A poster for the toothpaste "REGENERATE" stated "82% ENAMEL IS REGENERATED AFTER 3 DAYS". Small print stated "Based on an in vitro test measuring enamel hardness after 3 days' combined use of toothpaste and serum".
The complainant, who understood that enamel could not regrow, challenged whether the claim "enamel is regenerated" was misleading and could be substantiated.
Unilever UK Ltd said that once tooth enamel was lost the body could not restore it. However, the product's NR-5 technology could help regenerate the enamel by restoring tooth mineral content. They said Regenerate contained specific calcium silicate and phosphate salts which combined to form calcium hydroxyapatite (HAP), the mineral crystal constituent of tooth enamel. They said HAP formed with each use had identical mineral content and crystalline structure to natural tooth enamel. They also explained that with each use of the product, a layer of HAP was deposited onto the tooth which repaired early invisible surface lesions and restored the surface micro-hardness of the tooth enamel.
Unilever provided several peer-reviewed and published clinical studies and related documents which they said demonstrated the effects of the product and its mode of action and supported the claim. They said the claim "enamel is regenerated" was qualified with the small print statement "based on an in vitro test measuring enamel hardness after 3 days' combined use of toothpaste and serum". They said that statement made it clear that the claim referred to a measurement of enamel hardness and the word 'regenerated' was used as a metaphor for the scientific concept of remineralisation. They said 'regenerate' was used in the context of the product's ability to re-mineralise enamel through the formation of HAP, which was deposited onto the surface of the tooth, and that led to enamel reinforcement. They said that tooth mineral content assessment was achieved by measuring enamel microhardness and because this test could not be performed in the mouth, in vitro studies were instead conducted. They said the studies submitted demonstrated an increase of enamel microhardness after use of the toothpaste and serum for three days, relative to mineral loss. Unilever said it was confident that its scientific evidence fully substantiated the claim and therefore the claim "enamel is regenerated" was appropriate and accurately reflected the product's mode of action.
The ASA received various documents from Unilever in support of the "regenerate" claim including several trials and studies for a variety of products that related to decreasing sensitivity and remineralisation of enamel. Unilever also submitted several clinical studies which used the Regenerate product on samples of bovine and human teeth. Various trials included laboratory experiments conducted on the teeth such as a measurement of surface micro hardness. The study outcomes were mainly described in terms of 'repair', 'remineralisation', 're-hardening' or 'protection' of tooth enamel, although one study used the word 'regenerate'.
We understood 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. We noted Unilever's assertion that the claim "enamel is regenerated" was qualified by the small print related to hardness. However, we considered that the headline claim was likely to convey to consumers that by using Regenerate, it would have the effect of encouraging the tooth to regrow lost enamel. Because we considered consumers would view the headline claim "enamel is regenerated" in this way, we concluded that the small print which referred to the measurement of hardness contradicted the main claim and that the claim was therefore 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 state significant limitations and qualifications. Qualifications may clarify but must not contradict the claims that they qualify.
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 must not appear again in its current form. We told Unilever UK Ltd to accurately reflect the results of their clinical trials for Regenerate in future.