Category Archives: Blog

The FDA posted new frequently asked questions and additional tools to provide industry with more information about the FDA Food Safety Modernization Act (FSMA) Food Traceability Rule.

The Food Traceability Rule is designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and deaths. Foods subject to the final rule requirements appear on the Food Traceability List (FTL).

The new FAQs address questions to help clarify how the rule applies to specific situations and are largely based on questions received during the FDA’s regular interactions with industry and on questions sent via the Technical Assistance Network, a central source of information for questions related to the FSMA rules, programs, and implementation strategies.

Along with the FAQs, additional tools developed to help further educate and inform industry subject to the Food Traceability Rule are accessible from the FDA’s traceability website, including:

  • addition of the results for all foods and associated commodity-hazard pairs included in the Risk-Ranking Model for Food Tracing – beyond what appear on the food traceability list,
  • additional description on the Food Traceability List webpage to clarify that “nut butters” include all forms of nut butters – shelf-stable, refrigerated, and frozen products,
  • eight new supply chain examples that illustrate how the rule is applied in different scenarios for different commodities,
  • What you need to know about the Food Traceability Rule fact sheets:
    • Recordkeeping Information for Produce Farms
    • Coverage and Exemption for Produce Farms
  • guide to Getting Started with the Food Traceability Rule
  • additional foreign language translations of the Critical Tracking Event and Key Data Elements interactive tool and supply chain examples.

The compliance date for all persons subject to the Food Traceability Rule is January 20, 2026.

The rule is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA).

Resources:

Traceability Rule: Federal Register Notice

Full and Partial Exemptions to the Food Traceability Rule

The US Food and Drug Administration has issued a 30-day procedural notice on its plans to conduct a study entitled “Quantitative Research on Front of Package Labeling on Packaged Foods.” The study is a follow up to focus groups conducted in 2022 to further explore consumer responses to various front-of-package labeling schemes. As part of the Paperwork Reduction Act, federal agencies are required to publish a notice in the Federal Register on each proposed information collection to give the public the opportunity to comment.

The FDA is conducting this consumer research to help explore the development of a front-of-package labeling scheme, which is part of the National Strategy on Hunger, Nutrition, and Health, issued as part of the White House Conference held in September 2022 focused on ending hunger and reducing diet-related disease. Front-of-package labeling is intended to complement the Nutrition Facts label on packaged foods by giving consumers additional context to help them identify healthier food selections. A standardized, science-based scheme could help consumers, particularly those with less nutrition knowledge, quickly and easily identify foods that can help them build a healthy eating pattern. The experiences of countries worldwide that have adopted front-of-package labeling suggest that such labeling may help nutrition comprehension and the ability to make healthier choices.

The U.S. continues to face an epidemic of diet-related chronic diseases, many of which are experienced disproportionately by racial and ethnic minority groups, those with lower socioeconomic status, and those living in rural areas. To help address this, the FDA is continuing to prioritize its nutrition activities to help empower consumers with nutrition information to identify healthier choices more easily. The consumer research the FDA is announcing today is intended to further inform our work in this important area.

The comment period opens June 15, 2023. Comments on the notice are due to OMB by July 17, 2023. To find this information collection, visit Docket No. FDA-2023-N-0155 on Regulations.gov and select “Currently Under Review – Open for Public Comments” or use the search function. See the Federal Register notice for additional information on commenting.

For Additional Information

Federal Register Notice

Food Labeling & Nutrition

Front-of-Package Nutrition Labeling

The US Food and Drug Administration (FDA) is extending the comment period for the Draft Guidance for Industry entitled “Questions and Answers About Dietary Guidance Statements in Food Labeling” that appeared in the Federal Register on March 27, 2023. The new deadline for comments is September 25, 2023. The FDA is extending the comment period by 90 days in response to multiple requests from stakeholders to allow additional time for interested persons to develop and submit comments. Comments should be submitted to Regulations.gov and identified with the docket number FDA-2023-D-1027.

The US Food and Drug Administration (FDA) has released a draft Compliance Policy Guide to provide guidance for FDA staff on the FDA’s enforcement policy regarding major food allergen labeling and cross-contact. The draft CPG more accurately reflects FDA’s thinking on major food allergen enforcement policy based on the current regulatory framework and latest science. When finalized, it will replace the existing CPG 555.250 for FDA staff.

Among the updates, the draft CPG describes the labeling requirements for major food allergens and the proper use of the ingredient list and the “Contains” statement for major food allergen declarations. It also describes requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact. Further, the draft CPG describes additional allergen labeling violations. It also directs FDA staff to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations. The updated CPG reflects the FDA’s risk-based and science-based approach for the evaluation of potential allergen violations.

The FDA is aware that some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence. While the draft CPG does not specifically address the issue of industry adding sesame to products that did not previously contain it, the draft CPG does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame. The FDA is engaged with various stakeholders on this issue. The FDA recognizes that this practice may make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume-an outcome that the FDA does not support.

To ensure that comments are received before work begins on the final version of the guidance, submit electronic or written comments within 60 days of publication in the Federal Register. Submit electronic comments to http://www.regulations.gov. All comments should be identified with the docket number FDA-2023-D-1103. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

For More Information:

Federal Register notice

Compliance Policy Guide Sec. 555.250 DRAFT: Major Food Allergen Labeling and Cross-contact

Food Allergies

News from AAFC’s Market Access Secretariat

This message is to inform you that the South Africa has notified to the World Trade Organization (WTO) a set of new regulations relating to the labelling and advertising of foodstuffs. The full text of the measure in English is available here:https://members.wto.org/crnattachments/2023/TBT/ZAF/23_9235_01_e.pdf.

The new regulation will enter into force once comments received have been considered and after publication of the final regulations.  Comments and concerns from WTO member states will be possible until June 12, 2023.

Please provide any comments you may have on this measure to aafc.mas-sam.aac@agr.gc.ca by May 26, 2023.