Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2) | Guideline Explorer

Description

For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 301-436-1500 or the Center for Veterinary Medicine (CVM) at 240-276-9200.

Scope & Applicability

Product Classes

4

reportable food

Article of food with reasonable probability of causing serious adverse health consequences; Food that has a reasonable probability of causing serious adverse health consequences; An article of food for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death; instances of reportable food an admission that the food involved is adulterated

dietary supplements

Question regarding coverage under the rule

infant formula

Excluded from the definition of reportable food; Excluded from Reportable Food Registry but subject to notification requirements

Animal feed

Included in the definition of food

Stakeholders

5

responsible party

Entity required to submit clinical trial registration and results information.; Entity required to submit clinical trial information.

Safety Reporting Portal account holder

Individual linked to a single account for security purposes

authorized individual

Person authorized to submit a combined report on behalf of multiple facilities

Immediate Subsequent Recipient

Entities such as restaurants or supermarkets that acquired reportable food directly from the responsible party; FDA may require the foreign facility to identify the U.S. recipients

Immediate Previous Source

The entity from which the responsible party acquired the reportable food

Regulatory Context

Attributes

1

24 hours

Time limit for use or discard of compounded products after transfer from pharmacy

Identified Hazards

Hazards

6

serious adverse health consequences or death

Risk threshold for suspect and illegitimate product definitions

Potential health hazard

Information required in a notification to subsequent recipients

Salmonella

biological hazard in dried milk powder; Microbiological hazard in pet treats; hazard in animal-derived protein ingredients; biological hazard requiring control in turmeric

Clostridium botulinum

Toxin hazard in certain produce like mushrooms

Listeria monocytogenes

biological hazard in frozen ice cream novelty; Biological hazard in cheese

Undeclared major food allergen

Basis for a food being reportable under FALCPA

Related CFR Sections (4)

21CFR1.226§ 1.226 Who does not have to register under this subpart?
This subpart does not apply to the following facilities:Read full regulation →
21CFR1.225§ 1.225 Who must register under this subpart?
(a) You must register your facility under this subpart if you are the owner, operator, or agent in charge of either a domestic or foreign facility, as defined in this subpart, and your facility is engaged in the manufacturing/processing, packing, or holding of food for consumption in the United StatRead full regulation →
21CFR107.240§ 107.240 Notification requirements.
(a) Telephone report. When a determination is made that an infant formula is to be recalled, the recalling firm shall telephone within 24 hours the appropriate Food and Drug Administration district office listed in § 5.115 of this chapter and shall provide relevant information about the infant formuRead full regulation →
21CFR7.3§ 7.3 Definitions.
(a) Agency means the Food and Drug Administration.Read full regulation →