Food Industry Regulatory Update September 27, 2024

In This Week’s Edition:

  • FSMA Agricultural Water; Produce Safety Rule
  • FNS Withdraws Disaster Supplemental Nutrition Assistance Program Proposed Rule
  • APHIS to Allow Fresh Table Beet Root for Consumption from the UK Into the US
  • FDA Updates Compliance Program on Mycotoxins in Human Food
  • New FDA Video: Importing FDA-Regulated Seafood Products
  • FDA Advisory: Do Not Feed Certain Answers Pet Food for Dogs Due to Salmonella and Listeria monocytogenes
  • FDA CORE Outbreak Investigation Status Update
  • FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
  • FDA Import Alerts
  • FDA Warning Letters

FSMA Agricultural Water; Produce Safety Rule

FDA is announcing the availability of a guidance for industry entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide.” FDA is updating the small entity compliance guide to help small entities comply with revised requirements related to agricultural water in the “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” regulation.

FNS Withdraws Disaster Supplemental Nutrition Assistance Program Proposed Rule

This document informs the public that the Food and Nutrition Service of the USDA is withdrawing the proposed rule titled Supplemental Nutrition Assistance Program (SNAP): Disaster Supplemental Nutrition Assistance Program (D-SNAP) that published in the Federal Register on May 10, 2016. This rule would have amended the SNAP regulations to establish procedures for planning, requesting and operating D-SNAP.

APHIS to Allow Importation of Fresh Table Beet Root for Consumption From the UK Into the US

USDA is advising the public of our decision to authorize the importation of fresh table beet root for consumption from the United Kingdom into the continental United States, Hawaii, Puerto Rico, and the U.S. Virgin Islands. Based on findings of a pest risk analysis, which USDA made available to the public for review and comment through a previous notice, USDA has determined that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh table beet root from the United Kingdom.

FDA Updates Compliance Program on Mycotoxins in Human Foods

FDA updated the Mycotoxins in Domestic and Imported Human Foods Compliance Program to include the monitoring of additional mycotoxins of regulatory interest in human foods, specifically T-2/HT-2 toxins and zearalenone. The updated compliance program also reflects the transition by FDA regulatory laboratories to a multi-mycotoxin method for analysis in human foods, which will allow the agency to obtain results for multiple mycotoxins in a single sample analysis. The new data gained by the compliance program update will support enforcement actions, risk assessments, and international activities, as well as provide information on mycotoxin incidence, extent of contamination, and co-occurrence.

New FDA Video: Importing FDA-Regulated Seafood Products

FDA has released the third video in the “Importing FDA-Regulated Products” series. This new video provides an overview of the process for importing seafood, focusing on key regulatory requirements. It is designed to help importers, brokers, and foreign seafood producers better understand the steps involved in bringing safe and compliant seafood into the United States. 

FDA Advisory: Do Not Feed Certain Answers Pet Food for Dogs Due to Salmonella and Listeria monocytogenes

FDA is cautioning pet owners that samples of two Answers Pet Food products made by Lystn LLC tested positive for Salmonella, a third product tested positive for Listeria monocytogenes, and a fourth product tested positive for Salmonella and L. mono. The affected products are sold frozen in 4-pound cartons and consist of certain batches of Answers Pet Food Raw Beef Detailed Formula for Dogs, Answers Pet Food Raw Beef Straight Formula for Dogs, and Answers Pet Food Straight Chicken Formula for Dogs.

FDA CORE Outbreak Investigation Status Update

This week’s updates are:

  • For the outbreak of Cyclospora cayetanensis illnesses (ref #1245) linked to a not yet identified product, the case count has increased from 56 to 60.

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 and animal foods from foreign suppliers refusing FDA inspection, raw agricultural products for pesticides and more.

FDA Warning Letters

Aerosol and Liquid Packaging, Inc. 
CGMP/Finished Pharmaceuticals/Adulterated 
Nomida.biz 
Unapproved New Drugs/Misbranded
Azurity Pharmaceuticals, Inc. 
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug 
Wittman Pharma, Inc. 
CGMP/Finished Pharmaceuticals/Adulterated 
Brewing Market Coffee 
Acidified Foods/Emergency Permit Control/Adulterated
Restorative Botanicals, LLC 
CGMP/Dietary Supplement/Adulterated
Warbucks Seafood NY LLC 
Foreign Supplier Verification Program (FSVP) 
Accupack Midwest, Inc. 
CGMP/Finished Pharmaceuticals/Adulterated