Impact of EU food information regulation on food supplement marketing strategies – a case study on the German market Open Access

Under the paradigm of a risk-based regulatory approach, the European Union (EU) has adopted several horizontal food safety laws to promote educated consumer choices concerning their diet (Edinger, 2016). This approach aims to balance fundamental consumer rights, such as the right to information and the freedom of choice (Ramos and Squeff, 2020; European Commission, 2020d). It also contributes to the EU’s primary goal of establishing an internal market by, among other regulatory measures, streamlining competition and food advertisement conditions (Gokani, 2024). The relationship between nutrition and the sustainment or improvement of individual health has long been established by research in the medical and food-science fields (Samtiya et al., 2021). Following, food business operators (FBO) have recognized the potential benefits of science-based food-related health claims for the brand communication of their products (van Buul and Brouns, 2015). Likewise, as consumers’ interest in health improvement through an optimized diet has increased in recent years, health claims on food products serve a pivotal role in brand recognition and driving sales by influencing consumer choices (Principato et al., 2025). Therefore, to protect consumers from fraudulent claims and provide fair market competition conditions between stakeholders, a comprehensive and effective legal framework is necessary (Gokani, 2024). As food supplements are considered foodstuffs by Directive 2002/46/EC (Food Supplements Directive), the regulatory approach of promoting educated consumer choices also applies to them (Directive 2002/46/EC, 2002a). The increasing perception of consumers’ viewing supplements as viable options for personal dietary health improvement and their galenic similarities with pharmaceuticals underscores the need for a robust legal framework governing food-related health claims (Lordan, 2021; Gokani, 2024).

Although the current EU Food Information Regulation (Regulation (EU) No 1169/2011) and Health Claims Regulation (HCR) (Regulation (EC) No 1924/2006) have been adopted between 2007 and 2011, a certain number of their provisions have not been fully implemented so far (European Parliament, 2024). Components of concern of the Food Information Regulation mainly pertain to technical details and on-package statements (Reese et al., 2015; Ramos and Squeff, 2020). However, despite the aim of the European Parliament and the European Commission (EC) to fully harmonize health claims applicable to food within the EU via subsequent scientific assessment by the European Food Safety Agency (EFSA), the procedure has not been concluded since the HCR’s adoption (European Parliament, 2024). Moreover, EFSA decided to put their safety assessment of all claims for botanical food ingredients on hold due to a lack of available scientific data, a practice endorsed by the European Court of Justice (EFSA Panel on Dietetic Products, Nutrition and Allergies, 2016; European Court of Justice, 2025). The ineffective enforcement of both regulations contributes to the already fragmented legal framework regulating the manufacturing and sale of food supplements in the EU (Gulati et al., 2014). The EC has largely abandoned the development of a positive list of botanical and other bioactive ingredients permitted for use in supplements, as stipulated by Article 4(8) of the Food Supplements Directive, due to scientific complexity and anticipated harmonizing effects of other regulations (European Commission, 2008). Following, in the absence of harmonized Union law, the use of botanical ingredients is currently mostly regulated individually at the European Member State (EMS) level (Warda et al., 2024). The suspension of botanical claim assessments further complicates the addition of botanicals to food supplements and their subsequent sale and distribution by food businesses, as only claims permitted by EFSA are eligible for use by businesses (Gulati et al., 2014; Regulation (EC) No 1924/2006, 2006).

This study aims to investigate the influence of the fragmented application of the EU food information regulatory framework conditions on businesses manufacturing and distributing food supplements. Doctrinal legal analysis is carried out to illustrate the current legal system within the scope of food information and presentation applicable to food supplements. The analysis is supported by an empirical case study on the German food supplement market, drawing on expert interviews with representatives of affected manufacturing companies. The empirical analysis part primarily focuses on two subjects. First, the use and role of health claims for developing and distributing supplement products. Second, the significance and challenges of presenting supplements as health-focused dietary options to consumers are investigated.

