By Kim Tong-hyung
Staff Reporter
Biotech firms are up in arms against the move by health authorities to ban the use of materials derived from human stem cells or organs for cosmetic use due to infection worries.
The companies are hoping that beauty products will generate an early return on their lavish investments in stem cell technology, with the prospects for therapeutic applications remaining murky and distant.
However, the Korea Food and Drug Administration (KFDA), which is pushing the ban, claims that the use of human tissues in the making of cosmetic products raises safety concerns, as the materials could be contaminated with HIV, hepatitis and other infectious viruses and bacteria.
The new regulations, which could be approved as early as July, will remove cosmetics based on stem cells extracted from human fat from the shelves.
About four to five local biotech firms, including RNL Bio, Stem Medience and Prostemics, officially submitted letters opposing the KFDA proposal, government sources said.
Currently, stem cell cosmetic products in stores or under development use fat tissues sourced from hospitals, mostly those left from liposuction surgery at cosmetic clinics.
The companies harvest stem cells from the tissues in a culture dish, and then use the culture fluid as material for cosmetics products. Since the fluids contain the cell-growth chemicals produced by the stem cells, cosmetic products derived from them show improved efficiency in anti-aging products, the companies say, although the claims have never been proved by government tests.
Human fat tissue has a higher concentration of adult stem cells than any other tissue in the body.
The KFDA claim that since the fat tissues used in the process come from a random mixture of patients, contamination becomes a risk. And since the culture fluids contain fetal bovine serum (FBS) and different types of enzymes, cosmetic products made from them could cause allergic reactions in some people, officials said.
``It is obvious that the companies need to find a way to ensure that the products made from materials derived from stem cells won't harm the health of those who buy them,'' said a KFDA spokesman.
``European countries are already banning cosmetic products using stem cell-derived materials. We plan to continue to talk to the companies and see whether there could be a solution that makes both sides happy.''
Biotech companies claim that the KFDA concerns are exaggerated, and they have the ability to control the quality of the products they sell to consumers.
There are also claims that materials derived from embryonic stem cells are free from the safety concerns connected to adult stem cells derived from fat tissues, since the tissues don't come from different people and the culture fluids don't contain FBS.
```It is not that we don't review the health conditions of the patients who are the source of the fat tissue. We also strictly test the tissue and fluids for viruses,'' said an RNL Bio official.
Currently, the companies have been exploiting a legal loophole to sell their stem cell cosmetic products here, listing the culture fluids as cosmetic materials in the United States first to avoid screening at home.
However, with the KFDA now moving to block such a process, the companies are now finding themselves on a collision course with the government.