Impacts of EFSA Food Health Claims Evaluation - George Tsakraklides


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Report assessing the impacts of EFSA\’s health claims evaluation process

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Impacts of EFSA Food Health Claims Evaluation - George Tsakraklides

  1. 1. EFSA’s health claim evaluation process Key impacts on the European Food & Drink Market George Tsakraklides
  2. 2. What are Functional Foods? Health claims are increasingly appearing on our food.. A health claim is any statement used on product labels, marketing or advertising materials which implies benefits from the food or its components, e.g. vitamins, minerals, fiber, and ‘probiotic’ bacteria ..but the food industry is not allowed to make “medicinal” claims about foods Medicines undergo multistep validation before entering the market, a process which on average takes between 10 and 15 years Functional foods exist in the evolving and still uncertain realm between Foods and Medicines Directive 2001/83/EC of the European Parliament So where do Functional Foods fall? As the definition of functional foods takes shape, so does the regulatory environment Unlike medicines, most of the concern is about false claims The definition of functional foods is still evolving. To some they are fortified foods, to others they include supplements, while to some they can be any food which can make a valid health claim and “provides a health benefit beyond basic nutrition” Whereas in medicines the regulatory environment focuses on safety as well as efficacy, functional foods are so far considered a lowrisk category Institute of Food Technologists
  3. 3. A rapidly growing market 155 all inclusive estimate Rising public interest in healthy living and awareness that food is not only for energy or pleasure - but can serve specific health benefits - has led to a new and rapidly growing market. 31% 15.1 UK 1998-2007 Source: IGD Research 2007 19.7 Global Functional Foods Market (bn euros) 2011 Source: Leatherhead
  4. 4. EFSA Mission EFSA (European Food Safety Authority) is the EU’s risk assessor for food-related risk – providing scientific opinions and advice to: • • provide a sound foundation for European food policies and legislation support the European Commission, European Parliament and EU Member States in taking effective and timely risk management decisions Its remit covers food and feed safety, animal health and welfare, nutrition, plant protection and plant health Shortly after its formation, EFSA took on the ambitious task of regulating functional foods “…So that the consumer is not misled by exaggerated or untruthful claims”
  5. 5. The NDA panel and claims classification Health claims made in relation to food products require authorization under Regulation EC 1924/2006 before they can be used in labeling and marketing EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) is responsible for verifying the scientific substantiation of the health claim. It presides over specialist Working Groups Following ratification of the NDA Opinions by the EU Parliament, member states take on the task of enforcing the new law Two broad categories of claims • “general function and nutrition” - e.g. enhance immunity or learning ability, “low fat”, “source of omega-3 fatty acids” or “high in fiber” • “disease reduction” - e.g. “Plant sterol have shown to reduce cholesterol levels, a risk factor in the development of coronary heart disease” Article 13 • • • Growth, development and body functions Psychological or behavioural benefits Sliming, weight control Article 14 • • Reduction in disease Children’s development and health
  6. 6. Health Claims Evaluation - Key Milestones 2002 2006 2008 2010 2011 2012 is established Nutrition and Health Claims Regulation (NHCR; No 1924/2006) enacted EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) begins work of evaluating submitted health claims, prioritizing claims under Article 13.1 (March) last claims received (July) Panel’s last batch of its Register of Opinions published, consultation begins before critical vote in the European Parliament (January) the register of NDA opinions is presented and put to debate (May) article 13 list register wins approval in European parliament by 60% vote and becomes law. Companies given till December 14 to comply
  7. 7. The EFSA health claim evaluation Process in numbers Herbals and Botanicals put on hold
  8. 8. An uneven decision About 80% of claims were rejected. If Vitamins and Minerals are excluded, the rate approaches 95% Intertek Cantox Botanicals and microorganisms: lucky for now? Evaluation of claims for botanicals, has been put on hold as the EFSA has considered them “insufficiently characterised” and needs time to decide. These will continue to be allowed to be marketed for the time being, though it is at the discretion of member states. Confusion between THMPs (Traditional Herbal Medicinal Products) - which are allowed under separate regulation - and food products with similar ingredients could theoretically result in the same active ingredient being rejected and approved under separate regulations
  9. 9. The losers Probiotics were among the most highprofile as well as controversial casualties Ingredient Claim Probiotics Immunity claims, weight loss ingredients and antioxidants did not fare well in general However overall rejections did not focus on specific categories but were based on the strength of evidence to support each claim Bolster Immune system Gut microflora balance Antioxidants Various Omega-3 Cognitive development Chewing gum Dental plaque reduction
  10. 10. The winners Studying how EFSA came to its conclusions is quite important as it gives us an idea of what makes a successful health claim – and what companies should watch out for in the future Ingredient Claimed effect Minerals Various Lactose digestion Certain fibres FULL:EN:PDF Various Live yoghurt Full list of 222 approved claims in the official Journal of the European Union: Vitamins Glucose , cholesterol, weight Walnuts Blood vessel function Meal replacement Weight control Fatty acids Heart function Xylitol, sorbitol Tooth mineralisation CH/electrolyte drinks / creatine Sports performance
