FDA bans stem cells from animals, plants
MANILA, Philippines - Stem cells taken from animals and plant derivatives are not allowed in the country, according to a circular of the Food and Drug Administration (FDA).
In FDA Circular 2013-017, FDA acting director Kenneth Hartigan-Go said stem cells harvested from human embryos for research purposes, human embryonic stem cells and their derivatives as well as aborted human fetal stem cells and their derivatives are also not authorized.
Go said such stem cells are prohibited from creation, importation, promotion, marketing and use.
This means that selling and manufacturing of soap and other products that supposedly contain stem cells from placenta and animals, which have been flooding the market recently, are also prohibited.
The FDA circular said imported human stem cell-based products are allowed, provided they are not hand-carried and meet other requirements.
The FDA requires the “use of appropriate mode of transportation and storage” in transporting allogeneic stem cells or those derived from other humans and not the patient himself.
Under the guidelines previously issued by the Department of Health (DOH), only autologous stem cells, or those taken from the patients themselves, are acceptable.
In Circular 2013-012 issued last May 15, the FDA had also warned the public against receiving “unapproved stem cell preparations in non-health facilities.”
The agency said unapproved stem cell preparations and therapy without prior FDA-DOH approval could cause infectious diseases and severe complications which may lead to permanent disabilities, physical deformities, autoimmune diseases and even death, without the benefit of health insurance coverage.