At Tulsi Wellness Club, we often receive questions about Platelet-Rich Plasma (PRP) therapy, particularly why it is not FDA-approved despite its growing popularity in aesthetics, pain management, and regenerative medicine. While PRP has been widely used in medical settings for wound healing, joint pain relief, hair restoration, and skin rejuvenation, it remains an off-label treatment in the eyes of the U.S. Food and Drug Administration (FDA). Let’s explore why this is the case and what it means for patients considering PRP therapy.
What is PRP Therapy?
PRP therapy involves drawing a patient’s blood, processing it in a centrifuge to concentrate the platelets, and reinjecting the platelet-rich plasma into the targeted area. The growth factors and healing properties in PRP stimulate cell regeneration, collagen production, and tissue repair, making it a sought-after natural therapy for various conditions.
Despite its proven effectiveness, PRP is not FDA-approved—but this does not necessarily mean it is unsafe.
Why Has PRP Not Received FDA Approval?
PRP is an Autologous Treatment
The FDA primarily regulates drugs, biologics, and medical devices, but PRP is derived from the patient’s own blood, making it a biological product rather than a pharmaceutical drug. Since it is not synthetically manufactured or altered with additives, it does not fit neatly into the FDA’s traditional regulatory framework.
Lack of Large-Scale Clinical Trials
To obtain FDA approval, a treatment must go through rigorous, large-scale clinical trials to demonstrate its safety, efficacy, and consistency. While small studies and anecdotal evidence strongly support PRP’s benefits, there have not been enough large, standardized clinical trials to satisfy FDA requirements.
Variability in PRP Preparation Methods
PRP treatments vary based on:
The type of centrifuge system used
The concentration of platelets in the final injection
The method of application (injection, microneedling, etc.)
Because there is no universal standard for PRP preparation, the FDA cannot regulate it as a single, uniform medical treatment.
PRP is Considered "Minimally Manipulated"
According to FDA regulations, biological treatments must not be “more than minimally manipulated” if they are to be used without FDA approval. Since PRP only undergoes centrifugation without the addition of drugs or chemicals, it falls into a category that does not require full FDA approval—but also does not have it.
What Does This Mean for Patients?
Although PRP is not FDA-approved, it is widely used by physicians and wellness practitioners for joint pain, hair restoration, skin rejuvenation, and more. Many doctors view PRP as a safe and effective therapy with a low risk of complications since it comes from your own body.
However, patients should always:
Choose a licensed and experienced provider
Ensure PRP is performed in a medical setting
Discuss risks and expectations before treatment
Is PRP Safe Without FDA Approval?
Yes! PRP is considered very safe, with minimal side effects since it is an autologous treatment (using your own blood). Unlike pharmaceutical drugs, which can have chemical side effects, PRP has no risk of allergic reactions or foreign substance rejection.
Most patients experience only mild redness, swelling, or soreness, which subsides within a few days.
Final Thoughts
While PRP therapy is not FDA-approved, it continues to be a trusted natural healing solution in aesthetic medicine, sports medicine, and pain management. At Tulsi Wellness Club, we believe in the power of regenerative treatments to restore and rejuvenate the body naturally.
Interested in PRP therapy? Contact us today to learn more and book your consultation!
Dr. Devin Stone
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