ASA Adjudication on Johnson & Johnson Ltd

Ad

A TV ad for Imodium Instants showed a woman picking a strawberry from a bush and eating it. On doing so, a panel across her stomach opened to show a washing machine on its spin cycle. Her legs and feet suddenly appeared to be jogging. Voice-over stated "Diarrhoea is a symptom that your digestive system is working too fast. Imodium Instants dissolve on your tongue, working with your body to slow it down to its normal speed, quickly relieving your diarrhoea." The woman was shown taking the product. On-screen text stated "Can stop diarrhoea in under one hour. Always read the label." A speedometer on the woman's stomach was seen slowing down from the red into the green zone and her legs and feet slowed down. She was then shown in a sitting yoga position. A packshot of the product was shown while voice-over and on-screen text stated "Imodium. Restores your body's natural rhythm."

Issue

Five viewers challenged whether the ad was misleading and harmful because it suggested diarrhoea was an ailment in itself that Imodium Instants could cure. They believed diarrhoea could be a symptom of more serious conditions and were concerned that the ad could discourage people from seeking the necessary medical attention.

BCAP TV Code

Response

Johnson & Johnson said Imodium Instants was a licensed medicine classified as being available outside of pharmacies and without prescription. They said the indication for Imodium Instants was "For the symptomatic treatment of acute diarrhoea in adults and children aged 12 and over. For the symptomatic treatment of acute episodes of diarrhoea associated with Irritable Bowel Syndrome in adults aged 18 years and over following initial diagnosis by a doctor."

They said diarrhoea could be divided broadly between acute (short term) and chronic (persistent or recurrent). They said acute was sudden onset and was usually resolved in between one and four days. They said causes could be infectious, either viral or bacterial, or non-infectious. They said precipitating factors included diet (unfamiliar foods, excess consumption or dietary intolerances); hormonal (they said approximately 20% of women experienced diarrhoea around the menstrual period) or stress/anxiety. They said acute diarrhoea was a common ailment. They said it was the most frequent health problem experienced by travellers and that, when not associated with travel, they believed that one episode per person per year was a reasonable estimate. They said most cases of acute diarrhoea did not present to a GP; that self-treatment with over-the-counter remedies was frequently adopted and was viewed as an appropriate course of action. They provided website entries from CORE (Digestive Diseases Charity supported by the British Society of Gastroenterologists) and NHS Direct. Both entries stated that most episodes of acute diarrhoea got better without the need for specific medical advice. CORE said medical advice should be sought if diarrhoea persisted for more than 14 days or was associated with blood and/or high fever or if cramping abdominal pain became severe. They said loperamide (the active ingredient in Imodium Instants) was helpful to reduce bowel frequency. NHS Direct said diarrhoea usually cleared up in a couple of days and was not serious unless in a baby or an elderly person, because of the risk of dehydration. They said if diarrhoea was persistent or associated with symptoms such as blood, the person should see their GP. They also said loperamide could relieve symptoms by slowing down the movement of bowel contents.

Johnson & Johnson said Imodium Instants was also licensed for non-prescription use for diarrhoea associated with Irritable Bowel Syndrome in adults following initial diagnosis by a doctor. They said that was the most frequent form of chronic diarrhoea and, although troublesome, was not serious. They said that, following diagnosis by a doctor, self-medication with Imodium was often used to control diarrhoea. They said other causes of chronic diarrhoea were likely to indicate a more significant underlying medical condition. They said Imodium was restricted to prescription-only use in those circumstances but that those other causes were rare by comparison.

