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.

The regulatory framework of personalised nutrition

Posted: October 12, 2021 | Author: Jasmin Buijs | Filed under: Food | Comments Off

On 7 October 2021, Food Valley NL published its personalised nutrition position paper. With no less than 53 stakeholders, this paper was written to create a business definition of ‘personalised nutrition’ and to give insights into profitable business models. Axon Lawyers, together with Alie de Boer and Sabrina Röttger-Wirtz from Maastricht University, contributed to this paper a chapter summarizing the three main legal challenges related to personalised nutrition: (1) processing of personalised data, (2) the borderline between certain regulated products and (3) nutrition and health claims. Alie de Boer and Sabrina Röttger-Wirtz wrote earlier about the applicable legal framework to personalised nutrition (see here). In this blogpost, we present an extended version of our contribution to the Food Valley personalised nutrition position paper.

Processing of personal data
The essence of personalised nutrition is that it targets individuals, including their phenotypic and/or genotype information, their specific lifestyle and/or their dietary requirements. In order to do so, any supplier of personalised nutrition will have to process personal data, more in particular data concerning health. Under EU standards, personal data is defined as any information related to an identified or an identifiable person (art. 4.1 General Data Protection Regulation, or “GDPR”). While anonymised data does not fall under this definition, the bar for considering data to be anonymised is set very high. Health data are data relating to the physical or mental health of a person, including the provision of health care services, revealing information about his or her health status (art. 4.15 GDPR). Genetic data may also be relevant in the context of personalised nutrition, which are data relating to the inherited or acquired genetic characteristics of a person which give unique information about the physiology or the health of that person (art. 4.13 GDPR). For clarity, the “processing” of personal data includes but is not limited to each of the following actions with respect to such data: collection / storage / structuring / adaptation / consultation / transmission / destruction (art. 4.2 GDPR).

For any supplier of personalised nutrition products and/or solutions, it is of the essence to only process personal data based on a valid legal basis, such as consent (art. 6 GDPR). “Consent” is defined as any freely given, specific, informed and unambiguous indication of a data subject’s agreement with the processing of his/her personal data based on a statement or clear affirmative action (art. 4.11 GDPR). The use of consent as a legal basis for the processing of personal data is further detailed in Guidelines 05/2020 by the European Data Protection Board.

Even in case of a valid legal basis, the processing of health, genetic and other sensitive data remains however prohibited unless specific conditions have been met (article 9 GDPR). This is for instance the case when the data subject has given its specific consent for processing for a specific purpose (art. 9.2 (a) GDPR), or when processing is necessary for scientific purposes (art. 9.2 (j) GDPR).

Suppliers of personalised nutrition products and / or solutions should be able to demonstrate with respect to the personal data of each individual they are processing that the conditions of article 6 and 9 GDPR have been met. This could be done for example by documentation of written consent forms. Other grounds for processing than consent as provided for in article 6 and 9 GDPR may be used as well, although this is not very obvious in a commercial context.

Borderline products
By definition, any product that is intended for human consumption or which can be expected to be ingested – whether it is processed or not – is considered to be a food product. Due to the effects that products have or due to the nature of presenting their effects, it can become unclear how a particular product should be classified, i.e. whether it falls under the definition of a medicinal product, a medical device, or under other sectorial legislation. In the case of these ‘borderline products’, the decision on a product’s classification must be taken on a case-by-case basis. In the case of personalised nutrition products, the way in which their effect on health is communicated (for example through claims, further described in paragraph iii) is decisive for the qualification of the product being offered. For example, such a product could qualify as a medicinal product either by way of presentation or by function. A medicinal product is understood to be any substance or combination of substances presented for treating or preventing a disease in human beings (art. 1.2 Medicinal Products Directive). A product qualifies as a medicinal product by presentation if consumers are entitled to expect it to have a medicinal effect (even without a genuine therapeutic or medicinal effect – see Van Bennekom case (1983) of the European Court of Justice (“ECJ”)). A product is a medicinal product by function if it is capable of exerting a pharmacological action (see ECJ Hecht-Pharma case (2009)). Thus, food products that are customised to the nutritional needs of a specific individual and are claimed to treat, cure or alleviate the symptoms of a disease may be classified as medicinal products rather than as foods.

Personalised nutrition products or solutions, or certain components thereof, could also qualify as a medical device (e.g. a personalised nutrition app) or an in vitro medical device (e.g. a genetic testing kit). Unlike medicinal products that tend to improve physical functions by creating a pharmacologic, immunologic or a metabolic effect, medical devices do not achieve their principal intended action by these means (but they may be assisted in their function by such means). Medical devices are any device, software or other article intended by the manufacturer to be used for specific medical purposes, such as the diagnosis, prevention, monitoring or treatment of a disease (art. 2 Medical Devices Regulation or “MDR”).

