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!
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.
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.
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.
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).
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!