Aekyung Industrial Co., which imported and sold toothpaste containing triclosan, was given a three-month suspension of import operations.
According to the Ministery of Food and Drug Safety on the 5th, Aekyung Industrial Co. was found to have committed three violations: ▲ detection of an unapproved (unreported) ingredient (triclosan) ▲ failure to follow recall procedures ▲ violation of importer compliance requirements (quality nonconformity).
In response, the Ministery of Food and Drug Safety, citing the Pharmaceutical Affairs Act and the "Regulations on Safety of Drugs, etc.," issued penalties of a four months and 15 days suspension of imports for the relevant item (Mar. 18–Aug. 1) and a three-month suspension of all import operations (Mar. 18–Jun. 17). This is a strong measure that restricts not only the specific product but also the import of other products. An official at the Ministery of Food and Drug Safety said, "For matters where legal violations are clear, we have requested an investigation."
Triclosan is a preservative used to prevent products from spoiling easily, and its use in oral care products has been banned in Korea since 2016.
Earlier, on Jan. 20, the Ministery of Food and Drug Safety said that as a result of triclosan testing of Aekyung Industrial Co.'s 2080 imported toothpaste for all lot numbers and domestically manufactured toothpaste, triclosan was detected at up to 0.16% in 754 out of 870 lot numbers for the 2080 toothpaste imported into the country. In Europe and other overseas markets, triclosan in toothpaste is evaluated as safe when used at 0.3% or less.
An official at the Ministery of Food and Drug Safety said, "We are communicating with the National Assembly to establish a legal basis for imposing punitive penalty surcharge on manufacturers and importers of quasi-drugs," adding, "We are working to strengthen the management of quasi-drugs by expanding budgets and personnel and increasing on-site inspections of overseas manufacturers."