The essential question for the MDR’s applicability is therefore whether the product concerned has a medical purpose or is merely lifestyle or well-being related. For example, an app that provides dietary advice even when based on potential health data is a lifestyle product, but transforms into a medical device where it claims to help address or treat a medical condition like obesity or hypertension. 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 from the manufacturer that a product is not a medical device, or is meant for lifestyle purposes only, is insufficient 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. See also our earlier blogpost on personalised nutrition as a medical device.

How a personalised nutrition product or solution is qualified determines the applicable regulatory framework and significantly changes the legal requirements. Entrepreneurs should be open to a thorough product qualification analysis before market entry. This does not per se hinder the development of personalised nutrition, but unawareness of the regulatory borderlines can be a pitfall.

Nutrition & health claims
Even if personalised nutrition qualifies as a food product as opposed to medicinal product or medical device, this does not mean that just any health benefit can be claimed on such a product. In fact, there is a pretty strict legal framework that applies here, not only to mandatory food information, but also to voluntary food information. As to the latter, we refer to the framework on health & nutrition claims.

Any statement that describes, suggests or implies that a food product either has certain beneficial nutritional characteristics (nutrition claim) or that its consumption will result in certain health benefits (health claim) is regulated within the EU (Regulation (EC) No 1924/2006). Only pre-authorised claims which are considered substantiated by scientific evidence, based on an assessment by the European Food Safety Authority (EFSA), can be used on foods. Health claims can exclusively be used to address health benefits of foods, and no suggestions or implications can be made that consuming a food may result in treating, curing or alleviating symptoms of a disease (Regulation (EC) No 1924/2006). Only when health benefits are supported by pre-authorised claims and the product meets the conditions of use for this claim, health benefits of personalised nutrition products can be put forward. At the same time, food business operators may consider submitting authorisation requests for new health claims on personalised nutrition products. Currently, it is however uncertain whether referring to genetic predispositions in claims would be considered making a medicinal claim or a health claim (Ballke & Meisterernst, 2014; Röttger-Wirtz & de Boer, 2021). Also, it is unknown whether health claims, currently mainly targeting the general population, could be directed to specific target groups who would benefit from these personalised or tailored products (Röttger-Wirtz & de Boer, 2021).

Conclusion
Overall, personalised nutrition is subject to extensive regulation under existing EU legislation. In a birds-eye view of legal frameworks applicable globally, data protection, product qualification and the regulation of voluntary food information comprise similar concepts although the detailed rules differ. For example, globally, health claims are allowed to be used in different jurisdictions. Whereas pre-market authorisation is required – in different forms – in some jurisdictions including the EU as well as Australia/New Zealand, this is not necessarily the case for other jurisdictions such as Japan and the United States of America (de Boer & Bast, 2015; Dominguez Diaz et al, 2020). Awareness of the different regulatory frameworks is key before market entry.

Authors: Karin Verzijden, Jasmin Buijs, Alie de Boer & Sabrina Röttger-Wirtz

References

SH Adams, JC Anthony, R Carvajal, L Chae, CSH Khoo, ME Latulippe, NV Matusheski, HL McClung, M Rozga, CH Schmid, S Wopereis, W Yan (2020). Perspective: Guiding Principles for the Implementation of Personalized Nutrition Approaches That Benefit Health and Function. Advances in Nutrition 11(1), 25–34.
C Ballke, A Meisterernst (2012). Nutrigenomics – A New Trend from a Legal Perspective. European Food & Feed Law Review 7(1), 14-21.
A de Boer, A Bast (2015). International nutrition and health claims legislation. Food Policy 55, 61-70.
L Domínguez Díaz, V Fernández-Ruiz, M Cámera (2020). An international regulatory review of food health-related claims in functional food products labeling. Journal of Functional Foods 68, 103896.
European Data Protection Board (2020), Guidelines 05/2020 on consent under Regulation 2016/679.
JM Ordovas, LR Ferguson, ES Tai, JC Mathers (2018). Personalised nutrition and health. BMJ 2018; 361:bmj.k2173.
S Röttger-Wirtz, A de Boer (2021). Personalised Nutrition: the EU’s fragmented legal landscape and the overlooked implications of EU food law. European Journal of Risk Regulation 12(1), 212-235.

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.

CBD as a food product: no drug, isn’t it? The interaction between food and opium legislation.

