Probiotic health claims remain tricky

Posted: September 11, 2025 | Author: Maartje Hop | Filed under: Advertising, Food, Health claims | Comments Off

“Supports your intestinal flora” sounds harmless. Yet that promise cannot simply be used in advertising. This becomes extra clear in a recent ruling by the Dutch Advertising Code Committee (ACC). In this blog, I will analyse how the ACC reaches its decision, and what it reveals about the scope, or rather the limitations, for such and similar health claims.

The case
The label of the product Beautiful Immunity Kefir Mild contains, among others, the statements that kefir supports the intestinal flora (in Dutch: kefir ondersteunt de darmflora) and that their kefir drinks are high in protein, low in fat and a source of calcium and vitamin B12 (In Dutch: onze Kefir-drankjes bevatten veel eiwitten, weinig vet en zijn een bron van calcium en vitamine B12). Furthermore, two claims are made: calcium and vitamin B12 for your gut health* and support of your immune system** (In Dutch: calcium en vitamine B12 voor uw darmgezondheid* en ondersteuning van uw immuunsysteem**). The label also contains claims about *calcium supporting the normal function of digestive enzymes (in Dutch: *Calcium draagt bij tot de normale werking van spijsverteringsenzymen) and **vitamin B12 supporting the normal function of the immune system (in Dutch: **Vitamine B12 draagt bij tot de normale werking van het immuunsysteem).

Designation kefir mild
According to the complainant, the naming of the product “kefir mild” is confusing consumers. They would think this variant of kefir contains yeasts and alcohol, like the traditional kefir does, but in reality, it doesn’t. The ACC mentions that the advertiser must use a customary or descriptive name for the product. Kefir is designated as a milk product. In the Netherlands, kefir is not a protected product name or a legally established designation, like other dairy products as milk or cheese. According to Beautiful Immunity, a distinction must be made between commercial and traditional kefir. Since shops will mainly sell the commercial variety, which, like “mild kefir”, does not contain yeasts, the ACC does not consider this designation for “mild kefir” to be incorrect or insufficiently specific. The average consumer will think that it is kefir with a mild taste and not traditional kefir with yeasts. Therefore, the naming of the product “kefir mild” isn’t confusing for consumers. The ACC rejects this complaint. Nevertheless, Beautiful Immunity currently designates its product just as “kefir”.

Health claim
Secondly, the complaint states the text displayed on the label contains a misleading health claim. This concerns the claim that the kefir product supports the intestinal flora and contains billions of live cultures. According to the complainant, this suggests a broader effect than the product actually offers, especially since the product does not contain yeasts and does not undergo a traditional fermentation process. The ACC rules that the claim “supports the intestinal flora” qualifies as a health claim. According to article 10 of the Claims Regulation, only authorised health claims can be used. A quick research in the EU Health Claims Register reveals there is no authorised health claim linked to kefir.

Furthermore, article 5(1)(b) of the Claims Regulation requires a health claim to be specifically linked to ingredients or substances. In this case, the advertiser attributes the claimed effect to kefir and not to the ingredients calcium or vitamin B12. More specifically, Beautiful Immunity indicates that the health claim about kefir supporting the intestinal flora is a generic health claim that is accompanied by to the authorised claim for calcium stated on the back of the packaging (article 10(3) of the Claims Regulation).

The ACC does not agree. According to the ACC, the health claim “supports the intestinal flora” is located under the word “kefir” on the front of the packaging. Consumers will read that Beautiful Immunity claims that kefir supports intestinal flora. The name of the product and the health claim follow each other directly and appear to be related. This claim cannot be linked to the claim “Calcium contributes to the normal function of digestive enzymes”. The reason is that the claim is located on the back of the packaging and an asterisk that can clarify the link between the claims is missing. It is therefore an independent health claim, see the ruling of the Court of Justice of 30 January 2020, case C-524/18.

Because there is no authorised health claim for kefir, the health claim that kefir supports the intestinal flora is contrary to article 10(1) of the Claims Regulation. This results in the ACC concluding that this claim is not in accordance with the law as referred to in article 2 of the Dutch Advertising Code, so the ACC upholds the complaint.

For gut health
Beautiful Immunity states that it regularly updates its labelling and that the claim “supports intestinal flora” no longer appears on the new label. Instead, the text “For gut health” is used. This claim is more generic, but if it substitutes the text “supports the intestinal flora”, it is still displayed under the word “kefir”. So, it remains an independent claim about kefir, that is unauthorised. This shows claims about gut health, intestinal flora and probiotics remain tricky.

Intestinal flora and probiotic claims
In this procedure the ACC rules that the health claim that kefir supports the intestinal flora is not permitted and therefore contrary to article 2 of the Dutch Advertising Code. The health claim was actually intended for calcium. What is striking is that the ACC attributes the unauthorised nature of the health claim to the fact that it refers to kefir rather than calcium. The ACC does not assess the admissibility of claims about intestinal flora in general here. Would the health claim “supports the intestinal flora” be permitted if it referred to calcium rather than kefir?

One could argue that in this case article 10(3) of the Claims Regulation is complied with, assuming that the claim is accompanied by the authorised calcium health claim, but caution should still be exercised with health claims about intestinal flora. In the Netherlands, the list of the on hold claims, drawn up by the Dutch Health Advertising Knowledge and Advice Council (in Dutch: Keuringsraad), distinguishes between the categories of digestion and intestinal flora. This suggests that the claim about intestinal flora cannot be accompanied by the authorised claim that calcium contributes to the normal function of digestive enzymes. In fact, there still aren’t any authorised health claims on intestinal flora or probiotics, see our previous blog about probiotic claims.

In the meantime, the European Ombudsman closed a case about probiotic health claims. This case was about the interpretation of the term probiotics by the European Commission. According to the European Commission, the word probiotics suggests a health claim, while the complainant, an association of producers of probiotics, argued that this word rather suggests a nutrition claim. The European Commission intends to protect consumers from potentially misleading information about food. As such, it is not surprising for the Commission to interpret claims about probiotics as health claims. The European Ombudsman accepts the explanation of the European Commission that it does not rule out submitting new applications to authorise probiotic health claims in the future, if the health benefits are scientifically proven.

Conclusion
The ACC rejects the complaint about the name “kefir mild”, as it is accurate and sufficiently specific. The average consumer will think that the term “kefir mild” refers to kefir with a mild taste, and not to traditional kefir containing yeast (including alcohol). The ACC however upholds the complaint regarding the health claim “supports the intestinal flora”. In essence, the ACC rules that consumers would think that the claim is about kefir. And the claim that kefir supports the intestinal flora is an unauthorised health claim. In fact, all health claims about intestinal flora are unauthorised. The same applies to health claims about probiotics. This may change in future, if and when these types of claims are substantiated by scientific evidence regarding the health benefits offered. So, think twice, when selling the health benefits of your gut health product. And of course, I would be happy to help out in case of doubt.

The full case can be read here (in Dutch).

Image: https://nl.beautifulimmunity.eu/

No health claims for botanicals, unless… – implications for the Dutch market

Posted: May 19, 2025 | Author: Jasmin Buijs | Filed under: Advertising, Food Supplements, Health claims | Comments Off

Last April 30^th, the European Court of Justice (ECJ) answered the question whether so-called ‘on-hold’ health claims related to botanical substances are permitted (case C-386/23). As covered in an earlier blogpost, this question was submitted to the ECJ by the German Bundesgerichtshof in the summer of 2023. In this blogpost, we discuss the outcome of the case, the transitional regimes of article 28(5) and (6) Claims Regulation, and the implications of the case for the Netherlands.

The case
The question at hand came up during national German court proceedings concerning a food supplement of the company Novel Nutriology, which was advertised as mood enhancing and reducing feelings of stress and fatigue thanks to its extracts of saffron and melon juice. Health claims for botanical substances like the above are currently on-hold, since the European Commission has not yet completed its examination of such claims for the purposes of their inclusion in the positive lists of authorized health claims. Due to the absence of botanical-related claims on these lists, such claims can therefore not be used based on article 10(1) and (3) Claims Regulation. It namely follows from this article that the use of a specific health claim is only permitted if it is included on one of the positive lists, and any generic health claim must be accompanied by such a specific claim. The referring court therefore wanted to know whether it is indeed prohibited to promote botanicals with health claims as long as such claims are not included on the positive lists.