The European food supplement market is expanding and is projected to reach approximately 48 billion dollars by 2026 (Statista, 2023). Revenue and production volumes in the German market have shown consistent growth in recent years (Statista, 2024). Herbal formulations have become more popular with consumers, mostly due to perceived health benefits derived from their consumption (Restani et al., 2018). Companies seeking to enter the supplement market face the regulatory risk arising from insufficiently clear demarcation between supplements and pharmaceuticals, commonly referred to as borderline issues (Bilia and Costa, 2021). Especially botanical formulations have the potential to create such issues, as similar ingredients, galenic forms and dosages can be used in food supplements, herbal medicinal products (HMPs) or traditional herbal medicinal products (THMPs) (Bilia and Costa, 2021). Crossing the line between food and medicines can have significant impacts on companies’ business operations, as the sale and marketing of the latter is subject to stricter safety regulations (Tallon and Kalman, 2025). As positive lists or the permission of health claims for botanical supplements have not been implemented, the evaluation into which category a borderline product falls is often subject to jurisdictional disputes between companies and responsible safety authorities (Anadón et al., 2021). In the past, the Court of Justice of the European Union (CJEU) has defined certain delineation criteria which, besides nutritional and pharmacological effect threshold levels, focused on product presentation and advertisement to consumers or the intended product use (Gawronski, 2024).

While FBOs are legally obligated under Article 2 of Regulation (EC) No 178/2002 (General Food Law; GFL) to ensure that their products do not meet the criteria of pharmaceutical products, the application of delineation criteria established by CJEU case law remains subject to the assessment of national safety authorities (Lenssen and Boer, 2025). This could jeopardize the EU’s goals of creating a harmonized internal market and the realization of the free movement of goods, as companies have to spend additional human and financial resources to ensure the lawful marketing of food supplements within the Union (Tallon and Kalman, 2025). Therefore, highlighting the perspective of private supplement stakeholders on adapting to the current regulatory food information and advertisement framework may contribute to accelerating options for its future development.

Doctrinal legal analysis was applied to systematically examine the normative principles and concepts underlying the studied legal framework (Hutchinson, 2015). Since the legal system constitutes both the study object and analytical framework, this method enables a reasoned assessment and suggestions for potential improvements (Smits, 2017). Rather than limiting the study to statutory legal texts, general principles were derived through synthesis of diverse sources, including case law and institutional communications (Pradeep M. D., 2019). This approach allowed the research team to identify inconsistencies within the studied legal system (Smits, 2017; Pradeep, 2019). All legal texts and communications were retrieved from the EUR-Lex and data.europa.eu databases.

Within legal scholarship, the inclusion of empirical methods has been advocated as a possible complement to legal analysis methods (van Hoecke, 2015). An interdisciplinary approach merging doctrinal legal analysis with empirical research provides a more comprehensive perspective on how legal provisions are applied in practice (van Hoecke, 2015; Hutchinson, 2015). Qualitative research focuses on carefully interpreting and reflecting on the content of generated data instead of aiming toward generalizing observations (Sutton and Austin, 2015). Expert interviews as an empirical research method allow for gathering research results relating to social concepts and behaviors, which otherwise would be difficult to obtain (Helfferich, 2022; Anderson, 2010). In qualitative research, based on their individual knowledge and experiences of internal processes, experts are considered a functional information source within the institution they represent (Helfferich, 2022; Braun and Clarke, 2006; Soest, 2023). Thus, although typically limited to a small sample size of participants, qualitative analysis of data gathered through expert interviews contributes to the creation of meaningful research results (Kaiser, 2014; Lamnek and Krell, 2016; Soest, 2023).

Semi-structured expert interviews were conducted with representatives of seven German food supplement businesses. This method, enabling the extraction of institutional knowledge that extends beyond the individual interviewee perspective, benefits from a structured interview guide reflecting theoretical assumptions into the interview questions (Kaiser, 2014; Schnell, 2019a; Soest, 2023). The guide consisted of open-ended questions, allowing for flexibility in thematic emphasis (Schnell, 2019a).

Germany was selected as the jurisdictional case study, as it constitutes the EU’s largest market for food supplements and plays an influential role in the enforcement of EU food supplement regulations. The inclusion of experts from multiple EMS would have exceeded the methodological scope of this research.

FBOs were eligible for inclusion in the study if they were registered in Germany and actively engaged in the national food supplement market. Participants qualified as experts by holding senior roles in product development, food law compliance, or marketing activities within their respective companies. Recruitment occurred via publicly available email addresses or contact forms listed on company websites (Schnell, 2019b). The sample included small and medium-sized enterprises (SME), ranging from below ten to 250 employees as defined by EU law, and larger stock corporations (European Commission, 2003). Although all participating FBOs were registered in Germany, most of them also reported business activities on other EMSs.