Posted: March 5, 2021 | Author: Jasmin Buijs | Filed under: Authors, cannabidiol, cannabis, Food | Comments Off

A number of legal developments in the field of cannabidiol (CBD) took place in the last few months of the previous year. For example, the European Court of Justice (ECJ) ruled in November that a member state cannot prohibit the marketing of CBD that was lawfully manufactured and marketed in another member state. Less than a month later, the United Nations Commission on Narcotic Drugs (CND) voted on six recommendations of the World Health Organization (WHO) regarding the reclassification of cannabis in the Single Convention on Narcotic Drugs (Single Convention). In practice, there appears to be confusion about the meaning of these developments for CBD as a food product. This confusion seems to arise from the interaction between food and opium legislation, both of which are applicable to this product. This article aims to provide clarity on these latest developments.

CBD is not a narcotic according to the ECJ
On 19 November 2020, the ECJ ruled, in summary, that the free movement of goods entails that when CBD is lawfully manufactured and marketed in one member state, it may, in principle, also be marketed in another member state. This is, however, different when Article 36 of the Treaty on the Functioning of the European Union (TFEU) justifies an exception to the free movement of goods, such as for the protection of health and life of humans. Yet, the trade restricting or prohibiting measure must in such a case be appropriate for securing the attainment of the objective pursued (the protection of health and life of humans) and must not go beyond what is necessary in order to attain it. To reach the aforementioned conclusion, the preliminary question had to be answered whether CBD falls within the scope of the free movement of goods. This principle does namely not apply to narcotics, which are prohibited throughout the Union (with the exception of strictly controlled trade for use for medical and scientific purposes). Based on the Single Convention and the Convention on Psychotropic Substances, the ECJ reasoned that CBD is subject the free movement of goods. Both conventions codify internationally applicable control measures to ensure the availability of narcotic drugs and psychotropic substances for medical and scientific purposes and to prevent them from entering illicit channels. The Convention on Psychotropic Substances regulates psychoactive substances, whether natural or synthetic, and natural products listed in the schedules to the Convention, including tetrahydrocannabinol (THC). CBD is not included. The Single Convention applies, inter alia, to cannabis (defined as “the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated”). Although a literal interpretation of the above provision would lead to the conclusion that CBD (not obtained from the seeds and leaves of the cannabis plant) falls within the definition of cannabis, such an interpretation is not consistent with the purpose of the Single Convention, namely protecting the health and welfare of mankind. Indeed, according to the current state of scientific knowledge, CBD is not a psychoactive substance.

UN Commission on Narcotic Drugs reclassifies cannabis
Shortly after the ECJ ruling regarding, among others, the Single Convention, the CND put six WHO recommendations to vote on 2 December 2020. This voting session would have taken place earlier, though had been postponed so that the voting countries had more time to study the matter and to determine their position. The WHO recommendations dealt with the reclassification, removal and addition of cannabis (substances) in the various schedules (Schedule I, II, III and IV) to the Single Convention. These four schedules represent four categories of narcotics and each category has its own rules. The substances in Schedule VI are controlled most strictly; they are considered dangerous without relevant medicinal applications. Schedule I concerns the second most strictly controlled category. The substances in this Schedule are subject to a level of control that prevents harm caused by their use while not hindering access and research and development for medical use. The lightest criteria apply to Schedule II and III. For example, Schedule II lists substances normally used for medicinal purposes and with a low risk of abuse.

Bedrocan (currently the sole supplier of medicinal cannabis to the Dutch government) has summarized these six WHO recommendations as follows:

Extracts and tinctures are removed from Schedule I.
THC (dronabinol) is added to Schedule I under the category Cannabis & Resin. Subsequently, THC is removed from Schedule II of the Convention on Psychotropic Substances.
THC isomers are added to Schedule I under the category Cannabis & Resin. Subsequently, THC isomer is removed from the Convention on Psychotropic Substances.
Pure CBD and CBD preparations with maximum 0.2 % THC are not included in the international conventions on controlling drugs.
If they comply with certain criteria, pharmaceutical preparations that contain delta-9-THC should be added to Schedule III, recognizing the unlikelihood of abuse and for which a number of exemptions apply.
Cannabis and cannabis resin are removed from Schedule IV, the category reserved for the most dangerous substances.

In the end, only the recommendation to remove cannabis from Schedule IV (i.e., recommendation 6) was approved, on the grounds that there are also positive aspects to cannabis. However, this does not mean that cannabis can now be freely traded. Cannabis is still included in Schedule I and is therefore in principle a prohibited substance. Having said that, research and product development for medical purposes is permitted if a country so desires. In the Netherlands, the Dutch Opium Act already allowed for this under certain conditions. The reclassification of cannabis is therefore more symbolic in nature than that it brings about practical changes.

