Following a national press ad stating, “Diabetone comprehensive nutritional support for people with diabetes shown to help maintain wellbeing in UK nutritional research”. The ASA reviewed the product claims following a complaint.

In defence of the product Vitabiotics Ltd stated the product was a food supplement as stated on the packaging and not a medicine. Furthermore, they said they had research to support their claims surrounding each nutrient within the product as well as a trial on the whole product.

However, following a review of the data the ASA drew the following conclusions:

• The studies selected to substantiate the claim did not detail methodologies used and did not sufficiently demonstrate that the participants of said trial were healthy (The target audience).

• The data did not substantiate the collective effects of the ingredients within the product.

• Of greater interest is the assessment of the trial funded by the company to substantiate the product as a whole on patients with type 2 diabetes. The assessment concluded that there were not improvements in blood glucose, lipid profiles and that due to poor statistical analysis on the size effects (number of subjects) to produce a statistically significant effect psychological effects could not be proven to be accurate.

The take home message was that the ad could not appear in its current form and that it was likely to mislead the consumer. The real interest here for the food law group is to consider if you have robust data to support your claims and if you are making claims are they being represented in the right way i.e. should this have been registered as a PARNUTS product?

Source: ASA adjudication June 30^th 2010

With EFSA rejecting almost 80% of health claims submitted under article 13.1, industry is rightly concerned. However, these opinions are not yet law. Although EFSA has given its opinion and the commission intends to publish the list, the European parliament has still 3 months to look at the opinions and their implementation through the regulatory procedure with scrutiny, which could in theory mean a potential chance to block their adoption into law.

If parliament finds that the legislation and its implementation is not inline with the mother regulation then they can veto it, essentially blocking their legal acceptance and as such enforcement. At present one major issue is the nutrition and health claims regulation (NHCR) is being used to implement EFSA’s opinions in a batch by batch approach i.e. 500 + claims release and entered into law at a time. The NHCR should act not only in the interest of the consumer but also by proportionality, fair competition, and free movement of goods and it is the belief by many that this is not occurring.

One of the other issue is that the implementation of the regulation is not being carried out correctly with the likes of vitamins a minerals getting an easy pass (acceptance based on textbooks) as 13.1 claims whilst other nutrients are being ask to provide the same degree of evidence as required under article 13.5 and 14 (a more complex dossier requirement based on randomised controlled trials, and ingredient characterisation).

With the likes of high profile MEP’s including Mario Mauro and Bonislaw Sonic set to challenge the commission over implementation of the NHCR the next few months should be followed closely by all of use with a vested interested in the food and beverage markets.

Gaining a health claim is one thing but gaining one that makes sense to the general public is another. As part of the general conditions of article 13 claims (Art 13(1)ii) a health claim must be ‘well understood by the average consumer’. Claims must also protect the consumer from being misled, and balancing these two issues is causing some difficulties when the Commission is to provide guidance on the flexibility of claim wording.

In a recent meeting between the Commission and Member States (MS) on the 12^th April 2010, the issue of how flexible EFSA approved claim wording could be was discussed. The discussion covered a host of ingredients with health claim approvals including; biotin, calcium and vitamin D, copper, fluoride, iron, and lactase enzyme.

Using biotin as the poster child from this discussion it was clear there are going to be some significant amendments to how claims are interpreted and finally adopted in a consumer friendly manner. One of the approved claims for biotin by EFSA is:

‘Biotin contributes to normal energy-yielding metabolism’

The group discussed whether consumers would understand ‘energy-yielding metabolism and discussed ways of tackling this. One approach would be for MS to amend the wording to make it more consumer-friendly, However, any approved wording will not just stop at the feet of the commission once it provides its final opinion on wording. Any health claim might also be subject to additional changes as a result of translation into other linguistic versions of the Regulation and food business operators (FBOs) making use of the flexibility likely to be permitted to them, despite difficulties this may cause for enforcement. Based on these issues it was agreed that it was best to keep the authorised wording in the Regulation as close as possible to EFSA’s approved wording.

Further discussion about what wording is appropriate for the consumer included EFSA often used ‘normal’ [in EFSA-approved wording of claims] and MS considering if it should be replaced by the word ‘healthy’. Opinions varied and it seemed to depend upon the particular claim in question; therefore it was agreed that ‘normal’ should remain in most cases and that this point could be addressed in guidance. However, it does show that already there are significant issues in relation to MS accepting the clinical nature of EFSA wording.

