US Stem Cell Inc (USRM)

[Dragon Lady]

Quote LOL, "Yes I know dust in a air conditioning vent is a major offense lol!!!$$$$ "

WHAT???? Air conditioning, LOL, WHAT??????

Uh..thee FDA and their Commissioner Scott Gottlieb, aka thee FEDERAL GOVT has accused USSC and Comella of violating NUMEROUS portions of the FD&C act, aka the Food, Drug and Cosmetic act, AND of manufacturing and selling a "NON FDA APPROVED NEW DRUG".

About as serious as it gets.....people have been sent to FEDERAL PRISON by thee FDA and the assistance of U.S. Attorneys for those same types of violations. Just Google it- even just "dietary supplement" maker dudes (weight lifting powders, etc) that were deemed to be "drugs" and they got assets seized, a year or two in FEDERAL PRISON, then probation, fines, etc.

And THEY DIDN'T EVEN BLIND ANYONE with their non FDA APPROVED "NEW DRUG" they were peddling, LOL !!

"Air conditioning" NONSENSE. It's way, way, way past serious, what the FDA warning letter and associated PR and associated FDA Commissioner commentary to TIME magazine and numerous other news outlets are alleging took place at USSC....as serious as it gets:

FDA OFFICIAL COMPLAINT DOCUMENTS:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573431.htm

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm573187.htm

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm572416.pdf

http://time.com/4920259/fda-crackdown-stem-cell-clinics/

Therefore, your SVF product is a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)] and a biological product as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 U.S.C. 262(i)].2 It is also a human cell, tissue, or cellular or tissue-based product (HCT/P) as defined in 21 CFR 1271.3(d). 3

Your SVF product does not meet all of the criteria in 21 CFR 1271.10(a), and therefore does not qualify for regulation solely under section 361 of the PHS Act [42 U.S.C. 264] and the regulations in 21 CFR Part 1271. Specifically, your SVF product does not meet the minimal manipulation criterion set forth in 21 CFR 1271.10(a)(1) and defined for structural tissue, such as adipose tissue, in 21 CFR 1271.3(f)(1). Your product does not meet this criterion because your processing alters the original relevant characteristics of the adipose tissue relating to the tissue’s utility for reconstruction, repair, or replacement.

In addition, your SVF product fails to meet the 21 CFR 1271.10(a) (2) criterion that the HCT/P be “intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer’s objective intent.” As noted above, the SVF product is intended for use in the treatment of a variety of diseases or conditions. Because the SVF product is not intended to perform the same basic function or functions of adipose tissue, such as cushioning the body, using the SVF product for treatment of these diseases or conditions is not homologous use as defined in 21 CFR 1271.3(c).

Please be advised that in order to lawfully market a drug that is a biological 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, such products may be used in humans only if the sponsor has an investigational new drug application (IND) in effect as specified by FDA regulations [21 U.S.C. 355(i); 21 CFR Part 312]. Your SVF product is not the subject of an approved biologics license application (BLA) (b)(4).
"

BREAKING THE LAW....no "air conditioning" nonsense here...NOPER, FEDERAL LAWS TOO....doesn't get anymore serious....THE FEDS...the big boys on the block.....