Food Industry Regulatory Update October 4, 2024

In This Week’s Edition:

  • FDA Streamlined Complaint Process
  • APHIS Publishes Pest Risk Assessment for Importation of Lemon, Grapefruit, Mandarin and Sweet Orange From Botswana
  • Cell-Cultured Meat and Poultry Products Sampling Program
  • Modernization of Permit Application Requirements for Wine Premises
  • FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect
  • USDA Food Safety and Inspection Service Foreign Audit Report: Germany
  • FSIS Posts New Beef Intended Use Infographic for Retailers
  • 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 Streamlined Complaint Process

FDA’s Human Foods Program (HFP) is announcing a new, streamlined approach for processing complaints, including whistleblower complaints, that will improve the Agency’s ability to detect and respond to problems related to FDA-regulated products and better protect public health. A complaint may be about an illness, injury, allergic reaction, or other health-related issue or about defects in the quality or safety of an FDA-regulated food, dietary supplement, or cosmetic product. Now, the public will be able to direct complaints about foods and dietary supplements to HFP by using FDA’s online reporting forms.

APHIS Publishes Pest Risk Assessment for Importation of Lemon, Grapefruit, Mandarin and Sweet Orange From Botswana

USDA’s APHIS has drafted a pest risk assessment that describes potential pests associated with importing fresh commercially produced citrus fruits from Botswana into the United States. The PRA evaluates pest risk presented by lemon, grapefruit, mandarin, and sweet orange from Botswana for consumption.

Cell-Cultured Meat and Poultry Products Sampling Program

FSIS has published a notice that provides instructions to staff from FSIS Notice 31-23, Cell-Cultured Meat and Poultry Food Products Sampling Program, and has been updated to provide that after the initial 10 samples for a specific cell line or production method have been collected, FSIS will sample quarterly. This notice also provides instructions to inspection program personnel on how to collect cell-cultured meat and poultry food products and send samples to the FSIS Eastern Laboratory, in Athens, GA for microbiological, chemical residue, speciation testing, and pathology.

Modernization of Permit Application Requirements for Wine Premises

In this notice of proposed rulemaking, the Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes deregulatory amendments to its regulations to modernize and streamline the application requirements for wine premises. The proposed amendments also relax some reporting requirements associated with changes to the business of proprietors of wine premises. The proposed amendments are a result of TTB’s evaluation of its permit and registration application requirements and consideration of relevant public comments submitted to the Treasury Department in response to its request for recommendations concerning regulations that can be eliminated, modified, or streamlined to reduce burdens.

FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect

FDA has announced that the unified Human Foods Program, a new model for field operations and other modernization efforts is now in effect. This is the single largest reorganization in the agency’s modern history, as it impacts more than 8,000 employees and touches almost every facet of the FDA. The establishment of the Human Foods Program allows FDA to most effectively deliver on their mission to protect and promote public health through science-based approaches to prevent foodborne illness, reduce diet-related chronic disease, and ensure the safety of chemicals in our food. This will enable FDA to zero in on those issues where intervention has the greatest opportunity for the prevention of disease and for the promotion of wellness.

USDA Food Safety and Inspection Service Foreign Audit Report: Germany

FSIS maintains a list of comprehensive audits of foreign country inspection systems to ensure compliance with certain regulatory requirements. Germany has been added to this list.

FSIS Posts New Beef Intended Use Infographic for Retailers

FSIS posted a new Beef Intended Use infographic for retailers handling raw beef, on the FSIS Retail Guidance webpage. FSIS compliance investigators will use this infographic during retail outreach and education efforts. The infographic has been translated into multiple languages, which are available on the webpage.

FDA CORE Outbreak Investigation Status Update

This week’s updates are:

  • For the outbreak of E. coli O157:H7 (ref #1249) linked to a not yet identified product, FDA has initiated an inspection.

CORE Investigation Table

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 misbranded, food products that appear to be adulterated for economic gain, and more.

FDA Warning Letters

Healthwest Minerals, Inc. dba Mt. Capra Products 
Interstate Commerce/Food/Adulterated 
Troya Del Campo USA LLC 
Foreign Supplier Verification Program (FSVP) 
JJH Trading Inc. 
Foreign Supplier Verification Program (FSVP) 
Pacific Exchange Distributors LLC 
Foreign Supplier Verification Program (FSVP) 
Ice Cream House LLC 
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes 
NRS Enterprises, Inc. d/b/a Sunflour Bakery 
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated