During the two days event in Wageningen, on 17 and 18 May this year, food start-ups will have the opportunity to give their best before an audience of seasoned investors. In the same time, those investors will have the chance to satisfy their appetite for tasty food start-ups. During this event, Karin Verzijden will moderate a debate between food start-ups on the convergence of food and health. The Q&A below provides a sneak peak into the topics that will be touched upon during that debate.
F&A Next: What is “healthy food” and to what extent food can contribute to health?
Karin: Although there is no such thing as a definition of healthy food, there are numerous guidelines on healthy diets. At the end of 2015, the WHO published a report that shocked food business operators (“FBO’s”), especially those involved in the meat industry. One of the WHO recommendations was to eat less processed meat, as the consumption of 50 g processed meat per day would increase the chance to develop colon cancer with 18 %. In line therewith, the Dutch dietary guidelines 2015 (“Richtlijnen Goede Voeding”) published by The Health Council propagate that a shift in the direction of a more plant-based and less animal-based dietary pattern improves health. In general it can be stated that according to various different health organisations, the consumption of certain foods or refraining therefrom can certainly contribute to health.
F&A Next: How do specific groups benefit from e.g. personalized food?
Karin: Specific groups of people may require specific types of food. For instance, it is known that elderly people recovering from surgery in the hospital lose a lot of muscle mass. They could benefit from so-called food for special medical purposes rich in protein. Anticipating that such food will enhance their recovery, this may in the end reduce hospitalization time and thereby costs. For the time being, this is as close as its gets to personalized food, but this may be different in future.
F&A Next: How “personal” is food likely to become and what type of legal issues may come into play?
Karin: In the future, it is conceivable that food will be delivered through the use of 3D-printing, both in a care setting and at home. In a care setting, one could imagine that very fragile patients having swallow problems could benefit from smooth printed food delivered on their plate in a very attractive way. When a hospital nutritionist would like to add extra vitamins or minerals, it is very likely that the upper limits laid down in the legislation on fortified foods needs to be taken into account. Furthermore, both in a home and care setting, interesting questions as to food safety may occur. For instance, when safety of 3D-printed food is compromised, who would be responsible for that? The manufacturer of the 3-D printing machine, the supplier of the raw materials or the user of the 3D-printing device, who in fact has promoted from a consumer into a “prosumer”? Finally, when 3D-printed foods hit the market as end products, they may be covered by the Novel Food legislation on new production methods. This would imply that such product would require a market authorization prior to marketing.
F&A Next: How can FBO’s communicate on potential health benefits of food without incurring the risk that they advertise a medicinal product or a medical device?
Karin: In the EU, there is a well-defined framework for nutrition and health claims to advertise health benefits of food products. A nutrition claim implies that a food product has certain beneficial properties in terms of nutrients and energy (“What’s in the product?”). Health claims state there is a relationship between food and health (“What does the product do?”) As long as the FBO sticks to the authorized claims (of the allowed variations) and they satisfy their conditions of use, there is no problem to be expected. FBO’s should however stay away from claiming that their food product can prevent or cure certain diseases, as they then clearly enter in to the medical arena. Based on criteria laid down medicinal products legislation, food and health authorities are authorized to take enforcement measures regarding food products that are advertised as having such medicinal properties. This can result into serious fines of six digits.
F&A Next: What actions are required from FBO’s to substantiate the health effects of their food products?
Karin: This depends on the type of claim made. For instance if the FBO claims his product is high in protein, he has to be able to justify upon request that the 20 % of the energy value of the product is provided by protein. When a FBO claims regarding a barley product that barley beta-glucans may reduce blood cholesterol, whereas high cholesterol is a risk factor in the development of coronary heart disease, he should meet very specific criteria on the level of barley beta-glucan (3 g per day). Finally, when a FBO wants to obtain a so-called proprietary claim, he should initiate clinical trials in order to identify the relationship of cause and effect between a particular nutrient and its alleged health effect.
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.
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.
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.
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.
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.
In the last post of last year, we reported on the use of health claims for food products directed at weight loss. In essence, the level playing field is pretty limited. The Claims Regulation does not allow using any claims that make reference to the rate or amount of weight loss. Under certain conditions, it is allowed to market a food product stating that its consumption will decrease the sense of hunger or increase the sense of satiety, but that’s about it. Early this summer, the Dutch Advertising Code Committee (Reclame Code Commissie, “RCC”) ruled in a case relating to weight loss, but considered the claims made therein were not inappropriate. What was the background of this case and what type of product was involved? All those who are interested in advertising products targeting weight loss, keep on reading.
Self-regulation of Marketing Food Products in the Netherlands
The RCC is a self-regulatory body of the Dutch Advertising Code Authority, ruling on complaints that can be lodged by both companies and individuals. Rulings are made based on the Dutch Advertising Code and a number of satellite codes, such as The Advertising Code for Food Products and the Code for Advertising directed at Children and Young People. The RCC also bases its Rulings on the advertising provisions contained in the Dutch Civil Code, as well as on particular provisions from the Claims Regulation and the Food Information to Consumers Regulation. Although the RCC Rulings are not legally binding, there is a high degree of compliance (about 96%). This is explained by the fact that the Dutch Advertising Code Authority has been put in place by joint decision of the Dutch advertising companies, whom make a yearly contribution for its operation in proportion to their marketing budget.
Clearance and monitoring services
Clearing and monitoring services regarding the advertising of products based on various self-regulatory codes used by the RCC are offered by Inspection Board Health Products (Keuringsraad “KOAG/KAG”). The products targeted by KOAG/KAG are pharmaceuticals, medical devices and health products. The latter are described as products presented in a pharmaceutical form or claiming a health related primary function without qualifying as a pharmaceutical. Those are what we typically call borderline products. Hiring the clearance services of KOAG/KAG for the advertising of one of the products within its remit has certain advantages, as KOAG/KAG has the informal arrangement with the Dutch Food Authority that approved commercials shall not be subject to enforcement actions.
Facts of the XL-S Medical Case
The case in which the RCC ruled this summer, related to the product XL-S Medical marketed by Omega Pharma. The product is marketed in pills and promotes the formula of a healthy diet, enough exercise and using XL-S Medical. In the TV commercial subject to complaint, the famous Dutch singer René Froger arrives on his bike with a basket plenty of fruits and vegetables hanging from its steering wheel. Two ladies along the road enthousiastically greet him and ask “Hey René, what’s the score?” Before the singer replies to the ladies, one sees him attach to the wall a paper stating: “interim score: minus 8 kilo”. And the singer to confirm to the ladies, “Oh yes, I already lost 8 kilos, I feel great!” Finally a voice-over states: “Follow René and also lose 8 kilos. Before using this medical device, read the instructions.”
According to the plaintiff, it is prohibited to make this type of claims for this type of product. In order to substantiate the complaint, reference is made to particular information displayed at the website of the Dutch Food Safety Authority translating the prohibition laid down in article 12 (b) of the Claims Regulation. More concretely, according to this information it is prohibited to state that the consumption of a particular food product will result in the loss of X kilo’s in Y weeks. Also, it is not permitted to show testimonials “before” and “after” the use of a particular food product. The rationale is that the extent to which weight loss is achieved not only depends from the use of a particular food product, but also on what more the consumer at stake will eat and on how much exercise he/she gets.
In defence, Omega Pharma states that XL-S Medical is not a food product, but a medical device. In fact, this is a class IIb medical device market under CE-number CE0197. It is recommended that this product is taken in addition to regular food and it contains ingredients that lower the appetite and calorie uptake from food. Such product is not subject to the rules applicable on advertising food products, but to the Advertising Code Medical Devices. According to this code, it is not allowed to claim that the consumption of a particular product shall result in the loss of a certain amount of weight in a certain amount of time. It is allowed however to state the actual weight loss as a result of its use. Moreover, the singer René Froger indeed lost 8 kilos, by doing a lot of exercise, having a healthy diet and using XL-S Medical. As the commercial does not state a specific time frame during which this was achieved, the commercial is in line with article 7.2 of the Advertising Code for Medical Devices. The defence presented by Omega Pharma was endorsed by the RCC. Moreover, this commercial obtained pre-market clearance from KOAG/KAG.
This Ruling shows that depending on the qualification of a product, different rules may be applicable on the marketing thereof. The decisive factor in order to decide whether a product qualifies as a food product or a medical device, is it actual activity. Most slimming products, based on their physiological or nutritional activity, qualify as food supplements and are subject to the Claims Regulation. The product at stake however had a particular physical activity and as a result, it qualified as a medical device. On the one hand, this entails more preparatory actions before marketing, such as assessment by a notified body when a class IIb device is involved, like the in the present case. On the other hand, this qualification may offer advantages in the marketing thereof. It is therefore of the essence to begin with the end in mind when marketing borderline products: know what type of product is at stake and what is the applicable regulatory framework. Also, consider using pre-launch clearing services as described herein.
Shock and awe: they did it! A few days after the United Kingdom voted to leave the European Union, many sectors are investigating the consequences thereof for the services and products concerned. The more a sector has been regulated at an EU level, the more severe those consequences tend to be.
EU landscape of food law
If any sector has been highly regulated at an EU level, it is the food sector. The BSE crisis in the ’90-ies gave rise to the General Food Law Regulation in 2002, which has been the basis for a considerable corpus of rules relevant for the nutraceutical sector. These rules include the Food Supplements Directive (2002) as well as the Regulation on Fortified Foods and the Claims Regulation (both from 2006), as well as the Food Information to Consumers Regulation (2011) and the Regulation on Foods for Special Groups (2013) to name just a few.
What is going to happen next?
Although it is difficult to imagine that years of laws and case law can be cast by a vote, strictly speaking the European Regulations will cease to apply in the United Kingdom once it no longer forms a part of the EU. Also, there will no longer be an imperative to implement European Directives into English national law. Access for European nutraceuticals to the UK market and access for English nutraceuticals on the EU market will therefore depend on the instruments replacing the common European framework.
