Advertisment
An Instagram post featured an image of the product, including on-pack text which stated:
“MacuSave
One-A-Day Food Supplement
Food Supplement for Eye Health
The formulation supported by research. Lutein, Meso-Zeaxanthin, Zeaxanthin. Vitamin B2 and Vitamin E.
FloraGlo Lutein – the most clinically researched lutein brand worldwide”
Text around the product included:
“FloraGlo Lutein” and “contains all 3 macular carotenoids”.
Text accompanying the post included:
“Macu Save – Trusted Formulation for Vision Support!
Each one-a-day capsule contains:
All 3 macular carotenoids – Lutein, Meso-Zeaxanthin, Zeaxanthin
FloraGlo Lutein – the most clinically researched lutein brand worldwide”
“Scientifically backed. Trusted by eye health experts”
The advertisement also included the following hashtags:
“VisionCare” and “amd”.
Complaint
The complainants, Alliance Pharma plc, objected to the advertising on the following grounds.
Issue 1:
The complainants considered that the use of the terms “Clinically Researched” and “amd” were implying medicinal status. They said that their use suggested that the product had been subject to the same standards and procedures as a licensed medicinal product and therefore could treat, prevent or cure a disease. They said that such claims were not permitted for food supplements under both EU and Irish law. They considered therefore, that the average consumer could interpret the claims as an assurance of a therapeutic benefit or efficacy and as such, could influence their purchasing decision.
In regard to the use of “#amd”, they said that this was a medical claim as it referenced the eye condition Age-Related Macular Degeneration and by referencing this through the use of a hashtag, it was indicating that the product was able to treat or prevent a disease, therefore, it implied that the product was a medicine. As it was a food supplement, it had not been assessed for this indication and therefore, did not have the marketing authorisation to make such a medicinal claim.
Issue 2:
The complainant’s said that only nutrition claims listed under the EU Regulation (as reproduced in the EU Register of Health Claims) may be used in marketing communications, relating to food supplements. They said that the advertisement made a number of non-authorised health claims including – ‘Trusted Formulation for Vision Support!’ and ‘#visioncare’
They said that there were currently no authorised health claims relating to “vision support” that would justify this statement in relation to the product or its ingredients.
Issue 3:
The complainants said that the claim ‘The most clinically researched Lutein brand worldwide’ was an absolute claim, suggesting superiority over all competitors globally, to which no evidence had been provided. They said that without publicly accessible, verifiable data comparing all Lutein brands on a global scale, this statement could not reasonably be substantiated.
Response
The advertiser responded to the issues raised.
Issue 1:
The advertiser acknowledged that medicinal claims shall not be made on food supplements and while they acknowledged that ‘clinically proven’ claims were not appropriate for food supplements, they saw a fundamental difference between claiming a product effect and claiming the types of studies performed on an ingredient or a product, be it a food supplement.
They said that, in their view, the claim ‘clinically studied’ or similarly ‘clinically tested’ meant that the product/ingredient was tested on humans under the supervision of a medically qualified professional or another scientifically qualified professional according to a clinical protocol or in a clinical setting. They said that they would not expect that an average consumer who was assumed to be reasonably well-informed, observant and circumspect would understand this claim as an absolute effect claim.
They said that clinical studies were widely practiced using food supplements, referring, as an example, that they were a standard expectation in relation to EFSA applications for the approval of Health Claims within the remit of Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods.
In regard to the use of the hashtag ‘#amd’, they said that they did not see a significant chance of interpretation by consumers that #amd would refer to a medical condition due to the fact that no medical journal or regulation classified #amd as a medical condition. They said that it was a hashtag used for social media purposes.
Issue 2:
The advertisers said that ‘Vision support’ was a general health claim backed by specific article 13 claims . They said that MACU-SAVE contained Riboflavin (Vit B2), which contributed to the maintenance of normal vision, and Vitamin E, which contributed to the protection of cells from oxidative stress, including the cells in the eyes.
By way of further detail, they said that the product contained 0.35mg Vitamin B2 (Riboflavin) per daily dose which constituted 25% nutrient reference value (NRV). They said that meant that it had the article 13 claim authorised “Riboflavin contributes to the maintenance of normal vision” as health claims could be made according to regulation 1924/2006 when 15% NRV was provided per daily dose.
Issue 3:
In response the advertisers said that the ingredient Flora Glo Lutein, was backed by over 100 human clinical trials. They provided a study from the manufacturer which included a list of over 100 human clinical trials.
Further Information:
Issue 2:
The ASA Executive reviewed the Annex of Regulation 1924/2006 – Nutrition claims and the conditions applying to them. For the claim “Source Of (Name of Vitamin/s) And/Or (Name Of Mineral/s)” it stated:
“A claim that a food is a source of vitamins and/or minerals, and any claim likely have the same meaning for the consumer, may only be made where the product contains at least a significant amount as defined in the Annex to Directive 90/496/EEC or an amount provided for by derogations granted according to Article 7 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the additions of vitamins and minerals and of certain other substances to food.”
