REGULATORY UPDATE: FDA Clarifies Blood Labeling Requirements Related to COVID-19 Vaccination of Donors

AABB contacted the Food and Drug Administration to confirm the Association’s understanding of the requirements and limitations related to labeling of blood and blood components based on donor COVID-19 vaccination status. AABB is grateful for FDA’s prompt response and support.

FDA provided a formal response to AABB’s inquiry regarding the expectations that blood components could be provided to patients with a label claiming to be vaccine free or mRNA vaccine free:

“As noted in our Oct. 23, 2023, communication (Important Information About Directed Blood Donations that are Not Medically Indicated | FDA ), the justification for such requests and services may be based on misinformation and is not supported by any medical or scientific evidence. In addition, there is no validated method or test to determine whether a donor received an mRNA vaccine.

Blood establishments must label blood components according to the requirements of 21 CFR Part 606.121 and 606.122. 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."

Questions may be sent to regulatory@aabb.org or directly to FDA.