MS will need to consider how to handle these claims if the consumer is to benefit from the process and also if enforcement will be simplified across the EU or potentially made more difficult. One suggestion was that MS would look at the EFSA opinions and try to suggest more meaningful claims based on the scientific evidence; EFSA would then be asked to verify the new wording.

It was agreed that flexibility of wording would be addressed in future Commission guidance. Whatever the guidance one major concern is that every change in EFSA’s approved claim has the potential to take wording further away from the substantiated meaning of the claim. The fallout could make the process of enforcement and harmonisation of any claims throughout the EU more difficult and complex.

As part of the Nutrition and Health Claims Regulation (NHCR) EFSA was to implement and set the criteria for what is an acceptable nutrient profile for foods carrying an approved health claim.

Nutrient profiles (Article 4) were added to the regulation to avoid a situation where using a health claim on label could potentially mask a poor nutritional status (i.e. high fat or high sugar) of a food product. As such the development of specific criteria governing the circumstances in which claims can be made are a vital component of the NHCR.

Despite the requirement for nutrient profiles in the regulation there has been a significant amount of discord between the member states and what constitutes a ‘healthy’ nutrient profile. According to the regulations nutrient profiles should be based on generally accepted scientific data relative to the relationship between diet and health. However, the caveat is that profiling should also take into account the variability of dietary habits and traditions. It is this last statement, which is causing the main issues with the regulations as each EU member state has different ideas about dietary habits and tradition and also what constitutes generally accepted scientific data relative to the relationship between diet and health.

Although profiling should have been in place by January 2010 it is still to be agreed, and in a recent request of Renate Sommer (MEP), the Internal Market Committee (IMC) and Environment, Public Health and Food Safety Committee of the EP (ENVI) have voted to delete profiling from the regulation. Although it will take a vote by the European Parliaments plenary in late May to give more indications if profiling will be removed from the NHCR, for many it offers some excitement about health claims.

One of the biggest winners if profiling is removed will be the likes of the Chocolate manufacturers (whom are actively involved in research on heart and dental health) whom may have been excluded from the health claims process due to the high fat and sugar contents typically contained in chocolate.

According to a publication in the Journal ‘Food Policy’ researchers from Norway, Sweden, Denmark and Finland have shown that certain health claims can negatively influence the perception of a functional food. The researchers initiated a 30 minute online questionnaire, which was subsequently completed by 4612 respondents (All from Nordic countries).

[An audio discussion about the research available on the link below]

Online participants were shown four product descriptions. One of these had no health claim, and the other three carried claims that differed on structure, active ingredient, outcome benefit and framing. The participants were then asked to rate the product on eight criteria including; attractive to me; attractive to my family; healthy; natural; tasty; and ability to lower the risk of cardio-vascular diseases, dementia and weight gain.

The take home from the results was:

1. Health claims had a moderate but mostly negative impact on the perception of other product attributes,

2. Health claims decrease in perceived naturalness,

3. Ingredient awareness had a significant impact on the ability of consumers to connect and accept such claims,

4. Previous exposure to health claims impacted perception of the claims.

This study indicates previous exposure and as such familiarity of the ingredient linked to the claim is required for consumer acceptance. Furthermore, the source of such ingredients is also important if a perception of naturalness is to be retained. However, this trial simply reflects the relation of claims to naturalness and for many using health products such as dietary supplements rather than foods are about efficacy of effect rather than being natural. If you can offer both then you obviously are increasing your chances of consumer acceptance.

Lähteenmäki L, et al. Impact of health related claims on the perception of other product attribute. Food Policy. Ahead of publication.

AUDIO INTERVIEW WITH THE RESEARCHERS OF THE STUDY:

http://www.eufic.org/upl/1/default/doc/Health%20claims%20podcast.mp3

In the latest batch of 31 opinions (grouped from 416 submissions) from EFSA’s NDA panel we can see that this process of assessment is setting a precedent for the acceptance of only vitamins and minerals. The big losers are not unexpected antioxidants and probiotic based claims which have been rejected across the board. For the industry this is scary especially for the likes of the superfruit / smoothie market and giants such as Innocent, known for their use of the term Antioxidant on marketing materials and commercial communications. The opinions relate not only to the lack of characterisation but in this batch many opinions negative due to a lack of association between the claimed effects in human clinical trials.

However, the few positives give hope to those in the blood pressure, sport, immune, and potentially for the first time the weight control markets. Vitamin D was given a positive opinion in relation to normal function of the immune system as well as normal muscular function. Potassium was gifted with claims such as; “maintenance of normal blood pressure”, and “normal muscular function”.