What are the options?
Firstly, the UK could reach and agreement similar to the one that the EU has with Norway or Iceland. In that case, the impact in the field of nutraceuticals would be fairly limited; the UK forming part of the European Economic Area and to a large extent be bound by EU legislation. Secondly, if the relationship would be shaped after the one between the EU and Switzerland, the implications could be more important, as EU food law would not be of general application in the UK. Thirdly, the gap between the current and future situation would be even greater if the relationship will be similar to the one that the EU has with the USA under the WTO, as for each specific sector specific agreements would need to be negotiated.
The trigger and the transition period
In order to move to the next stage, the UK will have to inform the Council of its decision to withdraw from the European Union, based on the famous article 50 of the Lisbon Treaty. So far, the UK seems to be divided on the question when this process has to be initiated. Some (Europeans) speculate that it may not be initiated at all. However, once the Council has received notice from the UK, an agreement setting out the arrangements for withdrawal should be negotiated within two years. During this transition period, the EU regulatory framework for nutraceuticals shall – in principle – remain in force. However, it can be expected that food business operators shall anticipate on the shift in the regulatory landscape. The UK may become less attractive to trade nutraceuticals due to the uncertainly what will be the applicable rules there.
Open ends… or not?
Based on the EU regulatory framework, nutraceuticals generally do not require prior market approval. This implies that English nutraceuticals could in principle still be marketed in the EU after the Brexit becoming effective. However, any English nutraceuticals marketed in the European Union will have to meet the EU requirements regarding the type of vitamins and minerals that may or may not be used in food supplements and fortified foods respectively. Furthermore, English nutraceuticals to be marketed in Europe may only use those nutrition and health claims that have been authorized at an EU level and that bear information on ingredients and nutrition facts in line with the Food Information to Consumers Regulation. The other way round is much less clear, meaning that it will remain an open question for quite some time with what rules European nutraceuticals to be marketed in the UK will have to comply . This will depend on the rules applicable to nutraceuticals in the UK replacing the EU regulatory framework. Summarizing it seems that trading UK nutraceuticals in the EU will not become “easier” from a UK perspective, whereas marketing European nutraceuticals in the UK will become less attractive because of the regulatory flaw.
Homework on IP licenses
For those food business operators distributing nutraceuticals under license in the licensed territory of the European Union, it is mandatory to clarify whether or not that territory still includes the EU after a Brexit becoming effective. This will not only depend on the wording of the agreement but also on the trademark backing the license. If this is for instance an EU trademark (former Community Trademark), this will no longer be valid in the UK in future. Moreover, if the validity of this EU mark was mainly based on genuine use in the UK, the validity of the entire trademark could be at stake because such use would no longer be of relevance for the continued existence of the mark.
The majority of the British people do not seem to have done a favor to the nutraceuticals industry, to put it mildly. In order for English nutraceuticals to access the EU market, these products will have to meet the EU standards anyway. For European nutraceuticals to be marketed on the Brittish market however, it cannot yet be predicted to what rules they need to comply. It does not seem to be realistic that the UK will opt for the Norwegian model, as it deliberatly moved away from the EU and – presumably – from the EU regulatory framework. It is also hard to conceive that the UK, being such an important trade partner of the EU will put in the same position as the US under the WTO. Remains the Swiss model as a most likely option for the trade agreements to be negotiated between the EU and the UK, but the Swiss model currently also implies the free movement of persons, which is an issue for the UK. So this is not an easy one. Keep you posted.
Photo by Tolga Akmen/LNP/REX/Shutterstock (5738024r) Pro-EU campaigners protest against Britain leaving the European Union in Trafalgar Square – London Stays anti-Brexit demonstration, Trafalgar Square, London, UK – 28 Jun 2016. The referendum was won by the leave campaign and caused Prime Minister David Cameron to resign on 23 June 2016.
Botanicals are preparations made from plants, algae or fungi that are applied for uses in cosmetics, pharmaceuticals and food supplements. These products have become widely available in the EU and can be bought OTC in pharmacies, supermarkets, drug stores and via the Internet. As to foods supplements, typically these products are labelled as “natural foods” and they come along with various claims regarding potential health benefits. The authorization of health claims for botanicals is still pending in the EU, meaning that they have been neither authorized nor rejected. A recent case from the appeal body of the Dutch Advertising Code Committee perfectly demonstrates the room for manoeuvre for this type of claims.
Green coffee extract
The Dutch online store www.vitaminesperpost.nl offered for sale the product “Green Coffee Plus Extra Strong”, consisting of a green coffee extract, to which was added an extract from green tea and artichoke. The product was a food supplement advertised as being a powerful formula for fat burning, based on its high contents of chlorogenic acid. The Dutch Advertising Code Committee received a complaint regarding this product, as its allegedly beneficial properties could not be substantiated. Complainant had consulted the Natural Medicines Comprehensive Database regarding all 3 ingredients, but did not find any support for the claim regarding fat burning. Complainant considered the claim misleading and therefore unfair.
