Background
Summary of Council decision:
Three issues were investigated, all of which were Upheld.
Ad description
Two magazine ads for New Nordic food supplements:
a. An ad for “Blue Berry Eyebright plus” seen in February 2017 included text which stated, “Could Blueberries help your eyesight? In the Second World War pilots were said to have eaten blueberries to improve their night vision. Could they help your sight, too? Certain vitamins help prevent against loss of vision. Blueberries in particular contain the vital antioxidant vitamin A- known as the ‘eye vitamin.’ Vitamin A helps your body produce pigments for photoreceptor cells in the retina to work properly. And zinc, found in high concentrations in the eye, is vital for normal vision. In a study sponsored by the American National Eye Institute, researchers discovered that taking zinc, along with other antioxidants, could lower the risk of developing advanced age-related macular degeneration (AMD). New Nordic’s Blue Berry™ Eyebright Plus Mega-Strength one-a-day tablets contain both of these nutritional supplements. There are additional extracts, too, such as the micronutrient lutein, in this case derived from marigold leaves. Lutein is a yellow pigment that is found naturally in the macula, the central point of the retina responsible for fine focus”.
b. An ad for “Melissa Dream” seen in January 2017 included text which stated “I have often found that lack of sleep influences my mood, happiness and general wellbeing. Now I sleep like a DREAM! Borghild Ernulf is one of many people who have found it difficult to get the right balance between a naturally energetic lifestyle and restorative deep sleep, often seen as the alpha and omega for a healthy mind and body”. Text under the heading “Proper rest was hard to find” stated “Despite the fact that when we moved to France I no longer had to focus on business related issues, I was still finding it difficult to relax properly, which was affecting the quality of my sleep. I’d have lots of things racing around in my head, preventing me from finding that elusive restful sleep”. Text under the heading “Then she tried Melissa DreamTM” read, “About a year ago, Borghild told a good friend from Sweden about her problems with sleep. She explains: ‘That morning, I was more tired than usual after an almost sleepless night. Over lunch, we discussed the importance of good sleep for general wellbeing. My friend recommended that I try the natural food supplement Melissa DreamTM tablets, and after a few days, I started to feel a positive effect’”. Further text under the heading “Normal, calm and restorative sleep” read, “By taking Melissa DreamTM tablets regularly as part of her nightly ritual, Borghild’s sleep has become completely normal. ‘After I have taken it, I put my book on the bedside table and fall fast asleep straight away. Then I sleep, totally relaxed throughout the night, waking up feeling fresh and rested. I did not think that was possible – I tried several similar products over the years to find a solution which works for me, but it’s only now that I can really relax and sleep tight, waking up rested and ready for what the day might bring’, says a happy Borghild”. In a box at the bottom of the page, under the title “The connection between sleep and weight gain” text stated “People who sleep poorly often have a tendency to put on weight. Significant studies show that those of us who suffer from sleep problems will often be at increased risk of developing obesity. Therefore, it is a logical assumption that if you are trying to lose weight, you should take steps to achieve a normal good night’s sleep. Melissa DreamTM tablets contain natural ingredients to help enable calm, continuous sleep”.
Issue
The complainant challenged the following claims in the ads, which were subject to the requirements of Regulation (EC) 1924/2006 on nutrition and health claims made on food (the Regulation), as reflected in the CAP Code:
1. the specific health claims and reduction of disease risk claims relating to the improvement of vision in ad (a), and to assisting sleep, helping weight loss and reducing obesity risk factors in ad (b);
2. the general health claims relating to eye health in ad (a) and lack of sleep in ad (b); and
3. the claim to prevent human disease in ad (a).
Response
1., 2. & 3. New Nordic Ltd said in regards to ad (a) they agreed to amend the wording for the claims about both Vitamin A and zinc to the correct wording which was authorised in the EU Register of nutrition and health claims made on foods (the EU Register) and to delete the claims about lutein and Vitamin A and photoreceptor cells. They said they also used claims for Vaccinium myrtillus (blueberry) and Euraphasia officinalis (eyebright) which had been submitted to the European Food Safety Authority (EFSA) for approval and were classed as ‘on hold’. They referred to two specific claims. Further, they provided studies to substantiate the on-hold claims. They also agreed to delete the claim in regard to advanced age-related macular degeneration (AMD) from ad (a).
