On 14 June 2012, the Commission Regulation (EU) No 432/21012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's health, came into force. Unauthorised claims would be subject to a six-month period of grace until 14 December 2012. The complaints below were considered as they appeared in January 2012 under the then current rules on health and nutritional claims for foods.
Summary of Council decision:
Three issues were investigated, all were Upheld.
A TV ad for a chewing gum slimming aid seen on the Active Channel, which also appeared as a video on two websites:
a. The TV ad was approximately ten minutes in length and featured voice-over, interviews, testimonials and animations in which a number of claims about the product and its ingredients were made.
The voice-over stated, "A pioneering new gum by LA Muscle seeks to reduce your cravings by stopping the urge to overeat. It's called SlimGum." Later the voice-over stated, "The amazing thing about SlimGum is that it is helping people overcome snacking in between meals and stopping cravings for high-fat, high-sugar foods which cause weight gain as well as many other health problems.’ The voice-over also stated, "What makes SlimGum so effective is that it is an appetite suppressant and weight management supplement all in one. SlimGum suppresses your appetite and brings relief during moments of hunger. By chewing SlimGum people are transforming their bodies and changing their lives", while a woman was shown taking a piece of SlimGum out of a blister pack and chewing it.
The voice-over also stated, "There is a vast body of knowledge and research on the most effective nutrients to aid weight loss and support the body's natural functioning. SlimGum contains four clinically tested ingredients proven to increase fat burning functions in the body and suppress the appetite: L-carnitine, chromium, green coffee bean extract and green tea extract. By combining these four key elements, SlimGum not only regulates the body's metabolism but also boosts your energy." The ad then featured a man who was identified in on-screen text as "Jonny Spurling Qualified Personal Trainer". He said, "The antioxidants and the caffeine within green tea can boost our base metabolic rate giving us the ability to burn more calories over a 24-hour period." The ad then featured a man who was identified as "Jonny Rees Personal Trainer & Fitness Model" who said "Green tea, certainly. Chromium glucose dispersal agents will help you use the carbohydrates you take in more efficiently, if you take them at certain times, after training, they can be very effective." Jonny Spurling said, "Chromium's very good. It also helps to restore muscle balance as well, so if you're training for weights or even if you're just doing cardio because it can assist burning fat as well ... carnitine's very unique because what it does is mobilises fatty acids into the mitochondria [which is] the human equivalent of a battery cell, it's where we make all our energy, so if you can push more fatty acids in there and convert them into energy you'll have less fatty acids to be stored as body fat."
The voice-over then stated, "So how do you use SlimGum? Just chew one to four pieces a day the moment your stomach starts to growl and with no chunky tablets to swallow SlimGum can be taken anywhere without water." A blonde woman said, "With SlimGum you can take it anywhere you go and it really saves you the trouble of worrying about where your next meal's coming from."
Later in the ad the voice-over stated, "Here is the science behind this amazing gum; the active ingredients in the gum are locked in and then released using a patented delivery system. The functional ingredients are immediately released and absorbed as soon as chewing begins with absorption taking place through the mouth. This rapid uptake method triggers SlimGum's effects on hunger in seconds. Further chewing releases the full array of active ingredients in SlimGum for maximum effects." The ad showed a woman eating the gum followed by an animation of the inside of the brain.
The ad featured an interview with a man who was identified as "Dr Baber Nisar Dentist" who said, "We look at your mouth as being a gateway to the whole of your body. So if you have a good healthy mouth then you're more likely to be passing good bacteria back into your system." The ad also featured interviews with two individuals described as "Laura Church Nutrition & Fitness Expert" and "Martin MacDonald Consultant Nutritionist" who spoke more generally about nutrition.
b. Claims on slimgum.co.uk stated "LATONE SlimGum AN EASY WAY TO AID SLIMMING*". Claims below, next to a picture of a smiling woman and sitting on the floor, stated "Just chew up to 4 pieces of SlimGum a day before a meal or snack for effective weight loss and appetite suppression". Claims, in a green box below, stated "SUPPRESSES APPETITE; BURNS FAT NATURALLY". The page featured a picture of the product pack. Claims on the pack stated "Contains Green Coffee Bean Extract (Svetol*)'; Green Tea Extract; L-Carnitine; Chromium; Vitamins: Thiamin, Biotin". Small print on the pack stated "May help weight management when combined with a healthy diet and regular exercise".
