REGULATORY UPDATE: FDA Advises About Directed Donations That are Not Medically Indicated and Cautions Against Using Websites Advertising Directed Donations

The Food and Drug Administration issued a safety and availability communication on Monday advising patients and health care providers that directed blood donations from “personally chosen relatives, friends or other individuals with certain characteristics” such as vaccination status, sexual orientation and religion lack scientific support. FDA also urged consumers to be cautious about websites that offer memberships for delivery of blood and blood components from individuals who have not been vaccinated for COVID-19.   

It is important to note that the term "designated donor" can be used in multiple ways. Donors “personally chosen” by a patient must never be confused with the medically indicated selection of donors to meet the unique transfusion needs of a patient. Transfusion medicine decisions to select for certain donor compatibility characteristics routinely ensure the best possible patient care. This decision, fully supported by AABB and other organizations, for medically indicated donor selection for unique compatibility characteristics is the standard of care for many patient populations and should not be misconstrued as the subject of FDA’s concerns. 

FDA reiterated that there is no evidence that donors “personally chosen” by a patient provide safer blood and blood components for transfusion, since all blood donors must be determined to be eligible to donate blood under FDA regulations (21 CFR Part 630) and all donations intended for transfusion are tested for relevant transfusion-transmitted infections (21 CFR 610.40). FDA noted that studies suggest directed donations may carry a greater risk of infectious disease transmission compared with the general blood supply. The agency further stated that “the selection of blood or blood components based on donor characteristics that are not supported by scientific evidence might delay or interfere with appropriate medical intervention and life-saving blood transfusion.” 

In addition, FDA addressed the emerging issue of websites purporting to offer blood and blood components from donors who have not been vaccinated against COVID-19. These websites charge individuals for membership to receive directed donations from unvaccinated donors in the future.  

“The justification for such requests and services may be based on misinformation and is not supported by any medical or scientific evidence,” the communication read. In addition, the practice of “personally chosen” directed donors that are not medically indicated has been discouraged in a joint statement by AABB, America’s Blood Centers and the American Red Cross.  

FDA concluded by encouraging consumers and health care professionals to exercise caution about websites offering memberships for delivery of blood and blood components from blood donors who are not vaccinated against COVID-19. The agency also reminded owners or operators of establishments that manufacture blood products that they must register with the FDA and comply with all federal regulations related to registration, blood product listing and labeling. The agency cautioned that “blood and blood components labeled in a manner that is false or misleading are misbranded and are in violation of section 502(a) of the Federal Food, Drug, and Cosmetic Act.” 

The agency will continue to closely monitor this issue and take additional actions, as appropriate. AABB encourages all patients to seek treatment from an FDA-licensed or registered transfusion facility that is also AABB accredited.