[Kim Taemin's Food and Drug Story] Checks and Balances Are Needed in Safety Evaluation Work

HACCP Poor Management Issues Cause
Rapid Decline in MFDS Trust
Aloe Whole Leaf Toxicity Controversy
Revealed by Consumer Agency, Not MFDS

The Sole Food and Drug Licensing Authority
Unified Safety Evaluation and Monitoring
Repeated Delays and Evasion of Responsibility
Need to Separate Safety Evaluation
to Consumer Agency or Independent Third Party

After the presidential election ended and the transition committee began its work, the most frequently appearing news has been about the abolition or integration of government ministries. Every time the administration changes, the safety management tasks related to food and pharmaceuticals also change. Under the goal of protecting public health, strong support was given for changes such as the upgrade of a ‘Cheong’ (agency) to a ‘Cheo’ (office) and the unification of safety management tasks for livestock products. However, recently, due to a series of poor management issues with the Hazard Analysis and Critical Control Points (HACCP) system, trust in the Ministry of Food and Drug Safety (MFDS) has sharply declined. On top of this, the administrative notice to delete products containing ‘Aloe Jeonip’?which had been recognized as a functional ingredient in health functional foods after safety evaluations and consumed by many citizens for years?from the list of functional ingredients due to potential liver toxicity and other risks, has caused widespread dismay.

In fact, it was not the MFDS but the Korea Consumer Agency that first noticed this problem. In August last year, the Korea Consumer Agency announced, “The functional component of Aloe Jeonip, barbaloin, is a hydroxyanthracene derivative (HADs). Long-term consumption for more than 1 to 2 weeks can impair colon function and cause side effects such as nephritis and hepatitis. The World Health Organization (WHO) and the European Medicines Agency (EMA) limit the daily allowable intake (10?30 mg) to a consumption period within 1 to 2 weeks, but most domestic products on the market were sold in quantities intended for more than 30 days of consumption.” This was already a known fact, but the MFDS, responsible for functional evaluations, clearly neglected its duties. Despite knowing this, these products are still being sold. Of course, it is not necessarily correct to apply the same standards to our citizens as to people in other countries. However, what is important is the process the MFDS followed to resolve this issue.

This delayed administrative response by the MFDS is not the first time. Companies that had passed the HACCP certification smoothly were found non-compliant during surprise inspections for defective donuts, sundae (Korean blood sausage), and meal kits, causing controversy. The Korea Consumer Agency’s criticisms are also not new; from issues with the phospholipid content in krill oil to the fake Baeksuo incident, the MFDS has often overlooked problems that the Consumer Agency appropriately pointed out. Ultimately, just as corporations have boards of directors and auditors, and government ministries have the Board of Audit and Inspection and internal audit officers, these are necessary solutions. Currently, the MFDS lacks any effective checks and balances. It grants approvals itself, acknowledges problems itself, and must cancel approvals itself, so it inevitably ends up being late or evasive in taking responsibility.

When the MFDS was under the Ministry of Health and Welfare, the superior ministry continuously managed it, so it could not ignore oversight. When livestock product safety tasks were under the Ministry of Agriculture, Food and Rural Affairs, mutual checks and balances operated, allowing cooperation and correction of errors rather than wielding unchecked power. However, now that the MFDS is the sole licensing authority for food, pharmaceuticals, medical devices, and cosmetics, with unified safety evaluations and monitoring tasks, problems have occurred repeatedly. Retired officials have moved to executive positions in affiliated associations or large law firms, and although the COVID-19 pandemic and the focus on mask and diagnostic kit enforcement provided some excuse, there have long been criticisms that safety management tasks have been neglected.

Returning to the Aloe Jeonip issue, if the problem raised in August last year only now received an administrative notice, one wonders what processes took place during the intervening months. It is also questionable whether the MFDS actively conducts safety tests like advanced countries such as Europe and the United States. If it merely adopts foreign standards as they are, there is no reason to delay. Many are curious about the safety evaluation criteria. Recently, there was controversy over a hair dye shampoo product banned in Europe due to a prohibited substance, with measures taken to prevent its sale. Often, if there is information abroad that a substance is somewhat risky, the MFDS outright denies approval, only to lift the ban later after gauging public sentiment.

It has become difficult to trust the hundreds of functional ingredients in health functional foods approved by the MFDS. If one day Europe or the United States announces that a component in an ingredient is harmful, or if the Korea Consumer Agency or individual consumer groups raise concerns, the health supplements we have consumed for a long time suddenly become harmful foods. Although the MFDS promises to resolve issues through periodic safety re-evaluations, it is strange to abruptly cancel approvals for functional ingredients it had previously authorized as if turning over a new leaf overnight.

From this perspective, there is a need to separate safety evaluation tasks to the Korea Consumer Agency or a third-party independent institution. There must be a public institution free from the MFDS’s unchecked monopoly power and free from political pressure, focusing solely on the public’s interest to conduct safety evaluations. Stagnant water inevitably becomes foul. Those who criticize or speak harshly about the MFDS’s work are often excluded from appointments to various committees.

The reason the separation of powers system is implemented in democratic societies is precisely for checks and balances. When that balance is broken or power is monopolized, side effects inevitably occur, and ultimately, the damage falls squarely on the public. The MFDS’s role is extremely important for public health. Therefore, something that properly monitors and maintains balance is even more necessary.

Lawyer, Food Hygiene Law Research Institute

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