An article in ‘Nature’ magazine welcoming tough EU health claim laws has highlighted the conundrum facing EU regulators if the Union is to adopt different claim-substantiation criteria for about 2000 ‘on-hold’ botanical claims.
The article calls on the EU to hold tight to existing practices under the nutrition and health claims regulation, and suggests the botanical, probiotic and other sectors simply need to invest to win claims.
But industry groups said the piece glossed over the fact the NHCR demands a medicinal style of evidence that is incongruous with the majority of nutrition research.
“The bulk of existing science doesn't make the grade; the only way of meeting the European Food safety Authority's requirements is undertaking clinical trials dedicated to the purpose,” said the executive and scientific director of the Alliance for Natural Health International (ANH-I), Dr Robert Verkerk.
“A handful of contract research organisations and universities have become specialists in conducting such work, but only those with sufficient funds can play this game.”
“The European Commission must now face the music for separating botanicals and probiotics from the other general function claims, and its inevitable that this will result in complaints about disproportionate treatment. It will have to grapple not only with how claims for foods are treated, but also those for drugs.”
“Elephant in the room”
The Nature editorial stated there was, “an elephant in the room” regarding botanicals and urged the new EU health commissioner Tonio Borg to be tough on botanicals.
“[He] must decide whether plant-based products marketed as health-promoting foods should be treated with similar leniency, but the decision has been shamefully delayed. The new commissioner, Tonio Borg, has been in office for only a few weeks, but he needs to bring clarity quickly — and to firmly reject moves to weaken requirements for scientific evidence.”
The president of the International Probiotics Association (IPA), George Paraskevakos, reiterated a long-held industry gripe that what the system required was greater clarity around claim substantiation requirements.
''The continuous increase of moneys being poured into research could be better spent if more clarity were provided by EFSA. We believe this could come in the form of pre-meetings for health claim applications with the respective applicant(s).''
“Tradition of use is not a low standard.”
Patrick Coppens of the European Botanical Forum (EBF) said it was a gross misconception that the European herbals sector sought an easier path to health claim affirmation than was permitted to other sectors.
“The decision by the EC to put botanicals on hold was fully justified because of the different treatment of botanicals under food and medicinal law,” Coppens said.
“We observe that numerous statements today just simplify this to 'botanicals ask for a lower standard than other foods for making claims'. This unduly ignores the basic elements of this discussion.”
“Tradition of use is not a low standard. In fact, it represents experience that is observed in real situation in a very large population.”
Coppens said randomised controlled trials could show stronger cause-effect results, “but are limited by high costs and low number of subjects.”
“In addition, in the area of food is is difficult if not impossible to control all factors of the diet when doing such trials. This is the reason that for medicinal products the requirement to have randomised controlled trials is waived for traditional medicinal products.”
“Just deciding that botanicals should be treated as all other food components is not difficult if you chose to ignore the consequences.”
“The result would be that all claims for botanicals are rejected; products are left on the market with no possibility to communicate, resulting in potential dangerous situations for consumers; many products would ultimately disappear reducing the number of products on the market, resulting in the loss of a cultural heritage build over decades by natural products and herborist and leaving only medicinal products left to choose from (with claims that also are just based on tradition).”
“People stating that science should be the only thing basis for justifying health claims do not take these elements of reality in their equation. We know that the European Commission is aware of these consequences and is reflecting carefully on an appropriate decision, with the help of the Member States.”
What about vitamins and minerals?
Luca Bucchini, the project manager of EU-funded plant food science research project, PlantLIBRE, and director of Rome-based consultancy, Hylobytes Consulting, observed there already existed inequity in the manner in which claims were assessed under the NHCR.
"It should be recognised that EFSA was faced with an incredible amount of work, and did a decent job," he said. "But there are flaws. For example, EFSA grandfathered health claims on vitamins and minerals applying a much lower standard of evidence than the one used for other substances, for reasons which are unclear to this day."
"It is also unfair to brush off the herbal medicines issue. With that piece of legislation in place, consumers and, perhaps more importantly, physicians are told that products with the 'aura' of medicines are effective based on tradition alone (scientific plausibility is a rather vague concept). How can it be reasonable that the same plant can be legally marketed as a cure for a disease, and not as an aid to well-being?"
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