Authorized use of “claims on hold”
The Dutch branch organization for marketing health products (KOAG/KAG) currently permits the use of health claims for botanicals under certain conditions. The advertiser should be able to produce the EFSA ID number under which the claim is on hold, as well as the conditions of use and the recommended quantity per day of the ingredient at stake. Furthermore, when the use of such claim is disputed, the advertiser using it should be able to substantiate it. In the case at hand, the FBO selling Green Coffee Plus Extra Strong deduced from EFSA’s on hold claims database that it was permitted to associate at least green tea and artichoke with weight control and / or digestion.
Substantiation of claims made
In first instance, the Advertising Code Committee recognized the claim “stimulates fat burning” as a health claim, whereas it was not immediately obvious to which of the three ingredients this claim was linked. Due to the applicable transition regime with respect to the “on hold” claims for botanicals, it did not consider this claim to be in violation of the Health Claim Regulation. The Dutch Advertising Code Committee insisted however that the advertiser of the product Green Coffee Extra Strong substantiates its claim regarding fat burning. The plausibility of the claim made does not automatically follow from the fact that certain ingredients are placed on EFSA’s on hold database. As the advertiser did not succeed to provide the required evidence, his advertisement was considered incorrect. On the basis of this incorrect information, consumers might be inclined to buy the product, which is why the advertising was also considered misleading and therefore unfair.
From green coffee to green tea
On appeal, it became clear that the advertiser was aware that it was not allowed to make any health claims for green coffee. It had therefore added to its product a green tea extract for the minimum conditions of use to obtain the claimed effect. The advertiser clarified that the claim for fat burning was specifically linked to green tea. The Appeal body established that for green tea, a number of claims were on hold in connection with “weight management” and “fat metabolism”. It furthermore established that for such claims to be lawfully used under the transition regime captured by article 28.5 of the Health Claims Regulation, the following conditions should be met:
- the claims should not be misleading (article 3 Claims Regulation);
- the claims must be based on generally accepted scientific evidence (article 6 Claims Regulation); and
- the claims should be in compliance with national legislation.
Anticipating authorization procedure
When an advertiser uses an “on hold” claim and without reservation claims a particular effect, it in fact anticipates the outcome of the authorization procedure pertaining thereto. In such situations, said advertiser should be able to substantiate the claim when disputed. The rationale thereof is that the Health Claims Regulation aims to maintain a high level of consumer protection (article 1 Health Claims Regulation) and in general advertisers should be able to substantiate their claims (article 17 Health Claims Regulation). Once again, it was established that the advertiser was not able to do so and therefore its use of the claim regarding fat burning was considered misleading. The fact that he was also using the disclaimer that Green Coffee Extra Strong was not a miracle product and that it should be used as in support of a healthy diet and sufficient physical exercise, could not change this conclusion.
Negative EFSA opinion
Moreover, it appeared that EFSA had published a negative opinion stating that there was no relationship of cause and effect between the consumption of green tea and green coffee and fat burning. Basically, this was the end of the story, as EFSA had declared that substantiation of claim with respect to fat burning in relation to green coffee and/or green tea could simply not be delivered.
Under the current regulatory framework, it is not allowed to use health claims for botanicals, provided that the conditional character of such claims is clearly communicated. Before using any such claim, it is furthermore recommended to check if it is not covered by a negative EFSA opinion. Finally, when the claim made is being disputed, the advertiser should be able to substantiate it.
Some food supplements claim to help the consumer to lose weight and achieve the ideal bodyweight by consuming the product. Sounds too good to be true? Then this post is of interest for you. Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) was asked to provide a scientific opinion on the conditions of use for health claims related to meal replacements for weight control. In fact, the NDA Panel previously evaluated the conditions of use for these types of claims in 2010. We take this re-evaluation as an opportunity to report on the legal framework for weight loss claims regarding foodstuffs.
Relevant legal framework
The relevant legal framework is constituted by both the Health Claim Regulation and the Energy Restricted Diets Directive. Article 12 of the Health Claim Regulation prohibits the use of claims making reference to the rate or amount of weight loss. According to article 13 of the Health Claim Regulation however, it is permitted to use health claims describing slimming or weight control or a reduction in the sense of hunger. It is also permitted to use claims describing an increase in the sense of satiety or the reduction of the available energy from the diet. For these claims to be allowed, they should be in line with the requirements of the Energy Restricted Diets Directive (containing both compositional and labeling requirements) and they should be included in the Community list of permitted claims. Furthermore, these claims should be based on generally accepted evidence and they should be well understood by the average consumer.
