The European Federation of Associations of Health Product Manufacturers (EHPM) recently published a proposal on how they think botanical claims should be assessed in the future to finally overcome the deadlock on the pending botanical claim situation.
The core of the paper describes a tiered approach (grade A-C) together with the suggestion of how a systematic evaluation of botanical health claims could look:
- Grade A: ‘scientifically established’ claims based on conclusive clinical evidence incl. confirmatory human studies
- Grade B: ‘well-supported claims’ that reflect significant scientific evidence incl. pertinent human studies, observational studies and data on the mode of action
- Grade C: ‘traditional use claims’, similar to those already in use for Traditional Herbal Medicinal Products (THMP), which are based on recognized and scientifically plausible traditions of use.
Should this approach prevail, the question of the whereabouts of traditional herbal medicinal products would inevitably arise, since the effort involved in obtaining a medicinal product approval is much higher than for a food. In addition, the question arises whether the consumer actually understands the difference between Grade A (“A contributes to B”), Grade B (“A can contribute to B”) and Grade C (“A is traditionally used for B”) botanical claims.