'Browning' Dong-A Pharmaceutical's 'Champ Syrup'... Is the Indian Additive the Cause?

Shin Hyun-young "Indian D-Sorbitol is the Cause"
MFDS & Dong-A Pharmaceutical "Related Investigation Underway"

The cause of the browning phenomenon observed in Dong-A Pharmaceutical's children's cold medicine 'Champ Syrup,' which was suspended from manufacturing and sales amid quality controversies, is likely an additive sourced from India.

Children's fever reducer 'Champ Syrup' by Dong-A Pharmaceutical
[Photo by Dong-A Pharmaceutical]

According to the 'Dong-A Pharmaceutical 'Champ Syrup' Safety Measures Progress Report' and 'Dong-A Pharmaceutical 'Champ Syrup' Browning Phenomenon Occurrence Related Submission Materials' submitted by the Ministry of Food and Drug Safety, Shin Hyun-young, a member of the National Assembly's Health and Welfare Committee from the Democratic Party of Korea, announced on the 19th that the D-sorbitol used as an additive in the Champ Syrup product with the browning issue was confirmed to be an Indian ingredient rather than a domestic one.

Rep. Shin stated, "Looking at Dong-A Pharmaceutical's Champ Syrup, a sugar called D-sorbitol is used as an additive," adding, "Although it cannot be 100% confirmed, the most likely cause of the browning reaction is the reaction between the sugar in D-sorbitol and iron." She further speculated, "It was found that the D-sorbitol additive changed from domestic to Indian origin, and as a result, a significant amount of iron reacted, causing the discoloration to brown." Dong-A Pharmaceutical also analyzed that the iron content in the Indian D-sorbitol acted as a catalyst, causing caramelization and Maillard reaction. However, Rep. Shin added, "There is no clear evidence regarding the harmfulness of the browning reaction to human health."

According to Rep. Shin, Dong-A Pharmaceutical also revealed plans to change the D-sorbitol component to fructooligosaccharides as the cause of the browning phenomenon and to conduct self-quality inspections upon receipt of fructooligosaccharide raw materials to prevent recurrence.

However, both the Ministry of Food and Drug Safety and Dong-A Pharmaceutical stated that the investigation into the cause of the browning has not yet been completed. A Ministry official explained, "The information disclosed by Rep. Shin's office is based on investigation materials submitted by Dong-A Pharmaceutical," adding, "The Ministry is currently reviewing the cause of the browning phenomenon in Champ Syrup." A Dong-A Pharmaceutical representative also said, "Tests are being conducted at a testing agency designated by the Ministry of Food and Drug Safety," and "We are awaiting the results and will report them to the Ministry as soon as they are available."

Shin Hyun-young, member of the Democratic Party of Korea./Photo by Yoon Dong-ju doso7@

Meanwhile, Champ Syrup is currently suspended from manufacturing, sales, and use due to issues including microbial contamination as well as browning. Last month, the Ministry of Food and Drug Safety strongly recommended a 'mandatory recall' for two manufacturing batches where microbial limit issues were confirmed and a 'voluntary recall' for the remaining products, and temporarily suspended manufacturing and sales.

Rep. Shin also revealed that in one of the two batches, 570,000 cfu/mL of fungi were detected, and in the other batch, 120,000 cfu/mL of fungi were found, exceeding the Ministry's fungal suitability standard of 10 cfu/mL. A total of 722,660 packets of the product were produced.

However, the Ministry of Food and Drug Safety explained, "The Pichia sorbitophila detected in the two batches of Champ Syrup is a type of fungus used in fermented foods, beer, and soybean paste," adding, "It is classified as Biosafety Level 1." Biosafety Level 1 refers to microorganisms that have a very low likelihood of causing disease in humans or animals.

Rep. Shin also stated, "Although the excessively detected fungi are a type of yeast, the harmfulness to humans depending on the immune status of infants and young children is unclear," and urged, "The Ministry of Food and Drug Safety should establish continuous management measures for those who have consumed products with browning or fungal contamination."

This content was produced with the assistance of AI translation services.