Interviews were conducted as online video calls lasting around 30 min and recorded with participants’ consent for subsequent analysis (Schnell, 2019b; Soest, 2023). Audio files were then transcribed verbatim and anonymized using Microsoft Word Version 2013, Microsoft Corporation (2019). In total, six interviews were conducted, one participant provided written responses. The interview guide is provided in Supplementary Material 1.

The anonymized transcripts were analyzed using Mayring’s structured content analysis (Mayring, 2019). This approach assigns primary data to predefined analytical themes and corresponding codes while excluding data irrelevant to the original research data (Mayring, 2019). This is an essential procedure for analyzing data derived from open-ended interview questions (Mayring, 2019).

Applying a deductive a priori approach, analytical codes were developed independently in advance of the analysis based on the research questions and prior theoretical knowledge of the research topic (Azungah, 2018; Mayring, 2019). Although this approach potentially restricts flexibility in generating new codes or themes, it allows for a focused examination of expert knowledge on the specific research topic (Kiesler, 2024; Meuser and Nagel, 2009). Adjustments to the employed coding system remained possible at later analytical stages (Mayring, 2019).

Through iterative data analysis, a member of the research team established two themes and eight subsequent codes, primarily derived from the interview guide. The data were then categorized and coded using the qualitative analytical software MAXQDA (Verbi Software, 2024). The extracted information was then summarized and triangulated with data obtained through the doctrinal legal analysis. The developed codes and themes are presented in Supplementary Material 2.

Food supplements are considered foodstuffs in the EU by Article 2 of the GFL (Regulation (EC) No 178/2002, 2002b). The Food Supplements Directive aims to harmonize the manufacturing, distribution, permitted ingredients, and general labelling and advertising aspects across the Union (Directive 2002/46/EC, 2002a). However, due to the incomplete enforcement of certain provisions, such as the creation of positive lists for botanical and other bioactive ingredients, different national regulatory approaches apply across individual EMS (Warda et al., 2024). The regulatory fragmentation at the EMS level has been identified to further transpose into the enforcement practices of responsible food safety authorities (Warda et al., 2024).

In Germany, the Ministry of Agriculture (BMEL) and its subordinate Federal Office of Consumer Protection (BVL) are responsible for enforcing applicable food safety laws. Germany represents one of the EU’s major food supplement markets, valued at approximately EUR 4 billion (Statista, 2025). Analyses on the Rapid Alert System for Food and Feed indicate persisting quality issues of products available on the German and other EMS markets, including mislabeled items (Kowalska et al., 2019). The issue of borderline products arising from so-called dual-use substances, primarily botanical ingredients found identically in food supplements, HMPs and THMPs, has been recognized by German authorities as a potential hazard to consumer health (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, 2014). In response, the BVL has formed the Joint Commission in cooperation with the Federal Institute for Drugs and Medical Devices (BfArM) (Bundesministerium für Gesundheit and Bundesministerium für Ernährung, Landwirtschaft und Verbraucherschutz, 2012). The Joint Commission has published a non-exhaustive list of botanical ingredients, which are typically considered herbal medicines or food ingredients by German authorities (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, 2014).

The regulatory overlap between herbal medicines and supplements brings into focus how the potential health benefits of food products are marketed to consumers. According to Article 1(2) of Directive 2001/83/EC (Medicines Directive), products advertised as having medical properties are considered as medicinal products by presentation, thereby being subjected to pharmaceutical regulations (Directive 2001/83/EC, 2001). Thus, the ambiguous status of certain food supplement ingredients raises questions concerning consumer-facing product statements, which fall within the scope of food information regulation (Breitweg-Lehmann et al., 2019). Generally, food information serves a crucial function in guiding consumers in their nutritional decisions and promoting a healthier diet (Gokani, 2024). In the EU, Regulation (EU) No 1169/2011 sets framework conditions for nutritional labelling requirements and additional food information provisions mandatory for inclusion in advertisement materials to final consumers and on-pack labelling (Regulation (EU) No 1169/2011, 2011). The significance of establishing a legal foundation for informed consumer choices and the prevention of misleading consumers and unfair business practices, emphasized by Article 7 of the Food Information Regulation, is particularly evident in the context of food supplement marketing by the inclusion of additional labeling requirements in the Food Supplements Directive (Directive 2002/46/EC, 2002a; Regulation (EU) No 1169/2011, 2011). Beyond the scope of mandatory aspects, regulating food information also encompasses voluntary statements, such as the communication of health-related statements. Adopted in 2007, the HCR seeks to promote EU policy goals by streamlining advertising statements pertaining to the health and nutritional benefits of food products (Regulation (EC) No 1924/2006, 2006). Its underlying rationale, stated in Article 1(1) HCR, is consumer protection and the harmonization and development of the free internal market. Stated in Recital 28 and 35 HCR, additional objectives are the pursuit of truthful and scientifically based claims as a contribution toward healthy dietary consumer choices and the promotion of agri-food research and innovation (Regulation (EC) No 1924/2006, 2006). While the Food Information Regulation addresses mandatory and voluntary on-package labeling provisions, the HCR pertains explicitly to voluntary advertisement claims relating to health and nutrition (Regulation (EC) No 1924/2006, 2006). Its reference toward food supplements in particular (compare Article 2(1) (b)) underscores again the significance of health and nutritional claims for this food category (Regulation (EC) No 1924/2006, 2006).