The recommendation to explicitly exclude CBD from the scope of the Single Convention has thus been rejected. The industry considers this a missed opportunity to clarify the (legal) status of CBD with traces of THC. This rejection was on the other hand in line with the viewpoint of the European Commission, which advised its member states that sit on the CND (i.e. Belgium, Germany, France, Hungary, Italy, Croatia, the Netherlands, Austria, Poland, Spain, Czech Republic and Sweden) to vote against this recommendation since more research would be needed. For example, the European Commission takes the position that the proposed THC limit of 0.2 % is not sufficiently supported by scientific evidence. The WHO Expert Committee on Drug Dependence (ECDD) notes in this regard that medicines without psychoactive effects that are produced as preparations from the cannabis plant will contain traces of THC and provides the example of the CBD preparation Epidiolex as approved for the treatment of childhood-onset epilepsy, which contains no more than 0.15 % THC by weight. At the same time, WHO ECDD recognizes that it may be difficult for some countries to conduct chemical analyses of THC with an accuracy of 0.15%. Hence, it recommends the limit of 0.2 % THC. This limit is already known to food companies from the so-called Novel Food Catalogue of the European Commission, which recalls that in the EU, 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 THC content does not exceed 0.2 % (w/w). This does, however, not necessarily mean that products derived from such cannabis varieties can be freely marketed as food.

CBD as food product
With respect to cannabis extracts such as CBD, as well as its synthetic equivalent, no history of safe use has been demonstrated. As a result, these products qualify as novel foods and can only be placed on the EU market after approval by the European Commission. Several food companies such as the Swiss company Cibdol AG, Chanelle McCoy CBD LTD from Ireland and the Czech CBDepot, have already applied for the required novel food authorization. However, the assessment of the relevant dossiers has been paused, presumably because it was still unclear whether CBD qualified as a psychotropic substance and narcotic. Such a qualification would exclude use as a foodstuff. Thanks to the ECJ ruling, this has now been clarified, on the basis of which the European Commission will likely resume the evaluation of the various applications for CBD as a novel food.

CBD under the Dutch Opium Act
A potential approval of CBD as a novel food does, however, not automatically mean that CBD can be sold in the EU without any (legal) obstacles. The Novel Food Catalogue makes this reservation explicit by indicating that specific national legislation, other than food legislation, may restrict the placing on the market of a cannabis product as a food. In practice, it will in particular come down to opium legislation.

Although the ECJ clarified that CBD is not a narcotic, it did not specify how pure CBD must be to fall outside the scope of the Single Convention and to be freely traded. The respective rejected WHO recommendation referred to a THC content of up to 0.2 %. In the Netherlands is, however, only a contamination level of < 0.05 % allowed. This impurity can be caused by traces of THC, but also by the presence of other cannabinoids. Only pure CBD, i.e. with a purity level of > 99.95 %, falls outside the scope of the Dutch Opium Act. Having said that, there is another catch: although the Dutch Opium Act does not cover CBD, this Act is applicable to the cannabis plant (or its parts) from which the CBD is extracted. The production of (natural) CBD can therefore not take place in the Netherlands.

Conclusion
Recent developments in the field of CBD have clarified that CBD is not a narcotic and therefore does not fall under the Single Convention. Food businesses are nevertheless warned to not yet start celebrating. If they want to market CBD as a food, they will still have to go through the novel food procedure, or market a product in accordance with the terms of an already approved CBD product. The latter is possible insofar data protection does not prevent this. Besides this, the purity level of CBD is decisive to stay away from opium legislation. There is still no international agreement on what this level should be. Food businesses operating in different member states are therefore advised to seek local advice when marketing CBD in the EU.

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.

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.

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.

Market access of Chinese traditional herbal remedies in the EU

Posted: July 12, 2017 | Author: Karin Verzijden | Filed under: Food, Food Supplements, Health claims, novel food | Tags: botanical, market access, medicinal, novel food | Comments Off

The People’s Republic of China first law on Traditional Chinese Herbal Medicine came into force on the 1^st of July 2017. This law encompasses industrial normalization by guaranteeing the quality and safety of herbs in cultivation, collection, storage and processing. Producers of Traditional Chinese Medicine (hereinafter TCM) are not only targeting the Chinese market, but are also looking for access to the European market. With this new legislation in force in China, it is a good time to have a look at the current possibilities for market access of TCM on the European market. The name “TCM” would suggest the product could only be qualified as a medicinal product. However, other product qualifications are possible as well. In this post, it will be investigated how Chinese herbal remedies and products fit into the EU framework.

Qualification

For market access, product qualification is vital. Qualification of TCM as medicinal products might seem obvious. However, western medicine is mostly focused on curing a certain disease or disorder, whereas TCM is focused on healing the body itself. Healing in short means the body should be strengthened to ‘treat itself’. Many of the traditional herbal remedies have healing properties, such as strengthening the immune system. As an alternative to medicinal products, other qualifications of TCM could be botanicals, so that they could be marketed as food supplements or as other foodstuffs. We previously reported on product qualification in this blog, explaining what legal tools have been developed for this purpose over time in case law. These criteria equally apply to TCM.

