FDA warns vs bottled stem cell booster

MANILA, Philippines - The public was cautioned yesterday against a bottled stem cell booster being sold online.

In Food and Drug Administration (FDA) Advisory No. 2014-041, Director General Kenneth Hartigan-Go said the Inner Power Stem Cell Booster is not registered with the agency and does not meet the requirements for stem cell products.

 â€œThe public is hereby warned against buying and using the above-identified unregistered Inner Power Stem Cell Booster,” he said.

“There are no scientific and  clinical studies that would support or back up its health and therapeutic claims.”

Quoting FDA Circular No. 2013-017 dated July 2013, Go said all human cells, tissues, and cellular and tissue-based products (HCT/Ps) are required to be registered with the FDA.

Otherwise, these products shall be considered illegal after Aug. 31, 2013, he added.

Go said based on Department of Health (DOH) Administrative Order No. 2013-012, stem cells and stem cell products should be preparations of viable cells that have the capability to replicate and differentiate into different types of cells.

 â€œHCT/Ps are intended for implantation, transplantation, infusion or transfer into a human recipient. Products containing ingredients that are taken orally, or even applied topically, cannot pass as HCT/Ps,” he said.

 The FDA advisory showed that the product is being promoted and sold online through www.olx.ph.

 â€œThe product Inner Power Stem Cell Booster promoted and sold online, is not registered with FDA as a drug product, neither as a food supplement nor as human cells, tissues, and cellular and tissue-based products,” the FDA said.

The FDA said the product as monitored and sold online   has deceitful health and therapeutic claims.

 â€œAlso, as advertised, Inner Power Stem Cell Booster to be taken orally; hence, it will not pass as a product for registration as HCT/P,” the FDA  said.

The FDA has advised all consumers to  be more vigilant and critical about online and digital advertisements so as not to fall prey to the marketing schemes of Internet fraudsters.

“All FDA inspectors are hereby ordered to seize and confiscate the aforesaid products found being sold or offered for sale in outlets,” the FDA said.