Can unhealthy foods enter the ‘health halo’? The boundaries of health claims in the absence of nutrient profiles

To date, about 30% of pre-packed food products marketed in the EU have entered the ‘health halo’, attracting consumers by scientifically proven health benefits. The Claims Regulation provides that food products must comply with so-called nutrient profiles in order to bear health claims. Although the Commission had to establish these nutrient profiles by 2009, it is a well-known fact this has not yet been achieved. This might sound like a carte blanche for the food industry to guide consumers in their dietary decisions. Quite to the contrary, ‘common sense’ seems to set the boundary for food products that can carry health claims. The Court of Justice of the European Union (“ECJ”) recently demonstrated in the Dextro case (for an English summary, see here) that there is no unlimited freedom for advertising essentially unhealthy foods. This decision must be seen in the light of society’s battle against obesity and other adverse health effects related to food products high in fat, salt and sugar (“HFSS foods”). The current post puts the Dextro decision into context and aims to deduce some learning therefrom.

Dextro case

The German company Dextro Energy is known for its cubes almost entirely consisting of glucose. Back in 2011, the company requested the authorization of 5 claims stating the positive effects related to energy and muscle function that consumption of the cubes brings about. Examples include: “glucose supports normal physical activity” and “glucose contributes to normal muscle function.” Following the official procedure to have such a claim authorized, the cause-and-effect relationship between the consumption of the glucose cubes and the claimed health benefits needs to be proven by EFSA. While EFSA did provide a positive opinion, this did not result in an authorized health claim. The Commission has the last say in the procedure, including political, social and economic concerns into its decision. In the Dextro case, the Commission reasoned that the claims conveyed a ‘contradictory and ambiguous message’ to consumers. Although the human body needs a certain amount of glucose, the claim contradicts the current trend of the equally scientifically underpinned advice to reduce of sugar intake. According to the Commission, additional statements or warnings would not make up for the misleading claims. Dextro Energy challenged, amongst others, the Commission’s discretion to disallow a scientifically proven health claim. Both the Court in First Instance and the Court of Appeal countered the company’s arguments.

Setting the scene: health claims on other sugary products

The decision of the ECJ did not come as a surprise. Last summer, the European Parliament rejected controversial caffeine claims on energy drinks. Similar to the considerations in the Dextro case, health claims on sugary products were feared to nudge consumers towards poor consumption choices. Also, the request by Kinder Chocolate for authorization of a health claim on milk contributing the child development has been rejected. This rejection took place on a different ground, as the request was considered to lack the required scientific underpinning. Barry Callebaut was more lucky with its request for authorization of a health claim on cocoa flavanols in cocoa beverages with cocoa powder, dark chocolate, capsules or tablets. The claim refers to a beneficial contribution to the normal blood circulation and so the maintenance of elasticity of blood vessels. Of course, this claim might stimulate chocolate consumption. The difference, however, lays in the fact that the focus is on cocoa flavanols as bioactive compounds in cocoa extract. As opposed to the aforementioned substances glucose and caffeine – which are already controversial themselves – no HFSS food is directly involved. The claim was approved in 2015, being the first in kind in the chocolate field.

Industry pleas for nutrition profiles

Nutrition profiles were meant to prohibit nutrition and health claims on essentially unhealthy foods. As their establishment took so long, thereby creating uncertainty for the industry, the European Parliament initially considered to call them off. However, as shown in the Dextro case, the absence of nutrient profiles caused the Commission to rely on the very general principle of misleading in the appreciation of the claims at stake. This is the key item in food information matters both embodied in the Claims Regulation (article 3 (a)) and the Food Information to Consumers Regulation (article 7 (1)). As this concept of misleading is pretty broad and thereby not well-defined, food companies introduced a plea in favor of the establishment of nutrient profiles. This would shape the level playing field for all FBO’s and ensure that unhealthy foods cannot be promoted using health claims. Five leading food companies have recently called on the Commission in a public letter to take up its task of establishing nutrient profiles. Health and consumer organizations were also involved in the letter, arguing that a clear exclusion of nutrition and health claims on HFSS foods will benefit consumer behavior.

