The People’s Republic of China first law on Traditional Chinese Herbal Medicine came into force on the 1st of July 2017. This law encompasses industrial normalization by guaranteeing the quality and safety of herbs in cultivation, collection, storage and processing. Producers of Traditional Chinese Medicine (hereinafter TCM) are not only targeting the Chinese market, but are also looking for access to the European market. With this new legislation in force in China, it is a good time to have a look at the current possibilities for market access of TCM on the European market. The name “TCM” would suggest the product could only be qualified as a medicinal product. However, other product qualifications are possible as well. In this post, it will be investigated how Chinese herbal remedies and products fit into the EU framework.
For market access, product qualification is vital. Qualification of TCM as medicinal products might seem obvious. However, western medicine is mostly focused on curing a certain disease or disorder, whereas TCM is focused on healing the body itself. Healing in short means the body should be strengthened to ‘treat itself’. Many of the traditional herbal remedies have healing properties, such as strengthening the immune system. As an alternative to medicinal products, other qualifications of TCM could be botanicals, so that they could be marketed as food supplements or as other foodstuffs. We previously reported on product qualification in this blog, explaining what legal tools have been developed for this purpose over time in case law. These criteria equally apply to TCM.
Simplified registration procedure for traditional herbal medicinal products
An example of a traditional herbal medicinal product we can mention sweet fennel, which is indicated for symptomatic treatment of mild, spasmodic gastro-intestinal complaints including bloating and flatulence. For this group of traditional herbal medicinal products, just like for TCM, a simplified registration regime can be found in the EU Medicinal Products Regulation. In short, the efficacy of the product containing the herb used in TCM’s can be substantiated with data on usage of the herb. This eliminates the need for costly clinical trails to prove the efficacy of the active ingredient(s) in the product. However, safety and quality of the TCM still need to be substantiated.
Eligibility for simplified registration procedure
To qualify as traditional herbal medicinal product, a number of cumulative criteria should be met, including the following.
- Evidence is available on medicinal use of the product during at least 30 years prior to application for EU market authorization, of which at least 15 years within the EU.
- Such evidence sufficiently demonstrates the product is not harmful in the specified conditions of use and the efficacy is plausible on the basis of longstanding use and experience.
- The product is intended and designed for use without the supervision of a medical practitioner and can only be administrated orally, externally and/or via inhalation.
The presence in the herbal medicinal product of vitamins or minerals for the safety of which there is well-documented evidence shall not prevent the product from being eligible for the simplified registration referred to above. At least, this is the case as the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s). TCM intended and designed to be prescribed by a medical practitioner can enter the EU market, but cannot benefit from the simplified registration procedure for traditional herbal medicinal products.
Currently the focus of healthcare is shifting from purely curing diseases to prevention thereof. TCM could play an interesting role in such paradigm shift. Although food business operators (hereinafter FBOs) cannot claim a foodstuff can cure a disease, such product can contribute to prevention of a disease. As such, FBOs can inform the public that consumption of a particular foodstuff can support the regular action of particular body functions. An example of a herbal remedy used in TCM and currently on the EU market is cinnamon tea; used in Chinese medicine to prevent and treat the common cold and upper-respiratory congestion. Obviously, the advantage of bringing a foodstuff (for instance, a food supplement) to the market as opposed to a medicinal product is that unless the foodstuff is a Novel Food, you do not need a prior authorization.
As long as a foodstuff has a history of safe use in the EU dating back prior to 1997, FBOs do not need prior approval for market introduction. If no such history of safe use can be established, both the current and new Novel Food Regulation prescribe that the FBO receives a Novel food authorization. A helpful tool for establishing a history of safe use is the novel foods catalogue, being a non-exhaustive list of products and ingredients and their regulatory status. Another source is Tea Herbal and infusions Europe (hereinafter THIE); the European association representing the interests of manufactures and traders of tea and herbal infusions as well as extracts thereof in the EU. THIE’s Compendium, which should be read in combination with THIE’s inventory list (also non-exhaustive), contains numerous herbs and aqueous extracts thereof, which are used in the EU. Other herbs might not be considered Novel Foods, as long as the FBO can prove a history of safe use in the EU prior to 1997. For instance, the history of safe use of Goji berries has been successfully substantiated.