In regard to ad (b) they said they used claims for Melissa officinalis (lemon balm) which were also classed as ‘on hold’ and referred to three specific claims. They also provided studies in support of those claims. Further, they said they would delete the claims which related to weight and weight loss, and that in the future they would ensure their claims were compliant with the relevant rules.
Assessment
1. Upheld
The ASA noted that under the Regulation, which was reflected in the CAP Code, only health claims which appeared on the list of authorised health claims (the EU Register) could be made in ads promoting foods, and that marketers must also ensure that they met the conditions of use associated with the claims in question. Health claims must be presented clearly and without exaggeration. The CAP Code defined a health claim as any claim that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents and health.
Ad (a) included the claims “Blueberries in particular contain the vital antioxidant vitamin A – known as the ‘eye vitamin’”, “Vitamin A helps your body produce pigments for photoreceptor cells in the retina to work properly”, “And zinc, found in high concentrations in the eye, is vital for normal vision”, and “lutein is a yellow pigment that is found naturally in the macula, the central point of the retina responsible for fine focus”. We considered the claims were likely to be interpreted as suggesting a specific health benefit, of improved vision, could result from consuming the product. We considered the claims were therefore specific health claims which must be authorised on the EU Register.
With regard to the claim “Vitamin A helps your body produce pigments for photoreceptor cells in the retina to work properly” and “Blueberries in particular contain the vital antioxidant vitamin A – known as the ‘eye vitamin’”, we understood that “Vitamin A contributes to the maintenance of normal vision” was a health claim authorised on the EU Register. We noted marketers could exercise some flexibility in rewording claims, provided that the reworded claim was likely to have the same meaning for consumers as the authorised health claim and the aim of the rewording was to aid consumer understanding, and taking into account factors such as linguistic or cultural variations and the target population. We considered that the claim “Vitamin A helps your body produce pigments for photoreceptor cells in the retina to work properly” did not communicate the same meaning as the authorised claim and that the rewording was therefore not acceptable. We considered that the claim “Blueberries in particular contain the vital antioxidant vitamin A – known as the ‘eye vitamin’” also did not have the same meaning as the authorised claim and that the rewording was therefore not acceptable. We further noted the EU Register included authorised claims relating to the role of certain substances in contributing to the protection of cells from oxidative stress. However, none of those claims were authorised in relation to vitamin A, nor did they use the term “antioxidant”. We considered that both claims were in breach of the Code.
With regard to the claim “And zinc, found in high concentrations in the eye, is vital for normal vision”, we understood that “Zinc contributes to the maintenance of normal vision” was a health claim authorised on the EU Register. We considered that the claim would be understood by consumers to mean that zinc was required to be taken in high doses in order to ensure normal vision. We considered that this wording exaggerated the meaning of the authorised claim and that the rewording was therefore not acceptable and that the claim was in breach of the Code.
New Nordic had referred to a claim submitted to EFSA for the substance Vaccinium myrtillus (blueberry/bilberry), with the wording "Supports visual clarity, Supports retinal function, Maintains eye health, Supports blood flow to the eye, Well known source of antioxidants, Natural defense against free radicals, Provides antioxidant support for the eyes, Helps protect eyes". We understood the claim was currently listed as 'on hold' in a list of botanical substances. On-hold claims for such botanicals could be used in marketing, provided such use had the same meaning as the proposed claim and they were used in compliance with applicable existing national provisions (in this case the CAP Code), which meant that the claims needed to be substantiated by evidence. Such claims were still under consideration by EFSA and may or may not be approved in future. We noted that, as with health claims authorised on the EU Register, marketers could exercise some flexibility with wording of on-hold claims. However, we did not consider that the various claims in the ad about eye health and vision would have the same meaning to consumers as the claim submitted to EFSA. In particular, we considered that the claims in the ad went beyond the various elements of the on-hold claim, and instead implied that the product could improve vision. We therefore considered the claims in the ad exaggerated the health claim submitted to EFSA.
In regard to the claim “In the Second World War pilots were said to have eaten blueberries to improve their night vision. Could they help your sight, too?” the advertiser referred to an on-hold claim with the wording "Beneficial for eyes, Helps to support eye health, Helps to improve night vision, Helps to support faster adjustment to darkness, Helps to improve night time visual acuity". We considered that the claim would be understood by consumers to have the same meaning as the authorised claim and that the rewording was therefore acceptable.
