Food Industry Regulatory Update August 9, 2024

In This Week’s Edition:

  • EPA Bans Chlorpyrifos in Food
  • FDA Releases Two Draft Guidances, Seeks Public Comment on Pre-market Animal Food Ingredient Review Programs as AAFCO MOU Expires
  • FSS Updates Directive on Safe and Suitable Ingredients
  • National Organic Program: 2025 Sunset Review and Substance Renewals
  • FDA Enforcement Policy for Association of American Feed Control Officials; Draft Guidance for Industry; Availability
  • GNT USA, LLC; Filing of Color Additive Petition
  • FDA CORE Outbreak Investigation Status Update
  • FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
  • FDA Import Alerts
  • FDA Warning Letters

EPA Bans Chlorpyrifos in Food

EPA took action after determining the use of the pesticide on foods is unsafe.

FDA Releases Two Draft Guidances, Seeks Public Comment on Pre-market Animal Food Ingredient Review Programs as AAFCO MOU Expires

FDA released a set of documents regarding the transition phase after the FDA’s longstanding Memorandum of Understanding with the Association of American Feed Control Officials expires on October 1, 2024. 

The release included draft guidance for industry #293 entitled “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.” This draft guidance, when finalized, will communicate FDA’s enforcement policy regarding ingredients listed in chapter six of the 2024 Association of American Feed Control Officials (AAFCO) Official Publication after the expiration of the Agency’s memorandum of understanding (MOU) with AAFCO. The current MOU, which expires in October 2024, will not be renewed.

FSIS Updates Directive on Safe and Suitable Ingredients

This directive provides inspection program personnel with the latest updates to the list of substances that may be used in the production of meat, poultry, and egg products. As a reminder, this directive no longer provides the complete listing of approved substances, On-Line Reprocessing and Off-Line Reprocessing Antimicrobial Intervention Systems. Instead, it only provides a list of the latest changes. 

National Organic Program: 2025 Sunset Review and Substance Renewals

This document announces the renewal of 47 substances listed on the National List of Allowed and Prohibited Substances within the USDA’s organic regulations. This document reflects the outcome of the 2025 sunset review processes and addresses recommendations submitted to the Secretary of Agriculture, through the USDA’s Agricultural Marketing Service, by the National Organic Standards Board.

GNT USA, LLC; Filing of Color Additive Petition

FDA is announcing that they have filed a petition, submitted by GNT USA, LLC, proposing 
that the color additive regulations be amended to provide for the safe use of spirulina extract in foods generally in amounts consistent with good manufacturing practice.

FDA CORE Outbreak Investigation Status Update

This week’s updates are:

  • An outbreak of Cyclospora cayetanensis illnesses (ref #1245) linked to a not yet identified product has been added to the table. FDA has initiated traceback.
  • An outbreak of Salmonella Newport (ref #1248) linked to a not yet identified product has been added to the table.
  • For the outbreak of Salmonella Irumu (ref #1235) linked to a not yet identified product, FDA has initiated sampling.  
  • For the outbreak of Salmonella Typhimurium (ref #1234) linked to a not yet identified product, the case count has increased from 87 to 88.
  • For the investigation of illnesses (ref #1233) linked to Diamond Shruumz-brand Chocolate Bars, Cones, and Gummies, the advisory has been updated to include additional illnesses.

CORE Investigation Table

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

FDA Import Alerts

The latest FDA import alerts include processed human foods for pesticides, food containing illegal and/or undeclared colors, and more.

FDA Warning Letters

Alohma LLC d/b/a Kure CBD & Vape 
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 
High Quality Organics, Inc. 
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 
Velocity Pharma LLC 
CGMP/Finished Pharmaceuticals/Adulterated 
La Parcela Produce LLC 
Foreign Supplier Verification Program (FSVP) 
Guangzhou Baiyunshan Jingxiutang Pharmaceutical Co. Ltd. 
CGMP/Finished Pharmaceuticals/Adulterated 
Omega Tech Labs LLC 
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug