Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A TV ad for Oral B Gum and Enamel Repair toothpaste seen in August and September 2017 featured two different women.
The first woman stated, “I’ll pretend I didn’t feel that twinge” after sipping her drink and the second woman stated, “Ah, my gums feel really sore. No big deal right?” A dental professional replied saying, “Wrong. Actually most problems start with your gums and enamel. Tackle them, tackle most things.” The voice-over then stated, “New Oral B Gum and Enamel Repair toothpaste. Its active repair technology helps rejuvenate gums and repair enamel in just two weeks.”
During the ad small print stated “Dramatisation gum rejuvenation. Rejuvenates helps to restore gum condition” and “Repair in laboratory study on weakened enamel. Remineralisation”.
An image of the toothpaste was shown at the end of the ad, as the voice-over stated, “New Gum and Enamel toothpaste from Oral B …”.
Issue
The ASA received seven complaints, including one from a qualified dental nurse.
1. All of the complainants challenged whether the claim “Its active repair technology helps … repair enamel in just two weeks” complied with the CAP Code.
2. One complainant challenged whether the claim “Its active repair technology helps rejuvenate gums … in just two weeks” also complied with the CAP Code.
Response
1. Procter & Gamble (Health & Beauty Care) Ltd (P&G) believed that the claim "Its active repair technology helps … repair enamel in just two weeks" was not medicinal.
P&G stated that to classify a product as a medicine, it needed to meet the criteria according to Medicinal Products Directive 2001/83. It either had to be: presented as having properties for treating or preventing disease; or used with a view of restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.
P&G stated that weakened enamel was not a disease/adverse condition and that the toothpaste strengthening effect on enamel was not based on a pharmacological, immunological or metabolic action. They said that the claim was based on how tooth enamel was subjected to weakening through the action of lactic acid, which was generated by the bacteria in plaque in a process called demineralisation – the first stage in the process of dental caries. That demineralisation was characterised by a loss of mineral content and a reduction in the physical hardness of the enamel. However, studies had shown that the weakening could be reversed by fluoride along with the calcium and phosphate found in saliva, in a process called remineralisation, and P&G provided six clinical studies which they believed demonstrated that.
P&G stated that weakened enamel was a very common and well-known issue among consumers and believed that the claim, together with the on-screen text, made it clear to viewers to understand the cosmetic benefit that the advertised product could achieve.
Clearcast stated that the ad claimed to repair enamel by remineralisation which was expressed in the voice-over, super and visuals. They stated that the claim was supported by scientific testing, which was seen and approved by their independent specialist consultant.
Clearcast considered that the wording of the claim indicated what the product could do and referred to repairing enamel through remineralisation. Furthermore, the visual demonstration of the enamel represented mineral depletion, clarifying the accuracy of the claim.
2. P&G believed that the claim "Its active repair technology helps rejuvenate gums … in just two weeks" clearly communicated to consumers that the rejuvenation of gums was obtained through the restoration of gum conditions.
P&G stated that gum problems were very common and caused by the bacteria present in plaque and by the toxins they produced. However, those issues were reversible and the reduction of plaque bacteria and their toxins consequently resulted in a reduction in inflammation and bleeding, restoring the gum to a healthy condition.
P&G stated that their Oral-B Gum & Enamel Repair toothpaste contained Stannous Fluoride which was a powerful anti-bacterial ingredient that controlled plaque bacterial growth and the toxins that they produced. It had been shown in several clinical studies to reduce gum problems and therefore restore gum health.
P&G provided a copy of a study they had conducted on their Oral-B Gum & Enamel Repair toothpaste to measure its ability to reduce gum problems compared to a control treatment. The study found a 28% reduction in gingival bleeding after two weeks’ use of the product.
P&G believed that at no point did the ad make claims referring to treatment or state that the toothpaste was capable of treating a specific disease, medical condition, or restore a physiological function.
P&G stated that the claims focused only on the capability of their toothpaste to protect gums and improve oral health in general and were therefore cosmetic claims. They believed that under no circumstances did they make, or aimed to make, reference to a specific gum condition or specific pathogens and therefore did not present the product as a treatment for such a condition.
Clearcast stated that the claims were supported by scientific testing which was seen and approved by their specialist, independent, consultant. In line with the consultant's endorsement, they were confident that the claims and visuals were an accurate representation of how the product worked.
Assessment
1. Upheld
The ASA understood that medicinal claims could only be made for a product that was licensed by the Medicines and Healthcare products Regulatory Agency (MHRA), or under the auspices of the European Medicines Agency (EMA), or for a CE-marked medical device. We understood that the toothpaste was neither licensed as a medicine by the MHRA nor registered as a medical device, and therefore the ad was not permitted to make medicinal claims. A medicinal claim was a claim that a product or its constituents could be used with a view to making a medical diagnosis or could treat or prevent disease, including an injury, ailment or adverse condition.
