Scope & Applicability
Product Classes
6article of food that will cause serious adverse health consequences
The primary product category regulated by this guidance.
Category of safety information reported via the Safety Reporting Portal
Category of safety information reported via the Safety Reporting Portal
Products containing dietary ingredients intended to supplement the diet; The final product category for which the NDI is intended.
The primary product category covered by the guidance; Essential food product that is the sole source of nutrition for many infants.
Stakeholders
9food firms that are responsible parties as defined in the statute
Entities that received the reportable food
Official who may submit voluntary reports
Officials who may submit voluntary reports or identify reportable foods
User role allowed to log in and amend reports directly
The entity from which the responsible party acquired the reportable food
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
May submit instances of reportable food to the electronic portal
The individual required to sign the Food Defense Plan.
Regulatory Context
Attributes
2Initial test result that may trigger reporting evaluation
Product information typically found on packaging used for identification
Identified Hazards
Hazards
5biological hazard in dried milk powder; Microbiological hazard in pet treats; hazard in animal-derived protein ingredients; biological hazard requiring control in turmeric
Information required in notifications regarding the nature of the problem
Probability of harm to humans or animals
biological hazard in frozen ice cream novelty; Biological hazard in cheese
Basis for a food being reportable under FALCPA
Related CFR Sections (5)
- 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 →
- 21CFR1.226§ 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 →
See Also (8)
- Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 460.100 Hospital Pharmacies - Status as Drug Manufacturer (Status: Final)
- CPG Sec. 442.100 New Drugs - Export (Status: Final)
- CPG Sec. 400.325 Candy "Pills" Representation as Drug (Status: Final)
- CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines (Status: Final)
- CPG Sec. 446.100 Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations (Status: Final)
- CPG Sec. 450.300 OTC Drugs - General Provisions and Administrative Procedures for Marketing Combination Products (Status: Final)
- CPG Sec. 400.500 Identical or Similar Product Names (Status: Final)