Simplified registration procedure for traditional herbal medicinal products

An example of a traditional herbal medicinal product we can mention sweet fennel, which is indicated for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence. For this group of traditional herbal medicinal products, just like for TCM, a simplified registration regime can be found in the EU Medicinal Products Regulation. In short, the efficacy of the product containing the herb used in TCM’s can be substantiated with data on usage of the herb. This eliminates the need for costly clinical trails to prove the efficacy of the active ingredient(s) in the product. However, safety and quality of the TCM still need to be substantiated.

Eligibility for simplified registration procedure

To qualify as traditional herbal medicinal product, a number of cumulative criteria should be met, including the following.

Evidence is available on medicinal use of the product during at least 30 years prior to application for EU market authorization, of which at least 15 years within the EU.
Such evidence sufficiently demonstrates the product is not harmful in the specified conditions of use and the efficacy is plausible on the basis of longstanding use and experience.
The product is intended and designed for use without the supervision of a medical practitioner and can only be administrated orally, externally and/or via inhalation.

The presence in the herbal medicinal product of vitamins or minerals for the safety of which there is well-documented evidence shall not prevent the product from being eligible for the simplified registration referred to above. At least, this is the case as the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s). TCM intended and designed to be prescribed by a medical practitioner can enter the EU market, but cannot benefit from the simplified registration procedure for traditional herbal medicinal products.

Foodstuff

Currently the focus of healthcare is shifting from purely curing diseases to prevention thereof. TCM could play an interesting role in such paradigm shift. Although food business operators (hereinafter FBOs) cannot claim a foodstuff can cure a disease, such product can contribute to prevention of a disease. As such, FBOs can inform the public that consumption of a particular foodstuff can support the regular action of particular body functions. An example of a herbal remedy used in TCM and currently on the EU market is cinnamon tea; used in Chinese medicine to prevent and treat the common cold and upper-respiratory congestion. Obviously, the advantage of bringing a foodstuff (for instance, a food supplement) to the market as opposed to a medicinal product is that unless the foodstuff is a Novel Food, you do not need a prior authorization.

Novel Foods

As long as a foodstuff has a history of safe use in the EU dating back prior to 1997, FBOs do not need prior approval for market introduction. If no such history of safe use can be established, both the current and new Novel Food Regulation prescribe that the FBO receives a Novel food authorization. A helpful tool for establishing a history of safe use is the novel foods catalogue, being a non-exhaustive list of products and ingredients and their regulatory status. Another source is Tea Herbal and infusions Europe (hereinafter THIE); the European association representing the interests of manufactures and traders of tea and herbal infusions as well as extracts thereof in the EU. THIE’s Compendium, which should be read in combination with THIE’s inventory list (also non-exhaustive), contains numerous herbs and aqueous extracts thereof, which are used in the EU. Other herbs might not be considered Novel Foods, as long as the FBO can prove a history of safe use in the EU prior to 1997. For instance, the history of safe use of Goji berries has been successfully substantiated.

Traditional foodstuffs from third countries

In previous blogs we already pointed to a new procedure to receive a Novel Food authorization as of 1 January 2018, relating to ‘traditional foods from third countries’. EFSA published a guidance document for FBOs wishing to bring traditional foods to the EU market, enabling them to use data from third counties instead of European data for the substantiation of the safety of the foodstuff. The procedure is a simplified procedure to obtain a Novel Food authorization for a foodstuff, which has been consumed in a third country for at least a period of 25 years. For sure, this is not an easy one, but we have high hopes that such data can be established for TCM being used in Asia. In the affirmative, the FBO can use these data to substantiate the safety of the product and receive a Novel Foods authorization via a 4 months short track procedure, enabling the FBO to market the foodstuff at stake in the EU.

Health claims for herbal products

The EU Claims Regulation provides the legal framework for health and nutrition claims to be used on foodstuffs. In previous blogs we elaborated how such claims can be used for botanicals, being herbs and extracts thereof. So far, no authorized claims for botanicals are available, but their use is nevertheless possible under certain circumstances. In sum, an on-hold claim can be used when the FBO clearly states the conditional character thereof (by stating the number of such on hold claim on this claims spreadsheet. Upon dispute, the FBO should furthermore be able to substantiate that the compound in the final product can have the claimed effect when consumed in reasonable amounts. TCM can take advantage of this current practice, thereby communicating the healing effect thereof, which basically comes down to a contribution to general health. It should be carefully checked though, if the claim for the herbal remedy at stake has not been rejected, as happened to four claims regarding caffeine.

