The Korea Food and Drug Administration (KFDA) is set to improve the Good Manufacturing Practice (GMP) standards for health supplements to align with international guidelines and enhance consumer information for personalized health products. The agency plans to refine the quality management system and make it easier for consumers to access product information.
On July 21, the KFDA announced a legislative notice for a partial amendment to the Enforcement Rules of the Health Functional Food Act, inviting public comments until August 31.
The amendment includes new management standards for reprocessing, compressed air, and lubricants in the manufacturing and quality control of health supplements. It mandates the retention of relevant records during reprocessing and requires regular management of compressed air and lubricants to mitigate cross-contamination risks, thereby strengthening the quality management system.
For personalized health supplements, the amendment introduces dedicated designs to help consumers easily distinguish these products. It also requires labeling on product containers and packaging stating, 'This is not a medicine.' Additionally, expiration dates must be indicated on inner packaging, and sellers are obligated to provide warnings about concurrent use with medications either at the point of sale or through electronic means.
To enhance the reliability and transparency of quality inspection results, the use of a record management system will be mandatory. All quality inspection results, including self-quality tests, must be managed through this system. If establishing an internal system is challenging, companies can utilize the KFDA's Laboratory Information Management System (LIMS).
The KFDA aims to elevate the manufacturing and quality standards of health supplements through these regulatory improvements, creating an environment where consumers can confidently choose products.
* This article has been translated by AI.
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