The HCR delineates between different types of claims that food businesses may be eligible to voluntarily use for advertising their products (Regulation (EC) No 1924/2006, 2006). Nutritional claims generally refer to assertions that a food product possesses distinctive nutritional properties due to its caloric value or contained nutrients (Regulation (EC) No 1924/2006, 2006). In contrast, health claims state or suggest a beneficial relationship between a food product or specific ingredients and the sustainment or improvement of individual health (Regulation (EC) No 1924/2006, 2006). Furthermore, the HCR delineates between several subtypes of health claims. First, Article 10(3) HCR defines unspecific health claims, which refer to general benefits of a food ingredient for overall good health and specific health claims, referring to an individual nutritional benefit on human health. However, Article 10(3) HCR also sets narrow conditions of use for unspecific health claims, as their use is only permitted if they are combined with a specific health claim. Specific health claims are further divided by Article 13 HCR into functional health claims, pertaining to the role of a substance in the development or function of the body, and cognitive health claims, which relate to psychological and behavioral effects. Additionally, Article 14(1) (a) HCR introduces disease reduction claims, concerning statements that the consumption of an ingredient may reduce risk factors for developing a disease. Lastly, Article 14(1) (b) HCR also covers children’s development claims. An overview of the different claim categories and examples of health claims is provided in Table 1 and Supplementary Material 3, respectively.

The HCR sets specific conditions concerning the use of health claims, which operate on a default prohibition with allowance by exception, requiring prior authorization by the EC based on a scientific assessment by EFSA (Regulation (EC) No 1924/2006, 2006). Pursuant to Article 13(2) and 13(3) HCR, national food safety agencies were tasked with aiding EFSA to develop a consolidated list of approved claims by collecting and submitting health claims permitted in their respective jurisdictions by 2008 (Regulation (EC) No 1924/2006, 2006). Until 2011, EFSA reviewed around 2,300 submitted claims, of which around 260 have been approved and subsequently placed in the EU register (European Parliament, 2024). However, the assessment of more than 2000 health claims pertaining to botanical ingredients has been put on hold by EFSA since 2012 due to a lack of scientific evidence (European Parliament, 2024). EFSA’s decision is substantiated on Article 6(1) and Article 15(1) HCR, stipulating that the agency shall consider all available scientific data (Regulation (EC) No 1924/2006, 2006). Article 22(6) of the GFL mandates the agency’s scientific advice to be of the highest possible standard (Regulation (EC) No 178/2002). This policy is reflected in Recital 17 HCR, which specifically states that claims shall only be adopted following a scientific assessment of the highest possible standard (Regulation (EC) No 1924/2006, 2006). However, as human intervention studies and clinical trials, often regarded as essential for assessing nutritional and pharmacological effects, are largely lacking for botanicals, no meaningful progress has been made (Buttriss, 2015). Although Article 13(5) HCR provides food businesses the opportunity to obtain exclusive proprietary rights to a health claim for a five-year term in case sufficient evidence is provided during its application procedure, many businesses refrain from it due to methodological difficulties and financial costs of performing clinical studies (Regulation (EC) No 1924/2006, 2006; Buttriss, 2015).

