REGULATORY UPDATE: FDA Cautions Consumers Against ‘Young Plasma’ Therapies
December 10, 2024
The Food and Drug Administration issued a
safety and availability communication on Friday reminding the public that “young plasma,” – defined as plasma collected exclusively from young donors – is not approved to treat any medical conditions or to enhance health and wellness.
The reminder follows the agency’s
2019 advisory cautioning consumers about establishments marketing costly infusions of “young plasma” with unsupported claims of benefits such as slowing aging, improving memory or treating conditions like multiple sclerosis, Alzheimer’s disease and Parkinson’s disease.
FDA also reaffirmed that the agency is unaware of any clinical evidence supporting the efficacy of such treatments and cautioned that that some establishments claim to be registered with the agency or list studies of “young plasma” in the clinicaltrials.gov database. However, these listings do not signify “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.”
The agency reminded consumers that the only approved uses for plasma transfusion, regardless of donor age, are outlined in the
FDA-recognized Circular of Information for the Use of Human Blood and Blood Components, developed by AABB. FDA also reminded consumers that infusions of plasma for unapproved uses are not supported by clinical evidence and carry risks as described in the Circular, including allergic reactions, respiratory complications and transmission of infectious diseases.
The agency encouraged health care professionals and consumers to report any adverse reactions resulting from the administration of young plasma to
FDA’s MedWatch program.
