“A complaint is merely a set of
allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence."
Also...Selective prosecution of a subset of group or population area is a violation of the equal protection clause of the 14th amendment. The judge more than likely should either force the DOJ and FDA to close ALL clinics using adipose stem cells or ask why these two bureaucracies are pushing their weight around on such a small subset of the industry.
ALSO, congress recently passed a law telling the FDA they can not go after a company for strictly guidance (a set of internal procedures that the FDA created) Guidance is not law. The FDA is using guidance docs to go after USRM so theoretically USRM's case is pretty strong. I will say you never know what your going to get with this administration and with the type of money big pharma can throw around but to act like they have less than a 50% chance of winning when literally the law is on their side..is FUD. Not saying they will or wont win but just going off of the law, I like their chances.
And lastly,
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER L--REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION
PART 1271 -- HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
Subpart A--General Provisions Sec. 1271.15 Are there any exceptions from the requirements of this part?
(a) You are not required to comply with the requirements of this part if you are an establishment that uses HCT/P's solely for nonclinical scientific or educational purposes.
***********(b) You are not required to comply with the requirements of this part if you are an establishment that removes HCT/P's from an individual and implants such HCT/P's into the same individual during the same surgical procedure.
(c) You are not required to comply with the requirements of this part if you are a carrier who accepts, receives, carries, or delivers HCT/P's in the usual course of business as a carrier.
**********(d) You are not required to comply with the requirements of this part if you are an establishment that does not recover, screen, test, process, label, package, or distribute, but only receives or stores HCT/P's solely for implantation, transplantation, infusion, or transfer within your facility.
(e) You are not required to comply with the requirements of this part if you are an establishment that only recovers reproductive cells or tissue and immediately transfers them into a sexually intimate partner of the cell or tissue donor.
(f) You are not required to register or list your HCT/P's independently, but you must comply with all other applicable requirements in this part, if you are an individual under contract, agreement, or other arrangement with a registered establishment and engaged solely in recovering cells or tissues and sending the recovered cells or tissues to the registered establishment.
Love this post on USRM’s Facebook today.
Not me, but I thought it worth sharing.
