ASA Adjudication on Danone UK Ltd

Ad

A TV ad, for Danone Activia, in 2006 stated "Want to beat that bloated feeling? We spoke to real women suffering from digestive discomfort". The ad showed a woman who said "It does make you feel lethargic" and another who said "My tummy felt just like a football". The voiceover continued "After 14 days, 82% of people with digestive discomfort said they felt better by eating one or two pots of Activia every day … You too can beat that bloated feeling. Try Activia for 14 days …".

Issue

The Medicines and Healthcare products Regulatory Agency (MHRA), who considered that "bloated feeling" and "digestive discomfort" were symptoms of indigestion or a digestive disorder and suggested that the product could be consumed with a view to modifying digestion, believed the ad made unacceptable medicinal claims.  They were further concerned that the ad gave the impression that medical advice was not needed for conditions which might require it.

Response

Danone said bloatedness and digestive discomfort were normal signs of digestion in the gut that were commonly experienced by normal healthy adults.  They referred to a scientific paper which they said indicated that 10 to 25% of healthy people experienced bloating at some time or other and a book which apparently stated that functional abdominal bloating occurred in approximately 15% of the community based healthy population.  Danone said the terms "bloatedness" and "digestive discomfort" were frequently used by consumers to describe their perceptions of their normal digestive state.

They sent a letter from a leading expert in experimental gastroenterology which stated "Bloatedness, which relates to the presence of gas in the gut, and digestive discomfort, which can incorporate any of more than a dozen gastrointestinal sensations, are both entirely normal consequences of physiological digestion.  In surveys of the healthy population, up to 70% of people experience these symptoms regularly and bloating is particularly common, occurring in between 15% and 30% of healthy people.  These symptoms do not in any way represent ill health or disease and they do not need to be corrected or treated.  They are sensations perceived by individuals in response to the widely differing diets that we all eat some of which, for example a helping of beans, might give rise to more gas in the gut and a temporary feeling of what is known as bloating.  This sensation, through the production of gas in the gut, is closely linked to normal bacterial metabolism in the gastrointestinal tract".

He continued "[the complainants] are quite right when they say that bloating can be a symptom of a digestive disorder.  It is, for example, one of the minor components of the irritable bowel syndrome.  However, individuals recognise bloatedness and other digestive symptoms as a part of normal physiology and only consult their doctors if abnormal symptom patterns persist ... An example of a similar situation, occurring outside the gut, would be the symptom of tiredness, which is physiological and experienced by almost everybody at some point. Tiredness is also a prominent symptom in anaemia, but people are readily able to decide for themselves what is physiological and a claim to reduce tiredness could hardly be considered medical."

In a further letter the expert stated (including by reference to NHS Direct) that " ... bloatedness and digestive discomfort are not really indigestion, which is a problem of the upper digestive tract ... indigestion is not a disease or adverse condition, but a collection of symptoms ... acid and pain are the major features, not bloating ...".

Danone said their product was a food, not a medicine.  The MHRA had concluded in March 2005 that Activia was not a medicinal product.

Danone did not believe that the ad gave the impression that a medical consultation was not necessary for conditions for which medical advice should be sought.

The Broadcast Advertising Clearance Centre (BACC) said, when the product was first advertised in 2004 using the same claims, Danone assured them that "feeling bloated" and "digestive discomfort" were common, everyday descriptions of feelings associated with normal digestion and those feelings were totally different to symptoms of disease or adverse conditions that were indicators of a medical problem.  They said the claims had been used since 2004 without complaint and went no further than those for some other food products.  They said the product and claims had been approved separately by their consultant which, combined with Danone's evidence, led them to believe they were not medicinal claims nor did they refer to conditions requiring medical attention.

Assessment

Complaint not upheld

The ASA took the view that a medicinal claim under the Code was one that conveyed the impression, expressly or implicitly, that the product had qualities of a medicinal product.  To establish what constituted a medicinal product and its qualities, we considered, amongst other factors, EU and UK law, including Directive 2001/83/EC on the Community code relating to medicinal products for human use and the Food Labelling Regulations 1996.

We noted that, although "bloatedness" and "digestive discomfort" could be symptoms of a digestive disorder, they were also normal consequences of healthy digestion.  We considered that, because the ad did not claim to treat digestive disorders but merely help with bloatedness and digestive discomfort, which were common consequences of healthy digestion, the claims were unlikely to convey the impression to viewers that the product had the properties of a medicinal product and, therefore, the claims were not medicinal.  

We noted the MHRA considered that the claims "beat that bloated feeling" and "people with digestive discomfort said they felt better by eating ... Activia every day" implied the product could alter the way in which the digestive system acted; they therefore also believed they were medicinal because they suggested that the product could be consumed with a view to modifying digestion.  (The evidence Danone submitted suggested that Activia could be consumed with a view to modifying digestion.)  We understood that the MHRA was alluding to the second definition of a medicinal product in Directive 2001/83/EC: correcting, restoring or modifying a physiological function by pharmacological, immunological or metabolic action.  We noted, however, that the Food Labelling Regulations did not include that definition.  We were also aware that Regulation (EC) 1924/2006 on nutrition and health claims made on foods (which took effect on 1 July 2007, long after this ad was broadcast) allowed, if certain conditions were met, claims describing or referring to the role of foods in growth, development and the functions of the body.  In the circumstances, we did not consider it appropriate to regard the claims as medicinal for that reason.  

We considered that the claims did not go so far as to give the impression that a medical consultation was not necessary for conditions for which medical advice should be sought.  

We investigated the ad under CAP (Broadcast) TV Advertising Standards Code rules 8.2.3 (Products without a marketing authorisation) and 8.2.6 (Conditions requiring medical attention) but did not find it in breach.

Action

No further action required.

Adjudication of the ASA Council (Broadcast)