Weight loss claims – the proof in the pudding is in the eating

Vector illustration of changes in sizes choosing different dietSome 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.

 

 


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.

 


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.

 


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