Description
This guidance is intended to help manufacturers/processors of low-moisture, ready-to-eat (LMRTE) human foods comply with 21 CFR part 117 (part 117). Examples of manufactured/processed LMRTE foods that must be produced in accordance with the requirements of part 117 include powdered infant formula (PIF), peanut butter, nut butters, powdered drink mixes, chocolate, medical foods in powdered and paste forms, processed tree nuts, milk powders, powdered spices, snack foods such as chips and crackers, granola bars, and dry cereal. This guidance also is intended to help manufacturers/processors of PIF comply with 21 CFR part 106 (part 106). The recommendations in this guidance can help manufacturers/processors of LMRTE foods comply with the requirements for current good manufacturing practices (CGMPs), hazard analysis, and risk-based preventive controls to ensure a safe and sanitary food supply for these foods.
Scope & Applicability
Product Classes
7Primary scope of the guidance document; Draft guidance for establishing sanitation programs for LMRTE foods.; LMRTE; the primary scope of the guidance; Applicability of recommendations for manufacturers of LMRTE food.
Low-Moisture Ready-to-Eat Human Foods
Specific LMRTE food subject to Part 106 and Part 117; Plants that produce PIF are susceptible to Cronobacter establishment.; Specific food category with prescribed testing requirements; subject to part 106 requirements; PIF; specific category of low-moisture food; Specific product category subject to Part 106; Non-exempt PIF manufacturing requirements.
Example of LMRTE food in powdered and paste forms
Dry food production environment susceptible to pathogens.
Low-moisture ready-to-eat food
Powdered Infant Formula
Stakeholders
3Entities responsible for compliance with Part 117 and Part 106
exempt from certain preventive controls requirements, e.g., very small business
Team with expertise to plan and oversee wet cleaning
Regulatory Context
Attributes
2Lack of change to water activity
Facility area where water use is restricted
Identified Hazards
Hazards
5Contamination of food or food-contact surfaces with a pathogen; contamination of food or FCS with a pathogen
Presence of harmful microorganisms in the environment or food
A pathogen capable of surviving and persisting with the manufacturing processing environment
Environmental pathogen linked to low-moisture foods; Pathogen of concern in low-moisture foods; Study evaluated survival of Salmonella on inert contact surfaces.
Pathogen of concern in powdered infant formula
Related CFR Sections (15)
- 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 →
- 21CFR117.5§ 117.5 Exemptions.
(a) Except as provided by subpart E of this part , subparts C and G of this part do not apply to a qualified facility. Qualified facilities are subject to the modified requirements in § 117.201 .Read full regulation →
- 21CFR106.55§ 106.55 Controls to prevent adulteration from microorganisms.
(a) A manufacturer of infant formula shall establish a system of process controls covering all stages of processing that is designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment.Read full regulation →
- 21CFR117.130§ 117.130 Hazard analysis.
(a) Requirement for a hazard analysis.Read full regulation →
- 21CFR117.35§ 117.35 Sanitary operations.
(a) General maintenance. Buildings, fixtures, and other physical facilities of the plant must be maintained in a clean and sanitary condition and must be kept in repair adequate to prevent food from becoming adulterated. Cleaning and sanitizing of utensils and equipment must be conducted in a mannerRead full regulation →
- 21CFR117.170§ 117.170 Reanalysis.
(a) You must conduct a reanalysis of the food safety plan as a whole at least once every 3 years;Read full regulation →
- 21CFR106.70§ 106.70 Controls on the release of finished infant formula.
(a) A manufacturer shall control under a quarantine system designed to prevent use or distribution of each production aggregate of infant formula until it determines that the production aggregate meets all of the manufacturer's specifications, including those adopted to meet the standards of § 106.5Read full regulation →
- 21CFR117.80§ 117.80 Processes and controls.
(a) General.Read full regulation →
- 21CFR117.165§ 117.165 Verification of implementation and effectiveness.
(a) Verification activities. You must verify that the preventive controls are consistently implemented and are effectively and significantly minimizing or preventing the hazards. To do so you must conduct activities that include the following, as appropriate to the facility, the food, and the natureRead full regulation →
- 21CFR117.150§ 117.150 Corrective actions and corrections.
(a) Corrective action procedures. As appropriate to the nature of the hazard and the nature of the preventive control, except as provided by paragraph (c) of this section:Read full regulation →
- 21CFR117.190§ 117.190 Implementation records required for this subpart.
(a) You must establish and maintain the following records documenting implementation of the food safety plan:Read full regulation →
- 21CFR117.155§ 117.155 Verification.
(a) Verification activities. Verification activities must include, as appropriate to the nature of the preventive control and its role in the facility's food safety system:Read full regulation →
- 21CFR117.126§ 117.126 Food safety plan.
(a) Requirement for a food safety plan.Read full regulation →
- 21CFR1.227§ 1.227 What definitions apply to this subpart?
The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this subpart. In addition, for the purposes of this subpart:Read full regulation →
- 21CFR117.3§ 117.3 Definitions.
The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this part. The following definitions also apply:Read full regulation →
Related Warning Letters (10)
- 2025-11-11
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Compass Group USA
- 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
- 2025-08-26
Foreign Supplier Verification Program (FSVP)
Eurobread Inc. dba First Harvest
- 2025-08-19
Seafood HACCP/CGMP for Foods/Adulterated
Chaohu Daxin Foodstuffs Co., Ltd.
- 2025-06-24
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Marin Baking LLC
- 2025-06-24
Food Labeling/Misbranded
Revolution Foods, PBC
- 2025-06-03
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
One Roof LLC
- 2025-06-03
CGMP/Hazard Analysis/Risk-Based Preventive Controls for Food/Adulterated
La Milagrosa 1 LLC
See Also (8)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)
- CPG Sec. 454.100 OTC Ear Drop Preparations (Status: Final)
- CPG Sec. 430.300 Labeling Shipping Containers of Drugs (Status: Final)
- CPG Sec. 455.100 Inert Glandular Preparations *(OTC)*, Inadequate Full Disclosure and Claims (Status: Final)