One of the most interesting areas gaining some positive views from EFSA was in relation to meal replacements for weight control. Claims approved included, “safe, effective & healthy weight loss; greater weight loss than with conventional calorie counting”, and “maintenance of weight loss”. However, these claims must be considered within the framework of Directive 96/8/EC.

The take home is that more damage will likely be reported in the mainstream press and for many companies this will mean PR in overdrive to reduce the commercial damage. The only way forward for those companies currently using such rejected claims (provided all opinions are adopted via EC) will be submissions via 13.5 or 13.4, which are more costly but give the applicant the opportunity to construct a more robust dossier in defence of their specific claims. Such a defence was never possible under 13.1 – 13.3 and this is a big reason for so many of the rejections.

As of the 19th of January 2010 ‘nutrition claims’ such as low GI, Isotonic and hypotonic are under threat by enforcement bodies throughout the EU. For those in the weight management or sports nutrition market, labelling and other forms of commercial communication using such claims could be removed by enforcement agencies.

Under the terms of the Nutrition and Health Claims Regulation (EC No 1924/2006) those claims not currently contained within the 24 approved claims in the Annex (Article 8 ) cannot legally be maintained. The Annex of the regulation provides a list of specific nutrition claims such as ‘Low energy’ or ‘Low fat’ and importantly unlike functional claims it contains the conditions of use such as how many calories constitute a low energy claim.

According to Dr Mark J. Tallon Principle at UK consultancy Nutrisciences, the health claims annex may be already enforceable unlike those claims covered by article 13(1)(a) of the regulation relating to generic health claims. Tallon said, ‘transitional allowances are still clearly in existence for functional claims for a few reasons, including the lack of a comprehensive adoption of the community list referred to in article 13(3) and the failure of EFSA to meet its own responsibilities regarding the adoption of nutrient profiles. For claims already listed in the Annex conditions of use (a form of nutrient profiling) are already in place; as such it is possible nutrition claims in use throughout the EU not listed in the Annex are illegal.

According to many within the industry there is still concern over a lack or real guidance from EFSA regarding what is, and what is not possible to implement from the regulation. The issue maybe a legal minefield and for those SME’s throughout the EU and guidance from their member state authorities will be vital to address any challenges to their nutrition claims.

Tallon commented that his contact with enforcement bodies in the UK over past weeks lead him to expect guidance on such issues to be forthcoming this or early next month. He said, trading standards and LACORS (body which provides guidance and good practice for local authority regulatory services) are currently in the process of developing guidance for local enforcement agencies, I expect the guidance to take a pragmatic approach simply because clarification from the EC has been less than transparent. He also says those in charge of enforcement are acutely aware of the concern of these regulation and the potential impact on trade.

Although early in 2010 the impact of NHCR comes closer to implementation, industry stakeholders are under increasing pressure to consider issues of compliance. Dr Tallon was keen to highlight that industry has some breathing space thanks to transition periods and urged food industry members to remain positive, and to keep in close contact with the likes of the Food Standards Agency (FSA) or similar bodies throughout the EU whom should be able to provide clarity and guidance in relation to implementation of NHCR when it becomes available.

“On 1 July 2007, a new and important regulation governing nutrition and health claims for foods came into force. The regulation is complex and mandatory. CAP encourages advertising industry stakeholders to take advice on the effect of the regulation and to consult the Food Standards Agency’s Guidance to Compliance with Regulation (EC) 1924/2006 on Nutrition and Health Claims on Foods, which is available at http://www.food.gov.uk”

CAP code integration of NHCR

With this in mind many in the industry have been concerned with the early implementation of decisions on nutritional products and ingredients by EFSA’s Dietetic products, nutrition and allergies (NDA) panel. Although at present we have many products and ingredients, which have received a negative opinion from EFSA. Many of these claims are nothing to do with the science on the claims but rather other issues such as characterisation. Is it possible that the ASA could use these decisions to block your marketing claims? They may try!

On December 11^th 2007 the UK’s Department of Health and Foods Standards Agency (FSA) wrote to the Infant and Dietetic Foods Association (IDFA) informing them they would be implementing the labelling and advertising principles laid out in Commission Directive 2006/141/EC. This directive limits the nutritional claims manufacturers can make for their products i.e. it is illegal to claim that a formula is similar to breast milk. According to the regulation the measures were not enforceable until 1st January 2010, however the FSA wanted to bring its implementation forward by 2 years to 11^th January 2008. This would mean any manufacturers, suppliers or retailers making such claims would be open to criminal liability if they continue sale past this date.

