A website for Nuby, a baby products retailer, www.nuby-uk.com, seen on 19 March 2016. Text on the page promoting "Nuby All Natural Toddler Training Toothpaste and Toothbrush - Blue/Green" stated "Nuby's All Natural Toddler Training Toothpaste with Citroganix* and Toothbrush is the perfect combination for cleaning your baby's teeth ... the training toothpaste helps prevent tooth decay and is 99.99% effective against oral bacteria. The All Natural paste is Dentist approved, Fluoride Free and is safe to swallow ... *Citroganix is made from all natural ingredients found in the skin of citrus fruit and is anti-bacterial and anti-microbial".
The complainant, a registered dentist, who did not believe the ingredients contained in the product could be effective in preventing tooth decay, challenged whether the efficacy claims in the ad were misleading and could be substantiated.
Nuby UK LLP stated that their patented Citroganix formula reduced bacteria by 99.99%, which helped to prevent tooth decay. They referred to an article on the NHS Choices website and another on the website for National Institute of Dental and Craniofacial Research in the US, both of which explained the causes and process of tooth decay. They stated that antibacterial methods, such as the use of Citroganix, were known as effective measures in preventing tooth decay. They believed that was acknowledged by the Mayo Clinic, whose website provided advice on how to prevent tooth decay and included references to antibacterial treatments. They also provided a certificate of analysis of a test measuring the antimicrobial activity of the product on bacteria.
Nuby UK LLP stated that, unlike many of their competitors’ fluoride-free products, their All Training Toothpaste was sugar-free and sugar alcohol-free, and provided a list of the product ingredients. They referred to the NHS Choices article which advised readers to cut down on sugary and starchy food and drinks and look for sugar-free alternatives where possible. On that basis, Nuby UK LLP stated that because their Training toothpaste was sugar-free in formula, it helped to prevent tooth decay.
Nuby UK LLP also stated that, according to most research, the mechanical act of brushing helped to prevent tooth decay. They provided a link to an abstract of a study by the Department of Periodontology at the Academic Center for Dentistry in Amsterdam, published in the Journal of Periodontology. They said their product was a “training” toothpaste with a Tutti Frutti flavour which was well received and enjoyed by children, which encouraged them to want to brush their teeth. They said that helped to create good dental hygiene regimen and also helped to prevent tooth decay.
The ASA noted that the ad stated “the toothpaste helps prevent tooth decay and is 99.99% effective against oral bacteria” and considered that consumers were likely to expect that the product, which was fluoride free and “all natural”, was effective in helping the prevention of tooth decay amongst toddlers and that it was 99.99% effective against oral bacteria, including those that would cause tooth decay.
We understood that the Training Toothpaste did not contain fluoride, which we understood to be generally accepted as an ingredient effective in the prevention of dental caries. We therefore expected to see a body of evidence to demonstrate the effectiveness of the ingredient Citroganix in helping to prevent dental caries amongst toddlers, including, for example, studies and scientific literature on the chemical properties of Citroganix and its use in the prevention of tooth decay. We also understood that a number of factors could influence dental decay and the level of protection provided by the use of toothpaste products, for example, the frequency at which foods containing carbohydrates were consumed between brushing; whether brushing was carried out before or after those foods were consumed; brushing and rinsing behaviour; and the rate of saliva flow. We therefore considered that the claims should also be supported by trials of sufficient duration on human participants to establish the effectiveness of the Training Toothpaste, taking into account those factors.
We noted that the test, for which Nuby UK LLP provided the certificate of analysis, was carried out under laboratory conditions. The certificate did not contain substantive details on the methodology used, but appeared to have involved adding the toothpaste product to a mixture with bovine albumin and four strains of bacteria with a contact time of five minutes at room temperature. We noted the conclusion of the analysis was that the product showed “satisfactory” antimicrobial activity against the British Standards for efficacy of chemical disinfectants. Notwithstanding that, normal brushing conditions were not replicated, such as length of time of brushing; presence of saliva; brushing the product on teeth; and rinsing. Further, the test did not appear to have been controlled or blinded, and the most common strain of bacteria that produced the acids which caused tooth decay had not been included in the laboratory test. In addition, we had not seen evidence of trials of a suitable duration conducted on humans, particularly toddlers, which took into account factors such as dietary intake and oral hygiene habits, to observe the long-term effect of the product in preventing dental decay under normal usage.
We were not able to fully assess the study by the Department of Periodontology at the Academic Center for Dentistry in Amsterdam, given that Nuby UK LLP provided the abstract only. Notwithstanding that, we understood that the study compared the amount of plaque reduction on 36 subjects brushing their teeth with and without a standard fluoride toothpaste after a single brushing. It did not include a comparison with a fluoride-free toothpaste or the product in question, or relate to the efficacy of the Training Toothpaste or the ingredient Citroganix in tooth decay prevention. We therefore did not consider the study supported the claims that the product was effective in preventing dental caries amongst toddlers.
Further, we noted that the articles provided by Nuby UK LLP, particularly those from the NHS Choices and the Mayo Clinic websites, included general advice on dietary habits (for example, cutting down on sugary foods) and treatments (antibacterial treatments) in preventing tooth decay. However, the articles provided no commentary on, or evidence to support, the efficacy of fluoride-free toothpastes or toothpastes which contained similar ingredients to Citroganix.
For the above reasons, we considered that the evidence provided was not adequate to substantiate the claims that the toothpaste helped to prevent tooth decay amongst toddlers and that it was 99.99% effective against oral bacteria, including those that caused tooth decay. We therefore concluded the efficacy claims in the ad were misleading.
The ad breached CAP Code (Edition 12) rules
Marketing communications 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.
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
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).
The ad should not appear again in its current form. We told Nuby UK LLP to ensure that they did not make claims that the Training Toothpaste was effective in preventing tooth decay, unless they held adequate evidence to substantiate the claims.