Concluding remarks

Probably we must come to a pessimistic conclusion. Just to try to find a way to ameliorate the scenario, but without expecting to know the whole truth, it could be a reasonable proposal to extend as much as possible the Traditional Herbal Medicine Directive to give rules for most products. Furthermore, the application of this directive to herbal products will, probably, ameliorate the quality and safety level of these products. Herbals and herbal extracts, as a matter of fact, should be considered in a different way from food products because of their peculiarities. The main problem regarding herbal products is their safety. This fundamental aspect cannot be guaranteed by current food production rules (basic hygiene requirements plus the Hazard Analysis and Critical Control Points, HACCP, system). Generally speaking, a fundamental initial step to get a valid proof of safety (non-toxicity) regarding botanicals starts from a chemically defined raw material. To obtain a safe botanical product (herbs and herbal extracts category), means to obtain, first of all, a quality product and, consequently, being able to monitor the whole production chain, starting from the control of the growing plants, a botanical and chemical check of the biomass to be used, a quality control process, certain stability limits and a release of the finished botanical derivatives under strict quality controls. As you can easily see, the HACCP system and food production requirements do not set rules on all of the above-mentioned items. For these reasons, the plain application of the food supplements directive is probably to be considered inadequate. As regards establishing new regulations, it may be considered advisable that the new rules should be very similar (or equivalent) to pharmaceutical good manufacturing practice (GMP) and be applied even to the production of the active ingredients. Performing all the steps necessary to have a safe product, of course, is quite expensive and requires a big investment also in terms of organization. It is very likely that small companies (and larger ones) will not accept such a proposal, because, at the moment, it is too difficult or unappealing to them.

Nevertheless, the current market requires a major change in terms of levels of quality and safety offered to the consumer. The consumer is starting to be very confused about herbs, and, probably, is becoming very worried about their real efficacy. Being able to offer to the customer quality and safe products is the first step in having the opportunity to introduce an initial discussion about innovative herbal products.

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