Conclusion

EU market introduction of TCM could take place in various ways, depending on the qualification of the product at stake. Qualification as a regular foodstuff certainly ensures the quickest way to market, as no prior market approval is required. This will be different if the product qualifies as a Novel Food. However, as of 1 January 2018, a fast track authorization procedure will be available for traditional foods from third countries, from which TCM might benefit as well. TCM could furthermore use so-called botanical claims, in order to communicate the healing effects thereof. When the TCM qualifies as a medicinal product, the good news is that for traditional herbal medicinal products, a simplified registration procedure is available under the EU Medicinal Product Directive, provided that certain criteria are met. Registration takes place via the national competent authorities in each Member State, which in the Netherlands is the Medicines Evaluation Board (CBG).

Cross sector innovations and legal loopholes

Posted: December 7, 2016 | Author: Karin Verzijden | Filed under: Authors, Enforcement, Food, Health claims, Information, Nutrition claims | Comments Off

On 24 November last, the Dutch Life Sciences Conference took place in Leiden, the Netherlands. This conference brings together a large number of life sciences professionals from the Netherlands and abroad. One of this year’s sessions was dedicated to cross sector innovations, during which DSM, NutriLeads, i-Optics and Axon Lawyers shared their take on this topic. This post captures the legal presentation made during this session on cross over innovations, focussing on the applicable rules to borderline products. These rules are explained on the basis of landmark ECJ decisions and recent Dutch case law. The slides belonging thereto can be viewed here.

Product qualification

In order to demonstrate that it is not always easy to correctly qualify life sciences products, a few decisions from Dutch Courts and the Advertising Code Committee were discussed (see slides 3 – 7). According to a recent decision of the Dutch Supreme Court in the field of tax law, toothpaste and sun cream were surprisingly qualified as medicinal products. This case had been initiated in 2010 by two drugstores that were unhappy they had to pay the regular VAT rate of 21 % with respect to these products. According to the drugstores, these products qualified as medicinal products, to which a VAT rate of 6 % is applicable. Although their plea had been dismissed in two instances, the Supreme Court agreed with the drugstores that based on the presentation criterion (see below), both products indeed qualified as medicinal products, as they advertised therapeutic or prophylactic effects. With respect to toothpaste, this was due to the natrium fluoride protecting against caries and with respect to sun cream, the UVA and UVB filters were supposed to protect the skin against sunburn.

Legal framework

The case discussed above so far stands in isolation, but here are many cases that have shed light on the distinction between two categories of life sciences products, being food and medicinal products. Below you will find 5 criteria that will help you to apply this distinction. In slides 8 – 12, you will find the applicable legal sources.

The legal product definitions should be taken as a starting point. Bottom line, medicinal products are products aimed curing, prevention or diagnosis of a disease, whereas food products are products intended to be ingested by humans.
A distinction is being made between medicinal products by presentation and medicinal products by function. Extensive case law is available for the interpretations of these notions (see below). In case of doubt, the rules relating to medicinal products shall prevail.
It is prohibited to advertise medicinal products without having a market authorisation. For advertising of food products, it is permitted to use authorised health claims, but it is prohibited to use medical claims.
Medical claims are communications claiming that the advertised products improve health problems. It is a thin line between non-authorised medical claims and authorised disease risk reduction claims.
The notion of advertising can be pretty broad. According to the Dutch Advertising Code it comprises any public and/or systematic direct or indirect recommendation of goods, services or views for the benefit of an advertiser, whether or not using third parties.

Medicinal Products by presentation

In the landmark ECJ case Van Bennekom, the presentation criterion to qualify medicinal products was introduced. The case related to a Dutch national, who was caught with large quantities of vitamin preparations for medicinal purposes in pharmaceutical form, however without any required pharmaceutical authorisations. Van Bennekom did not deny the facts, but he alleged that he was not marketing medicinal products, but food products. The ECJ ruled that for the sake of consumer protection, the presentation criterion not only covers products having a genuine therapeutic or medical effect but also those regarding which consumers are entitled to expect they have such effect. In sum, the presentation criterium should be broadly interpreted on a case-by-case basis, taking into account all relevant factors. The concentration level of active ingredients forms only one of those factors.

Medicinal products by function

The ECJ Hecht-Pharma decision is still leading to set the parameters to decide if a product qualifies as a medicinal product by function. Hecht Pharma was marketing in Germany a fermented rice product in the form of capsules presented as being food supplements. Further marketing was prohibited, as the product contained significant levels of monalin k, which is an inhibitor of cholesterol synthesis. The product was considered as a medicinal product by function, for the marketing of which a market authorisation would be required. The ECJ ruled in this case that for the purposes of deciding if a product falls within the definition of medicinal product by function, the national courts must decide on a case-by-case basis, taking into account all characteristics of the product, such as its composition, its pharmacological properties and manner of use, the extent of its distribution, its familiarity to consumers and the risks, which its use may entail. As reported in a recent post, these criteria are still valid.

