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GUIDANCE DOCUMENT

Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls Draft Guidance for Industry and FDA Staff September 2018

Draft

Not for implementation. Contains non-binding recommendations.

Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine
Office of Regulatory Affairs

This guidance provides information on how and when FDA intends to publicize the identities of retail consignees that may have received recalled human or animal foods. FDA will primarily focus on those recalls where there is a reasonable probability that the use of, or exposure to, the food will cause serious adverse health consequences or death to humans or animals, which are also referred to as Class I recalls, and where providing such information is needed to help consumers identify recalled food. Identifying retail consignees can be a time-consuming process that often involves obtaining information from multiple entities throughout a supply chain, including the recalling firm and intermediate distributors. Therefore, FDA’s goal is to collect, compile, and make public retail consignee lists for those food recalls where publicizing this additional information will be of the most use to help consumers identify recalled food and to determine whether that food is in their possession as effectively and quickly as possible. 


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
ORA Office of Strategic Planning and Operational Policy (OSPOP)
Contact for guidance document questions
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