Prohibited, unless….
The ECJ confirmed that until inclusion of the so-called on-hold claims on the positive lists, it is prohibited to promote botanicals using health claims. This is however different if the use of such claims is permitted under the transitional measures provided for in article 28(6) Claims Regulation. Unlike earlier speculations, this applies not only to specific (art. 10(1)) claims but also to generic (art. 10(3)) claims. In other words: generic health claims for botanicals are prohibited, unless they are accompanied with a specific claim that meets the requirements of the transitional regime. Since the referring court starts from the premise that the health claims at issue are psychological claims, we note that the ECJ only covers such claims and no physiological function claims in its ruling, on which more later.

Transitional measures deepened
Article 28 of the Claims Regulation includes transitional measures that were intended to enable food businesses to adapt to the requirements of the regulation when it became applicable back in 2007. The transitional measures in art. 28(5) and (6) Claims Regulation however also apply to the botanical-related health claims that are currently still on-hold. This is made explicit in recitals 10 and 11 of Regulation 432/2012, which establishes a list of authorized function health claims (also known as Article 13 claims). As referred to by the ECJ in its ruling, the foregoing also follows from recital 9 of Regulation 536/2013, which amends Regulation 432/2012.

Article 28(5) and (6) Claims Regulation set forth different transitional regimes for respectively physiological function claims and other health claims. As relevant for the type of health claims made by Novel Nutriology, the ECJ applies the test set forth in article 28(6). The first question to be answered is whether the health claim has been used in compliance with national provisions before the date of entry into force of the Claims Regulation. Based on the input of the referring court, the ECJ relies here on the premise that this is the case. The claim can therefore continue to be used, provided that it either has been subject to evaluation and authorization in a Member State, or has been submitted for EU authorization prior to 19 January 2008.

Although not specified by the ECJ, it does not seem a requirement that the food business at stake has been using the claim before the data of application of the Claims Regulation itself and has, where relevant, made itself an application for authorization. The literal text of article 28(6) Claims Regulation does also not require this as it doesn’t specify the required user or applicant. A food business that wishes to use an on-hold claim does therefore not need to be the original user and applicant of the claim.

Novel Nutriology nevertheless fails to comply with the requirements of article 28(6). As was noted by the referring court, the health claim related to the saffron extract was the subject of a late application past the deadline set in the transitional measures. For the melon extract claim, no application has been submitted at all. Novel Nutriology can therefore not make the health claims at stake.

What about physiological function claims?
While the ECJ did not see reason to elaborate on the transitional measures for physiological function claims as dealt with in article 28(5) Claims Regulation, the Advocate-General does indicate in his Opinion what if the respective health claims were to be considered as such. These claims may than continue to be used under the conditions set forth in that article so long as the positive list of health claims has not been adopted in respect of botanical substances.

The question however remains whether generic claims accompanied with physiological function claims can be made under the applicable transitional measures to promote botanicals. An analogical application of the ECJ’s ruling to the transitional measures of article 28(5) Claims Regulation suggests that this should be possible, which is also the conclusion of the Advocate-General in his Opinion. A difference between article 28(5) and 28(6) Claims Regulation is however that the former explicitly refers to physiological function claims as meant in article 13(1)(a) Claims Regulation, whereas the latter covers “health claims other than those referred to in Article 13(1)(a) and in Article 14(1)(a)”. In accordance with this European implementation assessment, it may therefore as well be concluded that generic claims are not dealt with under the transitional measures of article 28(5). Whether such a strict (literal) interpretation should indeed be applied, remains unanswered.

Implications for the Netherlands
As explained in our earlier blogpost on this topic, health claims for botanicals are accepted in the Netherlands if the roadmap of the Dutch agency regulating health products (the Keuringsraad) in cooperation with the Dutch food safety authority (NVWA), is met. Also the NVWA Handbook on Nutrition and Health Claims provides a detailed guidance on the use of on-hold claims for botanical substances.

While the roadmap and NVWA handbook only accept on-hold claims with an ID number that is present on the so-called ‘on-hold’ list, we notice that in practice little attention is paid to the exact requirements of the transitional measures under the Claims Regulation. The ruling at stake may therefore be seen as a wake-up call for compliance. We recognize at the same time that it may not always be easy to prove e.g. that an on-hold claim has been used in compliance with national provisions before the date of entry into force of the Claims Regulation. So far we have not seen enforcement on this point, so future will have to tell whether this may change.

We further notice that the topic of generic claims that are substantiated with on-hold claims is not covered in the Dutch guidance materials. The case at stake however taught us that this also falls under the transitional regime of article 28(6) Claims Regulation. Since it remains unclear how this plays out under the transitional regime of article 28(5), it would be helpful for businesses if the Dutch enforcement body can share its take on this in its Handbook.

Conclusion
When it comes to psychological and behavioral function claims, the case at stake clarifies that the transitional measures of the Claims Regulation apply both to specific and generic claims. How this plays out for physiological function claims has not been covered by the ECJ, and could be argued different ways. It would be helpful if this question could therefore be answered in national guidance materials, and until that time we recommend that food businesses have a robust legal justification for their interpretation of the transitional measures, if these are what they rely on for their use.

Images are by freepik.

European harmonization probiotic claims possible? Here’s the latest.

Posted: April 24, 2024 | Author: Jasmin Buijs | Filed under: Advertising, Authors, Food, Food Supplements, Health claims, Information, Nutrition claims | Comments Off

The International Probiotics Association Europe (IPA Europe) is calling for harmonized use of the claim ‘probiotics’ in the EU. Aforementioned term is generally considered an unauthorized health claim under the EU Claims Regulation. Nevertheless, an increasing number of EU member states allows the use of this claim under certain conditions. This blogpost dives into the regulatory status of probiotic claims in different EU member states and the latest developments in this area.

When entering the keyword ‘probiotic’ in the EU Health Claims Register, one is confronted with over 100 rejected health claims. Over the past years, this has led to the question whether the term ‘probiotic’ should be allowed under certain conditions, and has resulted into divergent policies in different EU member states. To protect both the food industry (against unfair competition) and the consumer (against misleading information), these divergent policies are reason for IPA Europe to call for a harmonized framework.

Czech Republic, Northern Ireland and France
Although EU member states generally consider ‘probiotics’ to be an unauthorized health claim under the EU Claims Regulation, some EU member states take a different approach. ‘Probiotics’ is for example considered a nutrition claim in the Czech Republic. Such claim is allowed if the conditions set forth in the EU Claims Regulation are met. This means, amongst others, that the good bacteria in question are present in the food in an amount that, according to generally accepted scientific evidence, causes the claimed beneficial effect. By contrast, in France and Northern Ireland, the term ‘probiotics’ can be used as a general, non-specific health claim that is allowed in combination with the authorized health claim “live cultures in yoghurt or fermented milk improve lactose digestion of the product in individuals who have difficulty digesting lactose”.

Italy
Italy takes the view that the term ‘probiotics’ does not meet the definition of a health claim and therefore falls outside the scope of the EU Claims Regulation. Italy supports this view by EFSA’s conclusion that probiotic colonization in the intestinal flora (without further specification of bacterial species or strains) is insufficient evidence to substantiate a beneficial effect on human health. In other words, no link between probiotics and health can be demonstrated, for which reason ‘probiotics’ cannot be considered a health claim. Aforementioned reasoning is however not a free pass to unconditionally use the term ‘probiotics’ in Italy. Instead, the following conditions must be met if and when using this term: (i) safety for human consumption, (ii) a history of use for the benefit of the intestinal flora, and (iii) presence of the relevant bacteria in the food in live form and in an adequate quantity until end of shelf life.

Denmark and Spain
In Denmark, the term ‘probiotics’ can be used based on a different legal ground, namely as a mandatory category designation under the EU Food Supplements Directive. In France, such is also possible. Indeed, Article 6(3)(a) of the EU Food Supplements Directive requires that the labeling of the food supplement shall bear “the names of the categories of nutrients or substances that characterize the product or an indication of the nature of those nutrients or substances”. In Spain, the claim ‘probiotics’ is allowed thanks to the principle of mutual recognition. Based on this principle, a product lawfully marketed in one EU member state must also be accepted on the market of another EU member state. Since probiotic claims are therefore allowed on the Spanish market for products from other EU member states, banning the term ‘probiotics’ at national level would discriminate against national producers. Therefore, both food products produced within Spain and those produced outside of the country can bear the claim ‘probiotics’.

Netherlands
In the Netherlands – just like in Denmark and France – the term ‘probiotics’ can be used as a category designation for food supplements. This Dutch practice is laid down in the Guideline Document on the EU Claims Regulation by the Dutch Health Advertising Knowledge and Advice Council (in Dutch: Keuringsraad). An earlier version of the Nutrition and Health Claims Manual by the Dutch Food Safety Authority (in Dutch: NVWA Handboek Voedings- en Gezondheidsclaims) also explicitly mentioned this possibility. Such is now longer mentioned in the latest version of the Nutrition and Health Claims Manual, which can be explained by the fact that ‘probiotics’ as a category designation for food supplements is not a nutrition or health claim.