With that in mind, we considered that the issues under the Code were, whether or not the claims in the ads amounted to: 1. medicinal claims – i.e. whether damaged enamel was an adverse condition and if so whether the toothpaste was presented as preventing or treating it, in which case it would breach the Code because it did not have a license from the MHRA or a CE-mark; or 2. secondary medicinal claims made for products squarely fitting within the Cosmetics Regulation definition of cosmetic products, which, in order to comply with the CAP Code, would need to, among other things, be limited to preventative action; or 3. non medicinal or medical claims but claims consistent with the product's status as a cosmetic product, whose primary purpose was to clean, perfume, change appearance, protect, keep in good condition or correct body odour.
We acknowledged that reduction in tooth minerals led to enamel loss and softening, which left teeth susceptible to wear and tear, and that, once lost, adult enamel could not regrow through normal biological processes. However, we understood that like with most major toothpastes in the market, Oral B Gum and Enamel Repair toothpaste contained fluoride which was known to help protect teeth by strengthening existing enamel and was a process known as "remineralisation".
However, we noted that the ad featured the claim "Its active repair technology helps … repair enamel in just two weeks", as well as the qualifying text "Repair in laboratory study on weakened enamel. Remineralisation".
We considered consumers would interpret the claim and the qualifying text, particularly because of the references to "repair[ing]" tooth enamel, that the advertised toothpaste would reverse the effects of damaged enamel in two weeks. We considered that suggested that the toothpaste could be used with a view to treat an adverse condition, specifically damaged enamel, and was therefore a medicinal claim.
Therefore, because the ad made a medicinal claim, when we understood that the toothpaste was neither a licensed medicine nor a registered medical device, we concluded the ad breached the BCAP Code.
On that point, the ad breached BCAP Code rules
11.4
11.4
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, the 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.
and
11.19
11.19
Medicines must have a licence from the MHRA, the VMD or under the auspices of the EMA before they are advertised. Advertisements for medicinal products must conform with the licence. Advertisements must not suggest that a product is "special" or "different" because it has been granted a licence from the MHRA. For the avoidance of doubt, by conforming with the product's indicated use, an advertisement would not breach rule 11.3.
(Medicines, medical devices, treatments and health).
2. Upheld
We noted that the ad featured a woman who stated, "I'll pretend I didn't feel that twinge" after sipping her drink. Furthermore, she expressed her pain by saying "Ah!" and touched her tooth with her finger. We considered that illustrated that she had experienced physical pain in her tooth after sipping her drink. Another scene showed a different woman who touched her teeth with her finger and stated, "Ah! My gums feel really sore". We considered that illustrated that she had experienced some physical pain in her gums. After the woman stated "No big deal right?", a dental professional was then shown and stated, "Wrong. Actually most problems start with your gums and enamel. Tackle them, tackle most things".
The voice-over then made the claim that the toothpaste's "… active repair technology help[ed] rejuvenate gums … in just two weeks", and further into the ad was the qualifying text "Rejuvenates helps to restore gum condition".
We considered that following the scenes showing the women experiencing physical pain in their teeth and gums, and along with the dental professional's response regarding tackling such problems, viewers would interpret the ad's references to "repair" and "restore" to mean that the toothpaste would reverse the effects of damaged gums caused by gum disease within two weeks, symptoms of which included sensitive teeth and sore gums. We considered that suggested that the toothpaste could be used with a view to treating a disease and was therefore, a medicinal claim.
We considered that after viewers saw those same scenes, they would also interpret the ad's references to "rejuvenate" to mean that the advertised toothpaste could reverse the effects of damaged gums caused by gum disease, which was further reinforced by the ad's references to "repair" and "restore" as stated above.
Therefore, because the ad made a medicinal claim, when we understood that the toothpaste was neither a licensed medicine nor a registered medical device, we concluded the ad breached the BCAP Code.
On that point, the ad breached BCAP Code rules
11.4
11.4
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, the 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.
and
11.19
11.19
Medicines must have a licence from the MHRA, the VMD or under the auspices of the EMA before they are advertised. Advertisements for medicinal products must conform with the licence. Advertisements must not suggest that a product is "special" or "different" because it has been granted a licence from the MHRA. For the avoidance of doubt, by conforming with the product's indicated use, an advertisement would not breach rule 11.3.
(Medicines, medical devices, treatments and health).
Action
The ad must not appear again in its current form. We told Procter & Gamble (Health & Beauty Care) Ltd that they must ensure that their advertising did not make medicinal claims for their products unless they were licensed by the MHRA, or under the auspices of the EMA, or was a CE-marked medical device, and supported with adequate evidence.