As the assessment and subsequent authorized use of botanical claims have been temporarily suspended, FBOs may draw upon another approach laid out by the HCR. Article 28(6) contains a transitional provision, whereas in the absence of horizontal regulation, national regulations still apply, providing a possibility for an ongoing use of unapproved botanical claims as long as they meet certain conditions (Regulation (EC) No 1924/2006, 2006). Generally, such claims must have circulated in the EU prior to the HCR’s adoption in 2007 and need to be scientifically plausible (Regulation (EC) No 1924/2006, 2006). FBOs may obtain such proof via herbal pharmaceutical monographies provided by the Committee on Herbal Medicinal Products (HMPC) or European Scientific Cooperative on Phytotherapy (ESCOP) (Bilia and Costa, 2021). However, FBOs have to ensure they are not using a medical claim for food supplement advertisements (Bilia and Costa, 2021; Tallon and Kalman, 2025). This could present a significant legal challenge for FBOs due to similar ingredients and dosages found in food supplements, HMPs, and THMPs (Tallon and Kalman, 2025).

The current fragmentary state of health claims authorization and the obstacles it presents to the EU’s goals of consumer protection and free market progression have been criticized by several institutions (European Parliament, 2024; Bundesregierung, 2021; Bundesrat, 2021). In accordance with its Regulatory Fitness and Performance Programme initiative (REFIT) of assessing EU legal acts’ governance effectiveness, the EC published a report which highlighted the consequences of the HCR’s provisions not being fully enacted by 2020 (European Commission, 2020c). Primary concerns included the creation of trade barriers within the EU for FBOs, as several aspects of supplement regulation fall under national regulation with traditional health claims being similarly fragmented across EMS (European Commission, 2020c). The EC also highlighted that consumers’ limited ability to distinguish between botanical food supplements and pharmaceuticals poses challenges for pharmaceutical companies, which face stricter regulations and higher costs despite competing with virtually the same products (European Commission, 2020c). Moreover, continuous consumer exposure to non-assessed traditional botanical claims with the perception of such products as particularly beneficial for health was described as a potential health risk (European Commission, 2020c). The significance of non-fully attained goals of the HCR was subsequently reflected in the EC’s Farm to Fork strategy paper in 2022 (European Commission, 2020a). Despite the EC’s stated aim to improve conditions for developing health claims, little progress has been made in effectively addressing the identified regulatory issues (European Commission, 2020a). In response, the European Parliament adopted Resolution 2023/2081 in 2024, strongly criticizing the continued suspension of botanical health claims evaluations and urged the EC and EFSA to resume the process (European Parliament, 2024). The resolution emphasized the role of health claims in influencing consumer dietary choices and reducing borderline issues involving dual-use botanical ingredients (European Parliament, 2024). It further noted that enabling science-based claims contributes to meeting the consumers’ right to comprehensive food information and may encourage healthier food choices (European Parliament, 2024). Similar concerns were raised regarding the use of non-assessed traditional claims. In 2021, the German Federal Council called on the national government to fully apply the HCR to protect consumers from scientifically unsubstantiated claims and prevent the misperception of botanical supplements as HMPs (Bundesrat, 2021). The German Ministries of Health and Agriculture supported this position, citing the EC’s intended progress in line with the Farm to Fork policy (Bundesregierung, 2021).

The urgency of progressing the assessment of botanical claims was further underscored by CJEU case law. In its recent judgement C-386/23, the court decided, in accordance with Article 10(3) HCR, against the use of non-specific claims for botanical products, despite the assessment of specific botanical claims being suspended (European Court of Justice, 2025). Therefore, FBOs may only rely on traditional claims under the transitional provisions of Article 28(6) HCR. The CJEU did not consider the unavailability of approved botanical claims as an obstacle to the freedom of movement of goods, since FBOs are allowed to place botanical supplements on the market without using claims or by adapting to national regulations applicable to traditional claims under Article 28(6) (European Court of Justice, 2025). However, in a previous judgement from 2017, the CJEU stated that a prolongation of the transitional period concerning botanical claims assessment set by Article 13(3) HCR until 31 January 2010 does not meet consumers’ needs for scientifically substantiated claims recognized in Recital 23 HCR (European Court of Justice, 2017). Despite CJEU case law, the EC Farm to Fork roadmap does not explicitly mention botanical claims assessments (European Commission, 2020b).

The following section presents the results of expert interviews conducted to obtain insights into how German supplement manufacturers have adapted to the current health claims regulatory framework, as these aspects are insufficiently addressed in the legal texts and institutional communications examined in the doctrinal analysis. Structured content analysis was applied to identify systematic approaches to the employment of health claims during customer engagement practices and product development procedures.