  11. 11. What matters to the EFSA’s NDA panel? Sound science Lack of evidence for cause and effect was the reason for about 4 out of 5 rejections Cantox Relevant studies, properly designed and fit to purpose Studies among relevant human populations The link between cranberry juice consumption and decrease in Urinary Tract Infections was dismissed multiple times as results were based on in vitro studies as opposed to clinical trials among humans. Ironically Dutch-based Medical Brands won a much more significant Class II Medical Device claim in Germany which by mutual recognition allows marketing in EU27 Studies with humans subjects and, in the case of disease reduction claims, studies among healthy individuals who would be the target population as opposed to those having the disease. Glucosamine claims for preventing joint degeneration were rejected partly on the basis that research was done on people already suffering
  12. 12. What matters to the EFSA’s NDA panel? Specific claims with specific aims which can be tested Sufficient characterisation of food constituent and effect sufficient evidence to establish a link between the particular ingredient and the food Identification of the active ingredient as well as the specific effect it has, as opposed to a general effect. A good example is the rejection of a link between water and avoiding dehydration. Although obvious, the claim was deemed as medicinal. It was also submitted under the wrong article It is not enough e.g. to demonstrate that polyphenols in olive oil have antioxidant properties. The evidence must include an effect of olive oil consumption rather than polyphenols i.e. the actual food for which the claim is made Cantox
  13. 13. Wording is everything It is not only about the claim being made. It is about how it is worded proposed allowed Helps maintain a healthy blood flow and benefits circulation Helps maintain normal platelet aggregation Biotin contributes to healthy energyyielding metabolism Biotin contributes to normal energyyielding metabolism Milk is the richest dietary source of calcium Milk is the richest dietary source of available calcium Final re-wordings illustrate EFSA’s commitment to the accurate and precise description of the specifically proven effect rather than what this means to the consumer - In order to minimise the potential for various interpretations as well as positive generalisations of the claimed effect on overall health We can expect future claims to be: 1) 2) 3) 4) More specific and technical More difficult to decipher Less impactful More rational, less emotional
  14. 14. Impacts – Current products Expected fall in sales in products with rejected claims. 1600 claim associations will be banned which means claims will be removed from packaging and other marketing. The food industry has until Dec 14th to comply Current Products : challenging times ahead Direct threat to brands In limbo Brand names which themselves make a health claim may be under threat. Examples are Unilever’s Flora pro.activ and the iconic SlimFast brand. Jan 19, 2022 deadline for changing brand name if its health claim is not approved Decision on other claims has been postponed, leaving companies in the dark in terms of future planning. Some rejected claims can be resubmitted under other articles of the regulation. Others have been withdrawn,
  15. 15. Impacts – Innovation Innovation: limited options , increased competition Less NPD and innovation Lack of EFSA approval will rob manufacturers of the marketing messages that would have been the perfect ammunition for ingredients with newly-approved function Limited new approvals may spark product “mutations” More “All -rounders” and “blends” Although there will only be few new products that claim a “new function”, companies will try to maximise their take from the small new slice of the pie by including the new approved ingredients in as many products (existing or new) as possible Lack of innovation and competition for the very few new approvals will intensify the trend of multifunctional foods , as manufacturers try to outcompete each other by providing extra features - giving rise to more “blends” that can “do it all”
  16. 16. Impacts - Marketing The challenge of making science sound simple Lost in translation There will be more scrutiny for claims to refer to specific effects of the ingredient rather than simplified generalisations. Marketers will have to tackle complicated scientific jargon and convert it to a message which sells e.g. Instead of antioxidant they may have to say “reduces oxidative stress” Ensuring that the meaning of the claim is not altered, overstated or understated upon translation will be a challenge for marketers working under the watchful eye of EU country authorities and the EFSA New opportunities for future nutritional “buzzwords” Opportunity to get creative? Renewed emphasis on “sound science” and limited new approvals to work will leave many with no choice but to re-package their old messages but using new “buzzwords” – opening up the market for new consumer needs New messages will walk a fine line between science fiction and sales targets Flexibility in wording There are already signals from the EFSA that certain flexibility on the wording of claims will be allowed, recognising the challenge of communicating claims to consumers. Time will tell what exactly companies can “get away with”
  17. 17. Impact on Consumers – was it worth it? A new learning curve for consumers - but a new era for popular nutrition? New marketing messages will be more difficult to interpret as they focus on what the product does rather than what this means to the user. For those who have the knowledge, the new messages will be more useful than ever. For the majority who don’t, confusion will set in in the beginning Left In the dark – or more empowered to seek info? It has been argued that the removal of claims from packaging for many products will leave consumers in some instances with no information other than what is contained in the package. At the same time this may encourage some to rely on their own research and consult a variety of other sources, reliable or not European Food Information Council It is under debate whether consumers are now safer or not.. What is certain is that they will be challenged to learn more about what they eat.
