Description
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, defined 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.
Scope & Applicability
Product Classes
3foods sold individually that may lack identifiers
Substances used in animal food evaluated for safety.; Substances intended for use in food for animals.
Substances used in human food evaluated for safety.; Substances intended for use in food for humans.
Stakeholders
4delivers food products directly to the consumer
Entities in the supply chain between the manufacturer and retailer; entities that do not sell food directly to consumers
The firm that initiates a recall or has primary responsibility for manufacture and marketing.
Identities of entities that may have received recalled human or animal foods; retail establishments that have received or otherwise possess recalled food and sell directly to consumers
Regulatory Context
Attributes
1An increase in this attribute generally does not require a new 510(k) if protocols are met.
Identified Hazards
Hazards
1Public health risk the rule aims to mitigate; Public health threat requiring rapid identification of recipients
Related CFR Sections (3)
- 21CFR7.3§ 7.3 Definitions.
(a) Agency means the Food and Drug Administration.Read full regulation →
- 21CFR20.91§ 20.91 Use of data or information for administrative or court enforcement action.
Nothing in this part or this chapter shall prevent the Food and Drug Administration from using any data or information, whether obtained voluntarily or involuntarily and whether or not it is available for public disclosure, as the basis for taking any administrative or court enforcement action withiRead full regulation →
- 21CFR7.42§ 7.42 Recall strategy.
(a) General.Read full regulation →
See Also (8)
- Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Public Warning-Notification of Recalls Under 21 CFR Part 7, Subpart C : Guidance for Industry and FDA Staff (Status: Final)
- CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (Status: Final)
- Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food (Status: Draft)
- Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff (Status: Final)
- Postmarket Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff (Status: Final)