On 21st May 2011, the Alliance for Natural Health (ANH) hosted a conference on the above topic. The event was supported by the General Naturopathic Council and the British Association for Applied Nutrition and Nutritional Therapy. The theme was ‘how to develop your practice in spite of the EU regulatory juggernaut’.
The specific regulations and directives discussed at the conference were:
· Human Medicinal Products Directive (HMPD) – see page 5
· Nutrition and Health Claims Regulation (NHCR) – see page 7
· Novel Food Regulation – see page 10
· Advertising Standards Agency (ASA) / CAP Code – see page 11
The prime areas practitioners need to be aware of are:
a) application of EU medicine and food regulations in regard to natural healthcare
b) nutrition and health claims
c) marketing communications via any form of media - from 1st March 2011 this includes the use of digital media such as e-mails, twitter and Facebook
The ANH event lasted all day. Participants were given a 78-page book of notes and a CD with 14 pdf files of key supporting reference documents. ANH has produced a recording of the event and the full seminar pack is available for £40 to practitioners only at
Proceeds go to the ANH-Intl campaign fund and the CD provides 4.5 CPD hours. Please see the ANH website if you wish to keep updated with progress of their campaigns.
The legislation is voluminous and complex and the intention of this document, although lengthy itself, is to summarise these rules and regulations as a reference for you, and to help you develop your practice with these in mind.
Section A of this document covers practical application of these regulations and directives, helping you to decide where to make necessary changes to your websites, flyers and any other advertising material.
Section B gives an outline of the regulations and directives mentioned above. This section should be used for reference in conjunction with Section A.
It is inevitable that additional data will evolve over the next year or two. Nutri-Link is planning to provide a valuable service to practitioners by making information available on its website. For now you may want to look at the ‘suggested / approved wording’ document produced by Nutri-Link which is available via the website link:
This information has been prepared by Julie Green (on behalf of the London College of Naturopathic Medicine) and Jackie Day (on behalf of the Guild of Naturopathic Iridologists International & the Naturopathic Nutrition Association)
SECTION A
HOW THE LEGISLATION AFFECTS YOU IN PRACTICE
The following are key points to be aware of.
v Understand what constitutes a health claim, a nutrition claim and a disease-risk reduction claim. NHCR – see page 7
v Marketing communications that contain health or nutrition claims must have documentary evidence to show they meet the conditions of use associated with the relevant claim, as specified by the European Commission. CAP Code 15.7- page 11
v Serious underlying conditions should be referred to the client’s GP, and this recommendation should be clearly stated in your written report to a client after a consultation. HMPD – see page 5
v Don’t ‘diagnose’ any disease or medical condition. HMPD – page 5
v Don’t associate commercial products with modifying, correcting or restoring health or disease risk factors. HMPD – page 5
v Focus on balancing / supporting those systems of the body that you think are in need of support with a view to maintaining or achieving wellness / wellbeing etc.
v Don’t imply that a varied and / or balanced diet can’t provide adequate nutrients as this would contravene the Food Supplements Directive, NHCR and CAP code
v Marketing/advertising must not suggest that a nutrient or supplement is safe / safer / more effective by virtue of it claiming to be ‘natural’ or because it includes or omits a specific ingredient. Food Supplements Directive, NHCR and CAP code
v If you promote any products, such as supplements, you must avoid any reference to a specific disease, or to disease in general terms as it could be construed as implying that the product / ingredient / food will have a medicinal effect in relation to disease. HMPD
v Claims to correct, modify or restore physiological functions constitute a medicinal claim, whereas “promoting optimal health” or “the maintenance of health” are not medical claims. Make sure you use appropriate terminology if communicating with the public / patients in any verbal, written or email form or on your website.
For example, use wording such as:
· “I use nutritional and lifestyle approaches to facilitate:...”
Don’t use wording that names a ‘medical condition’ as it takes you into the realms of conventional medicine – HMPD. A few examples of acceptable wording are:
· Instead of “Chronic Fatigue” – say “optimal or healthy energy levels”
· Instead of “Blood sugar imbalance” – say “optimal or healthy blood sugar balance” or “balancing energy levels”.
· Instead of “stress/anxiety/mood disorders” – say “emotional and psychological wellbeing” or “promote feelings of wellbeing” or “an ability to adapt to the pressures of a modern lifestyle”.
· Instead of “digestive disorders including constipation, bloating, flatulence, IBS” – say “optimise gastrointestinal health” or “optimise digestion”.
· Instead of “food sensitivities/intolerances” – say “promote tolerance to a wide range of foods / food groups”.
· Instead of saying “I specialise in infertility issues” – say “I specialise in fertility issues”
· Avoid saying “you have adrenal fatigue” – say “you may benefit from adrenal support”
v When providing advice and recommendations to a client, it would come within the scope of NHCR if you also refer to / recommend commercial products (naming a specific product) for the patient to use. ANH consider that to avoid NHCR, you should provide a client with generic information in the body of the report / recommendations / information you give, and keep it separate from any information about products. For example it is perfectly acceptable to give information on magnesium that would be relevant for the client as long as the information comes from a reputable source and likewise for a certain food, PROVIDED that within this information you don’t name any relevant products.
You should give any product prescriptions on a separate plain piece of paper. Using the example above, on this sheet you should make no reference to the benefits of magnesium. Simply state the name of the product, the quantity to take, the frequency it should be taken, and the length of time for which you anticipate it will be needed.
For example: “Biocare Biomagnesium, 2 capsules per day, one with breakfast, one with evening meal. Take for an initial period of 2 months and then review.”
Ideally this product information would be given at a different time to your recommendations, but if given at the same time you should make sure it has no date on it or reference to your practice details. It’s considered that your exposure is going to be low in your clinic where you are in a one-to-one situation, but it would be much higher on a website or in marketing literature, in which situations you shouldn’t make specific recommendations such as this for Magnesium supplementation. CAP Code
v If practitioners are not medically qualified they must refer to their therapeutic skills and interventions in ways that demonstrate their ability to promote and/or maintain health, rather than correcting dysfunction.
v Words like ‘antioxidant’, ‘probiotic’ and ‘prebiotic’ are regarded as health claims, not nutritional claims as they imply a given function and, therefore, a health benefit. For example: ‘product X is high in antioxidants’ would be a health claim. Antioxidant claims that are substantiated adequately and that have been widely used prior to July 2007 can continue to be used under transitional measures of NHCR, but after the positive list comes into effect, practitioners will only be able to use EFSA authorised antioxidant and other health claims. A similar scenario would relate to claims such as ‘chromium supports healthy blood sugar balance’ and ‘product Y supports a healthy immune system’. NHCR
v ‘Detoxification’ is a much used word but as yet it has not been shown from clinical trials that detoxification pathways can become compromised. The word ‘cleansing’ is considered to be a health claim; although it is a term that has been widely used its use in regard to specific nutrients, botanicals and other substances may not be allowed after the positive list comes into effect. Even the term ‘elimination pathways’ can be considered medicinal in certain contexts so care is needed to avoid applying it as a ‘medical function’. Aim to talk about supporting natural detoxification and elimination pathways. HMPD
v There is no official definition of a superfood and the EU has banned the use of the word on product packaging unless the claim is backed up by convincing research. A number of well-known brands have been forced to drop the description. However, there are still some proponents of the term, in spite of its loose definition.
v Some practitioners have used testimonials on their websites or literature and these should avoid the use of specific disease terminology or medical conditions and should not imply a functional medicinal claim (by implying the correcting, modifying or restoration of health). HMPD
For example it would be inappropriate to include in a testimonial “I used to have IBS but since seeing Practitioner X I have been cured”.