Although claims that further elaborate on the health effect of probiotics (sporadically) occur on the Dutch (online) market, these are not allowed. Whether the expression “increases the good bacteria in the intestinal flora” (without using the term ‘probiotics’) is acceptable in the Netherlands, is yet unclear. Yakult uses this expression to advertise its fermented milk drink. The Dutch Health Advertising Knowledge and Advice Council would not allow this expression in the context of its preventive supervision in the context of food supplements, because this expression in effect creates a link between the food product and health. If the NVWA has however a different opinion on this and does consider aforementioned expression possible, then other food businesses can take advantage of this too. The call for harmonized uses of the term ‘probiotics’ by IPA Europe, about which more below, can possibly contribute to the acceptance of such expression at national level.

”Probiotics’ not a health claim”
As demonstrated above, various EU member states have introduced national rules on the use of the term ‘probiotics’. As a result, IPA Europe believes that the European Commission’s position that ‘probiotics’ implies a health benefit and is therefore a(n unauthorized) health claim no longer holds water. Instead, IPA Europe advocates qualifying the claim ‘contains probiotics’ as a nutrition claim, just like ‘contains vitamins and minerals’ and ‘contains fiber’. Aforementioned substances may have beneficial nutritional properties, but no specific health benefit is claimed. To strengthen its argument that ‘probiotics’ is not a health claim, IPA Europe explains that the term is not sufficiently precise to substantiate the claimed health benefit under reference to an EFSA guidance document published in 2016.

Call for harmonized use of the term ‘probiotics’
According to IPA Europe, ‘probiotics’ is therefore not a health claim and does not require authorization under the EU Claims Regulation. At the same time, it emphasizes the need for clear rules on the use of the claim as this contributes to a fair competitive environment for food businesses and helps consumers to make informed choices. In December 2023, IPA Europe therefore called for a clearly defined framework for the use of the term ‘probiotics’ in the EU. IPA Europe recommends the following four criteria for consistent use thereof:

characterization of the species level and identification of at strain level;
the probiotic strain must be safe for the intended use, e.g. based on the QPS list;
the probiotic status should be scientifically documented; and
the probiotic strains must be alive in the product and in a sufficient amount up to the end of shelf-life.

Final comment
The EU knows a fragmented regulatory landscape when it comes to the use of the term ‘probiotics’. Despite IPA Europe’s efforts for a harmonized approach throughout the EU, we will need European legislation or a ruling from the European Court of Justice to have the same rules in all EU member states. For now, the term ‘probiotics’ is (fortunately) not completely banned in the Netherlands and neither in quite a few other EU Member States.

This blogpost has also been published in Dutch at VMT.nl.

Food or medicinal product? New development in Dutch case law on EU harmonized provisions

Posted: December 1, 2022 | Author: Jasmin Buijs | Filed under: Advertising, Enforcement, Food, Food Supplements, Health claims | Comments Off

Intro

Food businesses operators that make medical claims for their products in the Netherlands can be fined for doing so under food law. However, they also run the risk of being fined under the Dutch Medicines Act (in Dutch: “Geneesmiddelenwet”), in which case much higher fine amounts apply. The latter sometimes provokes surprise and outrage. Based on three recent rulings, we see a positive trend, which is explained below.

Drug definition

In principle, a medicinal product cannot be sold in the Netherlands without an authorization. Advertising a medicinal product that has not been authorized is prohibited as well. If a product is classified as such and sold without a license, the seller risks a hefty fine.

The legal definition of the term medicinal product and the corresponding authorization requirement can be found in the Dutch Medicines Act, which is based on the European Directive 2001/83/EC (the “Medicinal Product Directive”). The Medicinal Product Directive provides two criteria for the definition of a medicinal product: qualification by presentation and qualification by function. If a product meets one of these two criteria, it is classified as a medicinal product. The aforementioned criteria are further elaborated in case law.

Qualification by function

A product is a medicinal product by function (see the Hecht-Pharma judgment) if it can be administered to cure or prevent disease, diagnose or otherwise affect a person’s bodily functions. Of particular importance here are the composition and properties of the product, the method of use, the extent of distribution of the product, the consumers’ familiarity with the product and the health risks associated with its use.

Qualification by presentation

When applying the presentation criterion (see the Van Bennekom judgment), consideration is – unsurprisingly – given to whether a product should be regarded as a medicinal product on the basis of its presentation. It is not necessary that the product is expressly indicated or recommended as a medicinal product. The presentation criterion is already met if the manner of presentation gives the average consumer the impression that the product has a medicinal effect. The form in which the product is presented may give an indication for this, especially in the case of tablets, pills and capsules.

In particular the presentation criterion poses a risk to food companies. If they (unintentionally) make a medical claim in respect of their product, the presentation criterion may result in this product being classified (also) as a medicinal product by the Dutch Food and Consumer Product Safety Authority (“NVWA”). In that case, the NVWA may issue a fine under the Dutch Medicines Act. The starting point for such fine is €150,000, which is then differentiated based on the Policy rules of the Dutch Ministry of Health 2019. Even if the product also falls within the legal definition of food, the Dutch Medicines Act may apply simultaneously. The foregoing follows from the so-called hierarchy provision embodied in article 2.2 of the Medicinal Products Directive, which has been implemented into Dutch law as well. On the basis of this hierarchy principle, the Dutch Medicines Act is applicable if there is any doubt about the applicable product category. The result of this provision is that even a seller of coconut oil can receive a fine under the Dutch Medicines Act.

New trend in enforcement of medical claims?

Dutch case law gives numerous examples of products being classified as medicinal products by courts based on (solely) the presentation criterion. Recently, three court rulings have been rendered which give reason to assume that there is a new trend in case law. These are a ruling of the District Court of Oost-Brabant of March 25, 2022, and two (materially identical) rulings of the District Court of The Hague of June 28, 2022, regarding food supplements and follow-on milk, respectively.

The first case concerns the sale of dietary supplements, for which medical claims were made. The NVWA therefore classifies these supplements as medicinal products based on the presentation criterion and imposes two fines under the Dutch Medicines Act (both for sale and for advertising an unregistered medicinal product). The seller’s defense is that the Dutch Medicines Act should be interpreted in accordance with the Medicinal Product Directive and that it follows from there that the contested decision of the NVWA is based on an incorrect legal basis.

The court agreed with this argumentation, referring to the amendment of the Medicinal Product Directive of 2004. The court deduces from the preamble to the amendment that the Medicinal Product Directive does not apply if there is no doubt that a product clearly exclusively belongs to another product category, such as food or food supplements. The court ruled that this was indeed the case for the specific circumstances that were under discussion. The products clearly fall under the category of food supplements and therefore solely food law applies. The court confirms that the Dutch Medicines Act must, after all, be interpreted in accordance with the Medicinal Product Directive. The court therefore does not proceed testing the medical claims made against the presentation criterion based on drug legislation at all.

Clearly food-only

The above ruling raises the question when a product is “clearly exclusively” a food and what aspects of the product are important in this respect. Indications for this can be found in the two recent decisions of the District Court of The Hague regarding specific food products for toddlers, namely follow-on formula. In its assessment of whether the follow-on formula in question could be a medicinal product by presentation, the court determined that such qualification is not obvious with regard to products sold in supermarkets and drugstores. Another factor in this case was that the detailed information about the follow-on formula, on the basis of which the Dutch Ministry of Health (the counterparty in the cases at stake) believed it to be a medicinal product by presentation, could only be found on the seller’s website.

Conclusion

Based on the rulings discussed, we signal a trend that judges are halting the current practice of enforcement of prohibited medical claims for food products based on the Dutch Medicines Act. The discussed rulings make clear that (prohibited) health claims for food supplements and for other food products such as follow-on formula should be assessed on the basis of the Food Information for Consumers Regulation (the “FIC Regulation”), and not via the presentation criterion based on the Dutch Medicines Act. In our opinion this is justified, because since the FIC Regulation became applicable, food law is specifically set up to do so. We are very curious to see whether the trend initiated above will be followed by other courts. Although it follows from a ruling of the District Court of Zeeland-West-Brabant of 21 October, 2022, that this is not yet the case, we trust this will only be a matter of time.

The above does however not mean that food business operators would be allowed to make medical claims for their products. Also, the FIC Regulation contains a ban on medical claims for food products and the Nutrition and Health Claims Regulation sets forth a strict regime for authorized health claims. Having said that, fines following a violation of food legislation are far lower than fines based on the Dutch Medicines Act. On balance, food companies are therefore better off with fines based on food legislation.