In a bold move a defence of the industry the IDFA believed the decision unlawful and successfully brought about an injunction via Judicial review against the government (Secretary of State). The transition period is now as outlined in the directive. In relation to the NHCR this suggests than the regulation, which should have the community list in place January 2010 should be enforceable by that point. However, many issues suggest the market will be able to play for time and avoid the ASA utilising this regulation to remove claims form the market.

This decision shows that looking closely at what are the key factors in the regulation in relation to implementation and transition periods are key to keep your current claims on the market. Issues which a legal challenge could be mounted if any reference to the regulation is used in a ASA decisions using the CAP code and / or reference to the NHCR include : 1. transitional measures – For food this means health claims can be used on label for 12months following the adoption of nutrient profiles (Currently there is no adoption). 2. In other circumstances (this is not an all inclusive article other transitional measures apply but not discussed) health claims may continue to be used for 6 months after a decision is taken.

At present we have many ingredients and products which have no decision completed as defined by the full authorisation procedure, which means most products will have until at least July /August 2011 to continue with their claims, whilst building a marketing strategy to deal with the regulation post-transition. In addition to these direct relationships to the NHCR we have implementation by each member states and in the UK discussions will continue with LACORS (Local Authorities Coordinators of Regulatory Services) and other bodies on real time sell trough timelines.

Following the significant damage of the first wave of article 13.1 opinions by EFSA and subsequent 70% rejection rate, what can industry do now given EFSA will not re-assess these claims via the 13.1 process, even if new or additional data is available?

Well there are potentially 2 routes, firstly is article 13.5 for newly developed scientific data (submitted via the procedures under art 15-18), or secondly via Article 13.4 for claims which meet generally accepted scientific evidence.

Article 13.4 of the health claims directive (1924/2006) should be adopted in accordance with article 24(2) relating to the implementing procedures of the committee (dee specifically - Article 5 and 7 of 1999/468/EC). Unlike article 13.5 no detailed procedures are currently available for an article 13.4 submission. This may mean that EFSA will need to lay down these procedures and then gain approval from the committee before any stakeholder could resubmit a failed 13.1 claim via the 13.4 route. My guess is that like article 13.1, no specific procedures will be implemented, simply a resubmission of claims using the same format as 13.1 will be allowed, but with new or additional reference data. The concern, as with the origional 13.1 submissions is what is ‘generally accepted scientific evidence’?

Of importance are some key differences between article 13.5 and 13.4…

Article 13.4 relates to ‘changes’ to the community list, article 13.5 relates to ‘additions’. These 2 words maybe the key differences on attempting to discover a time frame for the possible implementation of article 13.4. In the case of article 13.5 it could be argued that as soon as any health claim had been approved by the commission, any subsequent submission could be classified as an ‘addition‘ to the list, as such the 13.5 processes for assessment could begin. In the case of 13.4, the terminology ‘changes’ to the list will mean we must wait until the current 13.1 opinions are ratified, which maybe another 6 months or even longer for those still to be assessed before we can use the 13.4 submission route for health claim approval.

It seems likely we will be able to implement article 13.4 towards the end of the first quarter of 2010, which may mean another shot at a health claim approval for the probiotics market which failed simple on issues of characterisation. Let’s hope this time EFSA provides better guidance and a greater ability to push for an approval with specifically designed dossiers, which were not possible under article 13.1.

EFSA and the Food Safety Commission (FSC) of Japan have signed a Memorandum of Cooperation on the collection and sharing of data required for the assessment of current and emerging risks. As crops, animals and food products are transported around the globe, so can the risks associated with the food chain. Ensuring access to a larger pool of international data is one of the priorities of EFSA’s international strategy.

The Food Safety Commission of Japan, like EFSA, is responsible for the assessment of risks associated with the food chain and gives independent scientific advice to risk managers such as the Health and Agriculture ministries. Following the signing of the agreement the FSC delegation, led by FSC deputy chair Dr. Takeshi Mikami, met EFSA scientists to discuss a number of issues, including animal cloning, nanotechnology, food contact materials and contaminants.

The memorandum signed with Japan is the second formal international cooperation agreement EFSA has signed with a national food safety authority outside the European Union. In 2007, EFSA and the U.S. Food and Drug Administration (FDA) signed a memorandum designed to facilitate sharing of confidential, scientific information. EFSA is working towards strengthening cooperation on data collection and data sharing with food safety organisations around the world while respecting confidentiality obligations.

Source: EFSA 2009