Various claims allowed regarding normal metabolism
The consumer could be helped in achieving weight reduction by consuming products that replace some of the daily need for energy or that reduce the craving for more food. In fact, maintaining a healthy metabolism (of either lipids or carbohydrates) could result in weight loss on the long term. There are quite a few authorized claims relating to a normal metabolism. For instance, the claim “Zinc contributes to normal carbohydrate metabolism” can be used if the product to which it relates contains zinc in a quantity of 1,5 mg/100 g or 0,75 ml/100 ml. Furthermore, the claim “Calcium contributes to normal energy-yielding metabolism” is allowed if it relates to a product contains at least 120 mg/100 g calcium or 60 ml/100 ml Calcium. As a final example, the claim “Choline contributes to normal lipid metabolism” can be used if the food product at stake contains at least 82,5 mg of choline per 100 g or 100 ml or per single portion of food.
One single authorized claim regarding weight loss
Until now only one single claim with respect to weight loss has been authorized. The claim reads “Glucomannan in the context of an energy restricted diet contributes to weight loss”. Glucomannan is extracted from a plant called “konjac”, having very diverse nicknames, such as devil’s tongue or snake palm. The claim regarding Glucomannan is targeted at overweight adults and may be used only for food products that contain 1 g of glucomannan per quantified portion. Furthermore, the consumers should be informed that the beneficial effect is obtained with a daily intake of 3 g of glucomannan in three doses of 1 g each, together with 1-2 glasses of water, before meals and in the context of an energy-restricted diet.
Two authorized claims for meal replacement
Next to the Glucomannan-claim, there are two claims available for foodstuffs replacing one respectively two meals a day. Both claims are identical and read “Meal replacement for weight control”. Where nutrition and health claims in general are linked to particular nutrients, this claim however is not. In order to achieve the claimed effect, one meal respectively two meals should be substituted with meal replacements daily. Furthermore, foodstuffs bearing this claim should comply with specifications laid down in Energy Restricted Diets Directive. This Directive sets minimum and maximum limits for nutritional values of foodstuffs that are consumed as a replacement for one or two meals a day. Furthermore, this Directive prescribes the content of replacement products, in terms of energy, proteins, dietary fiber, vitamins and minerals. The foods under the Energy Restricted Diets Directive are not to be confused with so-called medical foods. These foodstuffs also regulated in terms of content and labeling and they are also used to replace meals, however only upon prescription and not for the purposes of weight loss.
Re-evaluation of the weight loss claim
The reason for the re-evaluation of the claims regarding meal replacements for weight control is a bit of a technical story. We will try to do our best to explain this in clear and understandable terms. As of 20 July 2016, the Energy Restricted Diets Directive will be repealed by a new Functional Foods Regulation providing a common framework for all types of functional foods: infants foods, medical foods and total diet replacement for weight control. As a consequence, the Annex to the Energy Restricted Diets Directive containing detailed guidance on the composition of foods for energy restricted diets will no longer apply Instead, guidance will have to be taken from the applicable Annex to the Food Information for Consumers Regulation (Annex XIII, Part A to be exact) introducing the Nutrient Reference Values’ for vitamins and minerals. This will cause some changes (increases or decreases) in the micronutrient content of meal replacements to occur.
Task of the NDA Panel
Under both the current and the future legal framework for meal replacements, the foodstuff has to contain specified quantities of certain vitamins and minerals to make sure that even when replacing meals as a whole, the consumer does not suffer a vitamin/mineral deficiency. Normally, the consumer is expected to loose weight on the basis that the replacement meal has a controlled energy content and a relatively high protein/low fat content. The NDA Panel was asked to give its scientific opinion about the substantiation of the health claim related to meal replacements under the new Functional Foods Regulation. The NDA Panel considered that the difference in micronutrient composition required under this new Regulation in respect to the Energy Restricted Diets Directive did not affect the scientific substantiation of said health claim, as previously assessed in 2010. As a consequence, the claim “contributes to weight loss” can still be used, provided of course that the conditions for use are met.
What more is allowed?
With respect to other ingredients and substances than Glucomannan, weight loss or similar claims have been made as well. As examples can be mentioned green tea extract and hyperproteins pasta. EFSA did assess more substances and the related claims and concluded that there was a lack of scientific evidence to substantiate such a claimed effect. Recently the claim; “fat-free yogurt and fermented milks with live yogurt cultures, with added vitamin d, and with no added sugars help to maintain lean body mass (muscle and bone) in the context of an energy-restricted diet” was not approved. In essence, products that carrying the claim, ‘contributes to weight loss’ which do not contain Glucomannan in the prescribed quantities and do not comply with the standards as set in the Energy Restricted Diets Directive, are not allowed on the European market. But with a little education of the consumer, explaining that a normal metabolism is actually at least as important as weight loss, plenty of other claims are available for healthy products. During the festive season, the emphasis may not be on the consumption of healthy products. But on a day-to-day basis, we strive for a healthy intake – or don’t we? That’s the point!
The author is grateful to Floris Kets, intern at Axon Lawyers at the time of drafting this blog.