This blogpost is written by Max Baltussen, Karin Verzijden and Jasmin Buijs.

The authors want to acknowledge Ebba Hoogenraad and Irene Verheijen for sharing the case law discussed here.

Personalized nutrition as a medical device

Posted: July 8, 2021 | Author: Jasmin Buijs | Filed under: Authors, Disclosure of information, Food, Health claims, Information, Nutrition claims | Comments Off

From May 26 this year, the personalized nutrition space has been enriched with a new piece of legislation: the Regulation (EU) 2017/745 on medical devices (hereinafter: “MDR”). The MDR is, generally speaking, applicable to all personalized nutrition (software) products, including apps and algorithms, with a medical intended purpose. Since most personal nutrition services that are currently on the market are lifestyle related, they will not be affected by the MDR. This will however be different for services that offer dietary advice for the prevention, alleviation or treatment of a disease. This blogpost aims to provide an introduction to the new rules on personalized nutrition as a medical device.

What is the MDR?

The MDR comprises of a set of rules that governs the full medical devices supply chain from manufacturer to end user in order to ensure the safety and performance of medical devices. It applies to any apparatus, application, software or other article intended by the manufacturer to be used for a medical purpose. This includes, like under the old medical devices legislation, the diagnosis, prevention, monitoring, treatment or alleviation of a disease. Since the application of the MDR, also devices designed for the prediction or prognosis of a disease qualify as a medical device. Genetic testing kits for medical purposes and other medical devices to be used in vitro for the examination of specimens such as blood are covered by the MDR’s sister, Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (hereinafter: “IVDR”). The IVDR applies from May 26 next year.

When does the MDR apply to personalized nutrition software?

The essential question for the MDR’s applicability is thus whether the article or software concerned has a medical purpose or is merely lifestyle or well-being related. For example, an app that provides dietary advice based on the users’ preferences and potential health data is a lifestyle product. But if the same app claims to help address obesity or treat hypertension, then it can be linked to a disease and transforms into a medical device. While the intention of the manufacturer of the device is leading for the application of the MDR, it should be noted that only a statement that a product is not a medical device, or is meant for lifestyle purposes only, does not constitute a reason to escape from this regulation. The intended purpose is inferred from every document and statement that expresses the intended purpose, including advertising and marketing material. Disclaiming a medical intended purpose in the instructions for use but claiming such purpose in marketing materials will still result in a finding of a medical intended purpose. The MDR contains an explicit prohibition on statements that may mislead the end user about the intended purpose or ascribes functions or properties to the device that it does not have, which would be caught in its scope.

Another example of a medical device is the wearable being developed by the Australian start-up Nutromics, which assesses dietary biomarkers to provide dietary advice to minimize users’ risk for lifestyle-related chronic diseases. This device is designed to predict the user’s likelihood of developing a particular disease and to subsequently provide advice to prevent such disease, and will therefore be subject to the MDR when placed on the Union market. On the other hand and as clarified earlier by the European Commission in its borderline manual for medical devices, a home-kit that enables the user to ascertain their blood group in order to determine whether a specific diet should be followed falls outside the medical sphere (as defined in the (old) medical devices legislation). The sidenote should however be made that this decision was not related to following a specific diet for medical purposes.

It is also relevant to state that software may as well qualify partly as a medical device and partly as a non-medical device. Think for example of an app that provides the user with personalized nutritional advice as part of the treatment or alleviation of diabetes, and additionally facilitates online contact with fellow patients. While the software module(s) that provide information on the treatment or alleviation of the disease will be subject to the MDR, the software module that is responsible for the contact amongst patients has no medical purpose and will therefore not be subject to the MDR. The manufacturer of the device is responsible for identifying the boundaries and the interfaces of the medical device and non-medical device modules contained in the software. The Medical Device Coordination Group has pointed out in its guidance on qualification and classification of software (October 2019) that if the medical device modules are intended for use in combination with other modules of the software, the whole combination must be safe and must not impair the specified performances of the modules which are subject to the MDR. This means that also the non-medical devices module(s) may have to be covered in the technical documentation that supports the device’s compliance with the MDR and as further introduced below.

Way to market of personal nutrition software

All medical devices placed on the Union market must in principle have a CE (conformité européenne) marking as proof of compliance with the law. To apply the CE-mark, the manufacturer has to prepare technical documentation and carry out a conformity assessment procedure, including clinical evaluation. The specific procedure that must be followed depends on the risk class of the device. The MDR distinguishes the risk classes I, IIa, IIb and III (from low to high). The higher the risk class of the device, the more stringent requirements for clinical evaluation apply to demonstrate safety, performance and clinical benefits. It could ironically be stated that MDR stands for More Data Required: where an analysis of available clinical data from literature may have been sufficient in the past, the MDR more often requires own clinical investigations to support the device’s safety and performance.

Under the MDR, software as medical device is classified as class IIa when it is intended to provide information which is used to take decisions with diagnosis or therapeutic purposes, or to monitor physiological processes. Translated to personal nutrition services, this would for instance include apps that track burned calories (monitoring of physiological processes) and that provide dietary advice as part of a treatment (therapeutic purposes). Risk increasing factors will however lead to a higher risk class than class IIa. While an app with which food products’ barcodes can be scanned to detect certain ingredients for allergen control purposes would normally be a class IIa device, it will be a class III device when food intake decisions based on the app may cause life-threatening allergic reactions when based on a false negative (safe to eat while it in fact is not safe).

All other software which is not specifically addressed but still has a medical intended purpose in scope of the definition of a medical device, is classed as class I. An example would be an app that provides nutritional support with a view to conception. The risk classification rules for software are new under the MDR, which means that existing medical devices software may be scaled in a higher risk class since 26 May 2021. This is relevant not only with regard to the conformity assessment procedure that must be followed, but also to the question who can perform the required assessment of legal compliance. Manufacturers of devices in a higher class than class I must always engage a so-called notified body in this regard, while class I devices can in principle be self-certified by the manufacturer. An exception exists however for class I devices that have a measurement function, for example by using the lidar of the user’s phone to measure the body as input for the functionality of the app, which also require the engagement of a notified body.

Take away for food businesses

When personal nutrition enters into the medical sphere, the MDR will come into play. This will impact first and foremost the manufacturers, importers and distributors of actual medical devices, including apps and algorithms. Having said that, food businesses that wish to market their food products through medical devices apps are advised to be aware of the implications thereof. This will help them to find a reliable partner and to ensure their interests are contractually protected.

A more elaborate version of this blogpost has been published at Qina in cooperation with Mariette Abrahams.

Active disclosure of inspection results: how to prevent naming & shaming?

Posted: October 2, 2020 | Author: Jasmin Buijs | Filed under: Authors, cannabidiol, cannabis, Disclosure of information, Enforcement, Food, Food Supplements, Health claims | Comments Off

Since 1 September 2020, the Dutch Food Safety Authority (NVWA) has been given the power to publish certain inspection results (including identification details of the inspected FBO) faster than before. Prior to that date, the legal basis for disclosure could primarily be found in article 8 of the Dutch Freedom of Information Act (in Dutch: Wet openbaarheid van bestuur). This act creates a duty for the administrative body concerned, for example the NVWA, to publicly provide information when this is in the interest of good and democratic governance. However, article 10 of the Freedom of Information Act requires an individual balancing of interests in order to avoid disproportionate disadvantage for the parties involved as a result of the publication. It also prohibits disclosure of certain sensitive information, such as company and manufacturing data that has been confidentially communicated to the government. This blog post explains what has changed since 1 September 2020, which FBOs are affected and what arguments they can use to prevent disclosure.

Additional basis of disclosure as of 1 September 2020
As of 1 September 2020, the NVWA is additionally bound by the Decree on the Disclosure of Supervision and Implementation Data under the Health and Youth Act (in Dutch: Besluit openbaarmaking toezicht- en uitvoeringsgegevens Gezondheidswet en Jeugdwet, hereinafter: Decree on Disclosure), as further elaborated in the Policy Rule on Active Disclosure of Inspection Data by the NVWA (in Dutch: Beleidsregel omtrent actieve openbaarmaking van inspectiegegevens door de NVWA, hereinafter: Policy Rule on Disclosure). This power of disclosure is based on article 44 of the Dutch Health Act (in Dutch: Gezondheidswet). Disclosure in accordance with the Decree on Disclosure does not require the balancing of interests: disclosure of information will simply take place when indicated in the relevant annex to the Decree on Disclosure. Companies that wish to prevent publication of information related to their business will therefore have to invoke factual criteria, such as that the information to be disclosed contains incorrect information or concerns information that is excluded from disclosure in Article 44(5) of the Health Act.

