Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A product listing on www.mypharmacy.co.uk, seen on 3 December 2021, for the food supplement HuxD3 included the claim “Effective In Treating Vitamin D deficiency” near the top of the webpage. Further text stated “Colecalciferol is a form of vitamin D used in the treatment of clinically relevant vitamin D deficiency conditions in adults. Colecalciferol 20 000IU Capsules contain the equivalent of 500 micrograms of vitamin D3 […]”.
Underneath the heading “Medication” text stated “My Pharmacy is the best place to Buy [sic] Hux D3 Capsules 20,000 In [sic] 2021. To Buy Hux D3 Capsules 20,000 in the UK you are not required to have a prescription, but you will need to complete a free online consultation service […] Hux D3 20 000 Unit Capsules are used to treat vitamin D deficiency conditions in adults. You may be suffering from a vitamin D deficiency and benefit from using Hux D3 20 000 Unit Capsules if you have the following symptoms: Fatigue; Bone pain; Muscle weakness, muscle aches, or muscle cramps; Mood changes, like depression. See more information on vitamin D deficiency on the NHS website”.
Further text stated “Whilst Hux D3 20 000 Capsules are available from other commercial stores like Hux D3 20 000unit [sic] Capsules Boots, most of those will require you to bring in your prescription before you can order the medicine […] From My Pharmacy you can purchase your prescription treatments online without ever having to leave your home, making it much easier for people to get the vital treatments they need safely and promptly”.
The ad included several additional references to the product as a “medicine”. In a drop-down menu towards the bottom of the webpage headed “Further Information”, the text “Patient Information Leaflet” linked to the Patient Information Leaflet for the prescription-only medicine “Colecalciferol 20 000 IU Capsules”.
Issue
Consilient Health Ltd challenged whether:
1. the claims that the food supplement was “Effective In Treating Vitamin D deficiency” and could treat symptoms of vitamin D deficiency such as fatigue, bone pain, muscle weakness, muscle aches, muscle cramps, mood changes and depression, breached the Code; and
2. the ad was misleading, because it referred to the food supplement as a “medicine” and implied that the product was identical or equivalent to a licensed prescription-only medicine.
Response
1. & 2. My Pharmacy (UK) Ltd t/a My Pharmacy acknowledged that the product was a food supplement which was not licensed as a medicine. They explained that the rationale behind the claims that HuxD3 could treat or alleviate the symptoms of vitamin D deficiency was that the food supplement had a similar chemical composition to, and contained the same mass of vitamin D as, Colonis Colecalciferol 20000IU, a medicine licensed by the MHRA for the treatment and prevention of vitamin D deficiency.
They stated that the inclusion of the patient information leaflet for Colonis Colecalciferol 20000IU had occurred in error. They had taken steps to amend the product listing by removing the leaflet, the term “medicine”, and any claims positioning HuxD3 as treatment of vitamin D deficiency or its symptoms. They added that they had recategorised the listing into the section of their website titled “food supplements”.
Assessment
1. Upheld
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. The ASA 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.
We noted that under the CAP Code, medicinal claims could only be made for medicinal products licensed by the MHRA. It further required that ads for foods, including food supplements, must not claim to treat clinical vitamin deficiencies, or state or imply that a food (or food supplement) could prevent, treat or cure human disease.
We considered that consumers would understand from the product listing, and in particular its claims that HuxD3 was “Effective In Treating Vitamin D deficiency” and could treat symptoms such as fatigue, bone pain, muscle weakness, muscle aches, muscle cramps, mood changes and depression, that the product could treat vitamin D deficiency and alleviate its symptoms. However, HuxD3 was a food supplement and not a licensed medicine; the ad therefore made medicinal claims for an unlicensed product. Additionally, the ad claimed that the food supplement could treat a clinical vitamin deficiency and its symptoms. We concluded that the ad therefore breached the Code.
On that point, the ad breached CAP Code (Edition 12) rules
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, treatments, health-related products and beauty products) and
15.6
15.6
These are not acceptable in marketing communications for products within the remit of this section:
15.6.2
15.6.2
Claims that state or imply a food prevents, treats or cures human disease. Reduction-of disease-risk claims are acceptable if authorised on the applicable register.
and
15.9
15.9
Marketing communications for foods must not claim to treat clinical vitamin or mineral deficiency.
(Food, food supplements and associated health or nutrition claims).
2. Upheld
The product listing repeatedly used the term “medicine” in reference to the food supplement. The listing also featured terms such as “dose”, “symptoms”, “side-effects”, and “patient”. Additionally, the linked patient information leaflet was for Colonis Colecalciferol 20000IU, which was a licensed medicine. We considered consumers would understand from the product listing that HuxD3 was a licensed medicine.
Additional text stated “Whilst Hux D3 20 000 Capsules are available from other commercial stores like Hux D3 20 000unit [sic] Capsules Boots, most of those will require you to bring in your prescription before you can order the medicine […] From My Pharmacy you can purchase your prescription treatments online without ever having to leave your home”. We considered those claims further implied that HuxD3 was identical to a licensed prescription-only medicine, and that the My Pharmacy website offered consumers a unique opportunity to bypass the requirement for a prescription.
Because the ad gave the impression that HuxD3 was (and was therefore equivalent to) a licensed prescription-only medicine when it was not, we concluded it was misleading.
On that point, the ad breached CAP Code (Edition 12) rule 3.1 3.1 Marketing communications must not materially mislead or be likely to do so. (Misleading advertising).
Action
The product listing must not appear again in the form complained about. We told My Pharmacy (UK) Ltd t/a My Pharmacy to ensure that their ads did not state or imply that a food supplement could prevent, treat or cure human disease or treat clinical vitamin or mineral deficiency. We also told them to ensure that their ads did not refer to a food supplement as a “medicine”, or otherwise state or imply that a food supplement was identical or equivalent to a licensed medicine. We told them not to make medicinal claims for an unlicensed product.
