US Stem Cell Inc (USRM)

[Dragon Lady]

Follow the CELTEX LINK and WARNING the FDA issued- as included in that email reply and read the FDA/warning ruling for "stem cells" that were more than "minimally manipulated"- ah, DRUG was the determination.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323853.htm

"
You are promoting the CellTex product in a manner that causes the product to be a drug under section 201(g) of the FDC Act [21 U.S.C. 321(g)] and a biological product as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)]. Please be advised that in order to lawfully market such a biological drug product, a valid biologics license must be in effect [21 U.S.C. 355(a); 42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, for example, while being studied in a clinical investigation, such products may be used in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations [21 U.S.C. 355(i); 21 CFR Part 312]. The CellTex AdMSC product is not the subject of an approved biologics license application (BLA) nor is there an IND in effect. Based on this information, your product violates the FDC Act and the PHS Act. "

"Overall Response

Please provide details as to how you plan to deal with the biological drugs that have already been manufactured at your Sugarland, Texas facility in violation of the FDC Act and PHS Act. Additionally, we note that SOP’s and records collected during the inspection as well as translated copies provided in your correspondence appear to relate to your RNL Bio facility in Korea and not your Sugarland, Texas facility. In your response, please address the concerns that your AdMSC product is a drug as defined in section 321(g) of the FDC Act and biological product as defined in section 351(i) of the PHS Act. "