Description
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables the FDA to better protect public health by helping to ensure the safety and security of the food supply. It requires FDA to promulgate food safety rules that focus on preventing food safety issues rather than relying on detecting issues and reacting to them after they occur.
Scope & Applicability
Product Classes
2Shorthand description for thermally processed low-acid foods packaged in hermetically sealed containers.
Subject of the guidance document regarding LACF regulation and FSMA.; Primary product category covered by the guidance.
Stakeholders
3Person qualified to prepare translations
persons affected by prior notice rules
Responsible for declaring acceptable market names on labels.
Identified Hazards
Hazards
4Chemical hazard that must be addressed in the food safety plan.
Hazards regulated under part 113 for LACF.
Risks addressed by food defense systems
Includes microbiological hazards like parasites and pathogens; Hazards associated with covered produce requiring controls.; Risks such as foodborne illness outbreaks.
Related CFR Sections (1)
Related Warning Letters (10)
- 2025-12-16
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Harbor Marine Product Inc.
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 2025-10-28
Foreign Supplier Verification Program (FSVP)
V & L Produce, Inc.
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Gracie's Kitchens, Inc.
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Hans Bakery Inc. d/b/a Andersen’s Bakery
- 2025-09-30
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Tan Nam Corporation
- 2025-09-09
Foreign Supplier Verification Program (FSVP)
Jalisco Fresh Produce, Inc.
- 2025-08-26
Foreign Supplier Verification Program (FSVP)
Eurobread Inc. dba First Harvest
- 2025-08-19
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
- 2025-07-15
Foreign Supplier Verification Program (FSVP)
A.D. Berries @ More LLC
See Also (8)
- Guidance for Industry: Frequently Asked Questions About Medical Foods - Third Edition (Status: Final)
- Guidance for Industry: Questions and Answers on Juice HACCP Regulation (Status: Final)
- Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act (Status: Final)
- Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507 (Status: Draft)
- CPG Sec 540.370 Fish and Fishery Products - Decomposition (Status: Final)
- CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and Omnivores (Status: Final)
- Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables (Status: Final)
- Guía para la industria: Evaluación de la inocuidad de los cultivos alimentarios para el consumo humano afectados por las inundaciones (Status: Final)