Instead, use positive terminology, don’t mention any disease or conditions, and ensure the testimonial doesn’t imply a functional medicinal claim by implying correcting, modifying or restoring health.
Appropriate wording in this case might be “I value the support of Practitioner X as it has enabled me to use nutritional and lifestyle approaches to help me rebalance my life. It’s an amazing feeling to enjoy good digestive health. I can’t recommend Practitioner X enough.”
If you include testimonials in marketing material you must have documentary evidence that it is genuine and you must have written permission from the client to use the testimonial for marketing purposes. Always state the name and location of the client, e.g. Elizabeth Jones, London. HMPD and CAP Code
v If you are involved in any work with the media be mindful of the NHCR and CAP when on the radio, writing in journals or speaking in public. Above all, avoid making any kind of commercial communication. Make sure everything you say can be substantiated with good science. If you give a personal opinion, make sure you qualify it as such. You can make medicinal claims for ingredients or foods as long as you are not talking about a particular product, or a commercial product, on the condition that what you are saying is well backed by science.
SECTION B
REGULATION IN GENERAL
European Union (EU) Regulators aim to develop regulation that gives a high level of consumer protection and helps the European internal market to function smoothly.
EU Regulators are using three principal methods:
1) Regulation of products – for example: EU Food Supplements Directive - vitamins and minerals being put on a “positive” list, the setting of “maximum permitted levels” (MPL) for vitamin and mineral supplements to be harmonised EU-wide, EU Herbal Directive - traditional herbal remedy registration- forcing products to be licensed for the public to purchase off the shelf and only statutorily regulated herbalists will be able to obtain and prescribe unlicensed herbal products), EU Medicines Directive, EU Novel Foods Directive.
2) Regulation of prescriber – for example of medical doctors and other registered health professionals and this will soon include herbalists who are being statutorily regulated by the Health Professions Council.
3) Regulation of information given to consumers – such as by the Advertising Standards Authority (ASA), the Committee of Advertising Practice Code (CAP code) and Nutritional and Health Claims Regulation.
Regulatory Acts
There are different types of Regulatory Acts – briefly as follows:
§ Directives – emerge from Europe and must be transposed into Member State legislature and our MPs can make minor changes as it goes into legislation.
§ Regulations – emerge from Europe and are effective EU-wide and we cannot make any changes at Westminster.
§ Decisions – from Europe are also effective EU-wide and we have no further say in them.
§ Delegated Acts – UK Parliament has 30 days to act on these or they become law.
§ National Laws – including Statutory Instruments based on transposed EU Directives.
HUMAN MEDICINAL PRODUCTS DIRECTIVE (HMPD)
Directive 2001/83/EC (base Directive). Key amendments to HMPD: Directive 2004/27/EC
When considering the various regulations outlined below, it’s important to know that this ‘Medicinal’ legislation takes priority over all other legislation / directives e.g. Nutritional and Health Claims Regulation. In the UK, it is the role of the Medicine and Healthcare Products Regulatory Authority (MHRA) to regulate medicines and medicinal products. Safety, quality and efficacy are the only criteria on which legislation to control human medicines is founded. It is the responsibility of the MHRA and the expert advisory bodies set up by the Medicines Act to ensure that the balance between safety and effectiveness is achieved. The first comprehensive licensing system for medicines in the UK was the Medicines Act of 1968. The current relevant legislation is given in European Directive 2001/83/EC (as amended) relating to medicinal products for human use. Although the European legislation takes precedence, there are regulations in the Medicines Act specific to the UK.
What is a medicinal claim?
A medicinal claim states or implies that a product has the property of treating, preventing, curing or diagnosing human disease. In order to be permitted to make a medicinal claim, a product must be classed as a medicinal product or device in accordance with the relevant legal definitions.
What is the definition of a medicinal product? Article 1(2), Directive 2004/27/EC
A product may be medicinal a) ‘by presentation’ or b) ‘by function’
a) any substance or combination of substances presented as having properties for treating or preventing disease in human beings, or
b) any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
Article 2(2) of the Directive states that ‘in cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a “medicinal product” and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply’.
The European Court of Justice confirmed that the quantity of active substances is the key criterion to distinguish foods from medicines. This means the same product may fall into both categories. It is a medicine if it significantly affects the metabolism and / or strictly modifies the way in which it functions. An ingredient or constituent cannot be determined as medicinal on its own – determination must be made for the whole product.
From this information it could be claimed that both food and indeed water could be classified under the definition of medicinal products, but there is an exemption in the Directive that states “Where a product comes ‘clearly’ under the definition of other product categories, in particular food, food supplements, medical devices, biocides or cosmetics, it is exempted.”
Understanding the definition of a medicine and its scope
Claims to correct, modify or restore physiological functions constitute a medicinal claim whereas promoting optimal health or the maintenance or promotion of optimal health don’t constitute health claims. Regulators consider claims:
a) that refer to normal, or homeostatic function
b) that refer to ‘optimal health’ status
c) that take you from a diseased or dysfunctional status back to ‘normal’ health
To explain this point, conventional medicine has laid claim to the area ‘below the line of homeostasis’: this is the realm of disease or dysfunction where pharmacological, immunological or metabolic action restores the individual to health. If practitioners are not medically qualified they are not allowed to claim to alter physiological function via one of the above three actions. As such, practitioners are only allowed to refer to their therapeutic skills and interventions in ways that demonstrate their ability to promote and/or maintain health. In short, natural (naturopathic) approaches must concentrate on ‘positive’ aspects.
In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) considers various factors when determining whether a product is making a medicinal claim. Factors include:
a) claims, explicit or implicit, which although they may not be claims ‘for treating or preventing (a specific) disease’ could suggest to the average consumer that the product can be taken ‘with a view to restoring, correcting or modifying physiological functions by exerting pharmacological, immunological or metabolic action...’
b) the risks which use of the product may pose
c) the familiarity of the product to consumers and the extent of its distribution in the UK
What does this mean to you in practice?
Focus on the systems of the body rather than the dysfunction of individual organs, i.e. use wording such as ‘I help promote fertility’ rather than ‘I treat infertility’; ‘I help provide support for the endocrine system’ rather than ‘I treat adrenal fatigue’.
Use of terms like: disorder, dysfunction, illness, disease, pain, bite, irritation, swelling, relating to any named disease, or mention of any clinical disease, would bring you under the remit of HMPD, as would wording such as: cure, improve, has been proven to, will treat, will enhance, will reduce, or may restore.
Instead, use wording such as: there is a view that xxx may assist, xxx may support optimal health, xxx has been found to, xxx could help / improve, many people have found that xxx.. (as long as you are able to justify this statement).
NUTRITION AND HEALTH CLAIMS REGULATION (NHCR)
Regulation (EC) No 1924/2006
NHCR aims to extinguish false, ambiguous or misleading claims by banning all health claims other than those that are specifically approved by the European Food Safety Authority (EFSA), which will produce a “Community list of permitted claims” in 2012. There will be a procedure for companies to submit product evidence for evaluation by EFSA, so that the company will legally be able to make a claim for its product in relation to health and disease. No food supplement or product ingredient can be marketed to reduce or treat a disease or reduce risk factors for a disease without evaluation of evidence by EFSA and the European Commission once NHCR is fully implemented.