 The road forward

To prevent ambiguous health claims, the prohibition of such claims on beverages containing more than 1,2% alcohol is already explicitly mentioned in Health Claims Regulation. Will claims on HFSS foods be limited in the same manner? The open letter by the industry and other relevant parties is a push into that direction. The establishment of nutrient profiles could mean that the beneficial health effects attributed to cocoa flavanols can no longer be used on those chocolate products classified as ‘unhealthy’, for instance due to their high sugar content usually present in milk choclate. However, at this moment, it cannot be predicted whether the Commission will take up its task after about 10 years of delay. Meanwhile, the ECJ backs the criterion of misleading to fill the regulatory gap. Based on the examples mentioned above, ‘common sense’ based on generally accepted scientific principles provides the line between acceptable use of health claims and misleading practices.

Conclusion

As demonstrated in the Dextro case, health claims on HFSS foods are perceived misleading in society’s current fight against obesity and other diet-related disorders. The ECJ backed a Commission decision rejecting Dextro’s claims, considering the pro-glucose plea contained therein to be in violation of the principle that food information should not be ambiguous and misleading This case is not the first of its kind. Other examples of claims possibly driving consumers towards unintended unhealthy food choices include caffeine in energy drinks. As a consequence, those claims were rejected too. The general learning that can be drawn from these cases is that claims should not be considered in isolation, but in the context of generally accepted scientific standards. As an advice to FBO’s considering filing or using such claim, I recommend not to lose an eye for the context in which the claim is used. This basically comes down using common sense when using or applying for health claims. Does not that make sense?

The author is grateful to Jasmin Buijs, intern at AXON, who co-wrote this post.

 

 


Investors meet food and agro start-ups

F&A Next logoDuring 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.


Cross sector innovations and legal loopholes

dls-beeldOn 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.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.


Brexit: what are the consequences for nutraceuticals?

Mandatory Credit: 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.

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.

Conclusion

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.

 

 

 

 

 


Who Does Not Want To Have A Healthy Breakfast?

Crude health blackThe 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”.

Recommendations

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.

  1. 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.
  2. 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.
  3. 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.
  4. When using general, non-specific claims, use the specific, authorized claim in the same field of vision.
  5. When in doubt, or if you simply need a sparring partner, consult an expert.

 


Use of nutrition claims in horticultural business

broccoli en paprika'sThe 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.

Central concepts

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

Based on the current state of the law, there are a total of 29 permitted nutrition claims, including, for example, “low fat” or “sugar free“. A breeding company will however not directly benefit from these examples. Therefore, a selection of claims has been made that potentially offers added value to the marketing of vegetable breeders, growers or other horticultural companies. On this basis, 13 potential valuable claims remained. For all these claims, the terms of use were specified and also the vegetables for the marketing of which they could be used. An example of such selected claim reads as follows.

 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

Explanation

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.

Qualifications

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.

Useful guidance

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.


Axon seminar Functional & Medical Foods

IE-Forum AXON Lawyers 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.

Functional foods

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.

Medical foods

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).

Ore_363832 The benefits of wine.

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 info@axonlawyers.com with your name, the names of colleagues you would like to register and contact information. Questions? Contact our office manager Marjon Kuijs at marjon.kuijs@axonlawyers.com or +31 (0) 88 650 6500.

Looking forward to see you there!

 

Missed our seminar? Download our slides!

The slides of our seminar on medical and functional foods can be found here and also via our SlideShare account.

 


Glimpse of IFT 2014

IFT2014From 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.

Functional foods

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.

Allergens

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.

 


Misleading Advertising of Food Supplements – or not?

The role of national customs and self-regulatory bodiesVibovit-bis

Introduction

Recently, the Rotterdam District Court decided a dispute between Omega Pharma and Procter & Gamble on allegedly misleading advertising of food supplements. The product in dispute was Vibovit, a multi vitamins product for mothers and young children marketed by Procter & Gamble (P&G) since January 2014. Although well-known for its consumer products such as detergents and toothbrushes, Procter & Gamble is a new player in the field of food supplements. Omega Pharma is a company focusing on OTC health and care products including food supplements, for instance Davitamon. It holds a market share of 61 % in volume and 65 % in value in this field. Omega Pharma clearly perceives Vibovit as a competing product for Davitamon. No doubt, clear scrutiny of the new competitor in the field of food supplements was the start of this case.

