“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” said Luciana Borio, M.D., the FDA’s acting chief scientist. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

The first local or non-travel related transmission of Zika virus in the U.S. by mosquitoes was reported from Puerto Rico in December 2015; and soon thereafter, local transmission was reported in American Samoa and the U.S. Virgin Islands. In July 2016, the first cases of local or non-travel related transmission of Zika virus in the continental U.S. were reported in Miami-Dade County, Florida.


In addition to protecting the nation’s blood supply, the FDA works to protect the safety of our nation’s supply of human cells, tissues, and cellular and tissue-based products; supports the development and availability of diagnostic tests that may be useful for identifying the presence of or prior exposure to the Zika virus; works with commercial and government developers to advance the development of investigational vaccines and therapeutics; and monitors for fraudulent products and false product claims related the Zika virus.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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