This framework of regulation controls what may be said, depicted, implied or published (in any medium) about any foodstuff or food constituent including nutritional and botanical supplements and ingredients. In order to avoid false, ambiguous or misleading claims, the NHCR aims to ban all health claims other than those that are specifically approved by European institutions. Nutrition and health claims must be based on and substantiated by generally accepted scientific data. The European Food Standards Agency (EFSA) is the EU risk assessment body for food and feed safety. It provides independent scientific advice to risk managers. The Food Standards Agency represents the UK Government on food safety and standards issues in the European Union; it may request a food business operator or a person placing a product on the market to produce all relevant elements and data establishing compliance with NHCR. As an example, EFSA is currently undertaking a risk assessment of the safety of aspartame based on all available scientific and technical data.
General Food Law Regulation (EC) No 178/2002; Food Safety Action 1990; General Food Regulations 2004; Food Labelling Regulations 1996.
In the UK, the legislation is overseen by the Advertising Standards Agency (ASA) in relation to the CAP Code (Committee of Advertising Practices) – the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing. The ASA will use the NHCR as the basis of what is, or is not, allowed; there are aspects of the NHCR that go beyond advertising rules.
The stated main objectives of NHCR are:
· High level of consumer protection
· Avoid false, misleading claims
· Free movement of goods / functioning of the single market
· Avoid claims that some foods are not sufficiently nutritious or healthy
· Not encourage or condone excess consumption of a given food
· Not state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general
Commercial context is the key determinant as to whether any claim is within or outside the scope of the NCHR. Commercial context NHCR relates to product labelling, product advertising or product sale. Non-commercial context (NHCR does not apply) relates to educational information, non-commercial website, training with no product recommendations, research papers.
The scope of NHCR is limited to claims made to the final consumer. Therefore, nutrition and health claims made to the product trade, to health professionals, practitioners, students, practitioner associations etc are outside the scope of the NHCR on the condition that they do not influence the final consumer – in the case of practitioner this would relate to recommendations made to clients.
If you provide a client with information, keep it generic e.g. it would be perfectly acceptable to give some information on magnesium from a reputable source or likewise for a certain food PROVIDED you do not within this information give a particular product name. You should give any product prescriptions on a separate plain piece of paper with no information about themother than the product name and dosage such as “Biocare Biomagnesium, 2 capsules per day, one with breakfast, one with evening meal”.
What is a nutrition claim?
A ‘nutrition claim’ means any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to:
a) the energy (calorific value) it
(1) provides
(2) provides at a reduced or increased rate - or
(3) does not provide; and/or
b) the nutrients and other substances it
1) contains
2) contains in reduced or increased proportions - or
3) does not contain
Nutrients’ refer to proteins, carbohydrates, fats, fibres, vitamins and minerals listed in the Annex to Directive 90/496/EEC, and substances belonging to or being components of one of those categories.
Examples of nutrition claims could be:
· Product X contains 10mg lycopene
· Product A is high in fibre
· Product B is low in sugar
· Product Y is a source of omega-3 fats
What is a health claim? A health claim is any statement used on labels, in marketing or in advertising that suggests or implies that a relationship exists between health and a food. Claims could be that health benefits can result from consuming a given food as a whole, or from one of its components such as vitamins and minerals, fibre, and ‘probiotic’ bacteria. Such health claims extend to nutritional supplements (or an individual ingredient in a supplement). Examples of health claims would be:
· Lycopene in product X is an antioxidant (as stated above ‘antioxidant’ is a medical term)
· Product X is high in antioxidants
· Product Y supports a healthy immune system
There are different types of health claims. For instance, statements that a food can help reinforce the body’s natural defences or enhance learning ability are called ‘general function’ claims. Examples also include claims on the reduction of disease risk and other substances that may improve or modify the normal functions of the body, e.g. ‘Plant sterols have shown to reduce cholesterol levels, a risk factor in the development of coronary heart disease’ or ‘Calcium may help improve bone density’.
A ‘reduction of disease risk claim’ means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease. Food supplements or product ingredients can’t be marketed to reduce or treat a disease or to reduce risk factors for a disease. Reduction-of-disease-risk claims are acceptable only if authorised by the EU.
· ... presence, absence or reduced content is shown by EFSA to have beneficial nutritional or physiological effect
· ... nutrient present in ‘significant quantity’ in foodstuff
· ... claim only allowed if ‘average consumer can be expected to understand the beneficial effects as expressed in the claim’
Specific labelling / presentations / advertising statements are required for all products containing health claims. Health claims that refer to a rate or amount of weight loss are disallowed.
Currently around 80% of claims evaluated by the EFSA have been rejected and around 95% of claims for botanical or herbal substances have been rejected. The reasons for rejection include:
Human studies on healthy populations are not available or they are insufficient or inconsistent, or a causative relationship is very difficult to prove.
On full implementation of the NHCR, possibly during 2012, all food and nutritional health claims will be outlawed unless they receive prior approval by EFSA and the European Commission.
What is the definition of foodstuff? – Foodstuff (Regulation (EC) 178/2002 / Food Safety Act 1990)
a) a food (or foodstuff) means any substance or product whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans
b) food shall not include.... medicinal products within the meaning of Directive 2001/83/EC
What is the definition of a food supplement? – Food supplement (Directive 2002/46/EC) / Food Supplement Regulations 2005)
Food supplements are defined as: foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marked in dose form
What does this mean to you in practice?
Practitioners are not allowed to suggest that any food or food ingredient might benefit health (unless a health claim has been substantiated by EFSA). The EU is to draw up a ‘positive list’ (see below) of substantiated claims.
EC ‘Community list of permitted claims’
The European Commission (EC) is required to draw up a ‘Community list of permitted claims”’ of the many well-established ‘general function’ health claims that existing within the EU, such as ‘calcium is good for your bones’, on the basis of claims submitted by the EU Member States. This type of health claim, dealt with under Article 13.1 of the Regulation, includes those referring, for instance, to growth, development and the functions of the body and to psychological and behavioural functions, but not to the reduction of disease risk nor to child development or health which are separately addressed under Article 14 and Article 13.5 of the Regulation. EFSA is providing scientific advice to support this process. So far, EFSA has published 125 opinions providing scientific advice for more than 900 health claims, out of the draft a list of 4,637 health claims submitted to EFSA by the Commission between July 2008 and March 2010. The list of authorised health claims will be adopted progressively by the European Commission and Member States taking into account EFSA’s opinions.
Once the Community list of permitted claims list is published across the EU, it will be a criminal offence to make a claim in any type of commercial communication as to the benefit of a food, food ingredient or food supplement, unless it has been approved by the EFSA and the EU. Commercial communications cover all types of media, i.e. verbal, written (including e-mail), pictorial (including video), Facebook, Twitter etc.
In the meantime, practitioners can use the NHCR transitional measures that allow the use of claims that were considered acceptable by the FSA / Department of Health prior to the NHCR coming into force in July 2007. Essentially, this means that they are common health claims that were widely used by reputable companies, products, practitioners etc. After the positive list is published, practitioners will need to use only claims that have been approved.
At this time, there are products on the market that technically are non-compliant with EU Food Supplements Directive (- only certain forms of vitamins and minerals being put on a “positive” list) because of the forms of vitamins and / or minerals they contain. As practitioners we are responsible for supplying / recommending supplements that are as safe as possible and are responsible for supply of non-compliant products. This should not pose a problem if using reputable suppliers.
