Assessing regulatory boundaries for botanical ingredients
The way botanicals are regulated in relation to health in different parts of the world reflects as many cultural assumptions as it does legal preconceptions.
At Interlink in India, Dr Smarta underlines the way in which health and nutrition sit alongside each other in Japanese and Chinese regulatory structures. “Some permitted health-related claims can be made,” he reports. “In Japan, health and nutrition claims are handled separately, and processed via different regulatory routes, while in China, operators are restricted to a pre-defined list of 27 health claims.”
India, with a government ministry dedicated to Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homeopathy (AYUSH), might be expected to regulate the botanicals sector in some detail. “In fact, while the regulatory framework for pharmaceuticals is well-established and organised, the system for traditional medicines and other plant-based products is still evolving and not so organised,” Smarta explains.
In the EU, the European Commission famously kicked the status of over 2,000 botanical claims into the long grass of an ‘on-hold’ position, close to a decade ago. In some respects, at least, this has favoured botanicals over many other ingredients, as international legal practice Keller & Heckman makes clear. “Claims may be used, as long as the food business operator is able to justify them by means of generally-accepted scientific evidence,” says partner Katia Merten-Lentz.
Since there is no harmonised position on these active ingredients, each Member State (MS) has the right to regulate use of the plants, principally as it relates to food supplements. “But mutual recognition remains a tool for business operators to market their products all around the EU,” she says.
Despite this, there can be obstacles to such a Europe-wide approach, says Food Supplements Europe (FSE). “The main problem is that in a number of MS, various botanicals have only been assigned to pharmaceutical use,” states director of regulatory and scientific affairs Patrick Coppens. St John’s wort and valerian are two high-profile examples, he says, but there are many others.
Various botanicals have only been assigned to pharmaceutical use in a number of EU Member States
“German authorities, for instance, would expect these products to be registered as medicines,” he says, adding that, in the UK, there might be similar expectations.
Last May, the European Commission published its assessment of requirements for botanical health claims, but it offered little in the way of new proposals. Any regulatory structure would need to take into account the traditional use of plant products.
“Traditional use could be built into a review of the Nutrition and Health Claims Regulation (NHCR),” says Coppens hopefully, not disguising his lack of appreciation for the NHCR in its current form. “The Commission would also want to address safety concerns.”
Realistically, he concedes that other, more urgent priorities such as the European Green Deal are likely to take precedence in any legislative programme.
For botanicals, as for other supplements, the situation in Europe contrasts with the US. As Foreman explains, the US botanicals sector remains governed by the 1994 Dietary Supplements Health & Education Act (DSHEA). “I believe the federal authorities are trying to make changes, but the process is taking forever,” he says, pointing out that, here, too, other more urgent legislation is likely to take precedence.
A process of maturation has taken place in the regulation of botanicals in the US, he believes, both on the part of those enforcing the regulation and those ruled by it. “The policies may not have changed,” he says. “But I think the authorities are better at enforcing them.”
With regard to Canada, Foreman believes that the rules governing the sector are effective. “It’s pretty strict,” he says. “But if you can provide proof of certain benefits, the authorities will grant you permission to use statements to that effect.”
In its new post-Brexit world, the UK could be at a regulatory crossroads. “We’re very careful not to make any health claims,” says Smale at Wunder Workshop. “Some of our larger retail customers such as Boots and Planet Organic, we know, are very aware of the EU regulations.”
He speculates that, in the future, domestic standards may be relaxed in order to open up UK markets to foreign competition.
“I don’t know what that might look like,” Smale says. “In independent retailers, for instance, you can find US brands with health claims all over the bottle, with a footnote that the Food & Drug Administration (FDA) has not approved the comments. The UK could take this direction.”
Meanwhile, coronavirus has dredged up another, more insidious overlap between botanicals and disreputable marketing. “We’ve seen online sellers advertising claims relating to the prevention and treatment of COVID, which, of course, is completely illegal,” says FSE’s Coppens.
Policing claims of this sort would normally be the responsibility of the individual MS. But in this case, as often happens, he says, the Commission has taking a lead in co-ordinating enforcement action.
This is all about protecting consumers, of course, but it is also about safeguarding the reputation of those botanical ingredients which do in fact offer real—and increasingly scientifically verified—benefits.