Required actions when companies disagree with disclosure
The publication of information as based on the Decree on Disclosure has consequences for the way affected companies can stand up to prevent disclosure and the speed with which they will need to object. Where the Freedom of Information Act offers affected companies the possibility to share their opinion (in Dutch: zienswijze) in reaction to the administrative body’s intention to disclose the information in question, this possibility does not exist under the Decree on Disclosure. If and when an affected company does not agree with disclosure on the basis of the latter decree, this company has two weeks to object to the respective administrative body’s intention of disclosure and needs to seek interim relief measures within this time frame in order to actually suspend the disclosure. In addition, under the Decree on Disclosure companies are provided the option to write a short response that will be published together with the information subject to disclosure. In this way, affected companies are given the opportunity to provide the outside world with a substantive (but very summary) response to the information to be made public. The Policy Rule on Disclosure in fact also grants this right of response to information disclosed by the NVWA under the Freedom of Information Act.

Relevant for all FBOs?
The aforementioned additional legal basis for disclosure by the NVWA applies for the time being to a limited number of supervisory areas only, namely the inspection results of the NVWA with regard to (i) fish auctions, (ii) the catering industry, and (iii) project-based studies into the safety of goods other than food and beverages. These areas may be expanded in the future, according to the explanatory notes to the Decree on Disclosure.

However, for companies with so-called borderline products that navigate between different regulatory regimes, it is relevant to know that Dutch Health and Youth Care Inspectorate (IGJ) has broader powers to actively disclose inspection results under the Decree on Disclosure. Since 1 February 2019, the IGJ has already been publishing information on the basis of this decree regarding, amongst other, compliance with the Dutch Medicines Act (in Dutch: Geneesmiddelenwet). This means that when the IGJ takes enforcement measures against a FBO handling food supplements or other foodstuffs that qualify as (unregistered) medicines, it may be obliged to make public the respective supervisory information. The same applies to enforcement under the Dutch Medical Devices Act (in Dutch: Wet op de medische hulpmiddelen) – think diet preparations – and the Opium Act (in Dutch: Opiumwet) – think CBD and other cannabis products.

An example: melatonin-containing foodstuff labeled as a medicine
An example of a FBO that was faced with disclosure in accordance with the Decree on Disclosure by the IGJ concerns a company involved in melatonin-containing products. The IGJ intended to publish an inspection report on these products, from which it would follow that the products in question qualify as medicines and that the FBO concerned would therefore illegally place them on the market (namely without the required licenses under the Medicines Act). The FBO at stake applied for a preliminary injunction suspending the publication decree. On 8 July 2020, the preliminary relief judge rendered a judgment in this case.

Possible factual criteria to prevent naming & shaming
Although disclosure under the Decree on Disclosure is obligatory and disclosure decisions thus do not require the balancing of interests, the above-mentioned melatonin case gives good insights into the factual criteria that can nevertheless be invoked to prevent disclosure. In this case, the respective FBO brought forward the following arguments.

The respective inspection report excluded from disclosure

Article 3.1(a) of Part II of the Annex to the Decree on Disclosure excludes certain supervisory information from disclosure, including the results of inspections and investigations established as a result of a notification by a third party. The FBO at stake (hereinafter: “Applicant’) takes the position that the present inspection report was initiated as a result of a notification or enforcement request by a competitor. This would mean that the respective inspection report must not be made public.

The preliminary relief judge cannot agree with this position in the present case and rules that the inspection report is clearly related to an earlier letter from the IGJ to the applicant in which it announced the intensification of supervision of melatonin-containing products. Moreover, the case file was silent on a notification or enforcement request by a competitor.

The preliminary relief judge additionally states that it agrees with the IGJ’s viewpoint that the inspection report does not concern a penalty report (the report was drafted within the context of supervision and only indicates that Applicant will be informed about the to be imposed enforcement measure by separate notice). The fact that Applicant had earlier received a written warning for violation of the Medicines Act has no influence on this. The inspection report is therefore neither excluded from publication pursuant to article 3.1(a)(ii) of Part II of the Annex to the Decree on Disclosure, which makes an exception for “results of inspections and investigations that form the basis of decisions to impose an administrative fine”.

Disclosure in violation of the goal of the Health Law: outdated scientific foundation conclusions IGJ

The purpose of disclosure under the Health Act, in the wording of article 44(1) of that act, is to promote compliance with the regulations, to provide the public with insight into the way in which supervision and implementation of the Decree on Disclosure is carried out and into the results of those operations. Pursuant to Article 44a(9) of the Health Act, information should not be made public where this is or may violate aforementioned purpose of disclosure. Applicant takes the position that publication of the present inspection report does not contribute to improved protection of the public or to better information about the effects of melatonin, as a result of which the report should not be disclosed. More specifically, the applicant complains that the report (i) contains obvious errors and inaccuracies, (ii) gives the impression that it concerns a penalty decision, and (iii) is based on an incorrectly used framework to determine whether the qualification of a medicine is met.

The preliminary relief judge first of all notes that the fact that Applicant does not agree with the conclusions of the inspection report does not mean that the report therefore contains obvious inaccuracies. The preliminary relief judge further summarizes Applicant’s position as follows: (i) the IGJ wrongly took a daily dosage of 0.3 mg melatonin to determine the borderline between foodstuff and medicines; (ii) in doing so, the IGJ did not demonstrate that products with a daily dose of 0.3 mg melatonin actually acts as a medicine; (iii) moreover, the product reviews refer to outdated scientific publications (a more recent study by one of the authors thereof as well as more recent EFSA reports have not been included in the inspection report), whereas the current state of scientific knowledge must be taken into account according to established case-law. For these reasons, the preliminary relief judge agreed with Applicant that the IGJ has not made it sufficiently clear that from a daily dose of melatonin of 0.3 mg or more a ‘significant and beneficial effect on various physiological functions of the body’ occurs scientifically – according to the current state of scientific knowledge – and that products with a daily dose of melatonin of 0.3 mg or more act as a medicine”. Having said that, the preliminary relief judge did not accept Applicant’s statement that disclosure is contrary to the purpose of disclosure under the Health Act. Instead, the preliminary relief judge sought to comply with the so-called principles of sounds administration (in Dutch: algemene beginselen van behoorlijk bestuur) and ruled that the disclosure decision was not diligently prepared and insufficiently substantiated.

Incorrect facts

Applicant claims that the inspection report contains various inaccuracies, including the incorrect information that Applicant would produce melatonin itself. Applicant had already raised these inaccuracies in her response to the draft version of the report, but this had not resulted into adjustments in the final, to be published version of the report. The preliminary relief judge ruled on this matter that the IGJ should further investigate Applicant’s concerns and should amend the report where relevant. After all, the content of the report must be correct and diligently compiled. The mere fact that Applicant was given the opportunity to respond to the draft version of the report and that the IGJ responded to this in its decision to disclose the report does not mean that this requirement is met.

Violation of article 8 ECHR: disclosure has a major impact on Applicant’s image

Applicant claims that the planned disclosure will have a major impact on Applicant’s image and that of the natural person involved in the company. This is in violation of article 8 of the European Convention on Human Rights (ECHR) concerning the right to respect for private and family life. The Explanatory Memorandum to the Amendment to the Health and the Youth Care Act (in Dutch: Memorie van Toelichting op de Wijziging van de Gezondheidswet en de Wet op de Jeugdzorg) deals with this in detail. It emphasizes that the disclosure of inspection data does normally not constitute an interference with private life, because the data normally relates to legal persons and not to natural persons. The aforementioned Explanatory Memorandum therefore concludes that article 8 ECHR does not preclude disclosure on the grounds of the Health Act. Nevertheless, the court has at all times the competence to review a disclosure decision in the light of that article, in which case it will in fact have to balance the interests involved. In the present case, preliminary relief judge sees however no reason to assume a violation of article 8 ECHR.

Although the above shows that the preliminary relief judge in the respective melatonin case does not agree with all arguments put forward by Applicant, the request for suspension of publication of the contested inspection report was nevertheless granted thanks to factual criteria that were sufficiently substantiated. In particular the (implicit) argument that the conclusions in the inspection report lack a sufficient factual basis affects the essence of the information to be disclosed.