They said diarrhoea was not generally a "comfortable" subject and the ad therefore took a lighter approach. They said the ad depicted, in a stylised and simplified way, how Imodium Instants could be used to treat an episode of acute diarrhoea. They said acute diarrhoea was the licensed indication for Imodium Instants for self-medication not requiring pharmacy supervision and that the way in which the product was shown to be used in the ad was in line with the authorised product particulars (Summary of Product Characteristics). They said medical advice was not usually required except under specific circumstances described in the product labelling. They said the injunction "Always Read the Label" was included in the ad. They said the ad described the use of Imodium Instants according to its licensed indication and did not imply it was a "cure" for a more serious underlying condition. Responding to a specific point made by two of the viewers, they said it was inaccurate to say that the body's natural process (diarrhoea) should not be interfered with. They said diarrhoea was generally considered by gastrointestinal experts as a symptom of disruption to the finely tuned absorption process in the bowels rather than a "natural" process and that the use of the kind of ingredients that were active in Imodium Instants to manage uncomplicated acute diarrhoea in adults was suggested by the British National Formulary (published jointly by the British Medical Association and the Royal Pharmaceutical Society of Great Britain to advise healthcare professionals on the use of medicines). They provided the relevant extract. They said the TV ad clearly depicted the treatment of a simple episode of acute diarrhoea with Imodium Instants, in line with the product's licensed indication. They said the circumstances under which medical advice should be sought were clearly outlined in the product labelling and that the ad stated the injunction "Always Read the Label". They said it was not feasible or required for an ad to describe the circumstances where self-medication was not appropriate.

Clearcast said they believed the ad was in line with ads for other licensed products that were currently on air. They said they had taken advice from an external consultant who was satisfied with the claims made in the ad. They said it was mandatory for an ad to state "Always Read the Label" to alert viewers to the fact that a product was licensed and that warnings and guidance on how to use it were listed in literature inside the pack. They believed it could be said that any ad that offered to relieve symptoms such as headaches or indigestion could be said to discourage people from seeking medical advice for symptoms which could be caused by something more serious.

Assessment

Not upheld

The ASA noted the points made by Johnson & Johnson and Clearcast. We noted that there were situations where NHS advice was that medical advice should be sought in cases of diarrhoea. The situations included those where diarrhoea became persistent or where it occurred in conjunction with certain other symptoms. In the normal adult population, however, we noted that NHS Direct advised that anti-diarrhoea medicines such as those with the active ingredient contained in Imodium Instants could be taken to relieve symptoms by slowing down the movement of bowel contents. We noted that that was how the effect of taking Imodium Instants was described in the ad. We noted that the Medicines and Healthcare products Regulatory Agency (MHRA), in their summary of the characteristics of Imodium Instants, described it as being suitable for the treatment of the symptoms of acute diarrhoea in adults, the elderly and children of 12 years and over and for the treatment of the symptoms of episodes of acute diarrhoea associated with Irritable Bowel Syndrome in adults aged 18 years and over following initial diagnosis by a doctor. We noted that the summary stated that persistent diarrhoea could be an indicator of potentially more serious conditions and so the product should not be used for prolonged periods until the underlying cause of the diarrhoea had been investigated. We noted that the summary also listed some symptoms or conditions which Imodium Instants should not be taken in conjunction with or in which it should be used with caution. We noted that that information was stated in the packaging that the product came with and that the ad stated "Always read the label".

We noted the concerns expressed by the viewers. We considered, however, that, while there were precautions associated with using the product, those precautions were highlighted in the normal way for medicines available without prescription for treating everyday symptoms (in the "Always read the label" warning used in the ad and in the full information provided with the packaging for the product) There was no reason why the normal adult population would be advised against using the product in the situation described in the ad - the treatment of the symptoms of acute diarrhoea - without seeking medical advice. Because of that, we did not consider the ad was likely to discourage people from seeking necessary medical attention.

We investigated the ad under CAP (Broadcast) TV Advertising Standards Code rules 5.1.1 (Misleading advertising), 5.2.2 (Implications), 8.2.6 (Conditions requiring medical attention) and 8.2.7 (Self diagnosis) but did not find it in breach.

Action

No further action necessary.

Adjudication of the ASA Council (Broadcast)