New Nordic had also referred to an on-hold claim submitted to EFSA for Euraphasia officinalis (eyebright), which we understood was in the product, with the wording "For maintaining the functions of vision and retina". We did not consider that the various claims in the ad about eye health and vision would have the same meaning to consumers as the claim submitted to EFSA. In particular, we considered that the claims in the ad went beyond the on-hold claim, and instead implied that the product could improve vision. We therefore considered the claims in the ad exaggerated the health claim submitted to EFSA.
We had previously assessed evidence submitted by the advertiser in relation to blueberry and eyebright which they believed substantiated the on-hold claims referenced above, and found that they did not substantiate the claims they had made in relation to improved vision or night vision. The advertiser provided the same documentary evidence in relation to the claims in these ads. In the absence of new evidence, for the reasons stated in our 2015 ruling we concluded the body of evidence was not sufficient to substantiate the claims in the ad.
In ad (b) we considered that the claim “People who sleep poorly often have a tendency to put on weight ... Therefore, it is a logical assumption that if you are trying to lose weight, you should take steps to achieve a normal good night’s sleep. Melissa DreamTM tablets contain natural ingredients to help enable calm, continuous sleep” made references to assisting with sleep and helping weight loss and that these were health claims which were likely to be interpreted as suggesting a specific health benefit could result from consuming the product.
New Nordic had referred to a claim submitted to EFSA for Melissa officinalis (lemon balm), with the wording “Used to help find a better sleep”, which was currently listed as on hold. We considered that the claim “Melissa DreamTM tablets contain natural ingredients to help enable calm, continuous sleep” did not have the same meaning to consumers as the claim submitted to EFSA. In particular, we considered that the claims in the ad went beyond claiming that the product could help to find a better sleep and instead implied that the product could improve sleep quality. We therefore considered the claims in the ad exaggerated the health claim submitted to EFSA.
New Nordic provided four studies which they believed substantiated the on-hold claim. The first study was a pilot trial of Melissa officinalis in the treatment of volunteers suffering from mild-to-moderate anxiety disorders and sleep disturbances. It was conducted on 20 volunteers – six males and fourteen females between the ages of 18 and 70 years, over 15 days. We noted that the study did not have a control group and was tested on a very small group of participants. We considered that the results of a trial conducted on participants with anxiety disorders were not representative of the general population. We therefore considered that the study was not sufficient to substantiate the claims. The second study was a double-blind, randomised, placebo-controlled trial in patients with mild-to-moderate Alzheimer’s disease. We considered that the results of a trial conducted on participants with Alzheimer’s were not representative of the general population or that the treatment of the symptoms of Alzheimer’s could be extrapolated to helping improve the quality of sleep in the general population. The third study looked at the modulation of mood and cognitive performance following acute administration of single doses of Melissa officinalis. We did not consider it relevant to the claims in the ad which did not make reference to mood or cognitive performance. Further, we noted that the average age of the participants was 19.2 years which was of limited relevance to the ad which was targeted to an older population. The fourth study looked at the attenuation of laboratory-induced stress in humans after acute administration of Melissa officinalis. However, as the supplement was advertised to assist with sleep, we did not consider the trial to be relevant. Overall, we did not consider the body of evidence was sufficient to substantiate the claims in the ad.
Ad (b) also included the claim “People who sleep poorly often have a tendency to put on weight. Significant studies show that those of us who suffer from sleep problems will often be at increased risk of developing obesity. Therefore, it is a logical assumption that if you are trying to lose weight, you should take steps to achieve a normal good night’s sleep”. We considered that this claim would be understood by consumers to imply that the product could help weight loss and/or as implying that sleep problems were a risk factor in the development of obesity, and that the product could reduce that risk factor.
Claims relating to weight loss were specific health claims which must be authorised on the EU Register. Claims which stated, suggested or implied that the consumption of a food category, a food or one of its constituents significantly reduced a risk factor in the development of a human disease (‘reduction of disease risk’ claims) also must be authorised on the EU Register. We had not seen evidence that the claim in the ad was authorised on the Register and therefore concluded that the claim breached the Code.
