EU herbals: Creative escape routes out of botanical claims limbo-land
In September 2010 the European Food Safety Authority (EFSA) put on hold the assessment of 1,548 health claims for botanicals after instruction from the Commission.
The problem was that the stringent human-studies, efficacy-based approach EFSA required for claims under the nutrition and health claims regulation (NHCR) was deemed inappropriate for botanical health claim dossiers, which rely on evidence of traditional use.
“It is clear that all claim applications for botanical products would fail if the NHCR guidelines were applied in their current form,” said Penny Viner, vice president of the Health Food Manufacturers Association (HFMA).
The dilemma now facing the Commission is how to deal with these in-limbo botanical claims, and Viner said the HFMA had been led to understand “that by 2019 the Commission will have worked out an appropriate strategy for the review of botanical claims”.
Which way forward?
Some stakeholders, among them the Council for Responsible Nutrition UK (CRN-UK), are lobbying for a completely new legal framework for the use of botanicals in foods.
“This would include claims based on tradition of use and incorporate quality and safety provisions, but would exclude claims for botanicals from the NHCR,” said Sam Jennings, technical adviser for the supplement trade group.
However, the European Federation of Health Products Manufacturers Associations’ (EHPM) position is that this would be “difficult” to achieve and “involve a lot of work”. Instead, this trade body favours adaptation of the NHCR.
Meanwhile, Luca Bucchini, managing director at Italy-based Hylobates Consulting, said he would like to see legislation that addresses “safety, plants permitted, quality and claims based on tradition…as long as such claims are not medicinal”.
Viner admitted that it would be ‘’difficult to see how borderlines would be overlooked” in the development of any strategy, given the divergence of approaches for regulating botanical supplements across Europe.
Most countries in Europe have notification systems for introducing food supplements onto the market. The UK is a notable exception, which probably stems from the more prominent role Traditional Herbal Medicinal Products Directive (THMPD) registration plays in this market.
Botanical lists: Harmonisation or fragmentation?
With no imminent end to the botanical health claims limbo in sight, those countries with sizeable food supplement markets are setting up their own systems for policing botanicals.
“Countries such as Italy, France and Belgium have very well established botanical food supplements markets that they want to maintain. Therefore, whilst botanical health claims are on hold, there has been a lot of activity in developing lists of ingredients that can be used in supplements. This is clearly in the absence of what is going to be decided in the review of botanical health claims,” explained Viner.
Belgium, France and Italy are working together to produce an agreed list of botanicals for use in supplements, called the BELFRIT list. There are other inter-state agreements too, that facilitate cross-border marketing of supplements. For example, botanicals that are authorised in Italy are automatically recognised in Spain.
Other member states, meanwhile, are working independently to produce positive and negative lists of botanicals for the food supplement sector.
“The problem is that the various member state lists differ across the EU, so mutual recognition cannot be used in all cases, and it is difficult for food supplement companies to produce a single botanical food supplement that can be marketed across all, or even most, of the member states,” said new EHPM chairman Michel Horn.
Use or abuse of medical device status?
The hiatus between the THMPD and NHCR has also fuelled another class of botanicals in some member states: those with medical device status.
Bucchini explained that this had come about because some member states, such as Italy, had been “very relaxed’ about granting medical device status, with medicinal claims, to products that used to be food supplements.
He said that this route had provided companies with an incentive to invest in clinical research as they saw medical device status as “a valuable option”, whereas they wouldn’t have been willing to invest in clinical research to obtain an EFSA-approved NHCR claim, as they saw this as “an unworkable path”.
“The problem is that neither the THMPD nor the NHCR have been able to provide an incentive for more research on botanicals. The THMPD has such a low threshold for evidence in the case of traditional use that there is really little incentive to conduct more research. In the case of the NHCR, the threshold is so high that it makes little sense to invest in most cases. The result is that a multi-billion euro industry is spending too little on reseach,” he said.
He continued: “The NHCR promised better information for consumers by rewarding businesses that spent on research. That has not worked for botanicals and needs changing.”
Examples of products on the Italian market with medical device status are grindelia syrups and botanical polysaccharide tablets.
However, there are indications that authorities are looking to close this legal loophole. Earlier this year, the Commission issued a draft that seeks to revoke the medical device status of proanthocyanadin-based cranberry products for the treatment and prevention of urinary tract infections.
Horn said: “it remains to be seen whether this situation will last; it was probably not what medical device status was designed for.”