Nelsons Natural World has won certification for a sulphur-based homeopathic product that permits skin health claims in the UK, after its whole range of 38 Bach Flower remedies had their medicinal status revoked last month.
Nelsons’ ‘Sulfur 30C’ won the approval under the ‘National Rules Scheme’ (NRS) from the UK Healthcare Products Regulatory Agency (MHRA) – the same agency that removed the Bach Flower remedies range’s medicinal status.
The NRS approval is the third for Nelsons. Its Arnicare arnica 30c was approved in 2009 and Nelsons Teetha Teething Gel won in 2012.
The new approval means Sulfur 30C can make the claim that it is, “A Homeopathic Medicinal Product used within the homeopathic tradition for the symptomatic relief of pimples and spots of mild acne that are not infected or inflamed and skin prone to eczema, irritation and itching.”
Nelsons global brand manager Emma Goessen welcomed the approval. “…It’s been a lot of hard work and dedication by Nelsons regulatory team, who have worked closely with the MHRA to ensure they had all the information they needed in order to approve the on-pack claims.”
She said the company would be applying for more applications under the NRS.
The products are available at outlets like health food chain, Holland & Barrett, and pharmacy, Boots, as well as online.
Medicine or food?
In altering the medicinal status of the Bach range, the MHRA said a more level playing field would be created if the products fell under food law.
“Indeed there are many Bach flower remedies on the UK market, (and we understand on the markets of other EU Member States) that are legally supplied under other regulatory categories, such as food supplements. This change would represent a useful simplification and create a more level playing field for suppliers of this kind of product.”
Bach 'bio-energy' flower remedies were developed by Dr Edward Bach in the 1930s.
Of the switch, Nelsons marketing manager Kate Haskins, said: “We are working with the MHRA and the Health Food Manufacturers Association to ensure all packaging has a seamless transition and that the change is made with no disruption to our customers or consumers, who we value greatly.”
“Nelsons will maximise the new marketing and communications opportunities that arise from this licensing change and we will continue to produce quality natural healthcare products that adhere to UK regulations, for our loyal consumers.”
Robert Verkerk, PhD, the executive and scientific director of the Alliance for Natural Health International (ANH-I), said the revocation illustrated the failure of EU laws to create categories based on medicinal criteria for products with a holistic tradition and use.
“They are trying to ring fence products into categories when what is needed is a lighter regulatory approach as is in places like France and Australia where the homeopathic tradition is acknowledged. The regulator in the UK has been handed a loaded gun and it uses it more discriminately than in say Germany and France.”
“NRS approval can help but only inside the UK – it won’t help intra-EU trade.”
Nelson's sulphur product may have won a NRS claim, but sulphur is not approved as a nutrient under the 2002 EU Food Supplements Directive (FSD), something Dr Verkerk said was, "bizarre".
A homeopathic medicinal product is defined in European legislation (Article 1(5) of Directive 2001/83/EC as amended by 2004/27/EC as: “Any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of principles.”
Information about NRS registrations can be found here.