Background
Summary of Council decision:
Two issues were investigated, of which one was Not upheld and one was Upheld.
Ad description
Two website ads, on www.boots.com, for homeopathic hay fever relief tablets:
a. A product web page, headed "Boots Alternatives Hayfever Relief - 72 Tablets", stated "Boots Alternatives Hayfever Relief Tablets are a homeopathic medicine for the symptomatic relief of hayfever [sic]. Please scroll down to view the active Ingredients and strengths". An image of the product’s packaging appeared next to that text. Text visible on the packaging stated "Boots ALTERNATIVES Hayfever Relief A homeopathic medicine 72 TABLETS". Underneath, text included "For the symptomatic relief of hayfever [sic] ... Precautions This is a medicine; Consult your doctor or pharmacist if you have an underlying medical condition, are taking any other medication or complementary therapy, or if symptoms persist ... Suitable For Adults and children ... Active Ingredients: Each tablet contains: Allium cepa 6c Euphrasia officinalis 6c Sabadilla officinarum 6c Also contains: Lactose and Sucrose".
b. A product web page, headed "Nelsons Pollena [sic] - 72 Tablets", stated "Nelsons Pollena [sic] is a homeopathic medicine for the relief of hayfever [sic]". An image of the product packaging appeared next to that text. Text visible on the packaging stated "nelsons natural care since 1860 pollenna for the natural relief of symptoms associated with hay fever & similar allergies homeopathic remedies". Underneath, text included "Nelsons Pollenna contains a selection of homeopathic remedies, specifically combined to protect from and bring fast, effective relief for the distressing symptoms of Hay Fever. Pollenna does not cause drowsiness and can be taken with other medicines. For best results Pollenna should be taken early on in the season ... Precautions This is a medicine; Consult your doctor or pharmacist if you have an underlying medical condition, are taking any other medication or complementary therapy, or if symptoms persist ... Suitable for adults and children ... Active Ingredients Allium Cepa, Euphrasia Officinalis and Sabadilla Officinarum".
Issue
The complainant challenged whether the references to the relief of hay fever symptoms breached the Code in:
1. ad (a), and
2. ad (b)
.
Response
1. & 2. Boots UK Ltd said that both products were homeopathic medicinal products registered in the UK with the Medicines and Healthcare Products Regulatory Agency (MHRA). Both products were covered by a Product Licence of Right (PLR) which allowed them to include the indication "for the relief of symptoms associated with hay fever and similar allergies". They considered the claim "for the symptomatic relief of hayfever [sic]" in ad (a) and "contains a selection of homeopathic remedies, specifically combined to protect from and bring fast, effective relief for the distressing symptoms of Hay Fever" in ad (b) were in line with the permitted indication. They said that all other information included on the ads was required under medicines advertising rules enforced by the MHRA. They provided copies of the relevant documentation, including images of the products’ packaging.
Assessment
The CAP Code required homeopathic medicinal products to have a licence from the MHRA before they were marketed and that claims for those products should conform with the 'indications' of the relevant licence. The two advertised products were licensed under the PLR system. The ASA noted the relevant PLR, which covered both products, provided for claims to be made in regard of "the relief of symptoms associated with hay fever and similar allergies".
1. Not upheld
We noted ad (a) included the claims "Boots Alternatives Hayfever Relief", "Boots Alternatives Hayfever Relief Tablets are a homeopathic medicine for the symptomatic relief of hayfever [sic]" and "For the symptomatic relief of hayfever [sic]". We considered those claims were restatements of the permitted indication in the PLR, and therefore concluded ad (a) was not in breach of the Code.
We investigated ad (a) under CAP Code (Edition 12) rule
12.1
12.1
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 and beauty products), but did not find it in breach.
2. Upheld
Ad (b) included the claims "a homeopathic medicine for the relief of hayfever [sic]" and "specifically combined to ... bring ... relief for the distressing symptoms of Hay Fever". We considered those claims were restatements of the permitted indication in the PLR, and were therefore not in breach of the Code.
Ad (b) also included the claim "specifically combined to protect from ... the distressing symptoms of Hay Fever". We considered that "to protect" oneself from the symptoms of hay fever would require taking the medicine before hay fever symptoms presented, and therefore the claim related to the prevention of hay fever symptoms rather than to the relief of symptoms. The PLR's permitted indication related only to the "relief of symptoms" and did not refer to the prevention of symptoms. We concluded the claim was not consistent with the wording permitted by the PLR and was therefore in breach of the CAP Code.
The permitted indication in the PLR related to "the relief of symptoms associated with hay fever and similar allergies" but did not include wording which related to the way in which the medicine could bring that relief. We considered ad (b) included two claims which related to the way in which the medicine could bring that relief: that the product was "for the natural relief of symptoms associated with hay fever & similar allergies"; and that it would "bring fast, effective relief for the distressing symptoms of Hay Fever". We considered those claims were related to the wording permitted by the PLR, but went beyond the specific wording stated in the indication. We understood that in such instances, advertisers must hold evidence in support of the claims. We had not seen such evidence, and further noted that we had previously investigated efficacy claims for homeopathic hay fever products which did not fall under the PLR licensing system, where we had not been provided with robust evidence to substantiate claims that homeopathic remedies were effective treatments for hay fever symptoms. In the absence of evidence to support those claims, we concluded they were misleading and therefore in breach of the Code.
Ad (b) breached CAP Code (Edition 12) rule
12.1
12.1
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 and beauty products).
Action
No further action necessary in relation to ad (a). Ad (b) must not appear again in its current form. We told Boots to ensure their claims for the Nelsons Pollenna product conformed with the permitted indication in the PLR.
