Description
The regulation applies to juice sold as such or used as an ingredient in beverages. Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree. Juice produced by a person who operates a retail establishment as defined in § 120.3(e) are not covered by the regulation.
Scope & Applicability
Product Classes
2Hermetically sealed product that does not demonstrate microbial growth at room temperature
Product category subject to FDA HACCP regulations.
Stakeholders
2Entity type with specific compliance dates
An operation providing juice directly to consumers, exempt from HACCP but subject to labeling.
Regulatory Context
Attributes
1Most resistant microorganism of public health concern in a specific juice
Identified Hazards
Hazards
1Metal fragments, wood splinters, or plastic pieces in food
Related Warning Letters (10)
- 2024-06-25
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Tamara Fruit CJSC
- 2024-06-25
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Raya Green Coconut Co.
- 2024-05-14
Juice/HACCP/Adulterated
G.N.R. Group Co., LTD.
- 2024-04-02
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Thuan Thien Producing Trading Limited Company
- 2024-03-05
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Barsotti Juice Company, Inc.
- 2023-08-22
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Sol-ti Inc.
- 2023-05-02
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Juicer Connections, Inc.
- 2023-03-28
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Liberty Fruit Co. Inc. DBA Carol’s Cuts
- 2022-12-27
Juice HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Bainbridge Beverage West, LLC
- 2022-09-13
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Chaur Fong Inc. dba 888 Food Company
See Also (8)
- Guidance for Industry: Frequently Asked Questions About Medical Foods - Third Edition (Status: Final)
- Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act (Status: Final)
- Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation 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- Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507 (Status: Draft)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)