Orientación preliminar de la industria: Preguntas y respuestas sobre el Registro de productos sanitarios en productos agroalimentarios, según establecido por la Ley de Enmiendas a la Alimentación y Medicamentos (FDA), 2007 (Edición 2) | Guideline Explorer

Scope & Applicability

Product Classes

6

Reportable Food

article of food that will cause serious adverse health consequences

Pet Foods

Category of safety information reported via the Safety Reporting Portal

Animal Drugs

Category of safety information reported via the Safety Reporting Portal

Dietary Supplement

Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.

Infant Formula

The primary product category covered by the guidance; Essential food product that is the sole source of nutrition for many infants.

Animal Feed

The primary product category regulated by this guidance.

Stakeholders

7

Responsible Party

food firms that are responsible parties as defined in the statute

Foreign public health official

FDA must notify these officials if an application is disapproved.

FDA District Office

Local FDA contact for notifications and diversion requests

Immediate Previous Source

The entity from which the responsible party acquired the reportable food

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

Public Health Officials

May submit instances of reportable food to the electronic portal

Owner, operator, or agent in charge

Persons to whom the PCHF requirements apply; Responsible for determining hazards requiring preventive controls; Person responsible for determining hazards requiring preventive control

Regulatory Context

Attributes

4

Confirmed positive

A result expected to be sufficiently reliable to trigger reporting

Public Disclosure

Availability of records under FOIA

Use-by Date

Product information typically found on packaging used for identification

Presumptive positive result

preliminary result that may or may not ultimately yield a confirmed positive result

Identified Hazards

Hazards

5

Salmonella

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

Potential Health Hazard

Information required in notifications regarding the nature of the problem

Serious adverse health consequences or death

Threshold for requiring an onsite audit of a supplier

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 (5)

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 →
21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.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 →