Food Industry Regulatory Update December 10, 2024

In This Week’s Edition:

  • FDA Seeks Food Date Labeling Info
  • Scientific Report of 2025 Dietary Guidelines Published
  • ITC to Review Mexican Tomato Case
  • FTC: Key Takeaways From Four Recent Cases on Consumer Location Data Violations
  • Best Practices for FDA Communication With Interested Parties: Draft Report for Public Comment
  • FDA Report and Plan on Best Practices for Guidance
  • FDA Issues Guidance on Notifying FDA of a Permanent Discontinuance in the Manufacture of an Infant Formula
  • FDA Issues 2024 Voluntary National Retail Food Regulatory Program Standards
  • FDA CORE Outbreak Investigation Status Update
  • FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
  • FDA Import Alerts
  • FDA Warning Letters

FDA Seeks Food Date Labeling Info

FDA and USDA are announcing a joint Request for Information (RFI) about food date labeling, which includes the use of terms such as “Sell By,” “Use By” and “Best By”. The RFI seeks information on industry practices and preferences for date labeling, research results on consumer perceptions of date labeling and any impact date labeling may have on food waste and grocery costs.

Scientific Report of 2025 Dietary Guidelines Published

The Scientific Report of the 2025 Dietary Guidelines Advisory Committee is now available on DietaryGuidelines.gov. The report contains the 2025 Dietary Guidelines Advisory Committee’s (Committee) independent, evidence-based findings and advice to the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA). The Scientific Report, alongside public comments and federal agency input, will inform the two departments as they develop the Dietary Guidelines for Americans, 2025-2030, which is expected to be published in late 2025.

ITC to Review Mexican Tomato Case

The Commission hereby gives notice that it will proceed with a full review pursuant to the Tariff Act of 1930 to determine whether termination of the suspended investigation on fresh tomatoes from Mexico would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. A schedule for the review will be established and announced at a later date.

FTC: Key Takeaways From Four Recent Cases on Consumer Location Data Violations

Since the start of this year, the FTC has announced four groundbreaking cases addressing issues with how businesses collect and, in some cases misuse, people’s location data. If your business collects, buys, sells, or uses location data, take a minute to read about the FTC’s most recent enforcement actions against data brokers and aggregators — Mobilewalla, Gravy/Venntel, InMarket, and X-Mode/Outlogic — and consider these takeaways:

  • Location data is sensitive personal information.
  • Certain sensitive location data should never be used or sold.
  • Get people’s permission and monitor the companies you work with.
  • Transparency is key.
  • Assess your risks, and establish and maintain a robust privacy program designed to protect location data and other personal information.

Best Practices for FDA Communication With Interested Parties: Draft Report for Public Comment

FDA is announcing the availability of a draft document entitled “Best Practices for FDA Communication with Interested Parties: Draft Report for Public Comment.” This draft report and implementation plan respond to the Consolidated Appropriations Act of 2023, which directs FDA to issue a report on FDA’s practices for broadly communicating with external interested parties and a plan for implementation of such best practices. In addition, FDA is to conduct a review of the types and methods of public communication that FDA uses to communicate and interact with medical product sponsors and other external interested parties; identify best practices for the efficient development, issuance, and use of such communications; and develop a plan for implementation of best practices for these communications. As directed, FDA is publishing and soliciting feedback on this draft report and implementation plan.

FDA Report and Plan on Best Practices for Guidance

FDA is announcing the availability of a document entitled “Food and Drug Administration Report and Plan on Best Practices for Guidance” (Report and Plan). FDA is publishing this Report and Plan in response to the Consolidated Appropriations Act, 2023, which directs FDA to issue a report identifying best practices for the efficient prioritization, development, issuance, and use of guidance documents and a plan for implementation of such best practices.

FDA Issues Guidance on Notifying FDA of a Permanent Discontinuance in the Manufacture of an Infant Formula

FDA has issued draft guidance outlining the requirements and procedures that infant formula manufacturers should follow to notify the FDA of a permanent discontinuance or an interruption of the manufacture of infant formula that is likely to lead to a meaningful disruption in the supply of such infant formula in the United States. The draft guidance titled “Notifying FDA of a Permanent Discontinuance in the Manufacture or an Interruption of the Manufacture of an Infant Formula” is intended to help the infant formula industry comply with section 424 of the Federal Food, Drug, and Cosmetic Act which requires, in part, infant formula manufacturers to notify the FDA of a permanent discontinuance in the manufacture or an interruption of the manufacture of infant formula that is likely to lead to a meaningful disruption in the supply of such infant formula in the United States.

FDA Issues 2024 Voluntary National Retail Food Regulatory Program Standards

FDA issued the 2024 edition of the Voluntary National Retail Food Regulatory Program Standards, which defines the key elements of an effective retail food regulatory program for state, local, tribal, and territorial food regulatory agencies.

FDA CORE Outbreak Investigation Status Update

This week’s updates are:

  • The FDA and CDC, in collaboration with state and local partners are investigating illnesses in a multistate outbreak of E. coli O157 (ref #1280) infections linked to an iceberg and romaine lettuce blend served at catering events, restaurants, and a school. Based on epidemiological information collected by CDC, a total of 69 people infected with the same strain of E. coli O157 have been reported from 10 states. FDA’s traceback investigation has identified an iceberg and romaine lettuce blend from a common supplier as the source of this outbreak; however, impacted product identified to date appears to be past shelf life and no longer on the market. FDA is continuing to work with the supplier to determine if any additional product could be impacted. At this time, there does not appear to be any ongoing risk to public health and there is no recommendation for consumers to avoid iceberg or romaine lettuce. FDA’s investigation is ongoing, and more information will be provided as it becomes available.

CORE Investigation Table

FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.

FDA Import Alerts

The latest FDA import alerts include human food products that appear to be adulterated, food products that are/contain unsafe food additives, and more.

FDA Food Industry Warning Letters

Mena Food Group, LLC 
CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions 
Calavo Growers, Inc. 
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated