Background
Summary of Council decision:
Three issues were investigated, two of which were Upheld. The other was informally resolved after the advertiser agreed to amend their advertising.Ad description
A website, www.uk.usn-sport.com, seen on 1 November 2018 selling food supplements featured text on a product page that stated “PHEDRA CUT LIPO XT … Phedra Cut Lipo XT is the latest breakthrough from USN. It consists of a two-in-one liquid capsule containing ground-breaking, clinically researched ingredients … What are the benefits? … Green Tea - Containing Phytofare, a green tea catechin complex, to support your … fat oxidation. Thermogenic - Green Tea itself inhibits an enzyme involved in the thermogenesis of body fat …”.Issue
The Good Thinking Society challenged the following claims which were subject to Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (the Regulation), as reflected in the CAP Code:
1. “Green Tea - Containing Phytofare, a green tea catechin complex, to support your … fat oxidation”; and
2. “Thermogenic - Green Tea itself inhibits an enzyme involved in the thermogenesis of body fat”.Response
1. & 2. USN (UK) Ltd said that the European Food Safety Agency (EFSA) had placed its consideration of health claims for botanicals on hold until they had considered the assessment criteria for such claims.
USN (UK) stated EFSA were considering two possible ways to assess such claims, either through scientific evidence or the historical use of the botanical’s traditional use, and until a decision was made over the assessment of such claims, they could continue to be used subject to the transition measures in Article 28(5) of the Regulation. They believed that meant that traditional history of use data rather than or in addition to randomised controlled trials might be accepted.
USN (UK) stated that the Department of Health and Social Care’s (DHSC) view was that ‘on hold’ claims had to be scientifically substantiated. However, USN (UK) said that the DHSC did not provide clarification on what was meant by “scientifically substantiated”. USN (UK) believed that recent commentary by the EC’s Directorate-General for Health and Food Safety (DG SANTE) suggested historical use of the botanical’s traditional use might form the basis of an ‘on hold’ claim. USN (UK) therefore believed that there was no clarity on what constituted substantiation for ‘on hold’ claims. USN (UK) stated that the advertised product contained a patented green tea extract (Phytofare®), which formed the basis of the health claims quoted in the ad, and referred to the three relevant ‘on hold’ claims for botanicals which they believed applied.
USN stated that 100 mg of Phytofare® contained 96% catechins, of which 57.8% was epigallocatechin-3-gallate (EGCG). They said the ad made clear that Phytofare® contained the active ingredient EGCG, and that the ‘on hold’ claims related to either green tea extract or EGCG. USN (UK) stated that the wording for an ‘on hold’ claim relating to green tea extract rich in EGCG stated that it increased fat oxidation/helped increase fat oxidation. Furthermore, the wording for an ‘on hold’ claim relating to Camellia sinensis (green tea) stated that it supported metabolism and fat oxidation and that green tea inhibited catechol-O-methyltransferase, an enzyme involved in thermogenesis.
USN (UK) stated that green tea and green tea extracts, and therefore the substances in them such as EGCG, had been traditionally used for health and wellness for thousands of years as a stimulant to support fat oxidation and were known to inhibit an enzyme involved in thermogenesis. Its general composition included 50 mg of caffeine per cup and 10–24% tannins. The catechins content was made up of 59% EGCG, 19% epigallocatechin, 13.6% epicatechin-3-gallate and 6.4% as epicatechin.
USN (UK) stated that they primarily relied on traditional use of green tea as a “stimulant” to support the advertised claims. However, they provided a copy of a study on the patented green tea extract component (Phytofare®) contained in the advertised product to support the claims. They said the study demonstrated that the EGCG in Phytofare® had greater bioavailability than the EGCG in a generic green tea extract. Therefore, based on the principle of biological plausibility, the amount of EGCG present in the blood from consuming the 60.2 mg of EGCG in Phytofare® (the amount in the recommended daily dose of the supplement) would be the same or greater than consuming 115 mg of EGCG from a generic green tea extract, resulting in the same health benefits. The minimum dosage of 115mg was the amount of EGCG referred to in the conditions of use for one of the three ‘on hold’ claims to which they had referred. They believed that the study demonstrated that the composition of active substances in the product’s green tea extract could increase fat oxidation, which was demonstrated by a reduction on respiratory quotient.
Furthermore, they believed that the study also demonstrated that green tea could inhibit catechol-O-methytransferase, which had a role in thermogenesis by its action on catecholamine production. USN (UK) stated that the term “stimulant” in its ordinary meaning was “raising levels of physiological or nervous activity in the body”. They believed that their evidence demonstrated that green tea, specifically its catechin and caffeine content, had an impact on the hormone catecholamine, which resulted in a thermogenic response and reduction in fat oxidation. USN (UK) referred to various studies in relation to how green tea extract and EGCG supplementation increased fat oxidation, as well the effect it, along with caffeine, had on thermogenesis. Furthermore, they referenced other studies regarding how catechins had an impact on fat metabolism and that specific amounts of EGCG and caffeine supported energy expenditure. They provided a screenshot of a folder containing the documents which they considered substantiated the claim.