Claims further down the page stated "An innovative new supplement to aid weight loss; SlimGum, contains four active ingredients proven to help reduce weight in a fresh minty flavour. Watch our video to learn more about SlimGum". The page included ad (a) as a video.
c. A page on theactivechannel.com, featured the channel logo which stated "active channel powered by LA Muscle". The page featured the same video as ad (a). Claims below the video stated "SlimGum is an innovative new chewing gum that can help you with your weight loss goals. Check out these testimonials from people who have tried Slim Gum".
1. The complainant challenged whether the claims, in all the ads, that the product could aid weight loss were misleading and could be substantiated.
The ASA challenged whether:
2. the claim that SlimGum could "boost energy", was misleading and could be substantiated;
3. the ads breached the Code by making medicinal claims for an unlicensed product.
LA Muscle Ltd (LAM) said a daily dose of four pieces of SlimGum contained 400 mg of green coffee bean extract (Svetol), 200 µg (micrograms) of chromium, 165 µg of thiamine, 7.5 µg of biotin, 40 mg of green tea extract and 12 mg of L-carnitine.
LAM said green coffee bean extract was one of the main ingredients in SlimGum because it reduced the glucose absorption from the intestines and increased fat burning. They said that extract, in the same amount as added to the SlimGum, had been shown to be effective in a weight loss study. They believed that conclusion was supported by a meta analysis conducted in 2011 which concluded that green coffee bean extract promoted significant weight loss. They provided a copy of that meta-analysis and another study which examined green coffee extract's effect on weight loss.
LAM said chromium was another of the main ingredients in SlimGum. Chromium picolinate reduced food intake, hunger levels (appetite) and fat cravings, which had been demonstrated in both human and rat studies. They said a systematic review of ten controlled human studies had shown a weight loss of 1.2 kg after 6 to 14 weeks of supplementation. LAM provided a study on the effects of chromium picolinate on food intake and satiety.
LAM said The European Food Safety Authority (EFSA) had evaluated the effect of thiamine and stated that, if thiamine was added in an amount of 15% EU-RDA (recommended daily allowance), then the following wording reflected the scientific evidence: "Thiamine contributes to normal energy-yielding metabolism". They said only the EFSA claim above was approved, but a slightly positive moderation of this claim to common English was "thiamine stimulates metabolism". They said thiamine had a central role in energy-yielding metabolism and worked as a co-enzyme in several reactions in the metabolism, especially in the metabolism of carbohydrates. They provided a copy of the EFSA opinion on thiamine.
LAM said EFSA had also evaluated the effect of biotin and stated that, if biotin was added in an amount of 15% EU-RDA, then the following two wordings reflected the scientific evidence: "Biotin contributes to normal energy-yielding metabolism" and "Biotin contributes to normal macronutrient metabolism". They said only the EFSA claims above were approved, but a slightly positive moderation of the claims to common English was: "biotin stimulates metabolism" and "biotin stimulates fat metabolism". Biotin is a cofactor for enzymes, which are involved in energy-yielding metabolism and macronutrient metabolism.
LAM said green tea extract was added in small amounts and was a supportive ingredient in SlimGum. In much higher doses green tea extract had been shown effective in weight loss and positive comments had been made about it in journal articles. They provided three abtracts from three studies relating to green tea extract.
LAM said L-carnitine was added in small amounts and was a supportive ingredient in SlimGum. In much higher doses L-carnitine had been shown to increase fat burning and had shown positive effect in weight loss in pilot studies. They said L-carnitine was a cofactor required for long chain fatty acids to be used in energy production. They provided a study and two abstracts relating to L-carnitine.
LAM said the ingredients in SlimGum had been found to have an effect in helping weight management, but chewing gum alone has also been found to have an effect on appetite. LAM provided the abstract from a UK study from 2011 which they believed showed that chewing gum could suppress hunger, appetite and cravings for snacks, and promoted fullness. They said it concluded that chewing gum could be helpful to those seeking an aid to appetite control. They believed another study from 2007 supported those results and provided a copy of that study.
LAM also provided a systematic review of the evidence relating to dietary supplements for body-weight reduction.
LAM said they would add a disclaimer to the ad which stated that the product should be taken as part of a calorie controlled diet and with regular exercise, and had not been proven to aid slimming. They said they were happy to provide contact details of all the people who gave testimonials about SlimGum, which had been made independently after using the product.
The ads made a number of claims about the efficacy of SlimGum. Although the ASA noted LAM's belief in the general efficacy of the product, we considered that each of the specific claims made for its efficacy needed to be considered separately under the relevant sections of the CAP and BCAP Codes.
