Special edition: Inside Europe’s food supplement markets

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

By Shane STARLING contact

- Last updated on GMT

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

Related tags: Food supplements, European union

European food supplement groups share insights from the law to distribution to marketing and science in this Q&A on the €7bn European supplements sector, according to Euromonitor International.

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.”

Helen Darracott -PAGB

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?

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“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.”

 

health supplements vitamins

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.

Robert Verkerk PhD_72 dpi

“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.

drugs herbals botanicals red rice

“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.”  

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1 comment

The great licensing paradox

Posted by Robert Scott,

The issue of product licensing is one that has been much used and abused by a number of self interest groups, which are acting against the interests of the public on often-spurious grounds. This is a matter that the International Register of Consultant Herbalists and Homoeopaths is currently contesting with government.

Whereas the traditional practice of herbal medicine is not dependent on industrial manufacturing techniques that did not even exist before the 20th century, the EHTPA has tried to encourage the government to believe this obvious fiction and has done so for the purpose of manipulating its professional standing. The organisation has claimed a dependency on un-licensed products and has used this as the basis for their attempt to become statutorily regulated (despite not qualifying for a number of reasons), as a means of accessing the THMPD derogation. This manoeuvre has in turn been declared illegal by the EU.

During my attendance at a meeting of the Herbal Medicines and Practitioners Working Group, the EHTPA representative was hostile to the suggestion by Professor David Walker DCMO, who was chairing the meeting, that the government was considering a “plan B” licensing regime. The rationale was that, if products were to become licensed, the call for access to unlicensed products through status manipulation would dissolve.

At the EU level, the development and sale of non-patentable health products is seen as a threat to the profits of the pharmaceutical industry, the Machiavellian practices of which were exposed in the House of Commons Select Committee Report on the Influence of the Pharmaceutical Industry Report 2005. This conflict of interests has been highlighted by the recent attack on cholesterol lowering spreads containing plant sterols. This grocery item was first attacked under the EU Health Claims Directive; however, this challenge failed, as the cholesterol lowering attributes of the plant sterols used had already been substantiated within the directive’s own protocols. This attack having been thwarted, the next move was to use the health benefits of this “go faster” margarine to have it reclassified as a “medicine” to either enforce the costs of the subsequent licensing program upon it, or perhaps more the intention, crush its financial viability in the process.

In both cases, there has been a clear motive to remove products from the market, against the interests of the public, for the sole benefit of furthering the vested interests of those claiming to act in its interests. One can but wonder just what George Orwell might have had to say on the matter!

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