FDA warns vs stem cells taken orally


03:00 AM September 16th, 2013

By: Jocelyn R. Uy, September 16th, 2013 03:00 AM

Bio Stem Plus as it was advertised in sulit.com.ph. The advertisement has become inactive as of Monday.

MANILA, Philippines—The Food and Drug Administration (FDA) on Sunday warned the public against buying unregistered stem cell supplements being peddled online.

In an advisory, the FDA cited in particular a product called Bio Stem Plus, saying that it was neither an FDA-approved stem cell preparation nor an approved food or dietary product.

According to acting FDA Director General Dr. Kenneth Go, the agency had been monitoring Bio Stem Plus supplements being sold and advertised “with deceitful health and therapeutic claims” through sulit.com.ph, an online buy-and-sell website catering to the Philippine market.

Go said the product was being promoted supposedly as a “natural stem cell nutrition” that increases adult stem cell circulation, repairs damaged tissues, decreases the effects of aging, aids in “up to 70 known human conditions” and cures high blood, vertigo and back pain.

“The public is hereby warned against buying and using unregistered Bio Stem Plus… There are no scientific and clinical studies that would support or back up its health and therapeutic claims,” said Go.

“As advertised, stem cell is to be taken orally and will not pass as a product for registration as human cells, tissues and cellular and tissue-based products (HCT/P),” he added.

Under the Department of Health’s Administrative Order No. 2013-0012, stem cells and stem cell products must be preparations of viable cells that have the capacity to replicate and differentiate into different types of cells.

HCT/Ps are intended for implantation, transplantation, infusion or transfer into a human recipient so stem cell products that are supposed to be taken orally or applied topically cannot pass as HCT/Ps, said the DOH.

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