Transition measures allow trademarks or brand names that were used before 1 January 2005 to be used until 2022, for example ‘Slimfast’.
NOVEL FOOD REGULATION
Regulation (EC) No 258/97.
This regulation governs ingredients which do not have a history of significant consumption within the EU prior to 15 May 1997. It is considered that responsible manufacturers are unlikely to sell non-compliant products.
Individual products are shown to fall into the 4 categories: authorised, food supplement, unauthorised, work in progress. Criteria include:
a) a product was on the market as a food or food ingredient and consumed to a significant degree before 15 May 1997. Thus its access to the market is not subject to the Novel Food Regulation (EC) No. 258/97. However, other specific legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States. Therefore, it is recommended to check with the national competent authorities. In the UK the competent authority is the Food Standards Agency in relation to the implementation of European food law, while the Medicines and Healthcare products Regulatory Agency is responsible for European medicines law.
b) according to information available to Member States competent authorities this product was used only as or in food supplements before 15 May 1997. Any other food uses of this product have to be authorised pursuant to the Novel Food Regulation. The herb Echinacea purpureae and Glucosamine sulphate fall into this category.
ADVERTISING STANDARDS AGENCY (ASA) and the CAP CODE
The Committee of Advertising Practice (CAP) and the Broadcast Committee of Advertising Practice (BCAP) write, review and amend the Advertising Codes (CAP Codes) which are underpinned by consumer protection legislation and reflect UK and EU law and this includes NHCR. CAP maintain an open dialogue with Government and have a close relationship with the Office of Fair Trading (OFT) and with statutory sector regulators in areas where there is, or might be, regulatory overlap. Such bodies include the Medicines and Healthcare Products Regulatory Agency and Food Standards Agency.
The Codes are written by the advertising industry through the Committee of Advertising Practice (CAP) and the Broadcast Committee of Advertising Practice. Standards have always covered verbal communications and from 1st March 2011 the code extends to digital media such as online marketing communications, e-mails, websites, Facebook, Twitter etc if the purpose of the communication is construed as advertising / marketing your services. This includes the website, marketing etc of a third party that includes information about you or your practice.
The Codes covers all marketing communications ‘directly connected with the supply or transfer of goods, services etc’. The CAP code has no legal framework but the ASA (the independent watchdog responsible for administering CAP Advertising Codes) works alongside laws and regulations, e.g. NHCR. The use of blogs may be acceptable as long as the material posted is strictly educational and does not contravene other aspects of the CAP Code. The CAP Code doesn’t cover public talks as these are considered to be providing information rather than advertising. Neither are press releases covered by the codes but be careful about newspaper columns (advertorials) as these are paid for and as such are considered to be advertising. Advertising in places such as shop windows aren’t covered by the codes and any complaint would be under the auspices of Trading Standards.
You can only use the word ‘treat’ for conditions where there is agreement from the CAP that sufficient evidence has been demonstrated to substantiate that your therapy offers a suitable form of ‘treatment’. The use of the word ‘treatment’ is not without problems as it implies you are able to ‘treat’ a condition. The CAP Copy Advice department should be consulted if you require agreement to use ‘treat’ or ‘treatment’ in any context.
Sections of the code specifically relevant to practitioners are:
Section 12: medicines, medicinal devices, health-related products and beauty products
Section 13: weight control and slimming
Section 15: food, food supplements and associated health or nutrition claims
As practitioners we must not make claims that:
· mislead the consumer
· encourage people to break the law
· cause fear and distress without good cause
· state or imply health could be affected by not consuming a food
· state or imply a food prevents, treats or cures human disease. Reduction of disease-risk claims are acceptable only if authorised by EFSA / EC
· claim to effect changes in bodily function that could give rise to or exploit fear
· cast doubt about the safety or nutritional adequacy of another product
· refer to a rate or amount of weight loss
Claims we make must:
· be decent and honest
· be substantiated (before being made)
· comply with NHCR where they are food-related and in a commercial context
Under Section 12:
· Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional
· Health professionals will be deemed suitably qualified only if they can provide suitable credentials, e.g. evidence of relevant professional expertise or qualifications, professional indemnity insurance, accreditation by a professional or regulatory body (that can take disciplinary action), minimum standards for training and qualifications (usually deemed to be National Occupational Standards).
· Marketing communications must not suggest that any product is safe or effective merely because it is ‘natural’ or that it is generally safer because it omits an ingredient in common use
· Marketing communications must not suggest that a product is ‘special’ or ‘different’ because it has been granted a licence by MHRA
· Marketers must not use health professionals or celebrities to endorse medicines
Under Section 15
· Rules must be read in conjunction with relevant legislation
· Nutrition and health claims must satisfy substantiation requirements of NHCR
· Marketers must not state or imply that a balanced or varied diet cannot provide appropriate quantities of nutrients in general
· Marketing communications for foods must not claim to treat clinical vitamin or mineral deficiencies
· Marketing communications must not give a misleading impression of the nutritional or health benefit of the product as a whole
Disallowed claims under the CAP Code include:
· Claims that state or imply health could be affected by not consuming a food
· Claims that state or imply a food prevents, treats or cures human disease.
· Reduction of disease-risk claims are acceptable only if authorised by the EFSA / EC
· Health claims that refer to the recommendation of an individual health professional
· References to changes in bodily functions that could give rise to or exploit fear amongst the public
· Claims of a nutrition or health benefit that gives rise to doubt the safety or nutritional adequacy of another product
· Health claims that refer to a rate or amount of weight loss
The ASA responds to complaints from consumers and industry about adverts that appear to have breached the Codes. An example of how the ASA investigates ‘misleading advertising’ can be seen in the ASA ‘Adjudication on LighterLife UK Ltd’ which upheld a complaint about a television advert. This adjudication is helpful as it enables practitioners to understand aspects of Section 13 of the code (weight control and slimming). Available at: www.asa.org.uk/ASA-action/Adjudications/2011/3/LighterLife-UK-Ltd/TF_ADJ_50065.aspx
If a complaint is made to the ASA the outcome is likely to be a request to you to remove the ‘offending wording’. The policy of the ASA is to ‘name and shame’ and decisions as to the outcome of adjudications are published on the ASA website. An example of a complaint upheld by the ASA as being in breach of several regulations can be seen at http://www.asa.org.uk/ASA-action/Adjudications/2011/6/Christina-Moore/TF_ADJ_50896.aspx
Placing and distribution of advertisements
You should ensure that advertisements appear in surroundings appropriate to professional advertisements, and are distributed by similarly professional means. When advertising in conjunction with practitioners of other therapies you should take reasonable steps to ensure that those other therapists are also registered with bona fide professional bodies.
Advertising should not be false, fraudulent, misleading, deceptive, self-laudatory, extravagant or sensational. It should not make unrealistic claims as to specialism, superiority or curability, and any other claims made should be capable of substantiation. It should not denigrate other members of the profession or other professions. Neither its content nor the manner in which it is distributed should be such as to put prospective clients under pressure and language used should not be overly technical or scientific in nature, i.e. it should be understandable to a lay-person. It should not be in a format that could be construed as misleading to a prospective client, for example it must mot use wording that could imply you are able to halt or reverse a disease process. Advertising should not create unjustified expectations about the length or type of therapeutic protocol or its prospects for relieving the condition concerned. You should ensure that your advertising does nothing to discourage clients or potential clients from seeking conventional medical advice, or from continuing with conventional medical treatment.
