As the 2016 Summer Olympics begins, the Medicines and Healthcare products Regulatory Agency (MHRA) has carried out a new review of unauthorised medicines being marketed as sports supplements, which shows a reduction of almost 50% compared to a similar study carried out in 2012.
Some products related to sports and body building for sale in the UK are brought to our attention and found to be unacceptable even if they are considered legitimate products in other countries.
The review, launched in the run up to the Rio Olympics, is part of the MHRA’s ongoing commitment to protect people from potentially dangerous products. This is an encouraging sign and points to the sports supplement industry taking account of MHRA concerns regarding the sale of products regulated as medicines.
The MHRA’s Medicines Borderline section invited 33 UK based companies to carry out a review of their product ranges and subsequently took action to remove unauthorised medicinal products from the market. These contained a number of ingredients which cause a significant physiological effect on the body.
The review found that 69 unauthorised medicines were being sold as sports supplements and 16 companies were found to be selling one or more unauthorised medicines.
This is compared to 128 unauthorised medicines and 36 websites prior to the 2012 London Olympics.
Dr Chris Jones, MHRA Medicines Borderline Section Manger said:
“During this period we anticipate that the public’s interest in sports and body building supplements is likely to rise, and with it, the potential for more unlawful products. We have decided to dedicate additional time and resources to this market area, to help both companies and the buying public.
“While sports supplements are regulated as foods we have worked with industry to review the market and have investigated the sale of targeted unauthorised medicines being marketed as sports supplements.
“The results of our second review into the sports supplement industry shows there are some signs of improvement, and more companies are acting on the MHRA’s concerns.
“People who are thinking of buying sports supplements should check the products comply with food law, and to speak with a healthcare professional if they have any concerns about any sports supplements they may be taking.
“If anyone is thinking about purchasing medicines online they should look for the distance selling logo which verifies whether a website is legitimate.”
UK Anti-Doping Chief Executive Nicole Sapstead said:
“UK Anti-Doping welcomes the work by the MHRA in clamping down on the use of unauthorised medicines in supplement products. As the supplement industry grows, we continue to work with sports, athletes and their support personnel to raise awareness of the risks associated with supplement use in our efforts to protect clean sport.
“We continue to be concerned about the number of supplement products being produced that contain ingredients not suitable for, or under the regulation of, the food industry. Equally, we also recognise the risks associated with contamination, counterfeit supplement products available to purchase online and the challenges with ingredients being listed by a variety of names. In the worst cases, these products can be extremely harmful to health.
“Our message to anyone considering using a supplement is simple - no supplement can ever guarantee to be free from prohibited substances. Always seek advice from a qualified nutritionist and where possible take a ‘food first’ approach. If you need to take a supplement then assess the risks by conducting thorough research and only using a batch-tested product such as those listed on informed.sport.com. Lastly, always consider the consequences to your sporting career and health before making any final decisions.”
European Specialist Sports Nutrition Alliance (ESSNA) chairman Dr Adam Carey said:
“These results are encouraging for customers and sellers of sports nutrition alike, as they show that the sector has responded to concerns about compliance by prioritising the safety of its consumers. Thanks to this focus on safety – encouraged and assisted both by authorities and responsible companies such as those that belong to ESSNA – consumers can be increasingly confident about buying reputable, effective sports nutrition both in stores and, importantly, online.
“But ESSNA knows through its own work to tackle non-compliance in the industry that there is still more to do. We will continue to work alongside the MHRA to make sure all products sold comply with all necessary regulatory regimes, and are safe for the public to buy and consume – and we reiterate the MHRA’s advice to all members of the public; please be careful when buying products online.”
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks. MHRA is a centre of the Medicines and Healthcare products Regulatory Agency which also includes NIBSC and CPRD. The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health.
Ephedrine, Yohimbine and Synephrine are substances that are extracted from certain herbs. Each is capable of causing significant physiological effects, especially to blood pressure and heart rate. They have considerable potential to cause harm if used without medical supervision or advice. Products containing these substances would normally be subject to controls as Prescription Only Medicines.
The MHRA has determined a number of products which contain DMAA to be medicinal products and may not be placed on the UK market without the appropriate authorisation. This substance is regarded as being capable of significant modification to human physiology. Products containing DMAA have already been subject to regulatory controls in various countries around the world following a series of suspected links to serious adverse effects. It is the MHRA’s view that the uncontrolled sale and supply of products containing DMAA poses potential risks to public safety.
The MHRA classifies products (not substances) according to the definition of a medicinal product.
The MHRA is responsible for ensuring that medicinal products work and are acceptably safe and is not responsible for the licensing of products such as sports supplements which are used by athletes to improve their performance. That said, the MHRA will investigate instances of the sale and supply of unauthorised medicinal products, including those that may be present in sports supplements but consideration needs to be given to whether it is more appropriately regulated elsewhere for example as controlled substances under UK drug legislation.