Functional foods

A recent Dutch decision on a licensing dispute entailed so-called functional foods. Although this notion does not have a legal definition under EU standards, it is usually understood as food having certain medicinal properties. The dispute divided Unilever and Ablynx, who both had obtained a license from the Brussels University (VUB) under certain antibody patents owned by VUB. Unilever’s licensed related to (roughly speaking) food products, whereas Ablynx’ license related to medicinal products. Under its license, Unilever developed so-called functional foods having certain beneficial effects against infections caused by the rotavirus. Ablynx claimed that Unilever had thus operated outside its licensed field and thereby acted unlawfully vis-à-vis Ablynx. The Hague Appeal Court endorsed Ablynx’ claims, on the assumption that Unilever’s license was clearly directed against non-pharmaceutical products. As such, it could target general health benefits (such as lowering cholesterol), but not specific pathogens.

Take home

What can you learn from the above? It is important to obtain pre-market clearance for the communication on health products. For this purpose, you can take guidance from the Advertising Code on Health Products (Code aanprijzing gezondheidsproducten), applicable to products having a pharmaceutical form and a health related primary function, however without being medicinal products. You could also request pre-market clearance from KOAG-KAG, whom actively evaluates claims on health products and provide endorsements. If and when you are confronted with enforcement measures by either the Dutch Health Care Inspectorate (Inspectie Gezondheidszorg or IGZ) or the Dutch Food Safety Authority (Nederlandse Voedsel en Waren Autoriteit or NVWA), first try to buy some time by claiming an extension for response. Subsequently, carefully consider if the claims made by the enforcement authorities are factually correct and legally enforceable. Whenever helpful or necessary, obtain professional support.

Enforcement measures regarding borderline products

Posted: October 14, 2016 | Author: Karin Verzijden | Filed under: Authors, Enforcement, Food Supplements | Comments Off

Nederland, Leiden, 18 maart 2015, Gaper in Centrum van Leiden. Drogist winkelstraat Leiden, Gaper, gapers vanaf de 17e eeuw als uithangteken voor een drogist gebruikt. De nar als gaper verwijst naar de kwakzalver die op jaarmarkten en kermissen zijn diensten aanbood. In gezelschap van zijn knecht (een nar in rare uitdossing) kon hij indruk maken en was hij verzekerd van klanten. Een andere gaper die veel voorkomt is de zieke zelf, soms met pil op de tong. medicijnen drogist apotheek pillen beeld pil patient patienten slikken apotheker medicijn zelfmedicatie medicatie farmaceutische farmacie geneesmiddelen zorgpremie gezondheidszorg Foto; Peter Hilz / HH

Photo Peter Hilz / HH

As observed in an earlier post, the boundaries between food products and medicinal products are sometimes blurred. However, the qualification of a product as either one or the other may have huge regulatory consequences. In recent litigation in several Dutch Courts the Hecht-Pharma decision from the EU Court of Justice (ECJ) was applied. This series of cases is of interest for food business operators, as it provides a clear message regarding enforcement measures directed against borderline products. The national health authorities should strike a fair balance between the free movement of goods and the optimal protection of public health. Whereas enforcement policies re. borderline products constituting a threat to public health may be justified, this does not entail that each and every food product containing a substance with a physiological effect automatically qualifies as a medicinal product by function.

Red Rice

The facts of the case Hecht-Pharma related to a food supplement with fermented rice that Hecht-Pharma had been marketing in Germany under the name “Red Rice”. The recommendations for use read “as food supplement, 1 capsule, 1 – 3 times a day”. The German authorities had qualified this product as a medicinal product by function, but Hecht-Pharma did not agree. It argued that having regard to the recommended dose, the product at stake could not exert a pharmacological action.

Medicinal product by function

In its request for a preliminary ruling, the Federal Administrative Court aimed to clarify if, after a change of the Medicinal Products Directive, criteria previously developed to establish if a product qualified as a medicinal product by function, still applied. Qualification as a product as a medicinal product by function implies that it is aimed at a change in physiological functions by exerting a pharmacological, immunological or metabolic action. The ECJ confirmed in its Hecht-Pharma decision that previously developed criteria were still in place. As a result, the national authorities must decide on a case-by-case basis, taking into account all the characteristics of the product at stake, in particular its composition and pharmacological properties, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail when they decide if a product qualifies as a medicinal product by function. Clearly, a product cannot be regarded as such, when it is incapable of appreciably restoring, correcting or modifying physiological functions in human beings.