Traditional foodstuffs from third countries
In previous blogs we already pointed to a new procedure to receive a Novel Food authorization as of 1 January 2018, relating to ‘traditional foods from third countries’. EFSA published a guidance document for FBOs wishing to bring traditional foods to the EU market, enabling them to use data from third counties instead of European data for the substantiation of the safety of the foodstuff. The procedure is a simplified procedure to obtain a Novel Food authorization for a foodstuff, which has been consumed in a third country for at least a period of 25 years. For sure, this is not an easy one, but we have high hopes that such data can be established for TCM being used in Asia. In the affirmative, the FBO can use these data to substantiate the safety of the product and receive a Novel Foods authorization via a 4 months short track procedure, enabling the FBO to market the foodstuff at stake in the EU.
Health claims for herbal products
The EU Claims Regulation provides the legal framework for health and nutrition claims to be used on foodstuffs. In previous blogs we elaborated how such claims can be used for botanicals, being herbs and extracts thereof. So far, no authorized claims for botanicals are available, but their use is nevertheless possible under certain circumstances. In sum, an on-hold claim can be used when the FBO clearly states the conditional character thereof (by stating the number of such on hold claim on this claims spreadsheet. Upon dispute, the FBO should furthermore be able to substantiate that the compound in the final product can have the claimed effect when consumed in reasonable amounts. TCM can take advantage of this current practice, thereby communicating the healing effect thereof, which basically comes down to a contribution to general health. It should be carefully checked though, if the claim for the herbal remedy at stake has not been rejected, as happened to four claims regarding caffeine.
EU market introduction of TCM could take place in various ways, depending on the qualification of the product at stake. Qualification as a regular foodstuff certainly ensures the quickest way to market, as no prior market approval is required. This will be different if the product qualifies as a Novel Food. However, as of 1 January 2018, a fast track authorization procedure will be available for traditional foods from third countries, from which TCM might benefit as well. TCM could furthermore use so-called botanical claims, in order to communicate the healing effects thereof. When the TCM qualifies as a medicinal product, the good news is that for traditional herbal medicinal products, a simplified registration procedure is available under the EU Medicinal Product Directive, provided that certain criteria are met. Registration takes place via the national competent authorities in each Member State, which in the Netherlands is the Medicines Evaluation Board (CBG).
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, Advocate General Wathelet rendered his conclusion in a case regarding the claim “Just as good as the daily glass of milk” used for a dairy product consisting of fruit curd. Why is this opinion of interest? It provides clarity on the scope and content of the notion of a health claim. Furthermore, opinions rendered by Advocate Generals have a good predictive power for the likely outcome of the decision by the Court of Justice of the European Union (CJEU). In other words, there is a good chance that said Court will follow the explanation proposed by the Advocate General.
Facts and figures
The German company Ehrmann marketed a fruit curd offered for sale under the name of Monsterbacke in six joint units of each 50 grams. According to the nutrition table of this product, it contains per 100 g 105 kcal of energy, 13 g sugar, 2,9 g fat and 130 mg. calcium. By way of comparison: a glass of milk contains per 100 g also 130 mg calcium, but only 4,7 g sugar. As of 2010, Ehrmann promoted its product with the slogan “Just as good as the daily glass of milk”, whereas none of the information obligations referred to in article 10.2 of the Health Claim Regulation was met. These obligations aim at securing full information on the product bearing a health claim, such as the quantity of the food and the pattern of consumption required to obtain the beneficial effect.
