Traditional herbal medicinal products and nutritional supplements: criteria of distinction
The case concerned a challenge to the lawfulness of the decree issued by the Ministry of Health on August 10, 2018 (on botanicals), in which the Ministry of Health added the herbal substance Pelargonium sidoides to the list of substances authorized to be used in nutritional supplements. Specifically, the claimant, who holds an authorization for a traditional herbal medicinal products based on such substance, argued that Pelargonium sidoides should be marketed exclusively as medicine and not as a supplement.
With its ruling, the court clarified the difference between traditional herbal medicinal products and nutritional supplements: that distinction is not based on scientifically recognized therapeutic efficacy, since neither group has been recognized such therapeutic efficacy. Rather, the distinction is based on a guarantee of safe use.
Indeed, while registration of traditional herbal medicinal products is based on their use in Europe for at least fifteen years, in accordance with Articles 21 and 23 of Legislative Decree No. 219 of April 24, 2006, as to nutritional supplements, it is necessary to provide a guarantee that they are safe to use in accordance with Legislative Decree No. 169 of May 21, 2004.
Therefore, the Ministry of Health may add substances to the list of herbal substances allowed in the preparation of nutritional supplements when new scientific evidence and deeper investigation permit to reach the prove of their safe use.