Italian Ministry Of Health Bans Turmeric Health Claims, Updates Product Labeling

Following recent cases of use-related hepatitis in Italy, the country’s Ministry of Health has banned health claims related to turmeric and curcumin supplements and updated product labeling protocols for these products.

Around 20 cases of hepatitis related to food supplements derived from the turmeric (curcuma longa L.) plant, including those containing the turmeric curcuminoid curcumin, have been recently reported in Italy.

While these cases are thought by the Ministry to be caused by idiosyncratic reactions to consumption, an interdisciplinary group of experts tasked with looking into the matter has advised that the following warning should be added to these products in future:

“In case of liver, biliary or calculosis abnormalities in the biliary tract, the use of the product is not recommended. Do not use during pregnancy and lactation. Do not use for prolonged periods without consulting your doctor. If you are taking medications, it is it is advisable to hear the opinion of the doctor.”

Additionally, concluding after a “thorough review of the scientific literature” that there is “no scientific evidence to support the physiological effects attributed to curcuma longa in the ministerial guidelines,” the advisory group also recommended that all health claims associated with these products should be prohibited.

Manufacturers have until 31 December 2022 to comply with these new rules.

Novel Food?

In its communication on the matter, the Ministry of Health also took the opportunity to remind manufacturers that the burden of proof lies with them to show their turmeric-based supplements do not fall under European Union novel food regulations.

“Please note that the use of a plant/its part/derivative/extract contained in the list referred to in the Ministerial Decree of 10 July 2018 is always subject to the assessment of the non-applicability of Regulation (EU) 2015/2283,” the agency warned.

As a food ingredient produced by hydrogenating curcuminoids from rhizomes of the turmeric plant into tetrahydrocurcuminoids, curcumin supplements would usually fall under Article 3 of the EU novel food regulation, as noted by a recent assessment by the European Food Safety Authority.

Thanks to this process, curcumin supplements like those produced by Sabinsa Europe GmbH, which recently received novel food approval, are much richer in curcuminoids than traditional turmeric food supplements. (Also see "Curcumin Touted For Oral Health Gets EFSA Novel Food Nod" - HBW Insight, 6 Jan, 2022.)

Bioavailability Concerns

Novel curcumin supplements like Sabinsa’s are also developed to improve the bioavailability of these tetrahydrocurcuminoids.

This has raised safety concerns in France, for example, where there have also been recent hepatitis cases linked to turmeric-based supplements use. (Also see "French Authority Asks For More Data On Turmeric Supplements After Hepatitis Cases Reported" - HBW Insight, 21 Jul, 2022.)

“Curcumin is very poorly bioavailable, which is to say that it passes through the bloodstream with difficulty and is eliminated very quickly by the body,” explained Fanny Huret, expert appraisal coordinator for the French food regulator, ANSES.

“Manufacturers have developed various formulations to improve this bioavailability and thus increase the effects of curcumin,” she continued.

While such supplements, in theory, do not exceed the agency’s recommended maximum daily dosage, currently set at 153mg, in practice, this higher bioavailability may push consumers over the limit.

“To date, food supplement labels rarely specify whether it is a classic or new formulation,” ANSES noted. “The consumer can therefore unknowingly consume a potentially toxic product.”

To prevent poisoning, therefore, ANSES has recommended that marketers provide details of the bioavailability data of their products so that a specific maximum daily intake dose for such new formulations can be defined.