줄기세포를 활용한 화장품 개발에 대한 정책 제안

Abstract

Stem cell cosmetics is the product bio-technologically developed, containing human stem cells itself or stem cell driven materials to activate cell division, growth and so on. Due to the use of stem cell, inherently, such cosmetics cannot be free from the concerns regarding science, ethics and law. Besides, for the most of them, there is no control to ensure the safety by regulation so far, whereas safety should be guaranteed regardless the potential or expected effect. Therefore the Korea Food and Drug Administration(hereunder, KFDA) will not permit the use of any material originating from human stem cells or organs in cosmetics, citing risk of infection until the implementation of relevant regulation. But it’s not easy to just ban the use or sale of such high-value-added product because of the increasing demand and pressure from scientists, businessmen and consumers. So KFDA is required to implement effective regulation and communicate clearly the required conditions of authority’s approval on the production and use of such materials. The purpose of this paper is to suggest condition should be considered for preparing alternative policy supposed to regulate new cosmetics effectively and guarantee the safety of cosmetics for consumers such as following; – The introduction of additional concept of cosmetics, cosmeceuticals, in Cosmetics Act. Cosmeceuticals is a new category of cosmetic products claimed to have biologically active ingredients with medicinal or druglike benefits. Currently, in Korean Cosmetics Act, there are only two classification for cosmetics : general and functional cosmetics. Such simple classifying systems can not regulate full range of new high tech products such as stem cell cosmetics. But by adopting the concept of cosmeceuticals in preparing policy, the KFDA can take advantages not only to regulate new high-tech cosmetics but also to ensure safety. It can also provide legal basis on enhanced regulation for druglike stem cell cosmetics and effective solutions to several problems of stem cell cosmetics in the respect of science, ethics and law.