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- FDA Enforcement Policy for Association of American Feed Control Officials; Draft Guidance for Industry; Availability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The release included draft guidance for industry #293 entitled “FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients.” This draft guidance, when finalized, will communicate FDA’s enforcement policy regarding ingredients listed in chapter six of the 2024 Association of American Feed Control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.
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 |