FDA Has Seized Control of Your Stem Cells



for the first time in history the FDA has encroached into the practice of medicine the FDA made adult stem cell therapy subject to the same regulatory oversight as mass-produced pharmaceutical agents without compliance to the Administrative Procedures Act requiring an extensive public comment period we're now going to explore how the FDA managed to expand its authority without input from patients and their doctors in the early 1990s the cells in your body were like any other body part that could be used by a physician and move from one area to the next they were body parts like a kidney or heart that was before an unprecedented power grab by the FDA in the 1990s the FDA proposed that the stem cells in your body legally be considered drugs they were met with stiff resistance they ultimately decided that if the cells were at all made more potent by growing them in bigger numbers they would be drugs even though they were still yourselves this was known as the minimal manipulation rule which was later codified the FDA without the proper notice and comment making period required by the Administrative Procedures Act made a one word midnight change in the 2006 Federal Register it changed a single word from another to a by doing this its regulatory authority was expanded from simple control over someone sells used as a transplant from another person to all cells from a person with this one word change FDA granted itself sweeping new authority over your body up until two thousand eight it was assumed that the FDA only meant to apply its rules to pharmaceutical companies that were processing cells then in 2008 the FDA went after a physician's office that was using the patient's own cells and treated the small doctor's office like a large pharmaceutical company this necessitated a suit by the doctor's office against the FDA but this chain of events now extended the FDA's authority even further as now your local family doctor was suddenly under the same cell based regulations as large companies like Pfizer in 2010 and 2011 the FDA decided to place fat tissue process at the patient's bedside to release stem cells into the same category as prescription drugs they made their intention clear that this simple processing of fat was something the FDA intended to control in addition it submitted warning letters to intel a cell and a doctor young codifying its intent to turn fat tissue into a drug as well so as you can see the FDI has gone from no control of your body stem cells as drugs in the 1990s to classifying an ever-increasing number of your body tissues as drugs this is despite massive opposition from these industry groups what is the impact of classifying simple medical procedures as prescription drugs the FDA has taken procedures that should be by now routinely performed as a practice of medicine and instead place them into a glacially slow drug approval process countless sick patients have been denied access to their own stem cells that may well cure or mitigate their disease

4 Comments

  1. March 2016: PatientsForStemCells has launched an effort to support Senators Kirk and Collins adult stem cell legislation, being introduced to the Senate HELP Committee on March 16th. There's still time time send an email or call your Senator to to support this bill. Instructions and sample emails are here
    http://www.patientsforstemcells.org/take-action/#Now

  2. Gee this sounds kinda like some form or slavery

  3. Makes no sense but then.. follow the money!

  4. One little word has changed the lives of so many and not for the better. The FDA now has power over whether you live or die.

Leave a Reply

Your email address will not be published. Required fields are marked *