An online sales promotion on Boots’ website stated “3 for 2 across all vitamins, complementary medicines and herbal products”. The promotion included the following products and claims:
"Metatone Original Flavour Tonic - 500ml ... Metatone Tonic Original Flavour helps restore Health & Vitality after illness such as colds and flus, and when you are feeling tired and run down".
"Potters Allerclear - 84 Tablets ... Potter's Allerclear Tablets contain a unique combination of herbal ingredients. Garlic and its oil are anti-catarrhal and helps [sic] loosen phlegm. Echinacea is anti-inflammatory and stimulates the immune system".
"Boots Teething Pain Relief - 24 Sachets ... Boots Teething Pain Relief is a homeopathic medicine which contains Chamomilla 6c. For the symptomatic relief of teething pain”.
"New Era for Coughs, Colds & Chestiness - 450 Tablets ... a homeopathically prepared biochemical remedy for Coughs, Colds and Chestiness”.
The complainant challenged whether the efficacy claims for the featured products were misleading and could be substantiated.
Boots UK Ltd (Boots) said all four products were licensed medicines. They said the Metatone and Potter’s products both had full marketing authorisations issued by the Medicines and Healthcare products Regulatory Agency (MHRA) and that the statements made on Boots' website were consistent with Summary of Product Characteristics (SPCs) for those products, copies of which they provided.
Boots said the Boots Teething Pain Relief product was a homeopathic medicine registered under the National Rules Scheme which predated the invention of SPCs by some decades. In place of the SPC they submitted a letter from the MHRA which approved labelling claims that the product could be used for the relief of teething problems in babies and infants. They said this was consistent with the claims on their website.
Boots said the licensed medicine New Era for Coughs, Colds and Chestiness (New Era) did not have an SPC but did have a Product Licence of Right (PLR), which they provided, and said the statement made online was consistent with the words clearly stated on the pack.
The ASA noted that the CAP Code required homeopathic medicinal products to be registered in the UK and to confine information given in marketing communications to that which appeared on the product label.
We noted for Boots Teething Pain Relief that the claim in the ad, “For the symptomatic relief of teething pain” was consistent with the claim which had been approved in the correspondence with the MHRA. Likewise, with the New Era product we noted that the approved indications in the PLR - “coughs, colds, chestiness and allied conditions” were also consistent with the ad which referred to “Coughs, Colds and Chestiness”.
We noted that the CAP Code also required medicines to have a licence from the MHRA before they were marketed and that ads for those products should conform with the SPC. We noted that the approved claim for Metatone as stated in the SPC was that it was “indicated in the management of convalescence and debility” and we considered that the claims on the website, “Metatone ... helps restore Health & Vitality after illness such as colds and flus, and when you are feeling tired and run down” and that it helped “provide a gentle boost after illness” were consistent with that approved claim. We noted that the Potters Allerclear product been given a PLR when it was first licensed and currently retained that licence and we therefore understood that the PLR replaced the SPC with regard to that product. We noted that the PLR provided for claims to be made in regard of the symptomatic relief of catarrh, rhinitis and nasal congestion and we considered that the claim “Garlic and its oil are anti-catarrhal and helps [sic] loosen phlegm” was in line with that description. We also noted that the exact claim “Echinacea is anti-inflammatory and stimulates the immune system” was also included in the SPC and concluded that the descriptions of the Potter’s product were consistent.
Because the descriptions of the products in the promotion were, in all cases, consistent with the approved claims, we concluded that the promotion was not misleading.
We investigated the promotion under 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.
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. and 12.20 12.20 Homeopathic medicinal products must be registered in the UK. Any product information given in the marketing communication should be confined to what appears on the label. Marketing communications must include a warning to consult a doctor if symptoms persist. Marketing communications for an unlicensed product must not make a medicinal or therapeutic claim or refer to an ailment unless authorised by the MHRA to do so. (Medicines, medical devices, health-related products and beauty products) but did not find it in breach.
No further action required.