Conclusion
Rapid action is required to prevent active disclosure of inspection results under the Decree on Disclosure as these will usually be published after two weeks. This is not only relevant for FBOs active in the supervisory areas of the NVWA as designated in the Decree on Disclosure, but also for FBOs that operate at the interface of legal regimes under the supervision of the IGJ. To suspend disclosure, interim relief proceedings will have to be instituted as the Decree on Disclosure no longer provides for the possibility of submitting an opinion prior to publication. Moreover, affected companies cannot invoke the argument of suffering a disproportionate disadvantage as a result of the publication. Publication on the basis of the Decree on Disclosure is namely not subject to an individual balancing of interests (apart from an assessment on the basis of article 8 ECHR, insofar relevant). Although the arguments that companies can bring forward to prevent publication are therefore more limited than in the case of disclosure under the Freedom of Information Act, this does not mean that companies cannot successfully object an intention of disclosure. The melatonin case mentioned above is an example of this: conclusions that are not based on most recent science may not be published without adequate justification. Also, facts that are alleged to be incorrect should be further investigated before disclosure.

Trends at Vitafoods … and what you should know if you decide to be part of it

Posted: May 13, 2019 | Author: Karin Verzijden | Filed under: Authors, beauty claims, cannabidiol, cannabis, Food, Health claims | Comments Off

From 7 – 9 May 2019, the Vitafoods conference took place again in Geneva. For a few years in a row, I presented at the Education Program. This year I was asked to discuss the application of CBD in food products, which is currently a hot topic. Below, I will share the insight from my presenation, as well as two other trends I came across at the trade show.

(1) Cannabis, cannabis, cannabis

Cannabis was omnipresent at Vitafoods 2019. I do not mean the smell of it, but its application in food, pharma and in cosmetics. FoodHealthLegal being dedicated to food products, this post will uniquely focus on food application of (parts of) Cannabis. In our practice, we also deal with the other applications thereof. As pointed out in an earlier blogpost, FBO’s in the field of Cannabis were recently confronted with a change in the Novel Food catalogue. Since 20 January this year, CBD was declared a Novel Food. In my presentation during Vitafoods, I explained that this does not necessarily mean that each FBO needs to obtain an (individual) NF authorization. In fact, I identified 5 ways to market CBD food products, as further detailed in my slides:

no Novel Food;
individual / joint Novel Food application;
rely on third party authorization;
take advantage from the transition regime;
use national consultation procedure.

(2) Nutricosmetics

Food supplements targeting a cosmetic effect, so-called nutricosmetics, were present in great numbers too. The rationale behind these products is that cosmetic effects do not only derive from topical applications but can just as well be achieved via food (“beauty from within”). Communicating the benefits of these products is to some extent easier than communication around “regular” food supplements, as one can rely on so-called beauty claims. These are claims that uniquely target appearance of skin, hair and nails and not any beneficial nutritional or physiological effect on the body. These types of claims are not covered by the Claims Regulation, so one has flexibility in the wording thereof. In practise, these claims are usually supported by efficacy studies, as the burden of proof obviously is on the FBO marketing the nutricosmetic at stake. In addition to beauty claims, a number of health claims relate to beauty as well. The compounds covered include biotin, iodine and Vitamins A, B2 and C amongst others. As a result, attractive general health claims can be used for nutricosmetics, when specific ingredients thereof meet the parameters for these specific claims.

As an example, the product Lycoderm can be mentioned. This is a carotenoids and rosemary blend aimed at enhancing the benefits of topical skin treatment. The product is marketed stating that “antioxidants like carotenoids help balance our skin from environmental stressors such as UV rays”. The shorter version thereof could be “carotenoids help maintain healthy, smooth skin.” So far, no authorised health claim for carotenoids is in place, but it is possible to make a beauty claim regarding the effects thereof in a nutricosmetic (if powered by science). When using the authorised health claim for Vitamin E (“contributes to the protection of cells from oxidative stress”), a short attractive claim could read “beauty comes from within.”

(3) Digital nutraceuticals

This is a new phenomenon according to which nutraceuticals are powered by digital support. Various examples of apps developed by manufacturers of nutraceuticals operating in a B2B context were shown, aiming to enhance the appreciation of the consumer in a B2C context. More than once, such digital support could be customized for each individual client, so that a whole new digital business is developing around food supplements.

As an example, the product Metabolaid can be mentioned. This is a food supplement manufactured by Monteloeder aiming at weight control by controlling the appetite of consumers. Clinical studies are reported to have shown that the intake of this product, together with a healthy diet and regular exercise, helps consumers to manage their body weight, blood pressure, cholesterol and glucose levels. Monteloeder has also designed an app, enabling the consumer to monitor his/her daily habits, including eating hours, frequency and sleep. Furthermore, this app allows the connection with other wearables to detect health related parameters like heart rate, steps taken and body weight. This should enable the consumer to achieve positive changes in lifestyle habits, by offering a more thorough control over his/her overall health.

Obviously, such digital support of a nutraceutical requires a decent data protection strategy. Not only this is required to be GDPR compliant, it is also of the essence to gain and maintain consumers trust. Any company offering such solution should clearly explain in its privacy policy for what purpose consumer data are used, what are the legal grounds for processing and with whom personal data will potentially be shared. In the case of Monteloeder, offering customized apps for clients, it will be interesting to know who will be the controller regarding consumer data: Monteloeder or its client? If the client is setting the means & purposes for processing, is Monteloeder than completely out of scope, or is it actually operating as a controller as well? It is of the essence that the consumer is properly informed thereof, especially now that the data generated most likely qualify as “data concerning health”. The GDPR applies a very strict regime for processing these data and Member States are at liberty to formulate national restrictions as well.

Take home

Overall the Vitafoods conference offered many new insights. When adopting these, check before going to market whether your regulatory strategy is up to standards!

Cannabis derived food products – what’s the current state of play?

Posted: February 25, 2019 | Author: Karin Verzijden | Filed under: Authors, cannabidiol, cannabis, Enforcement, Food, Health claims, novel food | Comments Off

Recently, CBD food products were qualified as Novel Foods requiring a market authorization. The lively trade in these products therefore currently seems to be at risk. However, not all cannabis derived products are Novel Foods. What is the current state of play regarding these products and how is enforcement going to look like?

Current state of play re. cannabis derived products

In the European Union, the cultivation of Cannabis sativa L. varieties is permitted provided they are registered in the EU’s ‘Common Catalogue of Varieties of Agricultural Plant Species’ and the tetrahydrocannabinol (THC) content does not exceed 0.2 % weight per weight. The Common Catalogue is embodied in the EC Plant Variety database, which currently lists 68 species of Cannabis sativa. Some products derived from the Cannabis sativa plant or plant parts such as seeds, seed oil, hemp seed flour and defatted hemp seed have a history of consumption in the EU and therefore, in principle, are not novel.

What’s new?

This is different for extracts derived from Cannabis sativa L. and derived products containing cannabinoids, such as cannabidiol (CBD). It follows from a recent clarification of the Novel Food Catalogue that these products are considered Novel Foods, as a history of consumption regarding these products has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient. If for instance CBD is added to hemp seed oil, the product can no longer be marketed just like that and requires market authorization. The status of Novel Food also applies to extracts of other plants containing cannabinoids and to synthetically obtained cannabinoids.

How does the market of CBD food products currently look like?

Currently, the market in CBD food products is flourishing. A variety of CBD nutraceutical products is being offered for sale, such as HempFlax CBD, CBD oil, but also CBD-infused tea, honey or sweets. Although there is no hard-scientific evidence, many health benefits are connected to CBD food products, such as stress reduction, good night rest and providing energy and increasing resistance. Contrary to products containing THC (tetrahydrocannabinol), which is also extracted from cannabis, you do not get high on CBD food products, as this is not a psychoactive substance.

Medicinal use of cannabis

The use of cannabis derived CBD in food is not to be confused with medicinal use of cannabis. In most cases of medicinally applied cannabis, the active ingredient is THC, not just CBD, or a combination of THC and CBD. Although medicinally applied cannabis does not play a role in the cure of diseases, scientific publications show it can alleviate suffering from diseases, for instance nausea, decreased appetite, slimming or weakening due to cancer.

Consequences for business of the change in legal framework

Due to the qualification of CBD food products as Novel Foods, the lively trade in these products is currently at risk. Any Novel Food has to obtain a market authorization in order to get market access. CBD food products currently marketed may face enforcement measures, unless they can benefit from the transition regime laid down in the Novel Foods Regulation. According to this transition regime, any product that did not fall within the scope of the former Novel Foods Regulation, was lawfully marketed prior to 1 January 2018 and for which an application for market authorization is filed before 2 January 2020, can continue to be marketed until an authorization decision has been taken. While this transition period is in principle drafted for Novel Foods that fall into one of the new novel food categories under the new Novel Foods Regulation, it is in the spirit of the transition regime to also include the CBD scenario.

