Health Canada advised new label warnings for Food Supplements and Health Products containing turmeric preparations

Within an increasingly dynamic and closely monitored regulatory environment, food supplements and self-care products are subject to growing scrutiny from health authorities worldwide.  

Drawing on the expertise of ProductLife Group’s Medtech & Consumer Healthcare teams, this article highlights recent regulatory developments concerning turmeric- and curcuminoid-containing products, with a focus on safety, labelling requirements and international regulatory alignment. Supporting companies across the full lifecycle of food supplements, PLG helps anticipate regulatory changes, ensure compliance and integrate scientific and medical considerations into robust, market-ready strategies.  

Turmeric comes from the rhizome of the Curcuma longa  plant, which is native to Asia and belongs to the ginger family. Curcuminoids, such as curcumin, are the active compounds. Curcuminoids can be extracted from the rhizome. Turmeric, when used as a culinary spice and consumed in food in typical dietary amounts, has not been identified as a safety concern.  

Most turmeric- or curcuminoid-containing NHPs for oral use are not authorized for use by individuals under 18 years of age in Canada. They are also not recommended for use by individuals with biliary disorders (conditions affecting the gallbladder and/or bile ducts). 

International regulators, such as Australia’s Therapeutic Goods Administration, the Italian Ministry of Health and the French Agency for Food, Environmental and Occupational Health & Safety, have implemented a number of regulatory actions, such as label updates for oral turmeric- or curcuminoid-containing health products to include the risk of hepatotoxicity and safety alerts to inform consumers of the risk. 

Health Canada’s review of the available information found a possible link between the oral use of either turmeric- or curcuminoid-containing NHPs and the risk of hepatotoxicity, which, in rare cases, could lead to serious outcomes. 

The evidence suggests that the risk of hepatotoxicity associated with turmeric- or curcuminoid-containing NHPs appears to be idiosyncratic, ie. not dependent on the dose or duration of use, and unpredictable in onset with risk factors not fully known. In most cases, the hepatotoxicity is reversible once use of the product is stopped. 

• Health Canada will update the monographs https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR1758121117867 that include the medicinal ingredients turmeric and curcuminoids for oral use to include the risk of hepatotoxicity. Health Canada expects licence holders to update the risk information on product labels for all licensed turmeric- or curcuminoid-containing NHPs to: 

• include information about the warning signs and symptoms of hepatotoxicity, including yellowing of the eyes or skin, dark urine, nausea, vomiting and stomach pain, 

• advise consumers to stop using these products and consult a healthcare professional if symptoms occur, and 

• advise consumers to consult a healthcare professional before use if they have a liver disorder or are taking medications 

• Recently, Italy has recorded around 20 cases of hepatitis involving food supplements containing turmeric. Italian Ministry of Health required that Food Supplements containing turmeric has no health claim on the botanical and the label warnings are now mandatory “IMPORTANT WARNING In case of alterations in the liver function, biliary or gallstones of 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 any medications, you should seek the advice of your doctor » 

• In France, ANSES’s nutrivigilance scheme  has received over 100 reports of adverse effects, including 15 reports of hepatitis, potentially related to the consumption of food supplements containing turmeric or curcumin. 

In this context, Food Supplements containing turmeric preparations, especially standardized extracts in curcuminoids may consider the new label warnings suggested by Health Canada for consumer’s information and health care practitioners best practice in EU countries as well. 

For the design and launch of innovative, science-based and compliant Self Care products, please contact us to discuss strategy, regulatory compliance and scientific & medical review for 2026. 

For tailored support on regulatory strategy, labelling updates and scientific review for self-care products, our experts are available to assist.

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