The ASA Executive also reviewed the Annex to Directive 90/496 EEC and noted it stated:
“Vitamins and minerals which may be declared and their recommended daily allowances (RDA ’s)”
Included in the list was Riboflavin with an RDA of 1.4mg
Underneath the list it stated:
“As a rule, 15% of the recommended allowance specified in this Annex supplied by 100g or 100ml or per package if the package only contains a single portion should be taken into consideration in deciding what constitutes a significant amount.”
The ASA Executive reviewed the EU Register for Health Claims and noted that the “Riboflavin contributes to the maintenance of normal vision” was an authorised health claim, and that the conditions of use were:
“The claim may be used only for food which is at least a source of riboflavin as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.”
https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6554
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=legissum:l21306
https://www.fsai.ie/business-advice/nutrition/permitted-claims
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32006R1924
https://eur-lex.europa.eu/eli/dir/1990/496/oj/eng
Note – the term Recommended Daily Allowance (RDA) was replaced by Reference Intakes (RI) and Nutrient Reference Values (NRV). Values remain the same.
https://ec.europa.eu/food/food-feed-portal/screen/health-claims/eu-register/details/POL-HC-6455
Conclusion
The Complaints Council considered the detail of the complaint and the advertisers’ response.
Issue 1 – Upheld:
The Council noted that the complaint was made on the basis that the use of “clinically researched” and “#amd”, implied that the product had medicinal status. The Council noted that the claim made had been that the FloraGlo Lutein brand was the ‘most clinically researched lutein brand worldwide’, as such, they considered it was clear that the claim applied to the research behind the named brand.
The Council also noted that the advertisement had included an image of the product packaging and that the on-pack text was visible and had stated in two places on the front of the pack that the product was a food supplement. The Council also noted that the advertisement had referred to the product containing ‘all 3 macular carotenoids’ and both the product pack image and wording in the advertisement had listed them.
In regard to the use of the term ‘#amd’, the Council noted that the full term was ‘Age Related Macular Degeneration’ and that ‘amd’ was a common term for the condition. The Council were aware that hashtags were used so that content could be discoverable in searches by categorising it and could help increase a content’s visibility.
The Council considered what the overall impression created by the advertising was to consumers. They considered that the use of the claims “most clinically researched lutein brand worldwide” and “#amd”, together with the inclusion of, the name of the product ‘Macu Save’, and wording such as ‘contains all 3 macular carotenoids’, ‘all 3 key macular carotenoids’, ‘scientifically backed’ and ‘trusted by eye health experts’, a reasonable interpretation by consumers would be that the product was for the treatment of or prevention of macular degeneration. As the product was a food supplement, they considered that the advertisement was in breach of Sections 4.1, 4.4, 4.9 and 4.10 of the Code.
Issue 2 – Upheld:
The Council noted the complaint issue was that there was no authorised health claim for the claims “vision support” or “vision care”. The Council noted that the claims “vision support” and “vision care” were based on a general health claim for Riboflavin (Vitamin B2) that was authorised in the EU Register as per Article 13 of EU Regulation 1924/2006, that ‘Riboflavin contributed to the maintenance of normal vision’. The Council noted the requirements of the legislation on the use of an authorised health claim, that for a product to be claimed as a source of a vitamin or mineral, the product had to contain at least a significant amount as per the Annex of Directive 90/496, which defined a significant amount as having 15% of the NRV. The Council also noted that the daily dosage of the product contained 25% of the NRV, therefore, it could claim to be a source of Riboflavin.
The Council considered the context of a product called ‘Macu Save’ together with a reference to ‘#amd’ (Age Related Macular Degeneration) and other statements included in the advertisement, such as ‘contains all 3 macular carotenoids’, ‘all 3 key macular carotenoids’. The Council considered that the consumer understanding, in the absence of the actual authorised claim, was that the product could positively impact on macular health because of macular carotenoids. The Council considered that the claim had been based on the entire formulation of the product, however, the general health claim authorised in the EU Register had applied to one ingredient (Riboflavin) only and this claim had not been stated in the advertisement. In the circumstances the Council considered that the advertising was in breach of Sections 4.1, 4.4, 4.9, 4.10, 8.9 and 8.11 of the Code.
Issue 3:
The Council noted that the claim ‘The most clinically researched Lutein brand Worldwide’ was an absolute claim, and that, as per the requirements of the Code, should be capable of substantiation and that such substantiation be held in advance of any claim being made. In this case, the Council noted the claim had been made regarding the FloraGlo Lutein brand and that a document had been provided which referenced over 100 clinical trials carried out on human subjects in the following areas:
Eye health
Brain health & cognitive function
Skin health
Maternal & infant nutrition & Health
Uptake, absorption & bioavailability
Other health related outcomes.
The Council noted that under the heading “Eye Health”, 34 clinical trials had been listed, and they also noted that the document included the claim “most clinically researched lutein brand worldwide”. The Council considered the requirements of the Code and that no evidence had been provided to show how the number of trials carried out compared to other brands ‘Worldwide’. In the circumstances, the Council did not consider that the claim had been evidenced, therefore, they considered that the claim “the most clinically researched Lutein brand Worldwide’ was in breach of Sections 4.1, 4.4, 4.9, 4.10 and 4.33 of the Code.
Action Required:
The advertising should not reappear in its current form again.