Melatonin-based products

The Dutch Court cases related to melatonin-based products, marketed by a number of companies represented by the Dutch foods supplements association NPN (Natuur- en Gezondheidsproducten Nederland). During the period between 2011 and 2014, The Dutch Health Inspectorate (IGZ) and the Dutch Food Safety Authority (NVWA) on the one hand and NPN on the other hand, corresponded on the topic of melatonin-based products. The Dutch authorities thereby took the view that they considered products containing 0,3 mg melatonin or more to be a medicinal product by function. They based their view on literature studies, from which it would follow that a single oral dose of 0,3 mg melatonin produced a pharmacological effect on humans. In view of their public role of safeguarding public health, the authorities intended to launch enforcement measures regarding products containing more than 0,3 mg melatonin, unless the manufacturer at stake had applied for an authorization to market these products as medicinal products.

Enforcement measures and subsequent summary proceedings

Early 2015, IGZ sent a letter to all Dutch manufacturers of melatonin-based products informing that they would require a market authorization for continued marketing of products containing 0.3 mg melatonin or more. Each such manufacturer should inform the authorities prior to 15 March 2015 for which melatonin-based products it would or it had already applied for such authorization, failing which enforcement measures could follow. NGN subsequently initiated summary relief proceedings, claiming inter alia that IGZ should refrain from enforcement measures, unless it had demonstrated with respect to each and every melatonin-based product that it qualified as a medicinal product according to applicable legal criteria as validated in case law. In these proceedings, NPN claimed that IGZ had not sufficiently demonstrated, based on scientific evidence, that products containing 0,3 mg melatonin or more could change physiological functions in the human body, for instance by a pharmacological effect. Furthermore NGN argued that IGZ had neglected to apply the criteria developed in Hecht-Pharma, according to which IGZ should have established with respect to each melatonin-based product that it qualified as a medicinal product, thereby taking into account all relevant circumstances. According to NPN, these products were food supplements, not medicinal products.

Evaluation by the Court in summary proceedings

Based on a very broad interpretation of the definition of medicinal product, as contained in article 1.2 of the Medicinal Products Directive, NGN’s claim was dismissed. According to the Court, assessment of each individual product could be done by the Dutch Medicines Evaluation Board or by EMA, upon filing of an application for marketing authorization. It was not necessary for IGZ to proceed to this evaluation at an earlier stage, as the chances that any deviations from the general conclusion would be found, were considered very small. The Court did consider however that IGZ’s communication and application of enforcement measures had not been unambiguous. Even if the manufacturers of the melatonin-based products followed the request to indicate by 15 March 2015 for which products they filed an application for marketing authorization, it would not be clear by when they would know if IGZ – pending such application – would refrain from enforcement measures. This created uncertainty in the market and was considered unlawful vis-à-vis NGN. The Court therefore ordered IGZ to set a term after 15 March 2015 during which the products for which a market authorization had been requested would be tolerated.

Decision reversed on appeal in summary proceedings

On appeal, the discussion was focused on the correct application of Hecht-Pharma. Contrary to the Court in first instance, the Appeal Court held that a public health authority announcing enforcement measures should at that very moment motivate why a product containing > 0,3 mg melatonin qualifies as a medicinal product. A different approach could create unjust market restrictions, for instance regarding products that upon application were not considered medicinal products. Moreover, the requirement to file a market authorization for each and any melatonin-based product containing > 0,3 mg melatonin is not just a formality, but would oblige manufacturers of this type of products to make an important investment in time and resources. Taking into account there were no acute health issues for the continued marketing of melatonin-based products, at least not for those containing a maximum up to 5 mg melatonin, the Appeal Court ordered that public health authorities should apply all criteria developed in Hecht-Pharma when considering enforcement measures against borderline products.

Confirmation in proceedings on the merits

This summer, the District Court of The Hague confirmed in a decision on the merits the appeal decision in summary proceedings discussed above. In short, this Court held that the unconditional qualification of a group of products as medicinal products, without any individual evaluation taking place, was not in line with EU case law. The Court in particular referred to paragraph 68 of the conclusion of the Advocate General. The Advocate General stated, inter alia, that the insidious extension of the scope of the Medicinal Product Directive by including products that do not belong there, would harm the free movement of goods. Therefore, until an individual assessment of a borderline product based on the Hecht-Pharma criteria has taken place, the public health authorities are not allowed to take any enforcement measures. No appeal was filed by IGZ against the present decision of The Hague District Court, but we were informed that where necessary, IGZ will proceed to enforcement in individual cases.

Take home

If and when your company receives a warning letter from IGZ announcing enforcement measures because of its borderline status, please bear in mind the following. Before considering any change in the product like the lowering of its active substance or even its withdrawal from the market, the public authorities should have unconditionally qualified the product at stake as a medicinal product. If and when this situation is not clear, make sure to obtain professional advice to properly deal with the health authorities.

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