Health claims for dietary supplements that describe a relationship between a food and health
 Botanicals are dietary supplements for which botanical ingredients are declared