Know Your Advertising Guidelines: Medicines vs. Food Supplements

Published on: 6th August 2019

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Are you a marketeer working with both medicines and food supplements? Do you often get confused as to what is allowed for each? If this sounds like you, please keep reading. Here is a list of the main differences in the advertising guidelines for medicines and food supplement to help you navigate through the dos and don’ts.

Essential Information vs. Supporting Health Claims

Victoria Trowse

The PAGB Consumer Code for Medicines states that all consumer facing advertising for over the counter (OTC) medicines which include claims, whether medicinal or consumer preference claims, requires the inclusion of the Essential Information (EI). This must be clearly legible and sufficiently prominent, which means a minimum 10pt font size for most types of fonts. In most cases the EI must be included within the advertising copy, however, it is worth highlighting that for certain advertising copy, such as pay per click or character restricted advertising posts, it is possible to include the EI one click away, provided the advertising copy meets certain conditions.

All food advertising, including the advertising of food supplements, must comply with the requirements of the Nutrition and Health Claims Regulation (EC) 1924/2006. The NHCR applies to commercial communications aimed at the final consumer. General health claims, also known as Article 10, are the most common type of claims made for food supplements. These refer to a general benefit of taking the supplement for overall good health such as for example ‘good for you’ or ‘supports your health’. In a similar way to medicines requiring the EI where claims are made, advertising for food supplements which includes general health claims will need to be supported with a relevant authorised health claim for a nutrient which is contained within the product. For example, ‘good for you as it contains iron which contributes to the normal function of the immune system’. Unlike the EI, the supporting health claim does not have to meet any specific requirement with regards to font size. However, the Regulation stipulates that these must be placed ‘next to’ or ‘following on from’ the general health claim. The Department of Health and Social Care takes a more flexible approach and its guidance stipulates that as long as the supporting health claim is placed within the same field of view, this should be sufficient. In practical terms, this means that the supporting health claim must always be present within the advertising and so, unlike medicines, on pay per click or character restricted advertising posts for food supplements, the supporting health claim cannot be one click away. Therefore, this is something that should be considered at the design stage for advertising copy where space is limited.

Medicinal Claims

Whilst medicinal claims are clearly acceptable in the context of advertising for OTC medicines (provided they are either in the SmPC or supported with evidence), advertising for food supplements cannot claim or imply to be able to prevent, treat or cure disease. Examples of words and phrases that would be considered ‘medicinal’ and are, therefore, not allowed in the context of food supplement advertising include: treatment, deficiency, prevention, restores, inflammation, clinically proven, medical research, or reference to specific disease states such as ‘cold and flu’ or ‘spina bifida’. Therefore, statements such as ‘calcium support normal bones to keep arthritis at bay’ or ‘getting enough vitamin D will prevent rickets’ would not be acceptable in the context of food supplement advertising. Please note, however, that Article 14 disease risk reduction claims which have been authorised by the European Commission are permitted. For example, ‘supplemental folic acid intake increases maternal folate status, low maternal folate status is a risk factor in the development of neural tube defects in the developing foetus’. It is worth highlighting though that, where this type of claim is used, a statement must be included which makes clear that the disease in question has multiple risk factors and that altering one of these factors may or may not have a beneficial effect.

Celebrity Endorsement

The PAGB Consumer Code for Medicines clearly prohibits celebrity endorsement in all consumer facing advertising for OTC medicines i.e. the inclusion of a recommendation by a person who, because of their celebrity, may encourage consumers to use a medicine. In contrast, it is generally acceptable to use celebrities in food supplement advertising. However, please note that any claims made by celebrities must comply with authorised health claims. Also, members should bear in mind that the CAP Code prohibits the use of licensed characters or celebrities popular with children in branded activities targeted directly at primary school or pre-school children.

Heathcare Professional Endorsement

The PAGB Consumer Code for Medicines requires that “advertising shall not state or imply that a product is recommended by or used by a healthcare professional”. Therefore, statements such as ‘recommended by Dr. X’ would not be acceptable in consumer facing advertising for OTC medicines. In certain cases, i.e. in non-broadcast advertising, it may be acceptable for healthcare professionals to recommend an ingredient or treatment type but only where this is part of a balanced overview of the ingredients or treatment types available for that indication. So, statements such as ‘ingredient X is often recommended by doctors for the treatment of…’ or ‘treatment X has been recommended by doctors for 20 years’ would be acceptable in non-broadcast advertising. It is also possible to include sections giving general health advice written by a healthcare professional, but such information must be clearly identified as having been written by a healthcare professional and separated from the brand advertising.

Healthcare professional endorsement in the context of food supplements is not quite as clear cut as with medicines and there are several guidelines that must be taken into consideration as follows:

Packs

Cartons and labels must include the statutory labelling requirements but can also include information that describes how the product works, or which highlights a particular attribute of the product, provided it is compatible with the SmPC. Pack design for first approval of mock-ups for medicines or following a granting of a marketing authorisation must be pre-approved by the Medicines and Healthcare products Regulatory Agency (MHRA), which means they do not require PAGB approval. However, PAGB can pre-vet the changes to pack design and layout as part of MHRA’s expedited, P3 assessment procedure. Please email the regulatory team for more information.

For the advertising component of food supplements’ pack copy, this must be reviewed and approved by PAGB. PAGB recommends members submit the text to PAGB for review and approval before the final artwork is produced. The final artwork must also be submitted to ensure any changes to the text, or implications created by the placement of graphics, can be evaluated prior to gaining final approval.

I hope this has helped clarify to some of the differences in advertising guidelines between medicines and food supplements and the dos and don’ts for each. For more information you can access the PAGB Consumer Code for Medicines and the PAGB Guideline on the Marketing and Advertising of Food Supplements by visiting the codes and guidance section of the PAGB website. You can also email the Advertising team for more information. If you work on food supplements you may be interested to know that as well as Food Supplements Regulatory Workshops, we now run a Food Supplements Advertising Workshop. For further information visit the PAGB website or email.

 

By Victoria Trowse, Senior Code of Practice Assessor

 

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