On 3.8.22, the Ministry of Health issued a circular where it emphasized the recurrence of possible health risks associated with the consumption of dietary supplements with turmeric extracts and preparations. (1)
The food safety risk had already emerged in 2019 in connection with 22 cases of cholestatic hepatitis in individuals with pre-existing alterations in hepatobiliary function who had taken such products (2,3).
An additional label warning is now urged and the entry Curcuma longa e spp in the Medicinal Plants Ordinance (4.5) is revised, raising the possibility that it is Novel Foods. However, without mentioning food safety risk management.
1) DIETARY SUPPLEMENTS WITH TURMERIC PREPARATIONS AND EXTRACTS.
The Ministry of Health, in the DGISAN Circular Office 4 10.8.22, recalls the Directorial Decree 28.7.22 where:
- correlations are confirmed between the consumption of dietary supplements with turmeric extracts and preparations and several cases of hepatotoxicity, ‘likely to be attributable to reactions of an idiosyncratic nature.’
- the requirement is extended to include an appropriate warning, on the labels of the above products, so that they are not taken by vulnerable consumers due to previous liver and/or biliary disorders (see para. 2),
- is revalued, ‘after a thorough review of the scientific literature’, the lack of evidence on the physiological effects previously attributed to turmeric in DM 10.8.18. Which therefore can no longer be used in labeling and advertising. (1)
2) NEW LABEL WARNINGS
Dietary supplements ‘containing ingredients derived from Curcuma longa e spp‘ must carry the following additional warning on the label
‘IMPORTANT WARNING. In cases of impaired liver function, biliary function or biliary tract stones, 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 medication, you should seek the advice of your doctor.’
Food business operators ‘are required to conform the labeling of food supplements containing extracts and preparations of Curcuma longa and spp by no later than 31.12.22.’ (1)
3) RISK ANALYSIS AND MANAGEMENT
Emergent risk analysis and its management is unfortunately not mentioned in the Health Ministry circular. And the memory of the scripted handling of a recent alert-during the long absence of a director general for food hygiene and safety and nutrition-by his Office 8 is fresh. Responsible, in theory at least, for ‘Food Crisis and Emergency Management’ (6,7).
Health Ministry Circular 3.8.22 is a food safety risk alert that operators cannot overlook. Indeed, failure to take it into account may result in liability, both civil and criminal, if one or more vulnerable consumers suffer liver injury as a result of consuming dietary supplements with turmeric extracts and/or preparations.
3.1) Risk analysis by FBOs.
FBOs (food handlers) on whom primary responsibility falls, following the notice issued by the Ministry of Health, must therefore activate a non-compliance procedure, which is structured as follows.
- Risk analysis on the various references produced and/or distributed by the operator, also taking into account the concentrations and/or titrations of turmeric extracts and/or preparations, as well as exposure levels (if needed, our FARE team is available).
- Traceability. Verify, through the records, the number of product units that can reasonably be considered still in commerce (having also regard to the quantities and dates of delivery, as well as the relevant TMCs) and the relevant distribution areas.
3.2) Risk management
Possible recall is an option to be considered if – as a result of the risk analysis – the operator assesses the possible existence of a concrete food safety risk on products that have already been distributed, are outside its availability and are reasonably still unsold.
In such a case, the FBO must notify the recall (and not also the recall, NB) of the affected products to the relevant health authority (where the operator is located), stating that it has decided and actually undertaken the corrective measures referred to below.
3.3) Corrective Actions
Outside of cases of serious risk – which may emerge as a result of risk assessment where significant levels of exposure are found compared to those indicated in scientific literature and/or gray literature, and results in the adoption of more drastic corrective measures (see Sec. 3.4) – the FBO that provides product recall may:
- Affix a sticker, bearing the information prescribed by the min. Sal. (see supra, para. 2), on all packages of the products involved still in its availability (including from agents and distributors, in the commercial network under its control),
- notify customers of the activation of a recall procedure (not also a recall) on products XYZ, lots 123, stating the reasons and clarifying the only need, based on the recent communication of min. Sal., to place a sticker on the packages of all unsold products. (8)
3.4) Possible Recall
If, on the other hand , the risk analysis referred to in paragraph 3.1 above reveals the possible existence of a serious food safety risk, albeit limited to certain categories of consumers, the operator must consider activating the public recall of the affected products. In this case the FBO will have to:
- require customers to remove products from the shelves or otherwise discontinue their distribution, segregate them, and return them (i.e., dispose of them, in a manner suitable to prevent their possible consumption by humans),
- Informing consumers who may have already purchased the products, with appropriate tools(online and offline, including in stores). With a recommendation not to take the recalled dietary supplements and return them to the point of sale or discard them, explaining the reasons. (9)
4) PROSPECTS, NOVEL FOODS?
