A TV ad for Oral B Gum and Enamel Repair toothpaste, seen in July 2018, featured two women talking to each other. The first woman was seen looking in the mirror at the inside of her mouth and said, "Gums, they're not worth worrying about, right?" The other replied "Wrong. Actually most problems start with your gums and enamel. Tackle them, tackle most things." The ad then showed an image of the toothpaste, with the product name "Oral-B. Gum & Enamel Repair". A female voice-over said, "Oral B Gum and Enamel Repair toothpaste. It's active repair technology actively protects gums and strengthens enamel in just two weeks", while the ad zoomed in on the gum area of the mouth and showed a dark swirling red liquid turn to a smooth, lighter purple liquid moving at a gentler pace. Numerous white blocks of different shapes and sizes were then seen to merge together into one flat surface. One of the nurses then said, "Healthy mouth, healthy me." A male voice-over said, "Oral B Gum and Enamel Repair toothpaste. Oral B, brush like a pro." The ad ended with an image of the toothpaste and its packaging, with the product name "Gum & Enamel REPAIR" visible on both.
Two complainants, including a dental nurse, challenged whether the claims that the toothpaste could repair gum and enamel, and the accompanying efficacy claims about the toothpaste complied with the BCAP Code.
Procter & Gamble (Health & Beauty Care) Ltd said they had amended the ad following a previous upheld ruling against them, where they had replaced the claim that gums and enamel would be repaired, with the claim that the toothpaste protected gums and strengthened enamel in two weeks. They believed the ad did not make any claims that went beyond the toothpaste’s cosmetic benefits that it was capable of protecting gums. They provided further evidence which they said showed that the toothpaste was capable of reducing gum problems and strengthening enamel.
Clearcast said that the claims that the product would repair enamel and gums had been removed following the previous upheld ruling, and replaced with claims that product protected enamel and gums. They believe that the new wording in the ad did not amount to a medical claim and would not be understood by viewers to mean that the toothpaste was claiming to treat an adverse condition – damaged enamel. They believed that the use of the trading name “Gum and Enamel Repair” was sufficiently removed from the implication of medical usage.
The ASA noted that Article 1(2) of the Medicinal Products Directive 2001/83/EC made clear that a substance was deemed to be a medicinal product either by virtue of its function or by virtue of its presentation. We understood that meant that a product could be rendered medicinal by its functional effect on the body, or by presenting itself as having properties for treating or preventing disease. 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. Article 2(2) of the same Directive explained that where a product fell within a definition of a “medicinal product” and within the definition of a product covered by other European legislation, including the Cosmetics Regulation, the provisions of the Medicinal Products Directive applied.
The Cosmetics Regulation defined a cosmetic product as a product the primary purpose of which was to clean, perfume, change appearance, protect, keep in good condition, or correct body odour. We noted that the European Commission published a Guidance Document on the demarcation between the Cosmetics Products Directive 76/768 and the Medicinal Products Directive 2001/8318 (the Demarcation Guidance Document). In relation to the definition of a cosmetic product, the Guidance stated that, “A product may have a principal cosmetic purpose and also a secondary purpose to maintain the health. A secondary preventive purpose does not exclude the classification of a product as a cosmetic product. However, if the product in question falls also within the definition of medicinal product (be it by virtue of its presentation or by virtue of its function, which is to be decided on a case-by-case basis), the principle of non-cumulation applies …”. We therefore understood that it was possible for a “cosmetic product” (defined in the Cosmetics Regulation) to have a secondary purpose to maintain the health without meeting the definition of a “medicinal product”, but that where a product met the definition of both a medicinal product and a cosmetic product the provisions of the Medicinal Products Directive applied.
We noted that under the BCAP Code, medicinal claims could be made for a medicinal product that was licensed by the MHRA or for a CE-marked device. We considered that the issues under the Code were whether or not the claims in the ads amounted to: 1. medicinal claims; 2. secondary claims made for products squarely fitting within the Cosmetics Regulation definition of cosmetic products, which would need to be limited to preventive action and would need to make no claims to treat disease; or 3. non medicinal or medical claims but claims consistent with the products’ status as cosmetic products.
We understood that Oral B Gum and Enamel Repair toothpaste was not a licensed medicine and was not registered as a CE-marked medical device, meaning that the ad was prohibited from making medicinal claims for the toothpaste.
The ad began with an exchange between two women, where one said "Gums, they're not worth worrying about, right?" and the other replied "Wrong. Actually most problems start with your gums and enamel. Tackle them, tackle most things." We considered that the conversation suggested that the advertised product could be used to address existing problems with gums and enamel. The ad then featured the claim “it's active repair technology actively protects gums and strengthens enamel”. The name of the product “Gum and Enamel Repair” was referenced twice in the voice-over, alongside images of the product, with the claim “Repair” clearly visible on the packaging. We acknowledged that the claims “protect gums” and “strengthens enamel” did not claim to treat or prevent gum and enamel conditions, and were therefore not necessarily medicinal claims themselves. However, those needed to be seen in context and we considered that the claim “repair technology” and the multiple references to “repair” suggested to consumers that the toothpaste could be used to repair gum and enamel conditions such as damaged enamel and gum disease. Furthermore, we considered that the ad’s visual effects – which showed the gums represented by a dark swirling red liquid transform into a smoother lighter liquid moving at a gentler pace - contributed further to the impression that the toothpaste was capable of repairing and treating existing conditions in the gums. As such, we considered that the overall impression of the ad was the toothpaste could be used with a view to treating adverse gum and enamel conditions, and was therefore a medicinal claim.
Because the ad made medicinal claims for an unlicensed product, we concluded that the ad breached the Code.
The ad breached BCAP Code rule
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. (Medicines, medical devices, treatments and health).
The ad must not appear again in its current form. We told Procter & Gamble not to make medicinal claims for the toothpaste, unless they obtained a medicinal license from the MHRA for the product or registered it as a CE-marked medical device.