On 21st May 2011, the Alliance for Natural Health (ANH) hosted a conference on the above topic. The event was supported by the General Naturopathic Council and the British Association for Applied Nutrition and Nutritional Therapy. The theme was ‘how to develop your practice in spite of the EU regulatory juggernaut’.
The specific regulations and directives discussed at the conference were:
· Human Medicinal Products Directive (HMPD) – see page 5
· Nutrition and Health Claims Regulation (NHCR) – see page 7
· Novel Food Regulation – see page 10
· Advertising Standards Agency (ASA) / CAP Code – see page 11
The prime areas practitioners need to be aware of are:
a) application of EU medicine and food regulations in regard to natural healthcare
b) nutrition and health claims
c) marketing communications via any form of media - from 1st March 2011 this includes the use of digital media such as e-mails, twitter and Facebook
The ANH event lasted all day. Participants were given a 78-page book of notes and a CD with 14 pdf files of key supporting reference documents. ANH has produced a recording of the event and the full seminar pack is available for £40 to practitioners only at
Proceeds go to the ANH-Intl campaign fund and the CD provides 4.5 CPD hours. Please see the ANH website if you wish to keep updated with progress of their campaigns.
The legislation is voluminous and complex and the intention of this document, although lengthy itself, is to summarise these rules and regulations as a reference for you, and to help you develop your practice with these in mind.
Section A of this document covers practical application of these regulations and directives, helping you to decide where to make necessary changes to your websites, flyers and any other advertising material.
Section B gives an outline of the regulations and directives mentioned above. This section should be used for reference in conjunction with Section A.
It is inevitable that additional data will evolve over the next year or two. Nutri-Link is planning to provide a valuable service to practitioners by making information available on its website. For now you may want to look at the ‘suggested / approved wording’ document produced by Nutri-Link which is available via the website link:
This information has been prepared by Julie Green (on behalf of the London College of Naturopathic Medicine) and Jackie Day (on behalf of the Guild of Naturopathic Iridologists International & the Naturopathic Nutrition Association)
SECTION A
HOW THE LEGISLATION AFFECTS YOU IN PRACTICE
The following are key points to be aware of.
v Understand what constitutes a health claim, a nutrition claim and a disease-risk reduction claim. NHCR – see page 7
v Marketing communications that contain health or nutrition claims must have documentary evidence to show they meet the conditions of use associated with the relevant claim, as specified by the European Commission. CAP Code 15.7- page 11
v Serious underlying conditions should be referred to the client’s GP, and this recommendation should be clearly stated in your written report to a client after a consultation. HMPD – see page 5
v Don’t ‘diagnose’ any disease or medical condition. HMPD – page 5
v Don’t associate commercial products with modifying, correcting or restoring health or disease risk factors. HMPD – page 5
v Focus on balancing / supporting those systems of the body that you think are in need of support with a view to maintaining or achieving wellness / wellbeing etc.
v Don’t imply that a varied and / or balanced diet can’t provide adequate nutrients as this would contravene the Food Supplements Directive, NHCR and CAP code
v Marketing/advertising must not suggest that a nutrient or supplement is safe / safer / more effective by virtue of it claiming to be ‘natural’ or because it includes or omits a specific ingredient. Food Supplements Directive, NHCR and CAP code
v If you promote any products, such as supplements, you must avoid any reference to a specific disease, or to disease in general terms as it could be construed as implying that the product / ingredient / food will have a medicinal effect in relation to disease. HMPD
v Claims to correct, modify or restore physiological functions constitute a medicinal claim, whereas “promoting optimal health” or “the maintenance of health” are not medical claims. Make sure you use appropriate terminology if communicating with the public / patients in any verbal, written or email form or on your website.
For example, use wording such as:
· “I use nutritional and lifestyle approaches to facilitate:...”
Don’t use wording that names a ‘medical condition’ as it takes you into the realms of conventional medicine – HMPD. A few examples of acceptable wording are:
· Instead of “Chronic Fatigue” – say “optimal or healthy energy levels”
· Instead of “Blood sugar imbalance” – say “optimal or healthy blood sugar balance” or “balancing energy levels”.
· Instead of “stress/anxiety/mood disorders” – say “emotional and psychological wellbeing” or “promote feelings of wellbeing” or “an ability to adapt to the pressures of a modern lifestyle”.
· Instead of “digestive disorders including constipation, bloating, flatulence, IBS” – say “optimise gastrointestinal health” or “optimise digestion”.
· Instead of “food sensitivities/intolerances” – say “promote tolerance to a wide range of foods / food groups”.
· Instead of saying “I specialise in infertility issues” – say “I specialise in fertility issues”
· Avoid saying “you have adrenal fatigue” – say “you may benefit from adrenal support”
v When providing advice and recommendations to a client, it would come within the scope of NHCR if you also refer to / recommend commercial products (naming a specific product) for the patient to use. ANH consider that to avoid NHCR, you should provide a client with generic information in the body of the report / recommendations / information you give, and keep it separate from any information about products. For example it is perfectly acceptable to give information on magnesium that would be relevant for the client as long as the information comes from a reputable source and likewise for a certain food, PROVIDED that within this information you don’t name any relevant products.
You should give any product prescriptions on a separate plain piece of paper. Using the example above, on this sheet you should make no reference to the benefits of magnesium. Simply state the name of the product, the quantity to take, the frequency it should be taken, and the length of time for which you anticipate it will be needed.
For example: “Biocare Biomagnesium, 2 capsules per day, one with breakfast, one with evening meal. Take for an initial period of 2 months and then review.”
Ideally this product information would be given at a different time to your recommendations, but if given at the same time you should make sure it has no date on it or reference to your practice details. It’s considered that your exposure is going to be low in your clinic where you are in a one-to-one situation, but it would be much higher on a website or in marketing literature, in which situations you shouldn’t make specific recommendations such as this for Magnesium supplementation. CAP Code
v If practitioners are not medically qualified they must refer to their therapeutic skills and interventions in ways that demonstrate their ability to promote and/or maintain health, rather than correcting dysfunction.
v Words like ‘antioxidant’, ‘probiotic’ and ‘prebiotic’ are regarded as health claims, not nutritional claims as they imply a given function and, therefore, a health benefit. For example: ‘product X is high in antioxidants’ would be a health claim. Antioxidant claims that are substantiated adequately and that have been widely used prior to July 2007 can continue to be used under transitional measures of NHCR, but after the positive list comes into effect, practitioners will only be able to use EFSA authorised antioxidant and other health claims. A similar scenario would relate to claims such as ‘chromium supports healthy blood sugar balance’ and ‘product Y supports a healthy immune system’. NHCR
v ‘Detoxification’ is a much used word but as yet it has not been shown from clinical trials that detoxification pathways can become compromised. The word ‘cleansing’ is considered to be a health claim; although it is a term that has been widely used its use in regard to specific nutrients, botanicals and other substances may not be allowed after the positive list comes into effect. Even the term ‘elimination pathways’ can be considered medicinal in certain contexts so care is needed to avoid applying it as a ‘medical function’. Aim to talk about supporting natural detoxification and elimination pathways. HMPD
v There is no official definition of a superfood and the EU has banned the use of the word on product packaging unless the claim is backed up by convincing research. A number of well-known brands have been forced to drop the description. However, there are still some proponents of the term, in spite of its loose definition.
v Some practitioners have used testimonials on their websites or literature and these should avoid the use of specific disease terminology or medical conditions and should not imply a functional medicinal claim (by implying the correcting, modifying or restoration of health). HMPD
For example it would be inappropriate to include in a testimonial “I used to have IBS but since seeing Practitioner X I have been cured”.
