Background
Summary of Council decision:
Six issues were investigated, all of which were Upheld.
Ad description
The website www.buynutricigs.co.uk, promoted a range of electronic cigarettes. The website stated "NutriCigs … FORTIFIED ELECTRONIC CIGARETTES". The website featured three electronic cigarette products and each one was accompanied with the claim "ALL-NATURAL". Individual products were accompanied with the text "SLIM NutriCigs … APPETITE SUPPRESSANT … Supports curbed appetite suppression. Eat less while enjoying an electronic cigarette … Give Your Body & Weight-Loss Goals A Kick By Eating What You Like, Just Less of it! … ENERGY NutriCigs … ENERGY BOOSTER … SLEEP NutriCigs … SLEEP AID".
Issue
The complainant challenged whether the following claims were misleading and could be substantiated:
1. "all natural";
2. "appetite suppressant";
3. "energy booster"; and
4. "sleep aid".
5. The complainant also challenged whether the ad was misleading and irresponsible because it implied the products had health benefits.
6. The ASA challenged whether the name "NutriCigs" along with the text "fortified electronic cigarettes" misleadingly implied the products had nutritional benefits.
Response
President Properties Ltd t/a NutriCigs UK said all claims were suggestive of the potential benefits and effects of the products and reflected information widely known about the ingredients. They said they had made no new, revolutionary, medicinal, factually incorrect, fictitious, untrue, exaggerated or unsubstantiated claims. Also they had not made any claims for the product ingredients over and above those already in the public domain. They said the claims suggested or implied no more benefit, effect or result than any other product with the same ingredients and the claims had not conflicted with accepted results of clinical trials that evaluated those ingredients.
NutriCigs said the effectiveness of the delivery method was not specified. The website highlighted the potential benefits of the products and that they 'may help' and that was not associated with overt or outright promised or guaranteed results. The effects depended on the individual, which was common to all types of supplements. They said that vapour delivery was a known method of transferring chemicals to the body and therefore the claims related to particular formulations and ingredients contained within the products.
1. NutriCigs said that some of the ingredients occurred naturally in the body or were a component of naturally occurring food.
2. 3. & 4. NutriCigs said all their products contained substances which were widely regarded as forms of nutrients and offered benefits akin to nutritional supplementation. They provided links to several abstracts and studies on the ingredients contained in their "NutriCigs SLIM" products.
NutriCigs said they saw no reason why their products should be brought within the scope of medicine classification or that they required medicinal licensing. They said their website clearly stated "This statement has not been evaluated by the Food and Drug Administration or the Medicines and Healthcare products Regulatory Agency (MHRA). This product is not intended to diagnose, treat, cure or prevent any disease" and therefore it was very clear that the products were not, or had not claimed that they were medicines.
5. & 6.
NutriCigs said that their products contained substances regarded as nutrients and their benefits were similar to supplementation, not medication, which could have been the case if they had named their product 'MediCig'. They said the product names were reiterations of the widely known effects of the ingredients, confirmed by clinical trials and that the word 'nutri' was widely used with other products. They said they could not find any legislation that defined 'Nutri' as one that required the approval of a regulatory body.
Assessment
1. Upheld
NutriCigs did not provide detailed information about the product contents, how they were sourced or manufactured. While some of the ingredients were naturally occurring in their original form, in order to render them suitable for human consumption, the ASA considered that it was likely that a number of processes would have occurred. We considered that consumers would expect that no additional technical or manufacturing processes would be used for a product described as "all natural".
Because we had not seen evidence that the NutriCigs products were in line with the consumer expectation of "natural", we concluded the claim was misleading and had not been substantiated.
On this point, the ad breached CAP Code (Edition 12) rules 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. and 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. (Misleading advertising).