They believed they had therefore satisfied the CAP Code’s requirement that before publishing an advertising claim marketers must hold documentary evidence to prove the claim. They did not provide copies of those documents to the ASA because they believed this would be a breach of copyright, although they offered to provide them to the DHSC or Trading Standards. They believed that alternatively the ASA should engage an expert who could separately access the documents.
Assessment
1. & 2. Upheld
Under the Regulation, which was reflected in the CAP Code, health claims were defined as those that stated, suggested or implied that a relationship existed between a food category, a food or one of its constituents and health, and that included food supplements. Only health claims that appeared on the list of authorised health claims (the EU Register) could be made in ads promoting foods, and marketers must also ensure that they met the conditions of use associated with the claims in question. 'On hold' claims could be used in marketing, provided they were in compliance with applicable existing national provisions (in this case, the CAP Code’s requirements that claims must be substantiated with adequate evidence, including studies that used human participants where relevant) and the product contained the same substance, in the same amounts, to which the ‘on-hold’ claim related.
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 (or, in this case, 'on hold') health claim and the aim of the rewording was to aid consumer understanding, and taking into account factors such as linguistic and cultural variations and the target population.
The ASA considered that in the context of the ad the advertising claims “Green Tea - Containing Phytofare, a green tea catechin complex, to support your … fat oxidation” and “Thermogenic - Green Tea itself inhibits an enzyme involved in the thermogenesis of body fat” would be understood by consumers to mean that the Phytofare® green tea catechin complex in the product helped the body to ‘burn’ fat, and as such helped with weight loss. We considered the claims were therefore health claims. The claims were made in relation to the food supplement Phedra Cut Lipo XT. We understood that one capsule of the supplement contained 50 mg of Phytofare® (described as “Highly bioavailable Camellia sinensis (green tea) catechin complex” on the product label).
It was recommended that consumers take two capsules of Phedra Cut Lipo XT per day for five days, followed by a two-day break. Based on USN (UK)’s response we understood that the supplement provided a daily amount of 60.2 mg of EGCG. USN (UK) referred to three proposed health claims which were currently listed as ‘on hold’ in a list of botanical substances. The first (ID 1544) related to the substance “Epigallo-catechin-3-gallate (EGCG) / Green tea extract, rich in EGCG”. The health relationship proposed by the applicants was “Weight management” and the proposed wording of the health claim was “Helps to maintain and control weight -contributes to the reduction of body fat -helps to increase fat oxidation -help to increase fat oxidation and to reduce body fat -when combined with a healthy diet and exercise, can help to control weight”. The conditions of use for the claim were “115-300 mg per day”.
The second ‘on hold’ claim (ID 1124) related to the substance “Green Tea” for which the proposed wording was “Green tea inhibits catechol-O-methyltransferase, an enzyme involved in the thermogenesis (burning) of body fat, “Supports of [sic] metabolism and fat oxidation”. The conditions of use for that claim were “Leaf/extract Usual consumption as traditional foodstuff in normal diet”. A third ‘on hold’ claim (ID 3698) related to the substance “Camelia sinensis (green tea)” with the proposed wording “Supports metabolism/fat oxidation”. The health relationship proposed by the applicants was “Natural green tea extract with EGCG helps to enhance metabolism/contributes to fat oxidation”. The conditions of use proposed for that claim were “40 mg leaf. Since green tea is consumed in the diet, the 40 mg is based on the ‘significant amount’ of 15% of what is considered in the bulk of the literature to be 270 mg. The 15% is based on the same logic that the vitamin and mineral claims use that 15% of RDA is enough of the nutrient to make the link between the nutrient and the benefit”.
We considered the advertising claims would be understood by consumers as referring to same health benefits specified in one or other of those three ‘on hold’ claims. We then reviewed whether the ‘on hold’ claims related to the same substance to which the health benefit in the advertising claims was attributed. As referenced above, we considered consumers would understand that the product’s ‘fat burning’ effects were attributable to Phytofare®. We noted USN (UK) also attributed the product’s effects to Phytofare® and particularly its EGCG content, although we noted that the ad did not include any reference to EGCG. We noted none of the ‘on hold’ claims related specifically to Phytofare®. ‘On hold’ claim ID 1124 referred to green tea “leaf/extract” but did not specifically reference EGCG, and the conditions of use related to the “Usual consumption [of green tea leaf/extract] as traditional foodstuff in normal diet”.
