Tag Archives: FDA guidance documents

FDA Logo
Beltway Beat

Foods Program Guidance Under Development

By Food Safety Tech Staff
No Comments
FDA Logo

FDA announced a list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the FDA’s Human Foods Program is considering. The announcement states that “We currently intend to develop guidance on each topic; however, the FDA’s Human Foods Program is neither bound by this list of topics, nor required to issue every guidance document on this list.”

Several factors may impact FDA’s ability to issue the listed guidances, including, for example, new Administration priorities, emerging public health issues, or other extenuating circumstances. FDA claims they are not precluded from issuing guidance documents on topics not on this list.

You may submit comments on the guidance topics at www.regulations.gov at Docket FDA-2022-D-2088.

Guidance for Industry

Food Chemical Safety, Dietary Supplements, and Innovation

Title of Guidance

Action Levels for Cadmium in Processed Food Intended for Babies and Young Children; Draft
Guidance for Industry
Action Levels for Inorganic Arsenic in Food Intended for Babies and Young Children; Draft Guidance for Industry
Action Level for Opiate Alkaloids on Poppy Seeds; Draft Guidance for Industry
Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food; Chapter 12: Preventive Controls for Chemical Hazards; Draft Guidance for Industry
New Dietary Ingredient (NDI) Notifications and Related Issues: Identity and Safety Information About the NDI; Guidance for Industry

Microbiological Food Safety

Title of Guidance

Preventing Contamination of Low-Moisture Ready-to-Eat Human Foods and Remediating a Pathogen Contamination Event if Prevention Fails; Revised Draft Guidance for Industry
Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce; Guidance for Industry
Hazard Analysis and Risk-Based Preventive Controls for Human Food: Chapter 10: Sanitation Program; Draft Guidance for Industry
The Accredited Third-Party Certification Program: Questions and Answers; Guidance for Industry
Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories: Guidance for Industry

 

FDA Logo

FDA Releases Small Entity Compliance Guide for the Food Traceability Rule

FDA Logo

The FDA has released a Small Entity Compliance Guide for the FSMA Food Traceability Rule. This guidance document is intended to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule. It offers recommendations—unless specific regulatory or statutory requirements are cited—on how small entities can comply with the new regulations, which were issued in November 2022. The compliance date for recordkeeping requirements is Jan. 20, 2026.

The guidance document covers:

  • Who is subject to the traceability rule
  • Who is exempt
  • What records must be kept, and for how long
  • How to apply for a modification or exemption
  • How to petition the FDA for waivers
  • Consequences of failure to comply

Download the compliance guide here.