The interdisciplinary committee specially established at the Ministry of Health is also gathering evidence about the actual use of extracts of Curcuma longa e spp high-curcumin content in food supplements marketed in the EU before 15.5.97 (the effective date of the first Novel Foods Regulation No 257/97). (1)
The data related to the specific ingredient, related to the significant food use by the aforementioned date, should be submitted by 31.10.22 to Office 4 DGISAN. (10). ‘Since, from the work of the interdisciplinary group, there does not appear to be a significant history of dietary consumption of such extracts/preparations‘, they may indeed amount to novel foods (11,12).
5) FOOD SAFETY MANAGEMENT
Work conducted by the Ministry of Health, DGISAN Office 4, reports ‘persistent cases of hepatotoxicity‘ (2022. See footnote 1). After noting in 2019 that ‘review of data from the scientific literature and information provided by other member states, reports of cases of acute cholestatic hepatitis related to the use of turmeric extracts also emerged in other countries.’ (3)
The culture of food safety management-which is referred to explicitly, most recently, in reg. EC 2017/625 (13) – is the real big absentee, in politics and high administration. Both in Italy and in the EU, as seen in the recent case of a false alert mismanaged by the top management of the European Commission’s DG SANTE, causing serious harm to allergic operators and consumers. (7)
6) TENTATIVE CONCLUSIONS
How is it possible today that the health and lives of thousands of consumers are being put at risk because of not a life-saving drug but a fad dietary supplement? How many cases of acute hepatitis have been recorded so far and associated with taking dietary supplements with what titrations of curcumin?
The authorities in charge of risk assessment and risk management must always get involved whenever a public health risk arises in any file managed by any other office in any capacity involved. And the responsibility for food safety management must be given to capable managers. (14)
Dario Dongo
Notes
(1) Food supplements containing extracts and preparations of Curcuma longa and Curcuma spp plants: amendment to Annex 1 of DM August 10, 2018. Ministry of Health, DGISAN. Communication 10.8.22
(2) Fabio Di Todaro. The “yellow” of turmeric and cases of acute cholestatic hepatitis. Umberto Veronesi Foundation magazine. 4.7.19
(3) Food supplements containing extracts and preparations of Curcuma longa. Ministry of Health. 26.7.19
(4) Dario Dongo. Officinal plants and botanical ingredients, decree scheme runs aground on hemp flowers and leaves. GIFT (Great Italian Food Trade). 23.6.21
(5) Ministerial Decree 10.8.18 on the use of herbal substances and preparations in food supplements [previously amended by directorial decree 4.8.21. See previous note]
(6) Dario Dongo. False alerts, passing the buck, abuses of power and social disasters. GIFT (Great Italian Food Trade). 2.7.22
(7) Dario Dongo. Allergens and RASFF, European blackout. GIFT (Great Italian Food Trade). 13.7.22
(8) It is good practice in such cases to ship directly by courier the stickers to be used, in quantities appropriate to the number of packages in each person’s reasonable supply. The warnings on the stickers must be clearly legible, in accordance with the requirements for this purpose in reg. EU 1169/11 (minimum character height 1.2 mm, referring to lowercase ‘x’, and adequate contrast, e.g., b/w)
(9) It may be useful, although not provided for in the General Food Law (EC Reg. 178/02, Article 19), to also inform consumers on what to do if the risk products have already been taken. All the more so, in a case such as this, when dealing with consumers vulnerable to the risk identified
(10) The data should be sent to dgsan@postacert.it, cc v.digiorgi@sanita.it and a.zovi@sanita.it, via PEC with ‘sending data on the significant use of Curcuma longa e spp extracts with high curcumin titer‘ in the subject line
(11) The application of the novel foods framework, it should be recalled, postulates the prior authorization of the European Commission for their placing on the internal market, as a result of risk assessment entrusted to EFSA. V. reg. EU 2015/2283, reg. EU 2018/456
(12) Indeed, EFSA has already ruled favorably on the application for authorization with exclusivity of tetrahydrocurcuminoids as novel food ingredients in food supplements, submitted on 3.2.20 by Sabinsa Europe GmbH. V. Dario Dongo, Andrea Adelmo Della Penna. Novel food, EFSA approves turmeric extracts and rejects Tongkat Ali. Water lentil in the center. GIFT (Great Italian Food Trade). 30.12.21
(13) Dario Dongo, Giulia Torre. Official public controls, EU Regulation 2017/625 kicks off. GIFT (Great Italian Food Trade). 18.12.19
(14) Burioni attacks Sandra Gallina, the Italian woman who dealt with BigPharma on vaccines for Europe. Europa Today. 25.2.21
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