  18. 18. Impact on Consumers – was it worth it? New approvals, products - is the Functional Foods market still alive? Although rejections will receive little notice, approvals will be highlighted in the media and over-exploited by manufacturers, providing consumers with new information. The new wave of a small number of approvals may be an advertisement for the whole functional foods market - enough to potentially reinvigorate it, offset the negative effects of rejections and ensure demand and interest continue to grow Quality vs. price Will product quality increase as a result of more careful research and validation? And if it does, will consumers be asked to pay the price?
  19. 19. What can companies do? Invest in research and people Provexis had to submit a 700-page dossier in support of its tomato extract which claims it improves blood circulation. The dossier addressed issues from the original, rejected application and had to specify: Larger companies will have more resource and money for “proper” research, complex dossiers and innovation The formulation of the extract to be used Products it can be used in Effective dosage and conditions of use ‘everything should be spelt out clearly – the health claim process is time consuming and costly, and we have learnt that a company should make every effort to communicate not just present but any potential conditions of use for their products ’ - Provexis COO
  20. 20. What can companies do? Smaller companies will have to do the best with what they can claim already - as well as what they cannot claim anymore Consult the scientists more Requirements are getting increasingly technical and detailed. Marketers will need to work more closely with the Food Scientists. The former advising on what sells, the latter advising on what can be claimed. Together they can formulate claims, agree on validation and finalise wording Create more subtle claims that do not require validation In this environment of increased scrutiny marketing departments will need to tread carefully and push their messaging to its legal limits Mergers and acquisitions may be the only option for some Small enterprises who cannot pay the legal and other fees for research and regulatory filing may seek the help of big companies, who will be happy to acquire manufacturing infrastructure in exchange for protection
  21. 21. EFSA’s health claim evaluation – the next day R&D • Approved claims • • Future claims Make the most of approved claims by • creating blends or other multifunctional foods Follow EFSA news in order to get in on the far and few opportunities for new claims as early as possible • In the face of intense competition, review pricing strategy if needed • • Rejected claims Sales Marketing • • • Study the plethora of rejection case studies available Appeal or submit the same claim under a different article or even different regulation Pay attention to what is important to the NDA • • • Create new claims which won’t be impossible and costly to support via research • Invest in experts who can design sound scientific studies. Learn from pharma and other industries • Conduct market research to understand customer needs • If possible, re-word or create more subtle claims that require no validation Re-brand or focus on other product strengths and USPs If necessary move from a product brand to an endorsed or corporate brand architecture model Educate consumers in order to promote your claims as well as your own brand Consult with the R&D more on claim strategy and wording early on in process Conduct market research to measure brand performance Target customers better • Shift attention to what sells • Lure customers via promotions • • Turn attention to non-EU markets Consider whether product price should take into account the cost of research undertaken to support and develop it
  22. 22. Sources EU / Government Food Standards Agency (UK) Food Safety Authority of Ireland General Media BBC News Google News Wikipedia Specialist & B2B Media nutraceuticals world FnB news NGOs / Non-Profit Organisations Institute of Food Technologists EPHA European Public Health Alliance European Food Information Council Conferences Vitafoods Europe IFT Research Organisations Meyer BCC Research Leatherhead IGD Intertek Cantox Special Interest Groups Alliance for Natural Health
  23. 23. George is a scientist and market researcher at MM-Eye sharp minds, safe hands George Tsakraklides