Preceding legal proceedings
The German Centre for Protection against Unfair Competition (Wettbewerbszentrale) took Ehrmann to Court (Landgericht Stuttgart), as it considered the slogan “Just as good as the daily glass of milk” to be misleading. In comparison to milk, Ehrmann’s fruit curd contained much more sugar and this was not mentioned on the packaging. Also, due to its comparison with milk, Ehrmann’s product hinted at containing just as much calcium as milk and thereby alluded to a health benefit. Ehrmann did not agree and argued that its fruit curd was a product comparable to milk in many respects, whereby the difference in sugar was just too small to mention. The first instance Court followed this line of reasoning, but the Appeal Court (Oberlandesgericht Stuttgart) did not. According to this Appeal Court, Ehrmann’s slogan was misleading, because 100 g of Ehrmann’s fruit curd contained much more sugar than 100 g milk. Ehrmann filed a so-called appeal for revision (“Revision”) with the German Supreme Court (Bundesgerichtshof), who dropped the qualification of misleading information, but found instead that the slogan “Just as good as the daily glass of milk” qualified as a health claim.
Case before the CJEU
The one single question that the German Supreme Court referred to the CJEU basically related to the transitional regime applied to the Health Claim Regulation, when the lists of authorized claims were not yet in place. The referring Court wanted to know if at that time (2010) the information obligations referred to above were already applicable. This question was answered in the affirmative, inter alia because the requirements laid down in article 10.2 of the Health Claim Regulation aim to protect the consumer. From that perspective, it would be contradictory to suspend those requirements any time. This would also not be in line with the authorized claims themselves that have an evolutionary character. Even more interesting than the proposed answer to the preliminary question were two other aspects raised by the Advocate General. (1) Is it up the CJEU to confirm whether indeed the slogan “Just as good as the daily glass of milk” qualifies as a health claim and (2) what is in fact the scope and content of the notion of health claim in general?
Qualification of slogan as health claim by CJEU?
The different German instances had taken different views regarding the question whether the slogan “Just as good as the daily glass of milk” qualified as a health claim. Whereas the Stuttgart Appeal Court for instance did not consider this slogan to be a health claim, the German Supreme Court came to a different conclusion. Ehrmann did not agree with this conclusion and considered that the CJEU had to provide guidance to this respect to the German Supreme Court. The Advocate General however does not agree. He is of the opinion that there is no reason to cast doubt upon the qualification of facts by the referring Court. Now that the German Supreme Court did not ask any specific question on the qualification of the slogan at stake as a health claim, it is not up to the CJEU to rule on that issue.
Scope and content of “health claim” in Deutsche Weintor and Green Swan
The Advocate General did take the liberty to explore the notion of health claim. As a start, he referred to its broad definition as “any claim that states, suggests or implies that a relationship exists between the consumption of a food category, a food or one of its constituents and health”. He then referred to the CJEU decision re. Deutsches Weintor, in which it was held that the notion of “easily digestible” for wines amounted to a health claim. The CJEU reasoned that the definition of health claim provides no information as to whether the relationship between the intake of a food and the claimed beneficial effect must be direct, indirect, or as to its intensity or duration. In those circumstances, the term “relationship” must be understood in a broad sense. This approach of the notion of health claim was confirmed in the CJEU decision Green – Swan Pharmaceuticals. In this decision, the CJEU held that for a claim to qualify as a reduction of disease risk claim, it is not required that such claim expressly states that the consumption of a food significantly reduces a risk factor in the development of a human disease. This is despite the fact that the notion of “significantly” figures in the definition of disease risk reduction claim (art. 1.4.6). To the contrary, it is sufficient that the claim may give the average consumer the impression that the reduction of a risk factor is significant.
Based on the explanation given of the notion of health claim in the CJEU decisions discussed above, the Advocate General concludes that the slogan “Just as good as the daily glass of milk” also qualifies as a health claim. According to him, the average consumer considers milk as a wholesome product. By linking the fruit curd to milk, an implied health effect is communicated. All the more so, since the relation between the intake of the fruit curd and the alleged beneficial effect is interpreted in a very broad way. As a more general conclusion for this contribution, it should be noted that claims on food products readily qualify as health claims. As a food operator, be aware that you meet all requirements for the use of such claims!
image Johannes Vermeer [Public domain], via Wikimedia Commons