It also says the infusion of plasma can be associated with infectious, allergic, respiratory, and cardiovascular risks.
Though the FDA didn't name any infusion companies specifically in its alert, one that has received a lot of media attention is a startup called Ambrosia.
In a statement released on Tuesday, the FDA warned that infusion of blood plasma from young donors into older individuals should not be assumed as effective or even safe. In a statement, FDA commissioner Scott Gottlieb and Peter Marks, the director of the FDA's middle for Biologics Analysis and Analysis, cautioned "customers" (learn: "Nosferatu's dread offspring, the Vampyr, conductors of the symphony of the evening") towards "young donor plasma infusions" (learn: "young donor plasma infusions").
Companies offering young blood infusion could face enforcement actions from the FDA.
Researchers at Stanford University have shown some promising anti-aging and Alzheimer's-reversing effects when they injected blood from young mice into older ones. The FDA said the treatment is not proven effective and is potentially unsafe.
Gottlieb said that consumers should be extra wary of where and how the plasma infusions are done, as many clinics could be claiming to have the solution but without clinical advice.
The FDA referenced reports of young people's blood plasma being touted as a treatment for conditions ranging from "normal aging and memory loss to serious diseases like dementia, Parkinson's disease, multiple sclerosis, Alzheimer's disease, heart disease or post-traumatic stress disorder".
"Young plasma treatments are intravenous infusions of plasma from young donors, who are in the age range of 16 to 25", Ambrosia's website said.
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Establishments in several states are now selling young blood plasma, which is the liquid portion of blood that contains proteins for clotting.
The thinking behind young blood transfusions stems from a somewhat gruesome experiment conducted in the 1950s, when a Cornell researcher connected the circulatory systems of a young and old mouse, according to New Scientist's Helen Thomson.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
One company, Ambrosia, has already stopped treatments. It worked so well, we're going to start treating people.
"We strongly discourage consumers from pursing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight", the FDA officials said.
He added that using plasma from young donors is not accompanied by compelling evidence on a clinical scale.
Karmazin opened clinics in Omaha, NE, Los Angeles, San Francisco, and Tampa, FL.