New Life Medical Services, LLC
FDA issued a warning letter to New Life Medical Services, LLC (Lutz, FL) following a May 2024 facility inspection, finding that its umbilical cord-derived products (Restor+, Regain, Renyte), amniotic fluid-derived product (ReCyte/Cytosomes), and exosome product (Rexo) are unapproved new drugs and unlicensed biological products marketed for treating pain, inflammation, neuropathy, orthopedic conditions, and tissue regeneration without an approved BLA. The products also fail HCT/P regulatory criteria under 21 CFR 1271.10(a) because they are more than minimally manipulated and are not intended for homologous use only. FDA warned that failure to address these violations may result in seizure and/or injunction, and required a written response within 15 working days.
Flagged claims (10)
Renyte is intended to supplement or replace damaged or inadequate connective tissue.
[New Life Medical Services] products across the board are utilized for pain management, inflammation of soft tissue, … and non-union fractures. 'The application for all products are copy, paste.'
Rexo is an innovative extracellular vesicle product derived from Wharton's Jelly that offers advanced healing properties.
has a strong anti-inflammatory effect reducing the expression of inflammatory cytokines.
Flagship Products … Restor+ and Rexo … Ideal Applications
Restor Charge and Rexo Charge provide strong healing potential at a lower price, making regenerative treatments accessible for everyone.
Recyte is intended to help with inflammation and to enhance the healing process.
to supplement the recipient's tissue and assist in the body's natural regenerative functions.
Restor+ facilitates healing by secreting powerful bioactive molecules, creating an optimal environment for tissue repair and regeneration.
Higher concentration of growth factors in Renyte act as anti-inflammatory and have been shown to prevent cell death.
Required actions (3)
Please submit your response in writing within fifteen (15) working days from your receipt of this letter, outlining the specific steps you have taken or plan to take to address any violations and prevent their recurrence.
Failure to adequately address these matters may result in action without further notice including, without limitation, seizure and/or injunction.
In your response, please provide a customer list for each of these products and indicate whether you believe you sell them in compliance with the FD&C Act. If so, include your explanation why; if not, include your plan for coming into compliance.
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