1. & 2. Upheld
We considered that the claim "SlimGum" itself and the claims that the product could "aid weight loss" and was a "weight management supplement" were health claims. We also considered that, in the specific context of ads for a chewing gum, which had a minimal ingested mass, and which made claims about the product's nutrient content, the claim that the product could "boost energy" would be interpreted as a health claim that the nutrients would have an energy-boosting effect.
The ads pre-dated the EU register coming into force and LAM therefore needed to provide evidence in support of the claims. Although LAM had responded regarding the effects of the individual ingredients we understood that they did not hold any evidence for the efficacy of the product specifically. Additionally and notwithstanding our concerns below about the evidence submitted in support of the efficacy of SlimGum's ingredients, we noted that SlimGum had not submitted any evidence that the ingredients contained in the product were absorbed and used by the body in the way suggested by the ads.
LAM provided an EFSA scientific opinion on the substantiation of health claims related to thiamine. The panel had considered that the claim "Thiamine contributes to normal energy-yielding metabolism" reflected the scientific evidence they had seen, but the panel also considered that, in order to bear that claim, a food should be at least a source of thiamine as per Annex to Regulation 1924/2006. We understood that in order to be a source of thiamine a food would need to contain a significant amount of thiamine and we referred to Commission Directive 2008/100/EC, amending Council Directive 90/496/EEC on nutrition labelling for foodstuffs which explained that, in deciding what constituted a significant amount, as a rule 15% of the RDA specified in the Annex to that directive should be taken into account. We noted that the RDA for thiamine was 1.1mg and that 15% of that amount was 0.165 mg. We understood that four pieces of SlimGum contained 0.165 mg of thiamine, however, we considered that the ads did not make clear that four pieces were required in order to achieve that intake. We considered that the ads implied that only one piece of SlimGum was required in order to have an effect and we understood that one piece of SlimGum contained 0.04125 mg of thiamine; substantially less than 15% of RDA. We therefore considered that the product, as it was likely to be consumed, did not contain a sufficient quantity of thiamine to be considered a significant amount and bear the claim "Thiamine contributes to normal energy-yielding metabolism". Notwithstanding that, we noted that the ads did not make that claim and we did not consider that the claims "SlimGum", "aid weight loss", "weight management supplement" and "boosts energy" would be interpreted in the same way by consumers. Furthermore, we disagreed with LAM's view that the claim "Thiamin stimulates metabolism" was likely to have the same meaning to consumers as the proposed wording in the EFSA opinion but rather would be seen as going beyond that meaning.
LAM had provided an EFSA scientific opinion on the substantiation of health claims related to biotin. The panel considered that the claims "Biotin contributes to normal energy-yielding metabolism" and "Biotin contributes to normal macronutrient metabolism" reflected the scientific evidence they had seen, but we also noted that the panel considered that, in order to bear that claim, a food should be at least a source of biotin as per Annex to Regulation 1924/2006. We understood that in order to be a source of biotin a food would need to contain a significant amount of biotin and we again referred to Commission Directive 2008/100/EC amending Council Directive 90/496/EEC. We noted that the RDA for biotin was 0.05 mg and that 15% of that was 0.0075 mg. We understood that four pieces of SlimGum contained 0.0075 mg of biotin, however, we again considered that the ads did not make clear that four pieces were required in order to achieve that intake and that the ads implied that only one piece of SlimGum was required in order to have an effect. We understood that one piece of SlimGum contained 0.001875 mg of biotin; substantially less than 15% of RDA and we therefore considered that the product did not contain a sufficient quantity of biotin to be considered a significant amount and bear the claims "Biotin contributes to normal energy-yielding metabolism" or "Biotin contributes to normal macronutrient metabolism". Notwithstanding that, we considered that the claims "SlimGum", "aid weight loss", "weight management supplement" and "boosts energy" were not the same as those claims in the proposed wording and we disagreed with LAM's assessment that the claims "Biotin stimulates metabolism" and "Biotin stimulates fat metabolism" would be interpreted in the same way. Again, we considered they would be interpreted as going beyond that meaning.
LAM had provided a published study comprising a systematic review and meta-analysis of randomised clinical trials on the efficacy of green coffee extract as a weight loss supplement. However, that study considered the methodological quality of the studies assessed to be poor and of short duration and had concluded that, while evidence seemed to indicate that green coffee extract could promote weight loss, more rigorous trials of longer length were required to assess its efficacy. We therefore did not consider that paper to be suitable substantiation for the claims made.