Pending CBD-application and expected EFSA opinion

Currently, one application for the authorization of a CBD food supplement is pending. The application was made by the company Cannabis Pharma from the Czech Republic and is based on publicly available safety and toxicological information and toxicity reviews. More in particular, the scientific data has been gathered from acute and long-term toxicity studies in animals and tolerance studies in humans. The data package submitted aims to support the safety of the use of CBD in food supplements for adults with a daily intake of up to 130 mg or 1.86 mg/kg body weight. It is reported by various sources that an EFSA opinion is awaited this March (see here and here).

Any benefits for the CBD market of a positive EFSA opinion?

Contrary to the situation under the former Novel Foods Regulation, the authorizations granted under the current Regulation have a generic nature. This means that any other company meeting the conditions of use stated in the authorization, would be at liberty to market CBD food supplements as well. The pending application made by Cannabis Pharma is therefore followed with great interest by the CBD market. As they do not seem to rely on data protection, a granted authorization would pave the way for other food supplement companies. It is not certain if this will happen still this year. If and when EFSA grants a positive opinion this March, the European Commission still has 7 months to submit an implementing act to the PAFF Committee. Upon a positive opinion of the PAFF committee, such implementing act could be quickly adopted. If the PAFF Committee has no opinion or a negative opinion, 1 or 2 months should be added to the procedure as a minimum.

Ireland: some CBD food products can be marketed

Meanwhile, there is some guidance available at Member State level. The Irish Food Safety Authority notes that recently a large number of CBD food products entered the market, typically marketed as food supplements in liquid or capsule form. Depending on the manufacturing process applied, the trade in CBD oil is not prohibited, as this oil naturally contains low levels of CBD, which is considered a non-psychoactive compound. This applies to CDB oil obtained by cold-pressing the hemp seeds. If and when the oil is obtained by supercritical CO2 extraction, then a Novel Food authorization is mandatory.

Denmark: available guidance not crystal clear

According to the Danish Ministry of Environment and Food, a number of Cannabis-derived products are not considered Novel Food, notably hemp seeds, seed flour, protein powder from seeds and seed oil from the Cannabis sativa L. varieties listed in the EC Plant Variety Database that are free from or contain low levels of THC. If these products contain CBD, the regulatory status is not exactly clear. According to the guidance of the Danish Food Ministry, the current status is that pure cannabidiol as well as hemp products with high (concentrated) levels of CBD or other cannabinoids are covered by the Novel Foods Regulation. It is not explained what is understood by “high levels of CBD”, but on the other hand an absolute prohibition to market these products in Denmark does not seem to apply.

Absolute prohibitions: Belgium and Austria

Other Member States seem to be stricter than Ireland or Denmark. For instance, the Austrian Health Ministry has made it perfectly clear that food products containing any type of cannabinoid extract without a Novel Food authorization are prohibited to be put on the market. In Belgium, the Federal Agency on Safety in the Food Chain has clarified that the production and marketing of food products based on cannabis is prohibited. The rationale is that the plant Cannabis sativa is mentioned in an annex to a national Decree listing dangerous plants that cannot be used for food production. The prohibition primarily seems to target the potentially dangerous substance of THC and allows derogations on a case-by-case basis, but not regarding food products containing CBD. These are considered Novel Foods requiring a market authorization.

Enforcement directed against (medical) claims in the Netherlands

Until CBD was declared a Novel Food, the trade in CBD food products was not prohibited in the Netherlands. Contrary to the substance TCH, the substance CBD is not mentioned in the Dutch Opium Act, listing prohibited substances having a psycho active effect. This does not mean that the trade in CBD food products was allowed just like that. In practice, enforcement in the Netherlands has been directed against the use of any unauthorized medical claims. A medical claim is any information according to which a food product could have a therapeutic or prophylactic effect. When using such a claim, one comes into the realm of the Medicinal Product Act, according to which it is prohibited to market and advertise any medicinal product without a market authorization. The Dutch Food Safety Authority announced fines up to
€ 10.000 regarding the sale of CBD food products in several cases (see here and here). Any food business operator that is serious about his business in CBD food products will therefore not only check the applicability of the Novel Foods Regulation to his products, but also carefully draft his advertisement for this type of product.

Conclusion

The production and marketing of food products derived from Cannabis sativa L. in the EU has been considerably restricted since CDB food products were recently declared to be Novel Foods. However, not all cannabis-derived food products require market authorization. Pending the evaluation of the Novel Food application filed for a CBD food supplement by the Czech company Cannabis Pharma, it is worthwhile for other CBD food products to verify whether they can benefit from the so-called transition regime embodied in the Novel Foods Regulation. Due to differences between legislation in the Member States, this may differ from country to country. Also, it is important to carefully position your CBD food product, in order to avoid any medical claims.

The author ackowledges Jasmin Buijs, paralegal at Axon, and Max Luijkx, intern at Axon, for their valuable input.

The Dutch National Probiotic Guide: an innovative alternative for health claims on beneficial bacteria

Posted: August 24, 2018 | Author: Jasmin Buijs | Filed under: Authors, Food, Food Supplements, Health claims, Information | Comments Off

Probiotics are known as “beneficial bacteria” that can be found in, amongst others, dairy products and food supplements. They are defined by the joint FAO/WHO expert consultation on probiotics as “live microorganisms that, when administrated in adequate amounts, confer a health benefit on the host”. Since the reference to probiotics implies a health benefit, it comes as no surprise that the statement “contains probiotics” in a commercial communication about a food product constitutes a health claim under the Claims Regulation. Moreover, “contains probiotics”, or “prebiotics”, is explicitly taken as an example of a health claim in the guidance on the implementation of Regulation 1924/2006 of the European Commission’s Standing Committee on the Food Chain and Animal Health. At this moment, no health claims for probiotics have been approved by the European Commission. The Dutch Research institute TNO and the world’s first microbe museum Micropia, located in Amsterdam, are nevertheless convinced of the health benefits of probiotics, in particular to protect against antibiotic-associated diarrhea (AAD). At the beginning of this month, they launched a so-called National Guide on clinically proven probiotics for use during antibiotic treatment in the scientific journal BMC Gastroenterology

National Guide
The National Guide is presented as a tool for healthcare professionals, patients and other consumers to recommend or use the probiotic products listed as scientifically proven to prevent diarrhea caused by the use of antibiotics. While antibiotics fight bacterial pathogens, they also have a disruptive effect on the body’s own gut bacteria. One in four adults experiences diarrhea caused by ADD. The National Guide promotes probiotics for their function of protecting the gut flora from the disruptive effects of antibiotic treatment, fostering recovery and reducing the risk of recurring infections.

Science-based approach
The research behind the Guide involves a literature study of clinical studies that are all based on randomized, double-blind and placebo-controlled trials. Moreover, all of the trials clearly define AAD and have a probiotic administration regime for a period no shorter than the antibiotic therapy. 32 of the 128 initially identified clinical studies were selected in line with the aforementioned criteria. After the selection and review process, available probiotic products on the Dutch market were listed to be subsequently matched with the formulations as proven effective in the selected clinical studies. Only eight probiotic dairy products and food supplements marketed in the Netherlands specified on their label the respective probiotic strain(s) and number of colony-forming units (CFUs) and could therefore be used in the research. The listed probiotic products were awarded with one (lowest) to three (highest) stars for their proven effect as demonstrated in at least one to three clinical studies. The strain Lactobacillus rhamnosus GG with a minimal daily dose of 2 × 10⁹ CFU was found in at least three clinical studies and therefore awarded with a three-star recommendation. This strain was found in 2 products, both of which are food supplements. Several multi-strain formulations resulted in a one-star recommendation; 5 food supplements and 1 dairy product matched such a formulation. The multi-strain formulation Lactobacillus rhamnosus GG, Lactobacillus acidophilus LA-5 and Bifidobacterium lactis BB-12 was present in two clinical studies and therefore assigned with a two-star recommendation. However, none of the listed probiotic products found on the Dutch market contained this formulation.

Plea for the labeling of probiotics
The research is not exhaustive as probiotic products other than the eight that were included in the study might also be effective. However, since this was not communicated on the label, they could not be included in the research. To overcome this gap, TNO and Micropia as the initiators of the National Guide call for the labeling of the probiotic strains and number of CFUs on all probiotic products EU-wide. This could also expand the potential of the Guide. At this moment, strain and CFU labeling of probiotic products is not legally mandatory under the Food Information for Consumer Regulation. The initiators also developed a special probiotic label to address this claimed deficiency. The label is based on the probiotic label used in the US as created by the International Scientific Association for Probiotics and Prebiotics (ISAPP). The labels are in line with the information that should be demonstrated on probiotic labels according to the FAO/WHO 2002 Working Group on Guidelines for the Evaluation of Probiotics in Food.

