Reports of adverse events following the consumption of health functional foods exceeded 18,000 cases over the past five years, with last year recording a record high of 5,250 cases. In particular, 32 cases were identified as serious adverse events requiring hospitalization or emergency room treatment, and high-frequency adverse events reported more than 10 times per month.
According to data submitted by the Ministry of Food and Drug Safety and the Korea Food Safety Institute, presented on the 28th by Democratic Party of Korea Supreme Council member (National Assembly Health and Welfare Committee member) Seo Mi-hwa, a total of 18,693 adverse events were reported to the 'Health Functional Food Adverse Event Reporting Center' operated by the Korea Food Safety Institute from 2021 through June 2026. The number increased from 2,064 cases in 2021 to 5,250 cases in 2025, a rise of approximately 2.5-fold over four years.
In particular, serious or repeatedly reported adverse events were also identified. Over the past five years, there were a total of 32 serious adverse events involving hospitalization and emergency room treatment, as well as high-frequency adverse events reported more than 10 times per month. Cases where individuals received emergency room treatment due to symptoms such as skin rashes, hives, headaches, constipation, and abdominal pain after consuming health functional foods were also confirmed.
Among these, two cases were classified as 'Grade 5,' deemed necessary for immediate public notification based on a very high likelihood of causality, the severity of symptoms, and a history of similar adverse event reports. Additionally, five cases were identified as 'Grade 4,' indicating a high likelihood of causality. It is pointed out that more proactive safety management and follow-up measures are needed for cases that are serious or repeatedly reported.
By type of symptom, digestive system-related symptoms such as indigestion were the most common, with 8,578 cases (45.9%). This was followed by itching and other symptoms with 3,438 cases (18.4%), dizziness and other symptoms with 2,200 cases (11.8%), and weight gain and other miscellaneous symptoms with 1,984 cases (10.6%).
By product category, adverse event reports were received in the following order: nutritional supplements with 3,215 cases, Lactobacillus gasseri BNR17 with 988 cases, DHA/EPA-containing oils with 965 cases, lactic acid bacteria (probiotics) with 611 cases, psyllium husk dietary fiber among dietary fibers with 517 cases, and phosphatidylserine with 342 cases.
Seo (Rep.) stated, "As the health functional food market grows, the number of adverse event reports is increasing rapidly," adding, "Thorough cause identification and prompt follow-up measures must be taken for products that are serious or repeatedly reported."
He/She further emphasized, "The management system must be strengthened to provide investigation results and safety information transparently to the public, enabling consumers to choose health functional foods with peace of mind."
in THEBIO