LAM provided another study which investigated whether green coffee extract induced weight loss and increased the lean to fat mass ratio in volunteers with overweight problems. We noted that, at the time the ads were in use, this study had already been assessed by EFSA who had noted that the baseline characteristics of participants in both the control and intervention groups were not provided, and that whether those groups were comparable for other variables was not reported. The EFSA Panel also noted that the background diet and physical activity at baseline and during the intervention were not reported, and that the study lacked detail as to the diet prescribed during the study and as to whether and how compliance with it was checked. The Panel noted the important methodological limitations of the study and considered that no conclusions could be drawn from it for the scientific substantiation of the claimed effect. We concurred with Panel's findings.
We noted that LAM had also provided a double-blinded, placebo controlled, published study entitled "Effects of Chromium Picolinate on Food Intake and Satiety" which randomly assigned 42 overweight adult women with carbohydrate cravings to receive either 1000 µg of chromium for eight weeks, or a placebo. We therefore understood that subjects had been given 20 times the amount contained in one piece of SlimGum (50 µg) and we did not consider that the findings from a study in which only women had received 20 times the amount found in SlimGum, could be meaningfully extrapolated to substantiate the general efficacy claims for the product.
LAM supplied an article relating to the efficacy of L-carnitine, however, that article comprised only a number of short summaries of the outcomes of trials involving L-carnitine's effectiveness in a wide variety of conditions, mostly unrelated to weight loss and energy, and did not itself investigate whether L-carnitine was effective as a weight management supplement or whether it boosted energy. Notwithstanding that we noted that the paper did include a brief reference to a double-blind study which investigated L-carnitine's effectiveness in weight loss which had found no effect. Although LAM supplied abstracts from two other studies involving L-carnitine, these did not relate to weight loss or energy.
LAM also provided the abstract from an evaluation of the evidence for green tea having an effect on body fat. However, we did not consider that an abstract alone was sufficient substantiation for health claims and we also noted that the abstract concluded that the published data were inconsistent and required more objective quantification. LAM also provided abstracts from two other studies which claimed that green tea may have been responsible for weight loss. However, those abstracts did not contain enough information for us to meaningfully assess the quality or conclusions of that research.
Because we had not seen evidence that showed that SlimGum could "aid weight loss", was a "weight management supplement" or could "boost energy" we concluded that those claims, and the claim "SlimGum" itself, had not been substantiated and were misleading.
On this point ad (a) breached BCAP Code rules
Advertisements must not materially mislead or be likely to do so.
Broadcasters must hold documentary evidence to prove claims that the audience is 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.
If they are necessary for the assessment of claims, broadcasters must, before the advertisement is broadcast, obtain generally accepted scientific evidence and independent expert advice.
Advertisements must not encourage indiscriminate or excessive use of a weight-control or slimming product or service.
12.6 12.6 Broadcasters must obtain suitably qualified independent medical advice or other suitably qualified health specialist advice on the safety and efficacy of weight control and slimming products or services before broadcast. In particular, the advice must satisfy broadcasters that: and 12.6.1 12.6.1 the slimming product or service is likely to be effective and will not lead to harm (Weight control and slimming).
On this point ads (b) and (c) breached CAP Code (Edition 12) rules
Advertisements must not materially mislead or be likely to do so.
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.
A weight-reduction regime in which the intake of energy is lower than its output is the most common self-treatment for achieving weight reduction. Any claim made for the effectiveness or action of a weight-reduction method or product must be backed, if applicable, by rigorous trials on people; testimonials that are not supported by trials do not constitute substantiation.
Only nutrition claims listed in the updated Annex of the EU Regulation (as reproduced in the EU Register) are permitted in advertisements.
Only health claims listed as authorised in the EU Register or claims that would have the same meaning for the audience may be used in advertisements:
www.ec.europa.eu/food/food/labellingnutrition/claims/community_register/authorised_health_claims_en.htm. (Weight control and slimming).
We considered that the claims that the product could suppress appetite, burn fat, stop cravings and regulate and boost metabolism were claims that the product could create a physiological change in the body and were therefore medicinal claims. The CAP Code required that such claims may only be made for a medicinal product licensed by the MHRA, but we noted that LAM did not have such an authorisation for SlimGum. We therefore concluded that the ads breached the Code on this point.
On this point ad (a) breached BCAP Code rule 11.4 (Medicines, medical devices, treatments and health).
On this point ads (b) and (c) breached CAP Code (Edition 12) rule
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease. (Medicines, medical devices, health-related products and beauty products).
Ad (a) must not be broadcast again in its current form.
Ads (b) and (c) must not appear again in their current form.
We told LA Muscle not make weight loss claims for their products unless they were able to substantiate them. We also told LA Muscle not to make medicinal claims for products unless those products were licensed by the MHRA. We told LA Muscle to contact CAP's Copy Advice team before preparing non-broadcast marketing in future.