The other ingredients are the probiotic Lactobacillus gasseri BNR17, mastic gum, boswellia extract, Spanish licorice extract, green coffee bean extract, lemon balm extract, hyaluronic acid and Rhodiola rosea extract, the MFDS announced.
Out of the nine ingredients, six were chosen for re-evaluation as part of a routine procedure once they have been sold in the market for a decade. The other three, however, were selected due to their links with adverse events.
In its “Plan to re-evaluate functional raw materials for health functional foods in 2026″, the regulator said that the three ingredients identified due to adverse events were turmeric extract, green coffee bean extract and lemon balm extract mixed powder.
“Three types were selected in consideration of social issues such as controversies over functionality and safety,” the MFDS said in a press release.
In the case of turmeric, Health Canada last year mandated that supplement products warn about the risk of liver toxicity on the labelling.
Australia’s Therapeutic Goods Administration (TGA), on the other hand, released a safety advisory in 2023 to warn consumers and health professionals that it may cause liver injury in rare cases.
Findings of the re-evaluation will be announced by the end of this year. Based on the results, the functional claim of the ingredients may be changed or removed. Precaution statements may also be added, or the daily intake amount revised.
Over 90 ingredients re-evaluated so far
Between 2017 and last year, the MFDS re-evaluated 91 ingredients. Precaution measures or daily intake amounts have been adjusted for 90 ingredients, with the remaining one no longer recognized as a health functional ingredient.
The ingredient is whole aloe leaf, as it contains aloe latex, which could cause adverse effects related to liver toxicity in long-term consumption.
Last year, nine ingredients were chosen for re-evaluation, including green tea extract and lactic acid bacteria derived from Lactobacillus plantarum CJLP133. In the year before, soybean isoflavone and Garcinia cambogia were re-evaluated.
Re-evaluation applies to ingredients that were approved on a case-by-case basis and to those notified in the Codes of Health Functional Foods.
In this year’s re-evaluation exercise, except for hyaluronic acid and Rhodiola rosea extract, the other seven ingredients were approved on an individual case-by-case basis.
Garcinia cambogia to undergo comprehensive review
The regulator said it would also “comprehensively review” the safety of Garcinia cambogia extract.
Last year, the regulator added precautionary statements around potential liver injury and how alcohol consumption should be avoided when taking Garcinia cambogia products, following complaints of acute hepatitis.
“The Ministry of Food and Drug Safety announced that it will continue to evaluate the safety and functionality of functional ingredients in health functional foods and incorporate these findings into its standards and specifications to create an environment where consumers can consume them with confidence,” it said.
