Mental Health Awareness Week: how EU diet pill rules are harming patients

Chloe Kent 15 May 2019 (Last Updated May 15th, 2019 17:19)

Mental Health Awareness Week 2019 is focusing on body image, concerns about which are associated with a poorer quality of life, psychological distress and an increased risk of disordered eating behaviour. Many eating disorder patients find themselves turning to diet pills, which are readily available on high street shelves across the EU due to a regulatory loophole which sees them classed as ‘medical devices’ rather than drugs.

Mental Health Awareness Week: how EU diet pill rules are harming patients
Most diet pills available in high street stores contain indigestible fibres which swell up to inside the stomach. Credit: Shutterstock

An estimated 1.25 million people in the UK have an eating disorder, a collective of conditions characterised by atypical and harmful eating behaviours. According to the British eating disorder charity Beat, anorexia nervosa has the highest mortality rate of any psychiatric condition.

Eating disorders are often linked to body dysmorphic disorder (BDD), a mental illness which sees the sufferer consumed by obsessive worries around body image. While a 2006 study found that a total of 32.5% of BDD patients had a comorbid eating disorder, the condition actually has more of a crossover with obsessive compulsive disorder (OCD), with latest edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) now classifying it as a subcategory of OCD.

Individuals with eating disorders are well-known to abuse diet pills and powders as part of their condition, with 32.3% of eating disorder patients surveyed having taken diet pills at some stage.

Diet pills are easily accessible in high-street chemists

Under EU regulations, many diet products are classed not as drugs or food supplements but as ‘medical devices’. This means they can be sold without the same intensive testing as regular pharmaceuticals and have laxer marketing restrictions. Consumers can thus purchase these products off-the-shelf from high street chemists across the continent, without any form of consultation with a physician.

The pills, sachets and shakes in question contain indigestible dietary fibres such as litramine or glucomannan, which swell up in the stomach and cause the user to feel fuller. This is how they’re able to obtain medical device status – under EU law, a medical device is a product for the diagnosis, prevention or treatment of a disease which does not use “pharmacological, immunological or metabolic means” to achieve this end.

The products aren’t absorbed by the body in the way of a medicinal product, nor do they have the “nutritional or physiological effect” of a food supplement. Instead, they come to be classed as medical devices due to the physical action they take on the body, despite having very little in common with the likes of wheelchairs, EpiPens and syringes, which fall more intuitively into this category.

The accessibility of these diet products has been widely criticised by both charities and healthcare regulators over how easy it is for eating disorder patients to purchase and abuse them.

Regulators have called for stricter laws around diet pills’ health risk

Beat’s director of external affairs Tom Quinn says: “Products marketed as diet pills pose severe health risks for people with eating disorders, especially if they are easily available. It is vital that people are aware of the dangers of abusing diet products and there should be more education on their effects. Doctors and pharmacists should also be made aware that use of diet pills may be one of the signs of an eating disorder, so that they can ensure vulnerable people get treatment.”

As well as making it physically easier for eating disorder patients to restrict their food intake, these fibre-based pills can cause a number of unpleasant and potentially dangerous side effects including bloating, abdominal cramps, nausea, vomiting, diarrhoea and constipation.

UK regulator the Medicines and Healthcare Products Regulatory Agency (MHRA) is now encouraging the EU to rethink the rules around these pills.

An MHRA spokesperson says: “Through our involvement in the negotiation of the new EU Medical Devices Regulation, we have championed changes that will place an appropriate level of additional scrutiny on these products to ensure their safety and clinical effectiveness.”

Additional scrutiny could help keep harmful products off the market

MHRA has called for the EU to instate a new classification rule specific to substance-based devices that better categorises these products by risk, which may see diet pills’ health risk re-examined a result of the harm they can do to vulnerable people.

It also hopes to see changes to the general safety and performance standards that require manufacturers to consider key concepts from medicinal products legislation, such as interaction with other medical devices or medicinal products – as bulking diet pills swell and fill the stomach, they may impact how certain medications are metabolised. XLS-Medical, manufacturer of some of some of the most popular diet pills in the UK, admits on its website that the interaction of its products with medications has not been extensively studied and “may affect the absorption of other medications into the bloodstream”.

MHRA is also championing a consultation procedure with a competent authority for medicine products that are systemically absorbed to achieve their intended effect, meaning a panel of experts would need to approve an expanding diet pill before it could be sold.

The implementation of MHRA’s policies wouldn’t necessarily mean the removal of all appetite suppressants from the market for good, but those which expand within the stomach would certainly find themselves under greater scrutiny. On a broader society level, as influencers and celebrities are increasingly criticised for promoting diet pills across their social media channels and more eating disorder patients speak out about the damaging impact they have had on their wellbeing, the net certainly appears to be closing in.