Health: Pain


INSIGHT
Published
Jun 15th '22
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Claims to treat or alleviate pain are likely to be considered medicinal and marketers would need to ensure that any necessary licences and marking authorisations are held and, where relevant, objective claims are supported by documentary evidence.

 

See advice on Medicinal claims.

 

Claims to treat or relieve pain are likely to be considered medicinal in nature.  Depending on the product or service being advertised, different requirements are likely to apply to those treatment claims.

 

  • Is it a therapy?

Therapists, including alternative and complimentary therapists, commonly make references to treating or alleviating pain caused by a variety of conditions.

 

The Advertising Standards Authority (ASA) and Committee of Advertising Practice (CAP) accept that the techniques used in physiotherapyChiropractic and Osteopathy can be used to relieve some types of pain.

 

In almost all other instances, marketers would need to hold documentary evidence in the form of clinical trials to support claims to treat or relieve pain.

 

In 2017, the ASA considered advertorial claims by clinic offering  treatment for people for various conditions, including those with “persistent joint pain”. The ad referred to various therapies offered by The Regenerative Clinic, including Activated Messenchymal Pericyte Plasma (AMPP), Platelet Rich Plasma Therapy (RPR) and Lipogems.  Although clinical trial evidence was submitted to support the claims, the ASA considered it was not sufficiently robust to support the claims that the therapies offered were effective in the long term treatment of joint pain (The Regenerative Clinic, 15 August 2020).

 

Similarly, in 2021 the ASA considered an ad by a clinic which included claims that they could provide “immediate and lasting pain relief” from a variety of causes using a “Super Inductive System” which involved a high-intensity pulsed electromagnetic field. Whist the marketer submitted some clinical trial evidence, the ASA found that it was not sufficiently robust to support the claims (Cheshire Health and medical professionals, 15 September 2021).

 

See CAP Guidance on the level of substantiation expected in health, beauty and slimming claims.

 

  • Is it a medical device?

If ads include claims that a product or device can treat or relieve pain, it is likely to be treated as a medical device. Following Brexit, the Regulations regarding device certifications changed meaning that marketers selling in Great Britain need to ensure medical devices are either CE Marked (the original EU system) or UKCA Marked.  From June 2023 onwards, all products (including those previously CE Marked) will need to be UKCA Marked into for them to be sold in Great Britain.

 

Marketers of devices that are not appropriately certified as a medical device should not make claims to treat, relieve or reduce pain (directly or indirectly).

 

Additionally, treatment claims, including claims that the device can treat, reduce or relieve pain, will need to be supported by documentary evidence in the form of clinical trials.

 

In 2018, the ASA considered an ad for a device which made claims that it was effective in the treatment of “knee pain”.  The marketers were unable to demonstrate that the product was appropriately certified as a medical device meaning that they were not permitted to make medical claims in ads.  Additionally, they did not provide any evidence to support the pain relief claims (UK Direct Shop, 11 April 2018).

 

The ASA previously ruled on a TV ad for a PainGone Plus device which claimed it used TENS technology for “pain control” and the relief of “minor aches and pains” and that the device could be used alongside traditional forms of pain relief.  The ASA and CAP understood that TENS devices more generally were capable of providing temporary pain relief when used alongside traditional pain medication. However, it was noted this ad did not make clear any relief was temporary or that to obtain the stated effect it needed to be used alongside standard pain medication.  Although the marketer was able to demonstrate that the device was appropriately certified, the ASA considered the ad that the pain treatment claims were misleading (Medi-Direct International Ltd, 28 March 2018).

 

See CAP Guidance on the level of substantiation expected in health, beauty and slimming claims.

 

  • Is it a medicine?

If the product is not a device or a therapy it might be a medicine (by presentation or by content).  Medicinal claims in advertising are only permitted for products that are licenced as medicines by the MHRA.

 

Marketers that hold a licence should be careful to restrict advertising claims, including those that relate to pain relief, to those that mirror the Summary of Product Characteristics (SPC) that accompanies that license.

 

Marketers with a licence should also familiarise themselves with other rules in the CAP Code (Section 12) in relation to the advertising of medicines.

 

The ASA considered an ad for a CBD patch which made claims that it could be used to relieve a number of ailments, including “chronic pain”, “back pain” “migraine pain” and “diabetic nerve pain”.  The claims were upheld due to the fact the ad made medicinal claims for an unlicensed product (Easylife Group Ltd, 18 March 2020).

 

A TV ad for a licensed medicine was investigated to establish if it made misleading claims that the analgesic could specifically target headache pain.  The ASA found that although the ad did specifically reference headaches, other elements of the ad including statements like “It acts at the source of pain” and “for pain relief” alongside graphics showed Nurofen acting on non-specific nerves did not suggest the medicine was targeted at specific types of pain.  In that case the ASA ruled that the ad was not misleading (RB UK Commercial Ltd, 22 November 2017).

 

  • Is it a food?

Claims to prevent or treat medical conditions are prohibited for foods and food supplements under UK (previously EU) Regulations (rule 15.6.2).  Medicinal claims for foods presented as medicines are also prohibited under medicines legislation unless the product is licensed as a medicine for that purpose (see above).

 

In 2020 the ASA considered an ad for a food supplement. It considered that the ad made explicit and implied claim that the food product could relieve pain including from ‘inflammation, cramps, pinched nerves and tendonitis’.  Because claims to treat human disease are prohibited for food supplements, the ASA ruled the ad breached that Code (Health Solutions Ltd, 25 November 2020).

 

  • What about conditions for which medical treatment should be sought? 

Pain, is not in itself likely to be a condition for which medicinal supervision should be sort.  However, references to certain types of pain (arthritic pain) or some descriptions of pain (like chronic pain) could be understood as a reference to a condition for which medical supervision should be sought.

 

Ads for devices and therapies should take care when referencing such conditions because unless that treatment is carried out under the supervision of a suitably qualified medical professional, those treatment claims could have the effect of discouraging essential medical treatment.

 

Marketers can contact the Copy Advice team for guidance but might be interested to learn that the clinical evidence for many painful conditions has been reviewed by groups such as the Oxford Pain Relief Group and the results can be found on this website.

 

The Cochrane Collaboration also is a resource of immense value.

 

Source: CAP

 

Note: This advice is given by the CAP Executive about non-broadcast advertising. It does not constitute legal advice. It does not bind CAP, CAP advisory panels or the ASA. CAP’s AdviceOnline entries provide guidance on interpreting the UK Code of Non-broadcast Advertising and Direct & Promotional Marketing.

 

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