We considered that because Phedra Cut Lipo XT was a food supplement intended to be consumed as an addition to a normal diet, it would not be understood as a “traditional foodstuff in normal diet” by consumers and therefore did not meet the conditions of use for that ‘on hold’ claim. As such that claim could not be used for the advertised product. The other two ‘on hold’ claims (IDs 1544 and 3698) referred to green tea extract and EGCG in different elements of the proposed wording. We understood that the conditions of use for claim ID 1544 were “115-300 mg per day” of EGCG.
We noted that the daily dose of Phedra Cut Lipo XT provided only 60.2 mg of EGCG. We noted USN (UK)’s argument about the greater bioavailability of the EGCG in Phytofare® compared to EGCG from a generic green tea extract, but considered that because the conditions of use for ‘on hold’ claims related to the amount of the substance consumed, rather than to the bioavailability of the substance, the supplement did not meet the conditions of use for that ‘on hold’ claim. As such that claim could not be used for the advertised product. The conditions of use for claim ID 3698 were “40 mg leaf”. USN (UK) had not provided an explanation of the relative amounts of EGCG in 40 mg of green tea leaf compared to that in their product, but in any case we considered it was clear from the wording of the proposed claim that it was intended to relate to the consumption of green tea leaf as opposed to an extract contained in a food supplement. As such that claim also could not be used for the advertised product.
Notwithstanding that none of the ‘on hold’ claims could be used in relation to the advertised product because they did not relate to the same plant parts and/or did not have the same conditions of use, we reviewed the evidence provided by USN (UK) and their argument that it was acceptable for claims to be supported by evidence of traditional use. USN (UK) attributed the effects of Phedra Cut Lipo XT specifically to the patented green tea extract Phytofare®. We understood that the extract had only recently been developed and therefore there was no evidence of its traditional use.
We further noted that USN (UK) had not provided any evidence to us demonstrating the historical traditional use more generally of green tea leaf, green tea extract or EGCG for ‘fat burning’ or weight loss. In any case, ‘on hold’ claims could only be used in marketing if they were in compliance with applicable existing national provisions, which in this case were the CAP Code’s requirements that claims must be substantiated with adequate evidence. Given that the claims related to a health benefit for humans, we considered that such evidence should consist of clinical trials of robust methodology, conducted on humans. In the absence of such substantiation, evidence relating to traditional use would not be sufficient.
Furthermore, we considered that USN (UK) must provide any evidence it wished to be considered in support of its advertising claims directly to the ASA for our assessment as to whether or not it was adequate. USN (UK) provided a copy of a study on Phytofare®, which they believed supported the advertising claim. However, we understood that the study’s objective was to compare levels of different catechin profiles of Phytofare® with a generic green tea extract. Therefore, the study did not assess whether the green tea extract had the effects claimed in the ad. The study was also conducted using a 200 mg daily dose of Phytofare®, which was double the dose contained in the recommended daily amount of Phedra Cut Lipo XT. USN (UK) had referenced studies regarding the effect of EGCG increasing fat oxidation and energy expenditure, and regarding the effect of EGCG and caffeine delivering a thermogenic response, but did not provide copies of those studies. We were, therefore, unable to assess the robustness of those studies to determine the credibility of the results that had been obtained.
We noted that a health claim for caffeine was listed as non-authorised on the EU Register and that marketers were therefore not permitted to use a claim that caffeine supported thermogenesis. We also noted that in 2016 we had assessed a body of evidence submitted in support of claims that the EGCG in green tea contributed to weight loss. In that case, we concluded that the studies we assessed were not adequate to support such claims. Furthermore, EFSA had reviewed the evidence submitted to them in support of the three ‘on hold’ claims referenced by USN (UK), as well as additional evidence, and come to the opinion in 2010 that a cause and effect relationship had not been established between the consumption of catechins (including EGCG) from green tea and contribution to the maintenance or achievement of a normal body weight.
Because the evidence was not adequate to substantiate the advertising claims, and the advertising claims did not in any case relate to the same plant parts and/or did not have the same conditions of use as the referenced ‘on hold’ claims, we concluded the claims “Green Tea - Containing Phytofare, a green tea catechin complex, to support your … fat oxidation” and “Thermogenic - Green Tea itself inhibits an enzyme involved in the thermogenesis of body fat” breached the Code.
The ad breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation), 15.1 and 15.1.1 (Food, food supplements and associated health or nutrition claims) and 15.7 (Food supplements and other vitamins and minerals).
Action
The claims must not appear again in their current form. We told USN (UK) Ltd not to make health claims for foods unless they were authorised on the EU Register, or properly reflected ‘on hold’ claims (including that the food must include the same substance named in the ‘on hold' claim, in the same amounts) that could also be substantiated.