Instead, use positive terminology, don’t mention any disease or conditions, and ensure the testimonial doesn’t imply a functional medicinal claim by implying correcting, modifying or restoring health.
Appropriate wording in this case might be “I value the support of Practitioner X as it has enabled me to use nutritional and lifestyle approaches to help me rebalance my life. It’s an amazing feeling to enjoy good digestive health. I can’t recommend Practitioner X enough.”
If you include testimonials in marketing material you must have documentary evidence that it is genuine and you must have written permission from the client to use the testimonial for marketing purposes. Always state the name and location of the client, e.g. Elizabeth Jones, London. HMPD and CAP Code
v If you are involved in any work with the media be mindful of the NHCR and CAP when on the radio, writing in journals or speaking in public. Above all, avoid making any kind of commercial communication. Make sure everything you say can be substantiated with good science. If you give a personal opinion, make sure you qualify it as such. You can make medicinal claims for ingredients or foods as long as you are not talking about a particular product, or a commercial product, on the condition that what you are saying is well backed by science.
SECTION B
REGULATION IN GENERAL
European Union (EU) Regulators aim to develop regulation that gives a high level of consumer protection and helps the European internal market to function smoothly.
EU Regulators are using three principal methods:
1) Regulation of products – for example: EU Food Supplements Directive - vitamins and minerals being put on a “positive” list, the setting of “maximum permitted levels” (MPL) for vitamin and mineral supplements to be harmonised EU-wide, EU Herbal Directive - traditional herbal remedy registration- forcing products to be licensed for the public to purchase off the shelf and only statutorily regulated herbalists will be able to obtain and prescribe unlicensed herbal products), EU Medicines Directive, EU Novel Foods Directive.
2) Regulation of prescriber – for example of medical doctors and other registered health professionals and this will soon include herbalists who are being statutorily regulated by the Health Professions Council.
3) Regulation of information given to consumers – such as by the Advertising Standards Authority (ASA), the Committee of Advertising Practice Code (CAP code) and Nutritional and Health Claims Regulation.
Regulatory Acts
There are different types of Regulatory Acts – briefly as follows:
§ Directives – emerge from Europe and must be transposed into Member State legislature and our MPs can make minor changes as it goes into legislation.
§ Regulations – emerge from Europe and are effective EU-wide and we cannot make any changes at Westminster.
§ Decisions – from Europe are also effective EU-wide and we have no further say in them.
§ Delegated Acts – UK Parliament has 30 days to act on these or they become law.
§ National Laws – including Statutory Instruments based on transposed EU Directives.
HUMAN MEDICINAL PRODUCTS DIRECTIVE (HMPD)
Directive 2001/83/EC (base Directive). Key amendments to HMPD: Directive 2004/27/EC
When considering the various regulations outlined below, it’s important to know that this ‘Medicinal’ legislation takes priority over all other legislation / directives e.g. Nutritional and Health Claims Regulation. In the UK, it is the role of the Medicine and Healthcare Products Regulatory Authority (MHRA) to regulate medicines and medicinal products. Safety, quality and efficacy are the only criteria on which legislation to control human medicines is founded. It is the responsibility of the MHRA and the expert advisory bodies set up by the Medicines Act to ensure that the balance between safety and effectiveness is achieved. The first comprehensive licensing system for medicines in the UK was the Medicines Act of 1968. The current relevant legislation is given in European Directive 2001/83/EC (as amended) relating to medicinal products for human use. Although the European legislation takes precedence, there are regulations in the Medicines Act specific to the UK.
What is a medicinal claim?
A medicinal claim states or implies that a product has the property of treating, preventing, curing or diagnosing human disease. In order to be permitted to make a medicinal claim, a product must be classed as a medicinal product or device in accordance with the relevant legal definitions.
What is the definition of a medicinal product? Article 1(2), Directive 2004/27/EC
A product may be medicinal a) ‘by presentation’ or b) ‘by function’
a) any substance or combination of substances presented as having properties for treating or preventing disease in human beings, or
b) any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
Article 2(2) of the Directive states that ‘in cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a “medicinal product” and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply’.
The European Court of Justice confirmed that the quantity of active substances is the key criterion to distinguish foods from medicines. This means the same product may fall into both categories. It is a medicine if it significantly affects the metabolism and / or strictly modifies the way in which it functions. An ingredient or constituent cannot be determined as medicinal on its own – determination must be made for the whole product.
From this information it could be claimed that both food and indeed water could be classified under the definition of medicinal products, but there is an exemption in the Directive that states “Where a product comes ‘clearly’ under the definition of other product categories, in particular food, food supplements, medical devices, biocides or cosmetics, it is exempted.”
Understanding the definition of a medicine and its scope
Claims to correct, modify or restore physiological functions constitute a medicinal claim whereas promoting optimal health or the maintenance or promotion of optimal health don’t constitute health claims. Regulators consider claims:
a) that refer to normal, or homeostatic function
b) that refer to ‘optimal health’ status
c) that take you from a diseased or dysfunctional status back to ‘normal’ health
To explain this point, conventional medicine has laid claim to the area ‘below the line of homeostasis’: this is the realm of disease or dysfunction where pharmacological, immunological or metabolic action restores the individual to health. If practitioners are not medically qualified they are not allowed to claim to alter physiological function via one of the above three actions. As such, practitioners are only allowed to refer to their therapeutic skills and interventions in ways that demonstrate their ability to promote and/or maintain health. In short, natural (naturopathic) approaches must concentrate on ‘positive’ aspects.
In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) considers various factors when determining whether a product is making a medicinal claim. Factors include:
a) claims, explicit or implicit, which although they may not be claims ‘for treating or preventing (a specific) disease’ could suggest to the average consumer that the product can be taken ‘with a view to restoring, correcting or modifying physiological functions by exerting pharmacological, immunological or metabolic action...’
b) the risks which use of the product may pose
c) the familiarity of the product to consumers and the extent of its distribution in the UK
What does this mean to you in practice?
Focus on the systems of the body rather than the dysfunction of individual organs, i.e. use wording such as ‘I help promote fertility’ rather than ‘I treat infertility’; ‘I help provide support for the endocrine system’ rather than ‘I treat adrenal fatigue’.
Use of terms like: disorder, dysfunction, illness, disease, pain, bite, irritation, swelling, relating to any named disease, or mention of any clinical disease, would bring you under the remit of HMPD, as would wording such as: cure, improve, has been proven to, will treat, will enhance, will reduce, or may restore.
Instead, use wording such as: there is a view that xxx may assist, xxx may support optimal health, xxx has been found to, xxx could help / improve, many people have found that xxx.. (as long as you are able to justify this statement).
NUTRITION AND HEALTH CLAIMS REGULATION (NHCR)
Regulation (EC) No 1924/2006
NHCR aims to extinguish false, ambiguous or misleading claims by banning all health claims other than those that are specifically approved by the European Food Safety Authority (EFSA), which will produce a “Community list of permitted claims” in 2012. There will be a procedure for companies to submit product evidence for evaluation by EFSA, so that the company will legally be able to make a claim for its product in relation to health and disease. No food supplement or product ingredient can be marketed to reduce or treat a disease or reduce risk factors for a disease without evaluation of evidence by EFSA and the European Commission once NHCR is fully implemented.
