May 17, 2020

Superfoods - are they really a 'cure all'?

superfoods
Lomax Bespoke Fitness
Nutrition & Wellbeing
Admin
5 min
Is there such a thing as superfoods?
Written by: Zoe Copsey, Head of Nutrition at [email protected] – Lomax Bespoke Fitness, Nutrition & Wellbeing ‘Superfood is the term often...

Written by: Zoe Copsey, Head of Nutrition at [email protected] – Lomax Bespoke Fitness, Nutrition & Wellbeing

‘Superfood’ is the term often used to describe a food that contains high levels of phytonutrients which provide an active health benefit. Whilst it is certainly true that there are identifiable beneficial foods and food groups, it is important to bear in mind that ‘superfoods’ is not a phrase commonly endorsed by qualified dieticians and nutritional scientists in the absence of scientific evidence.

The common understanding of superfoods is that they are especially good for you in some way – be it that they are particularly rich in nutrients, vitamins or minerals or are considered powerful antioxidants. Some of the foods frequently believed to constitute superfoods include broccoli and blueberries which are thought to help the immune system, and garlic, which is thought to reduce blood pressure and cholesterol.

Other foods commonly believed to have excellent health benefits are oats, avocados, nuts and seeds, oily fish, pomegranate and green tea. Some of the more unusual ingredients include maca powder – a root powder that can be added to porridge or smoothies – goji and acai berries, manuka honey and pink Himalayan rock salt, which can be used as a substitute for table salt in cooking.

Many studies have been done into the therapeutic effect of these and many other foods, however, more often than not, the mix of findings from various studies and different sources mean the results can never be said to be totally conclusive. Nutritionists, therefore, tend to err on the side of caution with regard to recommending that particular foods have a specific health benefit.

Furthermore, changes to the European Food Safety Authority’s (EFSA) laws actually mean that it is now a criminal offence to make any unsubstantiated claim regarding the benefit of any food or ingredient. The Nutrition and Health Claims Regulation was adopted in 2006, but it is only now that food companies are starting to feel the effects of the regulation, with the vast majority of health food claims submitted to EFSA by manufacturers being rejected. Among those claims that have already been thrown out are claims that “cranberry juice can reduce the risk of urinary tract infections in women” or that “green tea is good for blood pressure, cholesterol levels, bones, teeth and eyesight and that it works as an antioxidant.” This clearly demonstrates the importance of establishing the scientific evidence behind many so-called superfoods.

The reason why blanket claims can be so misleading is essentially that no two humans are the same and require different nutrients at different levels. One person may have a stronger immune system, whilst another may be much more susceptible to the common cold but is less likely to suffer from cardiovascular health issues. Individual requirements in terms of age and life stage are important too. For example, an elderly person will require a diet that is lower in calories due to a natural decrease in their basal metabolic rate, yet will have to ensure that it is nutrient dense to prevent disease or ill-health in their older age. Therefore, as an individual’s requirements will affect the foods which will be most beneficial to their body, it is not always appropriate to encourage the notion that certain food groups are ‘super’ for all those who consume them.

However, this has not stopped the general population yearning for foods that offer a magic cure for illnesses. The reality is that if you are unwell with a cold, a handful of blueberries, acai or even goji berries is not going to rid you of it. These so-called therapeutic foods need to be part of a well balanced diet, with good quantities of varied nutrients.

And mindful that it can be terribly complicated to keep track, a new Index – the Aggregate Nutrient Density Index (ANDI) – has recently been developed. This rates foods from 1 to 1000 depending on their nutrient composition for a given quantity, for example, levels of micronutrients including vitamins, minerals, phytochemicals and antioxidant capacities. The ANDI system recommends making up meals that are predominantly plant-based as these foods are richer in micronutrients compared to total calorific content. This is a good way of ‘nutrient counting’, which at Lomax we always recommend in place of ‘calorie counting’, as a food’s nutritional value is more important than its calorie content.

Taking an in-depth and holistic approach to healthy living is the hallmark of the ‘Lomax Way’; we combine nutritional advice tailored to the individual’s needs with the appropriate levels and styles of exercise to achieve the fitness goal desired. Ultimately, the most beneficial lifestyle is one that is balanced with a healthy diet, exercise and practices to promote the wellbeing of both mind and body. By taking this holistic approach, we reduce the need for dependence on any one superfood, focusing instead on adopting a sustainable, balanced and healthy way of life.

Food and nutrition planning with Lomax:

About Lomax Bespoke Fitness, Nutrition and Wellbeing

Established in 2007 by Jonathan Lomax, Lomax Bespoke Fitness, Nutrition and Wellbeing is a unique health concierge company, providing a contemporary and highly personal service beyond the reaches of pure fitness. Taking an unusually in-depth and holistic approach to healthy living, Lomax combines exercise, nutrition and wellbeing treatments in an innovative way – pioneering the next generation in health and wellbeing. The trusted team of specialists deploy the latest, cutting-edge techniques in Metabolic Conditioning, making exercise and nutrition fun, accessible and cost-efficient either by operating in-home, in-office or in their gym in Victoria. 

Clients are supported by the provision of nutritionally balanced meals and a range of treatments available at the [email protected] – including massage and aromatherapy, osteopathy and acupuncture alongside comprehensive health MOTs which combine with the rest of the programme to ensure a balanced, realistic and effective health and wellbeing routine.

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Jun 20, 2021

Medical device companies: how to prepare for Brexit

medicaldevices
supplychain
Brexit
Compliance
Ed Ball
6 min
Ed Ball, Senior Associate at RQM+ , explains how medical device companies can prepare for post-Brexit compliance

Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.

The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.

The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.

The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline. 

This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:

Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking. 

Rigorous Planning
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.

Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.

Authorised Representatives
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.

For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established. 

Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users. 

While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.

Clinical Investigations
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.

Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.

Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.

As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.

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