Claims made by Omega Pharma

In a nutshell, Omega Pharma accuses P&G of committing misleading advertising and unfair commercial practises regarding its Vibofit product and also of violation of legislation on health claim, food supplements and labeling. More concretely, Omega Pharma inter alia opposed (1) the claim that Vibofit did not contain any preserving agents, whereas it appeared from the list of ingredients that the product contained potassium sorbate. (2) Furthermore, Omega Pharma complained that the packaging of Vibofit stated it contained only natural colouring agents, as it did not agree that the colouring agents titanium dioxide and carbon dioxide qualified as such. (3) Also, Omega Pharma considered the claim “+Omega 3” mentioned on the Vibofit packaging was made in violation of the Claims Regulation.

P&G’s preliminary defence

As a first preliminary defence, P&G had argued that Octapharma’s claim could not be received by the Civil Court, as Octapharma should have brought this claim before the Dutch self-regulatory body that advises on advertisements for health products (KOAG-KAG). This defence was rejected, as this self-regulatory body is only competent to hear disputes on health claims and not regarding any other claims in the field of food or advertising law. As a second preliminary defence, P&G had advanced that Omega Pharma’s claim actually related to unfair B2C commercial practices and that Omega Pharma could not invoke these rules (meaning their national implementation) against its competitor. This defence was also dismissed, as the Court considered that Omega Pharma was entiteld to invoke the rules on unfair commercial practises, being a lex specialis on the general law of the torts, against P&G.

(1) Evaluation of claim re. preserving agent potassium sorbate

Although the parties agree that potassium sorbate can be used as preserving agent, P&G argues this is not the case at hand. Instead, it uses this compound as a processing agent for the preparation of the yellow colour of the Vibofit gummies. As a result of the carry-over principle, a mimimum quantity of potassium sorbate is present in the final product. However, since this quantity is only 0,00005 %, which is 2.000 times too weak to be able to function as s preserving agent, the Court accepts this defence. As a consequence, the claim “free of preserving agents” is not considered misleading.

(2) Evaluation of claim re. colouring agents titanium dioxide and carbon dioxide

Omega pharma opposes the claims “100 % natural colouring agents” and “no artificial colouring agents”, as it considers that both titanium dioxide and carbon dioxide qualify as synthetic instead of natural colouring agents. Since the Food Additives Regulation does not make a distinction between natural and synthetic colouring agents, P&G relies on evidence from two national authorities to refute Omega Pharma’s claim. The first piece of evidence is a list of additives issued by the Dutch Food Safety Authority (Nederlandse Voedsel en Waren Autoriteit – NVWA) based on their qualification by the Dutch Nutrition Center (Voedingscentrum). This authority qualifies titanium dioxide (E171) and carbon dioxide (E172) as “natural”, as opposed to “synthetic” and “of natural origin, chemically processed”.  The second piece of evidence is an NVWA fact sheet from which is follows that the colouring agents E171 and E172 are not considered synthetic. A consumer survey initiated by Omega Pharma investigating the misleading character of the claims used by P&G was considered not relevant, inter alia because it did not outweigh the opinion of the two Dutch national authorities and it was not considered completely neutral. As a consequence, P&G’s claims were not considered misleading.

(3) Evaluation of health claim +Omega 3

The notion + Omega 3 relates to the nutrition claim “source of Omega-3 fatty acids”. According the Health Claim Regulation, this claim is only allowed where the minimum quantities of 0,3 g ALA or 0,40 mg of the sum of EPA and DHA are met.  One Vibofit gummy contains 2,5 mg Omega 3. As the packaging does not differ amongst ALA, EPA or DHA, it is not clear if the applicable standards are met. P&G however argues that it received prior approval from the self-regulatory body KOAG/KAG regarding its Omega 3-claims. Such approval has such authority that in those cases the Dutch Food Safety Authority usually does not apply any fines. In this particular case however, KOAG/KAG changed its policy after said prior approval was granted. According to the new policy, ingredients claims will only be allowed in as far as no existing health or nutrition claim is in place. Although P&G was not happy with this change, it nevertheless removed the Omega 3 claims from the Vibovit packaging and showed the galley proofs during the hearing. As a consequence, the Court considered that Omega Pharma no longer has sufficient interest re. its claim directed at Omega 3.

Conclusion

From the correspondence exchanged between the parties and reproduced in the judgement, it appears that P&G did not simply dismiss Omega Pharma’s claim but had meticulously prepared this case. Where it estimated that its claims would not hold, it had decided to move and to do so quickly. This is of course a very strategic approach, which quite often is successful to avoid litigation. However Omega Pharma simply decided to go after its new competitor. What is most striking in this case from an EU perspective, is the role of national authorities and national customs formulated by self-regulatory bodies. The prior approval from KOAG/KAG with respect to an ingredients claim for the food supplement Vibovit carried an enormous weight in the present dispute. Also, interpretations of national authorities of European food additives standards proved to be a decisive factor in this case. Therefore, when preparing a case of misleading advertising involving labelling and health and nutrition claims, carefully consider where to initiate it in view of those local customs.