The Netherlands Food and Consumer Product Safety Authority (NVWA) has been pretty active this Summer. Following up on previous enforcement reports on nutrition claims, it recently published such enforcement report re. both nutrition and health claims for breakfast cereals. As this report relates to legislation that has been harmonized at an EU-wide level and it provides detailed enforcement information, this is an interesting read – not only for the Netherlands.
Less than 50 % fully compliant
Actually, the report publishes data on the review of claims regarding 126 different breakfast cereals marketed under 24 different brands. These data were compiled during the period between March – October 2014. From this review, It appeared that less than half of those products were fully compliant with the Claims Regulation. The NVWA considers it of the essence that Food Business Operators (FBO’s) offering for sale breakfast cereals fully comply with the Claims Regulation to enable consumers to make informed choices.
Nutrition and health claim framework
Since the entry into force of the Claims Regulation on 1 July 2007, only authorized claims can be used for food products. A claim is a message or representation in any form, that is not mandatory under EU law or national legislation and that states, suggests or implies that a food has certain characteristics. A nutrition claim is a claim that states or implies that a food has particular beneficial nutritional properties in terms of energy and/or nutrients. A health claim is a claim that states or implies there is a relationship between food and health. Amongst the health claims, a distinction is made between general claims, disease risk reduction (DRR) claims and claims relating to the health and development of children. In 2012, the Commission published a list of 222 authorized general claims that is dynamic and has currently evolved into 229 claims. Furthermore, there are currently 14 authorized DRR claims and 11 children’s claims. For both nutrition and health claims, strict conditions of use are applicable. For instance, in order to claim that a product is high in proteins, at least 12 % of the energy delivered by the product should be provided by proteins.
Method of enforcement
Contrary to previous claims enforcement reports that only related to nutrition claims, the NVWA this time also took into account health claims. More concretely, it report relates to pre-packed breakfast cereals that were offered for sale in the Netherlands at both retail and wholesale level. If the products at stake were advertised at websites as well, such information was also subject to enforcement. The products at stake consisted of granola, corn flakes, puffed rice grains, oatmeal and wheat meal, some of them supplemented by nuts, sugar, dried fruits or chocolate. The information reviewed was the name of the product and the nutrition labelling, in as far as related to nutrition and health claims. A warning letter was sent to those FBO’s whose products were not compliant, except when an unauthorized claim was used. In those cases, a fine was imposed under the suspensive condition of full compliance within a grace period. When I contacted the NVWA to know the average amount of such fine, I was informed that my query would be answered within 6 weeks. Apparently, the Summer scheme is still on at NVWA – too bad. But an update will be provided at FoodHealthLegal when more information is available.
Outcome of enforcement
As mentioned above, out of the 126 products that were reviewed, over half of them did not fully comply with the Claims Regulation, mostly because the claims used were pretty vague. Although it is permitted to use a variation on an authorized claim, the essence thereof should be the same as an authorized claim. An example of a claim that was sanctioned by the NVWA is “The cereals present in this product are the basis for a healthy and nutritious breakfast. It contains nutrients that are indispensable for the human body and that are quickly absorbed by the body.” Another reason why products were not compliant was that non-existent nutrition claims were used, such as “does not contain cholesterol” or “ contains many nutrients”. Furthermore, sometimes nutrition claims were made, whereas the strict conditions of use were not met. Although this is not visible from the product label, such is a violation of the Claims Regulation as well. Finally, on many products, the link between a specific nutrient and the health claim used on the labelling was missing. Instead, pretty general, non-specific, claims were made that can be quickly taken in by the consumer, but also easily be misunderstood. Therefore, such general, non-specific claims are only allowed if accompanied by a specific, authorized, health claim. For example, the claim “Crisply granola of brand X forms part of a healthy and nutritious breakfast” cannot be used alone, but it can be used jointly with an authorized claim for iron, like “Iron contributes to normal energy-yielding metabolism”.
The fact that the NVWA nowadays actively enforces health and nutrition claims shows that it considers B2C communication on food product to be an integral part of food safety. From our practise I know changing the packaging of your food products is a lot of hassle, so better get it right as from the start. Here are a few tips to help you along.
- At all times, it should be avoided to made a medical claim with respect to food products. Medical claims are claims directed at the prevention or treatment of a disease. Their use, if allowed at all, is strictly reserved for pharmaceuticals.
- If you consider the authorized claims are not persuasive or sexy enough, choose one of the variations published by the self regulatory body KOAG-KAG.
- Make sure you have data supporting the nutrition facts of your food product, as the burden of proof lies with the FBO when receiving a request pertaining thereto from the NVWA.
- When using general, non-specific claims, use the specific, authorized claim in the same field of vision.
- When in doubt, or if you simply need a sparring partner, consult an expert.
The use of nutrition and health claims is gaining wider application in the food industry. At the same time companies in the horticultural sector focus their marketing more and more at end users of their products. On the basis of this development, the Dutch Kenniscentrum Plantenstoffen (knowledge institute for plant compounds) initiated an investigation whether and how the vegetable chain can benefit from the use of nutrition claims. This information is relevant for breeders, growers, retailers, processors and consumers of vegetables.
