FDA Advisory No. 2013-012
The FDA has been receiving complaints
from the public and health professionals that stem cell therapies are
conducted in non-health facilities, such as hotel rooms.
The public is warned against receiving
stem cell preparations and therapies without prior regulatory
applications and approval from the Food and Drug Administration,
Department of Health. The following stem cell preparations require FDA
approval: a) genetically altered human adult and umbilical cord stem
cells, b) adipose or fat cells derived human stem cell, c) human cells,
tissues, and cellular and tissue-based products that are subjected to
genetic manipulation, and d) live animal embryonic, fetal, or adult stem
cells in parenteral form for human administration. The public is
further warned that FDA-DOH does not allow the creation, importation,
promotion, marketing and use of human embryos, human embryonic stem
cells and their derivatives, aborted human fetal stem cells and their
derivatives for human treatment and research, as well as plant parts
labeled as stem cells.
Patients who might receive stem cell
preparations and therapy without prior FDA-DOH approval run the risks
of contracting infectious diseases and severe complications which may
lead to permanent disabilities, physical deformities, serious iatrogenic
harm, autoimmune diseases and worst death, and without the benefit of
health insurance coverage.
All patients are advised to consult only
with duly-licenses medical practitioners who practice stem cell therapy
in health facilities that are approved by the DOH. Moreover, patients
are highly encouraged to verify with the FDA, Philippines, before
undergoing the procedures using our
info@fda.gov.ph. This health
warning and advice extend to all tourists who visit the Philippines for
their leisure needs as well as medical needs.
