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Update to Important Information about Young Donor Plasma Infusions Offered for Profit

December 6, 2024

In February 2019, the Food and Drug Administration (FDA) advised consumers to be cautious about establishments offering infusions of plasma collected exclusively from young blood donors and making various claims that the infused plasma will treat a variety of medical conditions or provide other health and wellness benefits. The agency is again reminding the public that FDA has not approved “young plasma” for any such uses, and we are not aware of evidence that demonstrates effectiveness for these uses. The only approved indications for plasma transfusion, from donors of any age, are described in the FDA-recognized Circular of Information for the Use of Human Blood and Blood Components (please see FDA’s Guidance for Industry, An Acceptable Circular of Information for the Use of Human Blood and Blood Components | FDA).

Summary of the Issue

FDA previously communicated that establishments located in several states were offering individuals infusions of plasma specifically collected from young donors (e.g., age 18-30 years), for a cost of up to thousands of dollars per infusion. Unfortunately, establishments have continued to market “young plasma” for a variety of medical conditions. We are not aware of evidence that demonstrates any clinical benefit of the infusion of plasma from young donors in the prevention of conditions such as aging or memory loss, or for the treatment of such conditions as dementia, Parkinson’s disease, multiple sclerosis, Alzheimer’s disease, heart disease, or post-traumatic stress disorder.  Some establishments claim to be registered with FDA and have studies of “young plasma” for these types of medical conditions listed on the clinicaltrials.gov database. The inclusion of a study of “young plasma” for certain uses in the clinicaltrials.gov database or the fact that an establishment has registered with FDA does not mean that “young plasma” is approved by FDA for such uses, or that the establishment has met applicable statutory or regulatory requirements for conducting research involving human subjects. If you have questions about whether a plasma treatment has been reviewed by the FDA for safety and effectiveness, please contact FDA at ocod@fda.hhs.gov.

Information for Health Care Providers and Patients

Plasma is the liquid portion of the blood that contains clotting factors, antibodies, and other proteins. The FDA-recognized Circular of Information for the Use of Human Blood and Blood Components published by AABB lists the following indications for the administration of plasma:

•    Management of preoperative or bleeding patients who require replacement of multiple plasma coagulation factors (e.g., liver disease, disseminated intravascular coagulation);
•    Patients undergoing massive transfusion who have clinically significant coagulation deficiencies;
•    Patients taking warfarin who are bleeding or need to undergo an invasive procedure before vitamin K could reverse the warfarin effect or who need only transient reversal of warfarin effect;
•    Transfusion or plasma exchange in patients with thrombotic thrombocytopenic purpura;
•    Management of patients with selected coagulation factor deficiencies, congenital or acquired, for which no specific coagulation concentrates are available; 
•    Management of patients with rare specific plasma protein deficiencies, such as Factor V deficiency, when recombinant products are unavailable.

In patients with one or more of the indications for administration of plasma listed in the FDA-recognized Circular of Information, the benefits of treatment with plasma outweigh its risks. In contrast, plasma components of any kind are not FDA-approved to treat other conditions such as normal aging or memory loss. Additionally, there have not been any well-controlled studies that show the clinical benefit of the administration of plasma collected exclusively from young donors, and there are associated safety risks with plasma transfusion.  The Circular of Information describes risks of plasma transfusion such as transmission of infectious disease, allergic reactions and respiratory complications.  The administration of plasma collected exclusively from young donors for indications other than those listed in the FDA-recognized Circular of Information must be performed by a qualified investigator or sponsor who has an active Investigational New Drug application (IND) with the FDA.

Reporting Adverse Events

The agency encourages health care professionals and consumers to report any adverse reactions resulting from the administration of young plasma to the FDA’s MedWatch program:

•    Complete and submit the report online at www.fda.gov/medwatch/report.htm
•    Download and complete the form, then submit it via fax at 1-800-FDA-0178

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