Posted 04 February 2015
FDA Advisory No. 2013-025
DECEPTIVE ON-LINE SALE AND MARKETING OF STEM ENHANCE TM PRODUCT
The Food and Drug Administration has monitored the product STEM ENHANCETM that is being promoted and sold on-line and dubiously labeled as a Dietary Supplement that Supports the Natural Release of Adult Stem Cells, manufactured by STEMTech Health Sciences. Inc. of Klamath Falls, Oregon, USA. This product is not registered by the FDA (http://www.fda.gov.ph/consumers-corner/registered-food-supplements/8732-fr-100019).
Based on FDA records, a similar product, StemEnhance AFA Extract Food Supplement, was granted registration by the FDA, labeled as a food supplement with “No
Approved Therapeutic Claims”. This is different from the one shown in the picture.
The consumers are hereby warned that STEM ENHANCETM has no curative value. No clinical studies or scientific justification has been shown to substantiate the claim that it can release adult stem cells from bone marrow into circulation. The health claim is deceitful and fallacious.
Considering that STEM ENHANCETM is not registered with the FDA, and its safety and health claims have not been evaluated by the FDA, the public is hereby warned not to use and patronize the on-line sale of the said product.
The case is now under investigation.