The so-called claim legislation (EC Regulation1924/2006 and EC Regulation 116/2010) is applicable to all food and distinguishes between nutrition and health claims. These and the central concept of foodstuff have been defined as follows.
• Foodstuff: any substance or product, whether processed or unprocessed, intended to be consumed by humans. This includes, of course, vegetables.
• Claim: any non obligatory indication that states or implies that a food has particular characteristics, including graphics representations and symbols.
• Nutrition claim means any claim that the impression that a food has particular beneficial nutritional properties with regard to energy, and / or nutrients (“What is in the product?“)
• Health claim means any claim that the impression that there is a relationship between a food and health (“What does the product do?”).
Importance of claims for the horticultural sector: targeted breeding and communication
The Kenniscentrum Plantenstoffen chose to focus its investigation of the importance of nutrition claims for the horticultural sector. The use of health claims generally requires further research and evidence than is required for the use of nutrition claims. The importance of claims for the horticultural sector is twofold. Not only offer claims the opportunity to provide detailed information about specific nutrients in a product. Also the possibility of the use of a nutrition claim can offer an incentive for product improvement. When it is known which claims are relevant in connection with which vegetables and what conditions must be satisfied, is it possible to adjust the marketing and / or the breeding activiteis accordingly. For this purpose two documents were produced.
(1) List of permitted nutrition claims
(2) List of permitted vitamins and minerals associated with specific nutrition claims
List of permitted nutrition claims
|Selected nutrition claim||Condition for use||Relevant crops|
|High fibre||Product should contain at least 6 g fibre per 100g or 3 g fibre per 00 kcal.||Cauliflower, broccoli, cabbage, beans, Romaine lettuce and celery|
List of permitted vitamins and minerals
A special group of nutrition claims are the claims that read “source of [name of vitamin / mineral]” and “rich in [name of vitamin / mineral]”, which may be used solely in conjunction with permitted vitamins and minerals. The applicable legislation (currently EC Directive 90/496 and as per December 13, 2014 EC Regulation 1169/2011) identifies 27 permitted vitamins and minerals. 16 of them have been identified as potentially interesting in connection with plants and flowers. Subsequently, it has been established which claim can be used in connection with which vegetable, both per 100g and per portion. An example is as follows.
|Selected vitamine||Nutrition claim: “high on [selected vitamin]|
|Per 100 g||Per portion|
|Vitamine A||Carrots (raw and cooked), Cantaloupe melon, spinach, kale, chard, celery and chili||Carrots (raw and cooked), Cantaloupe melon, spinach, kale, chard, celery and chili|
In order to make a selection of crops in the list of nutrition claims, the following actions were taken per ingredient: (i) identification of crops rich in fiber (in particular example stated above) in two independent sources, (ii) selection of relevant Dutch horticultural crops, (iii) identification of the quantity of fiber per 100 g and per portion on the basis of two independent sources, and (iv) selection of crops on the basis of the so-called reference intake. For the selection of crops on the list of vitamins and minerals, an identical selection process was applied.
Despite the care applied to the selection of crops included in the list of nutrition claims, this selection is of course not set in stone. The reason is that the amount of nutrients (such as vitamins and minerals) is dependent on the specific cultivar per crop. Furthermore, growing conditions such as sun, soil, water and temperature affects the amount of nutrients present in crops. Finally, in the literature consulted regarding nutrients (including vitamins and minerals) intra-and intercontinental differences were found in the same crops. In addition, differences may exist within the same crop per portion: the weight of one tomato does not necessarily equal any other tomato.
Despite the above qualifications, the lists of authorized nutrion claims and vitamins & minerals can be considered as a good indication for which nutrition claims could be used in combination with which vegetable. These lists will be published shortly at this website and they can serve as a new perspective for the Dutch horticultural sector for their marketing and communication of their crops. With respect to vitamins and minerals are also a large number of health claims is available. The Kenniscentrum Plantenstoffen will look into this in the near future.
Health and nutrition claims targeted at food and medical products
For further information on the use of health claims targeted at different products, reference is made to our previous post on this blog. The slides of our seminar on medical and functional foods can be found here.
On 24 September 2014 our firm organizes a seminar addressing the developments in Functional and Medical Foods. Where? Next door to our office in Pakhuis de Zwijger.
The Institute of Medicine has designated functional food as “any food or food ingredient that provides a health benefit beyond its nutritional benefit”. Functional foods comprise food supplements, probiotics and other foods having a beneficial effect on human health, which is often advertised by health or nutrition claims as using those claims in connection with this type of foods is very attractive from a marketing point of view.
Functional foods are just one step away from medical foods, catering for particular nutritional needs that regular foods do not supply. Contrary to functional foods, medical foods are highly regulated. Furthermore, both types of food are subject to specific legislation regarding health and nutrition claims as well as regarding food information to be provided to consumers.
