Q&A: Industry bodies lay down the law on key European issues

Helen Darracott, deputy chief executive, Proprietary Association of Great Britain (PAGB), which represents OTC and supplements firms and counts many pharma players as members:​

What impact has the EU nutrition & health claims regulation (NHCR) had on the EU supplements market?​

“The NHCR has had a significant impact; there has been an increase in generic ‘me-too marketing’ because of the limitations imposed by the wording of claims. Whilst the majority of companies strive for compliance, the overly scientific wording of the authorised claims is more difficult for people to understand and this is likely to impact their purchasing decisions.” ​

Are companies still investing in supplement science?​

“Yes companies are still investing.  This can be seen in the increasing number of gender and age specific formulations which are appearing on the market, as well as in the growth of more specific sectors such as the beauty market.  In recent years there has been a significant number of new product launches as well as new brands appearing on shelf.” ​

Is there a resurgence in vitamins and minerals?​

“There has been an increase in media interest in stories about nutrition and food supplements, notably on vitamin D, folic acid and omega-3 oils, which will have raised the profile of vitamins and minerals in the public domain.  It is not yet clear whether this has had an impact on sales in the category.”​

What impact has the EU Traditional Herbal Medicinal Products Directive (THMPD) had on the botanicals market?​

“The THMPD has had a significant impact as a large number of products which would previously have been sold under Section 12 [in UK herbal medicines law] did not go on to obtain licences and have subsequently either reclassified themselves as food supplements with reduced claims, or have disappeared from the market.  The comparatively high cost of obtaining a licence has dissuaded many companies from taking this route to market.”​

Is the internet and mid-level marketing (MLM) the dominant distribution channel now?​

“The internet and MLM is a major distribution channel. Nevertheless we are concerned about the potential sale and import of products which do not comply with EU food law. We are not aware of any planned enforcement activity but would welcome government action in this area.”​

How important is the EU medical devices channel?​

“The review of medical devices legislation is currently entering the trilogue stage of the European Union legislative process, and until the regulations are passed, it is difficult to say with any confidence what impact this will have.  It is likely that substance- based medical devices which could also be considered as foods will fall into the borderline, however the substance-based medical devices sector has not yet had time to mature. ​

“Whilst most products making medicinal claims would likely be classified as medicines, a small minority of medical devices are based on ingredients traditionally used in food, such as probiotics and some botanicals.”​

Is the EU novel foods regulation holding the market back?​

“PAGB believes there is potential for the novel foods regulation to stifle innovation in new product development, but it is not yet clear how significant an impact it is having.”​

Do supplement trade groups work well together?​

“PAGB has good relationships and ongoing dialogue with other trade associations in the supplements sector.  Where we have an area of common interest, such as folic acid or additives, we work closely together to support and represent the views of the industry.”​

Dr Robert Verkerk, ​scientific and executive director at the Alliance for Natural Health (ANH), a group representing firms operating in the natural products channel. He is also scientific director & regulatory specialist at ANH Consulting:​

What impact has the NHCR had on the EU supplements market?​

“​​In short, it’s been devastating to the communication of useful, scientifically relevant information to the consumer. In that sense, the NHCR has failed spectacularly with regard to its original objectives to avoid consumers being misled. The more than 2,000 non-authorised claims are a big barrier, yet different member states are enforcing these with very different levels of rigour. This hardly assists the functioning of a single market across the EU. ​

“Success in winning article 13.5 claims [based on proprietary or emerging science], or lack of it, is also really disappointing and was not foreseen. That’s down to the criteria for approval of health claims, and guidance around it, being very inadequate or inappropriate.”​

Are companies still investing in supplement science?​

“Big companies are, the smaller ones much less so. The cost of trials intended to win claims is great and there is now no incentive to undertake trials on diseased populations for risk of food supplement products subsequently being classified as unlicensed medicines.”​

Is there a resurgence in vitamins and minerals? ​

“​​Yes, but partially to benefit cheap reformulations of other products to justify authorised claims, despite inclusion amounts often being paltry and not truly justifiable by claims. The 15% NRV [Nutrient Reference Value] threshold for vitamins and minerals is laughable scientifically, and it’s interesting that EFSA [European Food Safety Authority] simply passes the buck on this one to the European Commission that in turn refers to the historic use of the arbitrary percentage as a labelling threshold.”​

What impact has the THMPD had on the botanicals market?​

“In countries with a lot of licensed products like the UK, the THMPD has impacted the overall diversity of products on the market. This is exacerbated by the loss of Section 12(2) of the Medicines License which supported a much more diverse product range than THRs [Traditional Herbal Registrations], and included more potent manufactured products that were relevant for dispensing by herbal practitioners. ​

“Food supplements containing herbs that are registered with the THMPD are now being challenged by regulators, often following complaints by THR licensees. Complainants and regulators argue about the lack of safety of some food supplements, when this is often a bogus argument that is attempting to mask concerns about unfair competition. ​

“When you scrutinise the THRs and food supplement products closely, the differences are apparent and it’s high time that the sector adapted to a dual regime. The development of the BELFRIT list [compendium of safe herbs developed by Belgium, France and Italy] is a big step in the right direction but some member states like the UK, Ireland and Sweden have yet to accept its relevance.”      ​

Which categories are struggling?​

“Multi-ingredient food supplements containing botanicals that are subject to THMPD licenses, albeit often with different dosages and galenic forms. The main challenge here is member state authorities classifying these as unlicensed medicines or selecting individual botanicals and categorising them as unauthorised novel foods.​

“Also probiotic/fermented products. These products are suffering in the marketplace because of the non-authorised status of health claims for probiotics.”​

Is the EU novel foods regulation holding the market back?​

“It still acts as fly trap for botanicals using novel extraction systems and as we move further away from the D-Day of 15 May 1997, it’s getting very hard to muster enough documentary evidence to convince authorities of significant use prior to this date.”  ​