The FDA classifies biological products into two categories. Section 361 products – like PRP – meet four criteria and can proceed without the lengthy drug approval process. WIF interprets CFT as aligning with these same four criteria:
Made from the patient's own blood
Activating natural cell pathways, not altering them
Supporting blood's natural communication and immune functions
No added pharmaceutical agents
Important Note: Formal FDA guidance specifically addressing CFT has not been published. PRP's established 361 status provides regulatory precedent.
CFT is not on the WADA Prohibited List, or on the league lists (NFL, NBA, NHL, MLB) that draw from it
Autologous, cell-free, contains only endogenous factors – no banned substances
WIF provides full compliance documentation to athletes and their teams
Multiple professional sports governing bodies have reviewed CFT without an anti-doping consequence
EU-compliant, GMP-certified laboratory in Germany. Full traceability, batch testing, quality assurance.
Complete tracking from patient sample to final preparation, ensuring accountability at every step
Rigorous testing protocols for each batch to verify quality, purity, and consistency
Continuous monitoring and documentation to maintain the highest standards of care
Cell-Free Therapy is not intended to diagnose, treat, cure, or prevent any disease. The information provided on this website is for educational purposes only and does not constitute medical advice. WIF's CFT preparation supports normal biological function consistent with the body's endogenous processes. Regulatory classifications discussed reflect WIF's interpretation; formal FDA guidance specific to cell-free secretome preparations has not been published. Athletes should verify compliance with their specific sport's governing body.
Our team can provide detailed regulatory documentation and compliance information.