FDA Statement on the Use of Sodium Nitrite

June 23, 2020 — 

In correspondence with the USDA, the Food and Drug Administration (FDA) provided the following statement regarding the use of sodium nitrite for the depopulation of swine during the COVID-19 pandemic:

"We are aware of the impact COVID-19 has had on the swine processing industry, as well as the ancillary impact on swine producers' ability to ship hogs for slaughter, thus creating a need for depopulation. We understand that these depopulation activities are being monitored by APHIS/VS and the swine industry is testing the use of encapsulated sodium nitrite as a depopulation agent.

"CVM has regulatory responsibility for animal drugs as well as animal food. Sodium nitrite intended for depopulation of swine is considered a drug under section 201(g)(1)(C) of the Federal Food, Drug and Cosmetic Act (FD&C Act), as it is intended to affect the structure or function of the body of swine by causing death, and a new animal drug under section 201(v) of the FD&C Act.

"We have limited information about the use of sodium nitrite for depopulation and its safety and effectiveness has not been established. We also have limited information regarding the likelihood of the presence of unsafe residues in the tissues of swine administered this drug. For the duration of the public health emergency declared by Department of Health and Human Services Secretary Alex Azar on January 31, 2020, or until further notice by CVM, whichever occurs first, CVM will not object to the use of sodium nitrite to depopulate production swine, provided the following conditions are met:

• Swine depopulated with sodium nitrite do not enter the human or animal food supply, including through the edible rendering process. We do not object to rendering for non-food use (such as biodiesel or other industrial ingredients) as long as no rendered material enters the human or animal food supply.
• Disposal of remains, including rendered materials, must be in conformance with federal, state and local environmental regulations.
• Sodium nitrite is presented in a concentration and form that ensures ingestion at a level that results in a toxic dose and death within an acceptable time frame (i.e., 1-3 hours).

"Please note that our current position is the result of the unusual circumstances that have arisen due to the COVID-19 pandemic. We may reevaluate this position if we become aware of any changes in the potential risks posed or for other reasons, we determine are appropriate. If you have any questions or need further assistance, please contact me, Eric Nelson at 240-402-5642 or eric.nelson@fda.hhs.gov."

Eric M Nelson
Director of Compliance
FDA/Center for Veterinary Medicine (HFV-230)
7519 Standish Place Rockville, MD 20855-2773
office: (240) 402-5642
fax: (240) 276-9241
e-mail: Eric.Nelson@fda.hhs.gov