This framework of regulation controls what may be said, depicted, implied or published (in any medium) about any foodstuff or food constituent including nutritional and botanical supplements and ingredients. In order to avoid false, ambiguous or misleading claims, the NHCR aims to ban all health claims other than those that are specifically approved by European institutions. Nutrition and health claims must be based on and substantiated by generally accepted scientific data. The European Food Standards Agency (EFSA) is the EU risk assessment body for food and feed safety. It provides independent scientific advice to risk managers. The Food Standards Agency represents the UK Government on food safety and standards issues in the European Union; it may request a food business operator or a person placing a product on the market to produce all relevant elements and data establishing compliance with NHCR. As an example, EFSA is currently undertaking a risk assessment of the safety of aspartame based on all available scientific and technical data.
General Food Law Regulation (EC) No 178/2002; Food Safety Action 1990; General Food Regulations 2004; Food Labelling Regulations 1996.
In the UK, the legislation is overseen by the Advertising Standards Agency (ASA) in relation to the CAP Code (Committee of Advertising Practices) – the UK Code of Non-broadcast Advertising, Sales Promotion and Direct Marketing. The ASA will use the NHCR as the basis of what is, or is not, allowed; there are aspects of the NHCR that go beyond advertising rules.
The stated main objectives of NHCR are:
· High level of consumer protection
· Avoid false, misleading claims
· Free movement of goods / functioning of the single market
· Avoid claims that some foods are not sufficiently nutritious or healthy
· Not encourage or condone excess consumption of a given food
· Not state, suggest or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general
Commercial context is the key determinant as to whether any claim is within or outside the scope of the NCHR. Commercial context NHCR relates to product labelling, product advertising or product sale. Non-commercial context (NHCR does not apply) relates to educational information, non-commercial website, training with no product recommendations, research papers.
The scope of NHCR is limited to claims made to the final consumer. Therefore, nutrition and health claims made to the product trade, to health professionals, practitioners, students, practitioner associations etc are outside the scope of the NHCR on the condition that they do not influence the final consumer – in the case of practitioner this would relate to recommendations made to clients.
If you provide a client with information, keep it generic e.g. it would be perfectly acceptable to give some information on magnesium from a reputable source or likewise for a certain food PROVIDED you do not within this information give a particular product name. You should give any product prescriptions on a separate plain piece of paper with no information about themother than the product name and dosage such as “Biocare Biomagnesium, 2 capsules per day, one with breakfast, one with evening meal”.
What is a nutrition claim?
A ‘nutrition claim’ means any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to:
a) the energy (calorific value) it
(1) provides
(2) provides at a reduced or increased rate - or
(3) does not provide; and/or
b) the nutrients and other substances it
1) contains
2) contains in reduced or increased proportions - or
3) does not contain
Nutrients’ refer to proteins, carbohydrates, fats, fibres, vitamins and minerals listed in the Annex to Directive 90/496/EEC, and substances belonging to or being components of one of those categories.
Examples of nutrition claims could be:
· Product X contains 10mg lycopene
· Product A is high in fibre
· Product B is low in sugar
· Product Y is a source of omega-3 fats
What is a health claim? A health claim is any statement used on labels, in marketing or in advertising that suggests or implies that a relationship exists between health and a food. Claims could be that health benefits can result from consuming a given food as a whole, or from one of its components such as vitamins and minerals, fibre, and ‘probiotic’ bacteria. Such health claims extend to nutritional supplements (or an individual ingredient in a supplement). Examples of health claims would be:
· Lycopene in product X is an antioxidant (as stated above ‘antioxidant’ is a medical term)
· Product X is high in antioxidants
· Product Y supports a healthy immune system
There are different types of health claims. For instance, statements that a food can help reinforce the body’s natural defences or enhance learning ability are called ‘general function’ claims. Examples also include claims on the reduction of disease risk and other substances that may improve or modify the normal functions of the body, e.g. ‘Plant sterols have shown to reduce cholesterol levels, a risk factor in the development of coronary heart disease’ or ‘Calcium may help improve bone density’.
A ‘reduction of disease risk claim’ means any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease. Food supplements or product ingredients can’t be marketed to reduce or treat a disease or to reduce risk factors for a disease. Reduction-of-disease-risk claims are acceptable only if authorised by the EU.
· ... presence, absence or reduced content is shown by EFSA to have beneficial nutritional or physiological effect
· ... nutrient present in ‘significant quantity’ in foodstuff
· ... claim only allowed if ‘average consumer can be expected to understand the beneficial effects as expressed in the claim’
Specific labelling / presentations / advertising statements are required for all products containing health claims. Health claims that refer to a rate or amount of weight loss are disallowed.
Currently around 80% of claims evaluated by the EFSA have been rejected and around 95% of claims for botanical or herbal substances have been rejected. The reasons for rejection include:
Human studies on healthy populations are not available or they are insufficient or inconsistent, or a causative relationship is very difficult to prove.
On full implementation of the NHCR, possibly during 2012, all food and nutritional health claims will be outlawed unless they receive prior approval by EFSA and the European Commission.
What is the definition of foodstuff? – Foodstuff (Regulation (EC) 178/2002 / Food Safety Act 1990)
a) a food (or foodstuff) means any substance or product whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans
b) food shall not include.... medicinal products within the meaning of Directive 2001/83/EC
What is the definition of a food supplement? – Food supplement (Directive 2002/46/EC) / Food Supplement Regulations 2005)
Food supplements are defined as: foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marked in dose form
What does this mean to you in practice?
Practitioners are not allowed to suggest that any food or food ingredient might benefit health (unless a health claim has been substantiated by EFSA). The EU is to draw up a ‘positive list’ (see below) of substantiated claims.
EC ‘Community list of permitted claims’
The European Commission (EC) is required to draw up a ‘Community list of permitted claims”’ of the many well-established ‘general function’ health claims that existing within the EU, such as ‘calcium is good for your bones’, on the basis of claims submitted by the EU Member States. This type of health claim, dealt with under Article 13.1 of the Regulation, includes those referring, for instance, to growth, development and the functions of the body and to psychological and behavioural functions, but not to the reduction of disease risk nor to child development or health which are separately addressed under Article 14 and Article 13.5 of the Regulation. EFSA is providing scientific advice to support this process. So far, EFSA has published 125 opinions providing scientific advice for more than 900 health claims, out of the draft a list of 4,637 health claims submitted to EFSA by the Commission between July 2008 and March 2010. The list of authorised health claims will be adopted progressively by the European Commission and Member States taking into account EFSA’s opinions.
Once the Community list of permitted claims list is published across the EU, it will be a criminal offence to make a claim in any type of commercial communication as to the benefit of a food, food ingredient or food supplement, unless it has been approved by the EFSA and the EU. Commercial communications cover all types of media, i.e. verbal, written (including e-mail), pictorial (including video), Facebook, Twitter etc.
In the meantime, practitioners can use the NHCR transitional measures that allow the use of claims that were considered acceptable by the FSA / Department of Health prior to the NHCR coming into force in July 2007. Essentially, this means that they are common health claims that were widely used by reputable companies, products, practitioners etc. After the positive list is published, practitioners will need to use only claims that have been approved.
At this time, there are products on the market that technically are non-compliant with EU Food Supplements Directive (- only certain forms of vitamins and minerals being put on a “positive” list) because of the forms of vitamins and / or minerals they contain. As practitioners we are responsible for supplying / recommending supplements that are as safe as possible and are responsible for supply of non-compliant products. This should not pose a problem if using reputable suppliers.