We considered that the claims made in ads (a) and (b) which related to improved vision, better sleep and weight loss were health claims which were not authorised on the Register or on-hold claims that were substantiated by the evidence. We also concluded that the claim in ad (b) which related to the reduction of a risk factor in obesity was a reduction of disease risk claim which was not authorised on the Register. We therefore concluded that the claims in both ads (a) and (b) breached the Code.
On this point, the ads breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation),
15.1
15.1
Marketing communications that contain nutrition or health claims must be supported by documentary evidence to show they meet the conditions of use associated with the relevant claim, as specified in the EU Register. Claims must be presented clearly and without exaggeration.
15.1.1
15.1.1
Only nutrition claims listed in the updated Annex of the EU Regulation (as reproduced in the EU Register) may be used in marketing communications.
http://www.ec.europa.eu/food/food/labellingnutrition/claims/community_register/nutrition_claims_en.htm
Only health claims listed as authorised in the EU Register, or claims that would have the same meaning to the consumer may be used in marketing communications.
http://www.ec.europa.eu/food/food/labellingnutrition/claims/community_register/authorised_health_claims_en.htm.
and
15.6.2
15.6.2
Claims that state or imply a food prevents, treats or cures human disease. Reduction-of disease-risk claims are acceptable if authorised by the European Commission
(Food, food supplements and associated health or nutrition claims) and
15.7
15.7
Nutrition and health claims for food supplements must be permitted or authorised as provided for at rule 15.1.1 above. Marketing communications that contain nutrition or health claims must be supported by documentary evidence to show they meet the conditions of use associated with the relevant claim as specified in the EU Register.
(Food supplements and other vitamins and minerals).
2. Upheld
According to the Regulation, which was reflected in the CAP Code, references to general benefits of a nutrient or food for overall good health or health-related well-being were acceptable only if accompanied by a specific authorised health claim.
In ad (a) we considered the claims “Could blueberries help your eyesight?” and “But on a daily basis, experts are now realising the benefits of diet to protect the eyes- and that’s where the power of blueberries comes in” would be interpreted by consumers to mean that if they consumed the product it would provide general benefits for their eye health. Because the ad did not contain any acceptable specific authorised health claims relating to eye health (as detailed in Point 1 above), we concluded the claim breached the Code.
Ad (b) included claims such as “I have often found that lack of sleep influences my mood, happiness and general wellbeing. Now I sleep like a DREAM!”. We considered that consumers would understand from such claims that if they took the product it would have a generally positive effect on the quality of their sleep. We considered these claims to include references to general, non-specific health benefits of the product. Because the ad did not contain any acceptable specific authorised health claims (as detailed in Point 1 above), we concluded the claims breached the Code.
On this point, the ads breached CAP Code (Edition 12) rule 15.2 15.2 References to general benefits of a nutrient or food for overall good health or health-related well-being are acceptable only if accompanied by a specific authorised health claim. (Food, food supplements and associated health or nutrition claims).
3. Upheld
The ASA noted that claims that stated or implied a food could prevent, treat or cure human disease were prohibited for foods (which included food supplements).
We considered the claim in ad (a) “In a study sponsored by the American National Eye Institute, researchers discovered that taking zinc, along with other antioxidants, could lower the risk of developing advanced age-related macular degeneration (AMD)” implied that taking zinc could help to prevent the development of AMD. We considered the ad implied that Blue Berry Eyebright Plus contained zinc and therefore that it could help prevent the development of AMD.
Because the ad made a claim to prevent, treat or cure human disease, which was prohibited for foods, including food supplements, we concluded the ad breached the Code.
On this point ad (a) breached CAP Code (Edition 12) rule 15.6.2 15.6.2 Claims that state or imply a food prevents, treats or cures human disease. Reduction-of disease-risk claims are acceptable if authorised by the European Commission (Food supplements and associated health or nutrition claims).
Action
The ads must not appear again in their current form. We told New Nordic Ltd not to state or imply that Blue Berry Eyebright plus could improve vision or to make any eye-related health claims for the product, apart from health claims authorised on the EU Register. We also told them to ensure that they did not imply that the product could prevent or treat human disease. Further, we told them not to state or imply that Melissa DreamTM could improve the quality of sleep or to make any sleep-related health claims for the product, apart from health claims authorised on the EU Register. We told them not to make general health claims for either product unless they were accompanied by a specific authorised health claim.
CAP Code (Edition 12)
15.1 15.1.1 15.2 15.6.2 15.7 3.1 3.7