2. & 4. Upheld
We consulted the MHRA regarding the claims and the product's ingredients. We considered that "appetite suppressant" and "sleep aid" were medicinal claims which could not be made for an unlicensed medicinal product and understood that the products did not have the relevant marketing authorisation from the MHRA. Furthermore, SLIM NutriCigs contained hoodia which we considered was a medicinal ingredient and products containing it were required to be registered under the Traditional Herbal Medicines Registration Scheme and, if it qualified, it was required to have been granted a marketing authorisation before it could be sold or supplied in the UK. We understood that the product did not have such an authorisation. The product, "SLEEP NutriCigs" also contained melatonin and gamma-aminobutyric acid (GABA). We understood that melatonin was a prescription-only medicine (POM) and that the advertising of POMs to the general public was prohibited under the Code. We also understood that GABA was considered to be a medicinal substance and products containing it required a marketing authorisation from the MHRA before it could be sold and supplied in the UK.
Because the products contained medicinal ingredients in their formulation which required marketing authorisations to be granted before they could be sold or supplied in the UK and because we had not seen relevant authorisation, we concluded the ad breached the Code.
On these points the ad 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),
12.1
12.1
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.
12.11
12.11
Medicines must have a licence from the MHRA, VMD or under the auspices of the EMA before they are marketed. Marketing communications for medicines must conform with the licence and the product's summary of product characteristics. For the avoidance of doubt, by conforming with the product's indicated use, a marketing communication would not breach rule 12.2.
Marketing communications must not suggest that a product is "special" or "different" because it has been granted a licence by the MHRA, VMD or under the auspices of the EMA.
12.12
12.12
Prescription-only medicines or prescription-only medical treatments may not be advertised to the public.
and
12.21
12.21
Marketers of traditional herbal medicines may advertise for the indications listed in the product's summary of product characteristics and must include mandatory information, which can be found in the MHRA's guidance, The Blue Guide: Advertising and promotion of medicines in the UK at:
http://www.mhra.gov.uk/Howweregulate/Medicines/Advertisingofmedicines/BlueGuide/.
Marketing communications for products that hold a Traditional Herbal Medicines Registration must not imply that registration is based upon clinical trials.
(Medicines, medical devices, health and beauty products).
3. Upheld
The abstracts and studies provided by NutriCigs focused on oral supplementation of the product's ingredients. None of the studies provided considered the efficacy of the product's ingredients via inhalation, in order to reflect the method of delivery when the NutriCigs product was used. Because the studies had not substantiated the efficacy of the product or individual ingredients via inhalation, we did not consider that they were adequate to support the claimed benefits for "ENERGY NutriCigs". We therefore concluded the claim "energy booster" was misleading and had not been substantiated.
On this point the ad 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) and
12.1
12.1
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 and beauty products).
5. Upheld
Notwithstanding points 2. & 4. above, regarding the medicinal nature of the claim "appetite suppressant", we considered the references to weight loss and improved energy were likely to be interpreted by consumers as health claims. Furthermore, we were not presented with evidence to support those claims.
Because we considered the ad implied the products were beneficial to health we concluded it was misleading and irresponsible.
On this point the ad breached CAP Code (Edition 12) rules
1.3
1.3
Marketing communications must be prepared with a sense of responsibility to consumers and to society.
(Responsible advertising),
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) and
12.1
12.1
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 and beauty products).
6. Upheld
The words "Nutri" and "fortified cigarettes" appeared alongside weight loss and energy booster claims, as set out under point 5. In that context, we considered that "Nutri" and "fortified cigarettes" would be interpreted by consumers as claims of nutritional benefits.
Because we were not presented with evidence to support the implied claim that the products had nutritional benefits, we considered the ad was misleading.
On this point, the ad 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) and
12.1
12.1
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 and beauty products).
Action
The ad must not appear again in its current form. We told NutriCigs (UK) not to make medicinal claims in the absence of a marketing authorisation, not to advertise prescription-only medicines or medicinal substances and to avoid implying their products had nutritional or health benefits. We also told NutriCigs to only use the claim "NutriCigs" if it was a registered trade mark and appeared alongside a prominent disclaimer.
CAP Code (Edition 12)
1.3 12.1 12.11 12.12 12.21 3.1 3.7