Transition measures allow trademarks or brand names that were used before 1 January 2005 to be used until 2022, for example ‘Slimfast’.
NOVEL FOOD REGULATION
Regulation (EC) No 258/97.
This regulation governs ingredients which do not have a history of significant consumption within the EU prior to 15 May 1997. It is considered that responsible manufacturers are unlikely to sell non-compliant products.
Individual products are shown to fall into the 4 categories: authorised, food supplement, unauthorised, work in progress. Criteria include:
a) a product was on the market as a food or food ingredient and consumed to a significant degree before 15 May 1997. Thus its access to the market is not subject to the Novel Food Regulation (EC) No. 258/97. However, other specific legislation may restrict the placing on the market of this product as a food or food ingredient in some Member States. Therefore, it is recommended to check with the national competent authorities. In the UK the competent authority is the Food Standards Agency in relation to the implementation of European food law, while the Medicines and Healthcare products Regulatory Agency is responsible for European medicines law.
b) according to information available to Member States competent authorities this product was used only as or in food supplements before 15 May 1997. Any other food uses of this product have to be authorised pursuant to the Novel Food Regulation. The herb Echinacea purpureae and Glucosamine sulphate fall into this category.
ADVERTISING STANDARDS AGENCY (ASA) and the CAP CODE
The Committee of Advertising Practice (CAP) and the Broadcast Committee of Advertising Practice (BCAP) write, review and amend the Advertising Codes (CAP Codes) which are underpinned by consumer protection legislation and reflect UK and EU law and this includes NHCR. CAP maintain an open dialogue with Government and have a close relationship with the Office of Fair Trading (OFT) and with statutory sector regulators in areas where there is, or might be, regulatory overlap. Such bodies include the Medicines and Healthcare Products Regulatory Agency and Food Standards Agency.
The Codes are written by the advertising industry through the Committee of Advertising Practice (CAP) and the Broadcast Committee of Advertising Practice. Standards have always covered verbal communications and from 1st March 2011 the code extends to digital media such as online marketing communications, e-mails, websites, Facebook, Twitter etc if the purpose of the communication is construed as advertising / marketing your services. This includes the website, marketing etc of a third party that includes information about you or your practice.
The Codes covers all marketing communications ‘directly connected with the supply or transfer of goods, services etc’. The CAP code has no legal framework but the ASA (the independent watchdog responsible for administering CAP Advertising Codes) works alongside laws and regulations, e.g. NHCR. The use of blogs may be acceptable as long as the material posted is strictly educational and does not contravene other aspects of the CAP Code. The CAP Code doesn’t cover public talks as these are considered to be providing information rather than advertising. Neither are press releases covered by the codes but be careful about newspaper columns (advertorials) as these are paid for and as such are considered to be advertising. Advertising in places such as shop windows aren’t covered by the codes and any complaint would be under the auspices of Trading Standards.
You can only use the word ‘treat’ for conditions where there is agreement from the CAP that sufficient evidence has been demonstrated to substantiate that your therapy offers a suitable form of ‘treatment’. The use of the word ‘treatment’ is not without problems as it implies you are able to ‘treat’ a condition. The CAP Copy Advice department should be consulted if you require agreement to use ‘treat’ or ‘treatment’ in any context.
Sections of the code specifically relevant to practitioners are:
Section 12: medicines, medicinal devices, health-related products and beauty products
Section 13: weight control and slimming
Section 15: food, food supplements and associated health or nutrition claims
As practitioners we must not make claims that:
· mislead the consumer
· encourage people to break the law
· cause fear and distress without good cause
· state or imply health could be affected by not consuming a food
· state or imply a food prevents, treats or cures human disease. Reduction of disease-risk claims are acceptable only if authorised by EFSA / EC
· claim to effect changes in bodily function that could give rise to or exploit fear
· cast doubt about the safety or nutritional adequacy of another product
· refer to a rate or amount of weight loss
Claims we make must:
· be decent and honest
· be substantiated (before being made)
· comply with NHCR where they are food-related and in a commercial context
Under Section 12:
· Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional
· Health professionals will be deemed suitably qualified only if they can provide suitable credentials, e.g. evidence of relevant professional expertise or qualifications, professional indemnity insurance, accreditation by a professional or regulatory body (that can take disciplinary action), minimum standards for training and qualifications (usually deemed to be National Occupational Standards).
· Marketing communications must not suggest that any product is safe or effective merely because it is ‘natural’ or that it is generally safer because it omits an ingredient in common use
· Marketing communications must not suggest that a product is ‘special’ or ‘different’ because it has been granted a licence by MHRA
· Marketers must not use health professionals or celebrities to endorse medicines
Under Section 15
· Rules must be read in conjunction with relevant legislation
· Nutrition and health claims must satisfy substantiation requirements of NHCR
· Marketers must not state or imply that a balanced or varied diet cannot provide appropriate quantities of nutrients in general
· Marketing communications for foods must not claim to treat clinical vitamin or mineral deficiencies
· Marketing communications must not give a misleading impression of the nutritional or health benefit of the product as a whole
Disallowed claims under the CAP Code include:
· Claims that state or imply health could be affected by not consuming a food
· Claims that state or imply a food prevents, treats or cures human disease.
· Reduction of disease-risk claims are acceptable only if authorised by the EFSA / EC
· Health claims that refer to the recommendation of an individual health professional
· References to changes in bodily functions that could give rise to or exploit fear amongst the public
· Claims of a nutrition or health benefit that gives rise to doubt the safety or nutritional adequacy of another product
· Health claims that refer to a rate or amount of weight loss
The ASA responds to complaints from consumers and industry about adverts that appear to have breached the Codes. An example of how the ASA investigates ‘misleading advertising’ can be seen in the ASA ‘Adjudication on LighterLife UK Ltd’ which upheld a complaint about a television advert. This adjudication is helpful as it enables practitioners to understand aspects of Section 13 of the code (weight control and slimming). Available at: www.asa.org.uk/ASA-action/Adjudications/2011/3/LighterLife-UK-Ltd/TF_ADJ_50065.aspx
If a complaint is made to the ASA the outcome is likely to be a request to you to remove the ‘offending wording’. The policy of the ASA is to ‘name and shame’ and decisions as to the outcome of adjudications are published on the ASA website. An example of a complaint upheld by the ASA as being in breach of several regulations can be seen at http://www.asa.org.uk/ASA-action/Adjudications/2011/6/Christina-Moore/TF_ADJ_50896.aspx
Placing and distribution of advertisements
You should ensure that advertisements appear in surroundings appropriate to professional advertisements, and are distributed by similarly professional means. When advertising in conjunction with practitioners of other therapies you should take reasonable steps to ensure that those other therapists are also registered with bona fide professional bodies.
Advertising should not be false, fraudulent, misleading, deceptive, self-laudatory, extravagant or sensational. It should not make unrealistic claims as to specialism, superiority or curability, and any other claims made should be capable of substantiation. It should not denigrate other members of the profession or other professions. Neither its content nor the manner in which it is distributed should be such as to put prospective clients under pressure and language used should not be overly technical or scientific in nature, i.e. it should be understandable to a lay-person. It should not be in a format that could be construed as misleading to a prospective client, for example it must mot use wording that could imply you are able to halt or reverse a disease process. Advertising should not create unjustified expectations about the length or type of therapeutic protocol or its prospects for relieving the condition concerned. You should ensure that your advertising does nothing to discourage clients or potential clients from seeking conventional medical advice, or from continuing with conventional medical treatment.