 


Food information all over the place

Google Food InfoFood information services by Google

Recently, Google added nutritional information into its search functionality relating to more than 1,000 food items ranking from fruits to vegetables and from meats to complete meals. The new functionality is a part of Google’s Knowledge Graph that was launched in May 2012 in the US. Knowledge Graph is a database interconnecting various search results in order to enhance understanding. By offering information in this way, Google aims developing its information engine into a knowledge engine. As to food information, Google wants to help its users to make healthier choices – so it says. For examples how Google’s food information service will be operated, reference is made to its blogspot.

Food information in the EU

In the European Union, food information is considered to be of the essence as well. To that end, rules on food information were revamped under Regulation 1169/2011 (“the Regulation”) on the provision of food information to consumers . This Regulation will enter into force on 13 December 2014 and will bring about a great number of changes in the food information landscape in Europe. On the one hand, the Regulation aims to ensure a high level of protection of consumers’ health and interests by enabling them in making informed choices. On the other hand, the Regulation aims to realise free movement of legally produced and marketed food. But how is this going to be achieved?

Fair information practices

Firstly, food information shall not be misleading (a) as to the characteristics of the food, (b)  by attributing to the food effects or properties it does not possess, (c)  by suggesting that the food possesses special characteristics when in fact all similar food possess such characteristics, (d)  by suggesting the presence of a particular food or an ingredient, while in fact substitution with another food or ingredient occurred. It should be stressed that food information comprises all information about a food made available to a final consumer. So not only product labels, but also information published on company website, leaflets, advertisements etc.

Specific guidelines for mandatory information

Secondly, the Food Information Regulation provides specific guidelines for mandatory food information, such as the name of the food, the list of ingredients etc. These guidelines relate for instance to the legibility of this information, requiring a minimum font size of 1,2 mm for the x-height, defined in Annex IV to the Regulation. They also relate to the place where mandatory information is shown, requiring that such information appears directly on the package or on a label attached thereto, so not on a separate leaflet. In cases of distance selling, most of the mandatory information should be available before the purchase is concluded. i.e. it should clearly appear on the website where the food at stake is offered for sale. Furthermore, these guidelines cover language requirements, stipulating that mandatory information shall appear in a language easily understood by the consumers of the Member States where a food is marketed. For the Netherlands, this would clearly be Dutch, but the Member States also have the authority to stipulate that the particulars shall be given in one or more languages of the official languages of the European Union. Such language could be used as an alternative but also in addition to the national language.

Nutrition declarations

Thirdly, nutrition declarations have become mandatory under the Regulation. Such declarations shall imperatively include the following seven elements contained in the food product: (1) energy value, (2) amounts of fat, (3) amounts of saturates, (4) amounts of carbohydrates, (5) amount of sugar, (6) amount of proteins and (7) amounts of salt. Furthermore, they may be supplemented with another six elements such as starch and fibre. The nutrition declaration should come in the form of a table, if space permits, and may be placed on the side or on the back of a packaging (not necessarily at the front side). The information provided must be given per 100 mg or 100 ml – only in addition thereto, information per portion can be given, provided that the portion is quantified. In order to indicate reference intakes of food ingredients, quite often the term GDA (Guideline Daily Amount) is used. This is not a requirement under the Regulation, but if used, this should be done in a way consistent with the Regulation. For vitamins and minerals, it is mandatory however to use the term RDA (Recommended Daily Amount).

Conclusion

The Food Information Regulation brings about such important modifications for food information, that it is very likely that the packaging of most of the products marketed in Europe needs to be adjusted. The nutrition declarations that Google intends to publish for various foods are just one element of those modifications. It is thereby ironic that in an attempt to harmonize the rules on food information, the Food Information Regulation in the same time creates barriers to EU-wide trade, by means of the language requirements for food information. Furthermore, even if the Regulation regulates food information in great detail (e.g. font prescribed font size), it is questionable whether that framework will work for B2B transactions or in cases where the food is not sold to final consumers (e.g. mass caterers). This is certainly food for further thought. Stay tuned to FoodHealthLegal!

 


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