National Guide to circumvent limitations under the Claims Regulation?
The Claims Regulation applies to health (and nutrition) claims made in commercial communications of foods to end consumers. This may be in the labeling, presentation or advertising of the food. Besides information on or about the product itself, also general advertising and promotional campaigns such as those supported in whole or in part by public authorities fall within the scope of the Regulation. Moreover, since the Innova Vital case, we know that (science-based) communications made to healthcare professionals may also be regulated by the Claims regulation. The rationale thereof is that the healthcare professional can promote or recommend the food product at issue by passing the information on to the patient as end consumer. Only non-commercial communications, such as publications that are shared in a purely scientific context, are excluded from the Regulation.

It must be noted that the National Guide is, unlike health claims, not a commercial communication originating from food business operators. This does, however, not necessarily mean that food business operators are free to use the science-based Guide in their communication with (potential) consumers or even with healthcare professionals without any reservation. The Guide, which not only lists the probiotic formulations that are beneficial for the human gut flora, but even the names of products that contain those formulations, could turn commercial when referred to by a food business. Moreover, when shared in such a context, the claims made in the National Guide may even enter the medical domain due to the preventive function assigned to foods containing probiotics.

Conclusion
The history of probiotic health claim applications has shown that EFSA is not easily convinced of the evidence that is correspondingly provided. The National Guide is, however, not subject to approval from the European Commission, backed by a positive opinion from EFSA. The Guide’s publication in the peer-reviewed journal BMC Gastroenterology nevertheless contributes to the verification of its scientific substantiation. The Guide therefore appears as an innovative, science-based alternative for probiotic health claims. At the same time, food business operators should be careful in referring to the National Guide to not act beyond the borders of the Claims Regulation and to stay away from medical claims. As a very minimum however, it seems to be valuable work to be adopted by branch organizations or research exchange platforms, such as the International Probiotics Association.

Dutch scoop: new Advisory Group on the Status of Borderline Products

Posted: July 16, 2018 | Author: Karin Verzijden | Filed under: Authors, Enforcement, Food, Health claims, Nutrition claims | Comments Off

Last week, the creation of the new Advisory Group on the Status of Borderline Products was published in the Dutch Government Gazette. The Advisory Group consists of expert representatives from the Healthcare Inspectorate, the Food Safety Authority, the Medicines Evaluation Board and the Central Committee on Research Involving Human Subjects. Its task is to issue advice on the legislation to be applied to individual products / product groups / substances belonging to a group of so-called borderline products. The reason that this Advisory Group was created is that the regulations in the field of market authorization and research with such products are complex and that it is not always clear which law is applicable. In such case it is also not clear which enforcement authority is competent to act in case of violations of the law. This is deemed undesirable by both the marketplace and the government authorities and the Advisory Group aims to change this.

Demarcation issues not new

Demarcation issues at the interface of the laws applicable to food products and medicinal products are not new. Already in a 2008 Letter to Parliament, the Dutch Health Minister reported that there was insufficient clarity about the demarcation between medicinal products and herbal remedies. The Minister reported the issue that a herbal remedy could also be a medicinal product within the meaning of the Dutch Act of Medicinal Products (in which the Medicinal Products Directive 2001/83 has been implemented). This is a consequence of the fact that the Act does not make a distinction between the origin of any active substance, which can be of human, animal, vegetable or chemical origin. When a herbal preparation qualifies as a medicinal product by function or by presentation, the Act on Medicinal Products is equally applicable.

Measures announced in the Letter of Parliament

At the time, the Health Minister did not consider it necessary to adjust the regulations to prevent demarcation issues between food products and medicinal products. He considered the criteria of “medicinal product by presentation” and “medicinal product by function” to be sufficiently clear in the first place. Secondly, he expected a beneficial effect from the list of permitted health claims that still had to be published back in 2008. He anticipated that products bearing such claims would not qualify as a medicinal product by presentation. He did, however, consider it desirable to improve cooperation between the Heath Care Inspectorate and the Food Safety Authority. This was implemented by adjusting the Decree on Supervision of Public Health, as a result of which the Food Safety Authority gained authority to enforce violations of the Act on Medicinal Products. Furthermore, it was stipulated that the structured consultation between the Heath Care Inspectorate, the Food Safety Authority and the Medicines Evaluation Board should be intensified, particularly regarding the discussion of the status of borderline products. One can say that this consultation in fact operated as an Advisory Group avant la lettre. Finally, it was determined that the already existing cooperation agreement between the Heath Care Inspectorate and Food Safety Authority had to be updated.

Demarcation issues more topical than ever

We now know that the clarification brought by the list of authorized health claims published in 2012 should not be overestimated. Nowadays many functional foods and nutraceuticals are marketed that claim medical properties. It quite often happens that it is not clear what is the applicable legislation to these products, because the boundary between health claims, disease risk reduction claims and medical claims is not immediately clear in all cases. Even when no specific claim is used, it can be debatable whether a product is a medicinal product by function or any other health product. It also happens that more or less the same products are marketed simultaneously as a medicinal product and as a foodstuff. Consider, for example, products containing glucosamine or St. John’s Wort. This means that food products containing the same active substance as medicinal products have not passed the prior testing for quality, safety and efficacy, which can be confusing for the consumer.

Consequences of product qualification

There are many examples of food products that were considered medicinal products by presentation. Consider, for example, the melatonin products which, after a remarkable turn in the Health Care Inspectorate policy, initially not but later on were considered to be medicinal products. More recently, a medical claim that Milk Thistle could prevent liver fattening was considered misleading. Furthermore, it was determined that a dietary supplement that would promote the natural immune system, would have a beneficial effect on heart and blood vessels and would help to treat fatigue qualified as a medicinal product. When such disputes are dealt with before the Civil Court, quite often fines are imposed for violations of the Act on Medicinal Products, prohibiting, among other things, the marketing and advertising of medicinal product without a marketing authorization. When these disputes are submitted to the Advertising Code Committee, usually a recommendation is made to no longer use such misleading information based on these regulations and the Code on Public Advertising of Medicinal Products. In order to prevent such enforcement activities, manufacturers of health products have every interest in knowing in advance how their product qualifies. They then know which regime applies to their product and can take this into account in their communication (advertising campaigns).

Working method Advisory Group

How does the Advisory Group work and which aspects are covered by its advice? Upon request of one of the competent authorities, the Advisory Group advises on the applicable legislation to individual products, product groups or substances. This advice gives a motivated indication of the law that applies to the opinion of the Advisory Group at the time of assessment and given the available information. “Available information” refers not only to factual information but also to applicable case law, both in the Netherlands and abroad. The advice will be presented to the Healthcare Inspectorate, the Food Safety Authority, the Medicines Evaluation Board and the Central Committee on Research Involving Human Subjects, who will subsequently respond to this within four weeks if so desired. If the responses give cause to do so, the Advisory Group reconsiders the advice and if necessary adjusts it. The advice is then recorded in its database, which is managed by its secretariat. There is also a possibility that the Advisory Council will not reach agreement on the applicable legislation. In such a case no advice is issued; this is also recorded in the database. The Advisory Group can also change its advice in the event of changes in the legal framework. The competent enforcement authorities must report those change to the Advisory Group, which registers an amendment to a previous advice in its database, if and when applicable. For clarity, the advice assesses neither the efficacy, safety or efficacy of medical products nor the content of any research protocols.

Added value Advisory Group

Can it be expected that the Advisory Group will make a substantial contribution to demarcation issues? In itself, the intensified co-operation between all the authorities involved, at market entry rather than upon enforcement during marketing, is to be welcomed. For example, in practice, food business operators also benefit from the working agreements between the Council on Advertising Health Products and the Food Safety Authority, on the basis of which health products bearing a “stamp” of said Council are in principle not exposed to enforcement actions by the Food Safety Authority. However, it appears from the currently published agreement between the parties involved in the Advice Group that only the enforcement authorities and not the individual manufacturers can request advice from the Advisory Group. This appears to be a missed opportunity, as is the fact that the efficacy of medicinal products remains explicitly outside the Advisory Council’s assessment. To qualify the essential character of a health product, efficacy is one of the essential factors. Furthermore, it is noteworthy that the Advisory Group does not seem to address the issue of medical devices, while this qualification is closely linked to that of medicinal or food products. For example, cranberry pills against bladder infection qualify as medical devices and osmotic laxatives can be either medicinal products or medical devices.

Advice on market access for health products

For the time being, manufacturers of health products will continue to rely on private advice from qualified advisors on market access for health products. Nevertheless, the body of opinions to be produced by the Advice Group can be a valuable source of information, provided that its database will be publicly searchable. The rules of procedure of the Advice Group, which are yet to be made available, will have to provide clarity in this respect.