The regulatory requirements for health and nutrition claims offer a chance and a challenge. Also, as of 13 December 2014, all food business operators have to comply with very strict, new information requirements on the basis of the Regulation on Food Information to Consumers. To what extent does this regulation help the final consumer to make healthy choices and how does this impact the entrepeneur? Our seminar will address these issues and provides practical guidance on solutions. Speakers are: Bernd Mussler (Innovation Project Manager at DSM), Ruud Albers (CEO at Nutrileads) and us (Karin Verzijden and Sofie van der Meulen).
A few spots left!
We still have a few spots left! Attendance is free and you are welcome to bring along your colleagues. More info? Check the invitation on our website. For registration, please send an e-mail to firstname.lastname@example.org with your name, the names of colleagues you would like to register and contact information. Questions? Contact our office manager Marjon Kuijs at email@example.com or +31 (0) 88 650 6500.
Looking forward to see you there!
Missed our seminar? Download our slides!
From 21 – 24 June, the yearly conference of the International Food Technologists (IFT) took place in New Orleans, Louisiana. During this conference, over 16.000 food science and technology professionals discussed the most recent product, ingredient and technology developments, as well as the potential business impact and regulatory framework. Below, you will find a selection of topics discussed. It will also be commented how these impact food business operators in the EU.
So far, no proper legal definition exists of functional foods. Since 1984 however, the Institute of Medicine has designated as functional food “any food or food ingredient that provides a health benefit beyond its nutritional benefit”, which I consider a clear working title. In the functional food market, functional beverages are the fastest-growing sector. In the IFT-session “The evoluation of functional beverages” advances in ingredients were discussed, such as new vitamin forms, dietary fibers and certain omega-3 fatty acids. Also, trends towards more natural forms of coloration were discussed, for instance from lycopene and beta-carotene, which also increase antioxidant properties. Obviously, using health claims in connection with these functional foods is very attractive from a marketing point of view. However, this remains a strictly regulated area in the USA, where different rules apply to “classical” health claims, structure function claims and qualified health claims. As discussed in our posts of 8 May 2014 and 2 November 2013, this is not any different in the EU.
Health benefits of prebiotics
In IFT-session Presenters Detail Gut Health Research some of the latest research was shared on the ways in which prebiotics affect the gut microbiota. Prebiotics are substances that are selectively fermented by gut microbes, thereby delivering health benefits to the host. It was reported that during the last 20 years, research has shown that prebiotic ingredients stimulate the growth of beneficial gut bacteria. Furthermore, evidence has been obtained suggesting that diet can contribute health benefits by changing the composition of the gut microbiota. It was pointed out during this presentation, however, that regulatory bodies like the EFSA have refused to permit health claims for prebiotics. Although this may be true in general, it is not entirely correct for lactulose, regarding which EFSA’s NDA panel acknowledged the beneficial effect consisting of a reduction of transit time.
From the session Allergens-Free Food Formulation, it became obvious that allergies (being defined as an abnormal response to a food triggered by the body’s immune system) constitute a prominent item on the agenda of food business operators for the years to come. Currently, millions of people have food allergies and that total is growing. Presenters during this session referred to the statistics from the Centers for Disease Control, according to which food allergies among children surged by 50% between 1997 and 2011. In order to respond appropriately, food manufacturers not only have to formule allergen-free foods, but also create an allergen-free manufacturing environment. Also, all of this should be effectively reflected in the product information, in order to meet the applicable labeling requirements. As reported already in our post of 17 September 2013, with the entry into force of the Food Information Regulation by the end of this year, specific measures apply regarding 14 named allergens, both for pre-packed and non pre-packed food.
Product qualification: food or pharmaceutical?
In the session Food Clinical Trials and IND-applications, it was explained when clinical studies for foods would require the filing of an Investigational New Drug (IND) application. This question was answered based on a recent guidance document (Guidance for Clinical Investigators) issued by 3 organisations involved in the evaluation of drugs, biologicals and food and of course on the basis of the criteria contained in the Federal Food, Drug & Cosmetic Act (FFD&C Act). It was explained that if the intent of the clinical study is to investigate a physiological effect of the food on the structure or function of the body beyond the provision of taste, aroma, or nutritive value, then the study will require the filing of an IND application. Furthermore, guidance can be found in FFD&C Act, according to which a food qualifies as a drug if it is intended for use in diagnosis, cure, mitigation, treatment or prevention of disease and if it is intended to affect the structure or any function of the body inter alia. In the EU, we regularly see legal decisions dealing with similar qualification issues based the European Drug Directive. Clearly, this is a topic in the centre of interest on both sides of the Atlantic. It is therefore expected that US guidance on this topic may be of interest for its European counterparts as well.
Further topics @ IFT and subsequent updates @ FHL
Other topics discussed at IFT were overweight and obesity, perception of food in media and GMO’s in the food industry. At FoodHealthLegal, we continue to follow all these topics, and in particular their legal and regulatory implications, with interest and we will provide you with further updates shortly. Please feel free also to join Axon’s life sciences seminar on medical and functional food, which will be held on 24 September 2014.