Drawing conclusions about the recent raft of liver injury warnings about turmeric – including official action in Brazil – could ignore the ingredient’s strong safety record in favor of an overemphasis on a few case reports, experts claim.
In early March, ANVISA, the Brazilian governmental department that regulates the health of foods and drugs, published a warning about the risk of liver injury from the use of turmeric supplements. The agency will immediately require new warnings on two branded turmeric-based herbal medicines that are on the market in Brazil. And, the agency said, supplements will also require warnings in the future and a process will be initiated “to reassess the use of these substances,” which could imply further restrictions.
According to a recent communication from the International Association of Dietary Supplement Associations (IADSA), Brazil now joins Canada, Australia and the U.K. as countries where these concerns about turmeric have been raised by regulators.
In all of these cases, officials have made a distinction between turmeric as a spice, which has a millennia-long safe history of use, and supplements based on isolated and concentrated active compounds, known as curcuminoids.
(Confusingly, for unknown reasons the ANVISA notice equates the spice turmeric with saffron, even though these are completely unrelated botanicals that have only their intense gold color in common.)
Expert: Individual case reports often misconstrued
These regulatory moves appear to be motivated by some recent case reports of liver injury that were idiosyncratic in nature, meaning the results cannot be reliably equated to the general public. It’s a common error when looking at these reports, said Rick Kingston, co-founder and president of scientific and regulatory at SafetyCall International.
“This action is unfortunate and unwarranted. You don’t typically impose warning labeling for very rare idiosyncratic reactions reported in post-market incident data,” Kingston told SupplySide Supplement Journal.
Usually, a true safety signal would arise from multiple streams of data, with case reports forming just one leg of the stool, he emphasized.
And, Kingston said, the regulators in these cases are already admitting that these cases of liver injury are very rare. In markets like Canada, there have been billions of servings consumed by millions of people. That exposure has resulted in just a handful of liver injury reports.
Manufacturers know their own products best
Manufacturers of turmeric supplements stress that responsible companies will have reams of safety data, not only for ethical reasons but also as a bulwark against product liability.
Shaheen Majeed, global CEO and managing director of Sabinsa, had this to say: “Turmeric has been consumed safely for centuries as a food, and standardized curcumin extracts like Curcumin C3 Complex (Sabinsa’s branded ingredient) have been evaluated in numerous clinical studies with a strong safety profile. The recent regulatory discussions stem from a small number of rare, idiosyncratic case reports where causality is not clearly established and transparency around patient history, co-medications and product composition is limited.
“Regulators are appropriately exercising caution, but it would be inaccurate to generalize these findings to turmeric or high-quality curcumin extracts as a category,” he added.
Rory Coleman, assistant director of science, regulatory and advocacy for turmeric supplier Omniactive, said a big concern with these case reports is that there is usually little to no specific information about the product the subject of the case report was using. The proliferation of different forms of turmeric ingredients has made that a complicated question.
“[T]he modern supplement landscape has evolved significantly with the introduction of high-dose products, modified formulations, and variability in manufacturing quality. Increased consumption, particularly at high doses and among individuals with pre-existing health conditions, has contributed to a more complex safety and regulatory landscape,” he said.
What can brands do?
Both Majeed and Coleman said regulators were doing their jobs by acting in a precautionary manner. But to prevent the issue from creating unnecessary regulatory burdens, brands need to act proactively.
“Brands have a critical role to play in ensuring responsible use and consumer confidence. This starts with a deep understanding of their ingredients’ safety, quality, and clinical substantiation,” Coleman said.
Majeed said a brand’s road map should look like this: “Brands should prioritize clinically validated, well-characterized ingredients; full traceability and quality assurance; responsible dosing and formulation strategies and clear, science-based communication to consumers and regulators.”
