Food Industry Regulatory Update January 13, 2025
In This Week’s Edition:
- FDA Guidance on Lead Levels
- Final Rule on Standards of Fill for Wine and Distilled Spirits
- FDA Update on Outbreak Investigation of Salmonella: Cucumbers
- FDA Releases a Print-ready Version of the 2022 FDA Food Code with Index
- FDA Publishes Guidance on Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Food
- FDA Updates Guidance on Animal Food Ingredient Consultation
- Evaluating the Public Health Importance of Food Allergen; Guidance for FDA Staff and Interested Parties Released
- FDA Publishes Guidance on Labeling of Plant-Based Alternatives to Animal-Derived Foods
- FDA Updates Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the FD&C Act
- Food Contact Notifications That Are No Longer Effective
- 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 Guidance on Lead Levels
FDA is announcing the availability of a final guidance for industry entitled “Action Levels for Lead in Processed Food Intended for Babies and Young Children.” The guidance establishes action levels for lead in certain processed foods intended for babies and young children less than 2 years old. The guidance is intended to set achievable action levels that will help further reduce lead in the food supply.
Final Rule on Standards of Fill for Wine and Distilled Spirits
The Alcohol and Tobacco Tax and Trade Bureau (TTB) has published a final rule which amends regulations that govern wine and distilled spirits containers to add 13 standards of fill for wine and 15 for distilled spirits. TTB is also amending its regulations to eliminate the distinction between standards of fill for distilled spirits in cans and those for distilled spirits in containers other than cans.
FDA Update on Outbreak Investigation of Salmonella: Cucumbers
The FDA, CDC, and state partners investigated a multistate outbreak of Salmonella Typhimurium infections linked to American/slicer cucumbers grown by Agrotato, S.A. de C.V. in Sonora, Mexico. As of January 8, 2025, 113 people infected with the outbreak strain of Salmonella were reported from 23 states. Of the 99 people for whom information was available, 28 were hospitalized. No deaths were reported. Of the 69 people interviewed, 56 reported eating or likely eating cucumbers. CDC declares the outbreak over.
FDA Releases a Print-ready Version of the 2022 FDA Food Code with Index
The complete 2022 Food Code print-ready version document with Index includes:
- Introductory material (i.e., the Front Cover, Previous Editions of the Code, Preface, and the Table of Contents)
- Codified text (Chapters 1 – 8)
- Index
- Annex Cover, Annexes (Annexes 1 – 7, Summary of Changes, and the back cover)
FDA Publsihes Guidance on Establishing Sanitation Programs for Low-Moisture Ready-To-Eat Human Foods
FDA is announcing the availability of a draft guidance for industry entitled “Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event.” The draft guidance, when finalized, will explain FDA’s current thinking on establishing a routine sanitation program for low-moisture ready-to-eat human foods that can help prevent contamination of food or a food-contact surface with a pathogen and will explain our current thinking for corrective actions, including corrective actions to remediate contamination of food-contact surfaces, if prevention fails.
FDA Updates Guidance on Animal Food Ingredient Consultation
FDA is announcing the availability of a final guidance for industry #294 entitled “Animal Food Ingredient Consultation (AFIC).” This guidance describes FDA’s interim AFIC process and explains one way FDA will work with firms that are developing animal food ingredients now that the Memorandum of Understanding with the Association of American Feed Control Officials expired on October 1, 2024, and while FDA evaluates the animal Food Additive Petition and Generally Recognized as Safe Notification programs.
Evaluating the Public Health Importance of Food Allergen; Guidance for FDA Staff and Interested Parties; Availability
FDA is announcing the availability of a final guidance for FDA staff and interested parties entitled “Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act.” This guidance document provides FDA’s current thinking on the approach they generally intend to take when they evaluate the public health importance of a food allergen other than one of the major food allergens (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, wheat, peanuts, soybean, and sesame) listed in the FD&C Act.
FDA Publishes Guidance on Labeling of Plant-Based Alternatives to Animal-Derived Foods
FDA is announcing the availability of a draft guidance for industry entitled “Labeling of Plant-Based Alternatives to Animal-Derived Foods.” This draft guidance, when finalized, will provide FDA’s recommendations on best practices for naming and labeling of certain plant-based foods that are marketed and sold as alternatives for animal-derived foods, especially in the absence of a common or usual name for the product.
FDA Updates Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the FD&C Act
FDA is announcing the availability of a revised final guidance for industry entitled “Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry.” The guidance explains FDA’s current thinking on a number of issues related to the labeling of food allergens, including requirements in the Food Allergen Labeling and Consumer Protection Act of 2004 and the Food Allergy Safety, Treatment, Education, and Research Act of 2021.
Food Contact Notifications That Are No Longer Effective
FDA is announcing its determination that the Food Contact Notifications listed in this notice are no longer effective. Several manufacturers notified FDA in writing that they ceased producing, supplying, or using the listed food contact substances for their intended use in the United States.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the outbreak of E. coli O157:H7 illnesses (ref #1280) linked to romaine lettuce, the outbreak has ended.
- For the outbreak of E. coli O157:H7 illnesses (ref #1269), FDA’s investigation is closed.
- For the outbreak of Salmonella Typhimurium illnesses (ref #1277) linked to American/slicer-type imported cucumber, the outbreak is over, and FDA’s investigation is closed. FDA has updated the advisory.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include food products that appear to be adulterated for economic gain, foods containing undeclared major food allergens, and more.
FDA Food Industry Warning Letters
| Candymar Produce Inc |
| Foreign Supplier Verification Program (FSVP) |