Generally, interview participants perceived the German food supplement market as dynamic with high potential for future growth. Depending on company size and its establishment within the market, two divisions of customer target groups were identified. Larger companies typically aimed to exhibit market growth within the food supplement mass market, appealing to a wide range of customer profiles. Although not limited to them, comparatively smaller companies instead reported focusing their portfolio and subsequent customer engagement on specific customer target groups. As stated by the interviewees, among them are women and individuals experiencing gynecological conditions, professional and amateur athletes, seniors at risk of developing or suffering from loss of joint or bone health, vegans and vegetarians. Consumers who are interested in supporting their individual health through an optimized diet and daily nutrition were also a major focus group. Sales channels that candidates mentioned for distributing their products on the German market were national drug store chains, pharmacies or online shops. Two interviewees mentioned that an exclusive sale via pharmacies was chosen to mutually benefit from product promotion through health care professionals.

This aligns with other interview statements, whereas the communication of potential individual health benefits derived from food supplement consumption was considered a significant factor in marketing narratives. However, all interviewees mentioned that solely EFSA-approved health claims are used to make health-related statements. One interviewee mentioned the use of approved health claims as beneficial for consumers to better delineate between food supplements and medicinal products containing the same ingredient. Although FBOs may vary from the official claims wording, if keeping its original meaning, interviewees identified such divergence as a risk factor for increased authority controls, legal and financial repercussions, including recalls and fines. Hence, a majority of interviewees stated dissatisfaction with the current discontinuation of botanical health claims assessments by EFSA.

In line with this finding, the advertisement and promotion of botanical ingredients in single or multi-ingredient supplements was considered difficult by most candidates. Three approaches to the marketing of botanicals by FBOs under the current implementation state of the HCR were identified. First, FBOs indicated to refrain from using traditional health claims, and benefit from recognition by consumers based on general ingredient knowledge or pre-existing health-related interests instead. Second, interview participants indicated that in multi-ingredient supplements, botanical ingredients were frequently combined with minerals or vitamins, for which health claims are approved. Thereby, botanical ingredients benefit from consumers associating them with mineral or vitamin claims. Finally, one interviewee stated that their company chose to market botanical ingredients as pharmaceuticals, citing Germany’s traditional focus on HMPs, avoidance of borderline issues and a clearer foundation for making health-related claims.

The issue of creating borderline issues by notifying a product as a food supplement instead of seeking authorization as a medicinal product or vice versa was known to all participants. Although not all of them mentioned them as specific regulatory or legal issues within their institution, borderline issues were perceived as a substantial risk for reputational and financial sanctions. To avoid such negative consequences, companies were reported as spending considerable resources to ensure the lawful placement of their products on the market. All interviewees stated that, depending on the company’s size and available resources, the employment of an internal regulatory affairs department, collaboration with external legal specialists, or a combination of both as necessary to oversee and advise during different product development stages. Guidance documents from national safety agencies or EFSA were considered an informational source during product development, but do not constitute a legally binding statute.

Finally, most interviewees expressed dissatisfaction with the lack of harmonization in the EU supplement market. The absence of a positive list of botanical and other bioactive ingredients, as well as maximum dosages for minerals and vitamins, was seen as a risk factor for sanctions and a barrier for market entry and sales. Interviewees also indicated that, from the FBO perspective, the declared product purpose and advertisement claims significantly contribute to the delineation between pharmaceuticals and food supplements.

Health claims are an integral part of the EU’s agenda due to their role in guiding consumers toward healthier food consumption. FBOs can benefit from leveraging science-based claims for advertising and on-package labelling purposes. A harmonized approach to regulating their use could improve fair market conditions, stimulating further economic growth. As highlighted by the results from the doctrinal legal analysis, streamlined health claims evaluations and authorization procedures could serve the purpose of diminishing the fragmentation of EU food supplement regulation identified by previous research (Jost et al., 2025).

The results from expert interviews with food supplement industry representatives highlighted the perspective of the private sector on the current state of EU health claims regulation. Presenting food supplements as health-focused to consumers was reported as an important aspect within marketing narratives and developing business growth. Reflecting the consumers’ perception of supplements as a tool for positively influencing personal health, this marketing approach extensively relies on a robust regulatory framework. However, during the expert interviews, companies reported difficulties due to missing harmonization efforts in this regard. Instead, FBOs must spend substantial financial and human resources to accommodate complex regulatory conditions, preventing financial repercussions and other sanctions.

The difficulties in lawfully using health claims described by FBOs are in line with other research. Khedkar et al. (2017) and Bröring et al. (2017) highlighted that the introduction of Article 13(1) HCR did not foster innovation in the food sector, as financial costs and lack of transparency were considered major challenges by companies. Buttriss (2015) recommended lowering administrative costs and improving economic conditions, especially for SMEs, by providing greater wording flexibility and better clarification of health claim communication limits. The empirical findings of this study seem to support these hypotheses, as interview candidates indicated difficulties with health claims wordings or a preference for switching to pharmaceutical authorizations. Although the study focused on issues present in the German market, previous research highlighted that difficulties in complying with horizontal EU food information laws are also present in other EMS. For example, supplement advertisements on Spanish radio were found to endorse unauthorized claims (Muela-Molina et al., 2021a, b). In the Czech Republic, online advertisements for food supplements were also identified as often non-compliant with EU regulations and providing only low-quality information to consumers (Baudischova et al., 2018).

Previously identified issues concerning the use of botanical and other bioactive ingredients in food supplements appear to extend into advertisement and labelling requirements. Noble (2017) described that the suspension of botanical claims assessments contributes to the fragmentation of botanical ingredient regulation at the EMS level. Lenssen et al. (2018) highlighted that inconsistencies and a lack of transparency in EFSA’s claims assessment procedures have created legal uncertainties for FBOs. Other research also highlighted that companies require more in-depth information and clarity on how to fulfill criteria for conducting food and health studies in order to obtain health claims authorizations (González-Díaz et al., 2018). De Boer (2021) examined the use of traditional evidence, similar to that applied in the authorization procedures for THMPs, as a potential basis for claim approval consistent with the EC’s Farm to Fork agenda on harmonized front-of-pack labelling. This corresponds with the expert interviews, where the marketing of botanical supplements was perceived as challenging, often requiring substantial legal consultation. Although the HCR permits the use of traditional claims, most interviewees stated that to avoid them to reduce the risk of regulatory conflicts.

Empirical evidence on the use of health claims by food supplement businesses in the EU is limited, as the majority of comparable research in this field has focused on consumer perceptions and understanding of circulating health claims (Meijer et al., 2022). Doctrinal legal studies primarily analyzed regulatory framework conditions for using health claims in the EU (Gonzáléz-Díaz et al., 2018). Brandenburger and Birringer (2015) conducted an online survey comprising sixteen food and beverage enterprises, highlighting anticipated comparatively higher costs for SMEs. This study underscores the impact of the fragmented EU food supplements regulatory framework on FBOs, particularly by incomplete enforcement of the HCR. Doctrinal legal analysis confirmed its partial implementation in the EU, despite calls from the European Parliament and EMS. Empirical research emphasized the significance of health claims in supplement marketing strategies aimed to align their products with consumer expectations. As the CJEU clarified, the EC did not fulfill its obligations under Article 13(3) HCR to adopt, within the prescribed period, an exhaustive list of permitted health claims and its communication concerning the suspension of suspension of the health claims assessment did not amount to a defined position within the meaning of EU primary law (European Court of Justice, 2017). Statements of German authorities on the stalled assessment of on-hold botanical claims further highlight the need for a harmonized regulatory framework (Bundesregierung, 2021).

As this study focused exclusively on stakeholders in the German market, the findings from both the empirical and doctrinal legal analyses should not be directly generalized, given the significant divergences in market structures, legal cultures, and regulatory frameworks across jurisdictions. In addition, the study is subject to limitations due to its relatively small sample size, encompassing companies of varying sizes, resources and target consumer groups.

Regulation of food supplements in the EU remains a persistent challenge to both companies and authorities. Legal fragmentation and resulting legal uncertainties extend into health claims regulation, particularly affecting herbal product manufacturers, which face heightened scrutiny and potential sanctions by safety authorities due to the institutional inactivity of responsible EU entities, posing financial and reputational risks. Given the central role of health claims in marketing strategies of the German food supplement market, greater harmonization is needed to support EU internal market development. Future research should focus on obtaining empirical insights from private stakeholders participating in other EMS markets or engaged in cross-border trade within the Union.

Ethical approval for the conduction of expert interviews during this study was obtained from the Ethics Committee of the University of Bayreuth. The authors adhered to all institutional guidelines and Good Scientific Practices.

All interview participants were informed about and consented to the scientific and academic purposes of the conducted interviews.

We would like to thank all interviewees for participating in this study and sharing their experiences with us.

The supplementary material for this article can be found online.