FDA warns vs 'Stem Enhance' product being sold online

Health authorities on Thursday warned the public against a dietary supplement being sold online and claiming to support the natural release of adult stem cells.

The Food and Drug Administration said the product "Stem Enhance" made by STEMTech Health Sciences. Inc. of Oregon is "dubiously labeled" as a dietary supplement.

"This product is not registered by the FDA," acting FDA head Kenneth Hartigan-Go said, adding product is now under investigation.

However, Go cited FDA records showing a similar product, StemEnhance AFA Extract Food Supplement, was granted registration by the FDA.

Go said StemEnhance AFA Extract Food Supplement is labeled as a food supplement with "No Approved Therapeutic Claims" and is different from "Stem Enhance."

"The consumers are hereby warned that STEM ENHANCE 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 [benefit] claim is deceitful and fallacious," he added.

Also, he said that since the product's 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."

Arthrite plus

Meanwhile, the FDA clarified another food supplement, ARTHRITE PLUS is registered and contains glucosamine hydrochloride and chondroitin sulfate but has no approved therapeutic claims.

It also said ARTHRITE SGC 150 mg capsule of Rotex Pharma Philippines, lnc. Makati, is registered as a "Traditionally Used Herbal Product" with Registration No. THPR-18.

"As a Traditional Herbal Product, it is classified as an Over the Counter (OTC) preparation, and this could be advertised as long as the claim/s are those contained only in the
approved label or packaging registered with the FDA," Go said.

"Since the two products are not in the same product classification, the brand name ARTHRlTE 150 mg SOFTGEL CAPSULE for Traditional Medicine and the product name ARTHRITE Plus with Glucosamine and Chondroitin Sulfate for Food Supplement are allowed," he added. — LBG, GMA News