The Decree, dated 26 July 2019, requires supplement makers to label curcuma-containing preparations with warnings that apply to those with liver conditions.
“In the event of alterations of liver function, biliary or calculosis of the biliary tract, the use of the product is not recommended,” the label requirements state.
“If you are taking other pharmaceutical treatments, it is appropriate to seek the advice of a physician.”
The Decree is an update to a list of botanicals included in rules governing the use of herbal substances and preparations in food supplements that formed part of the Ministerial Decree of 10 August 2018.
The Ministry introduces its additional warnings based on current scientific evidence having garnered the opinion of the Dietetic and Nutrition Section of the Technical Committee on 24 July 2019.
End of year compliance deadline
“Food supplements containing extracts and preparations of plants of the genus Curcuma in accordance with provisions of annex 1 of the executive decree 9 January 2019, must conform to provisions of this decree no later than 31 December 2019,” wrote the Ministry’s general director Dr Gaetana Ferri.
In July of this year, Italy’s National Institute of Health concluded that the hepatitis cases linked to the consumption of curcumin-containing supplements was due to “individual susceptibility” or “pre-existing alterations.”
In an update by the authority, the analysis carried out on the products in question excluded the presence of contaminants or voluntarily added substances as possible causes of liver damage.
“The interdisciplinary group, section dietetics and the technical committee for animal nutrition and health concluded that, to date, the causes are likely to be related to individual susceptibility, pre-existing alterations, latent hepato-biliary function or even the use of drugs.”
“The situation will continue to be carefully followed in relation to the emergence of any new scientific elements or data to be considered in order to protect consumer safety.”
