Food Industry Regulatory Update June 21, 2024

In This Week’s Edition:

  • Cottage Cheese Traceability Rule
  • FDA Takes Additional Steps Following Investigation of Elevated Lead and Chromium Levels in Apple Cinnamon Puree Products
  • Section 8e Import Inspection Fee Structure
  • USDA Recognizes National Pollinator Week
  • FDA CORE Outbreak Investigation Status Update
  • FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
  • FDA Import Alerts
  • FDA Warning Letters

Cottage Cheese Traceability Rule

FDA is proposing to grant an exemption for certain cottage cheese products from the requirements of the FSMA Section 204 Traceability Rule rule to provide regulatory relief.

FDA Increases Screening of Imports Following Investigation of Elevated Lead and Chromium Levels in Apple Cinnamon Puree Products

FDA is continuing to take steps following the investigation of lead and chromium in apple cinnamon fruit puree pouches this past fall that was prompted by findings of elevated blood lead levels in children. This includes increasing screening of imports. While initial response activities to investigate the source of the contamination and prevent additional illnesses are completed, the Agency is continuing to explore prevention, compliance, and surveillance activities going forward.

Section 8e Import Inspection Fee Structure

USDA’s AMS proposes to revise the regulations governing the inspection and certification for fresh fruits, vegetables, and other products by amending certain fees charged for Section 8e import inspections from a per-carlot basis to a per-pound basis, reducing the fee for each additional sublot by 50 percent, and establishing a new fee calculation for lots less than a carlot. 

USDA Recognizes National Pollinator Week

During the week of June 17-23, 2024, USDA is recognizing and celebrating National Pollinator Week. Pollinator species, such as bees, other insects, birds and bats play a critical role in producing more than 100 crops grown in the United States.

FDA CORE Outbreak Investigation Status Update

This week’s updates are:

  • A new outbreak of Salmonella Typhimurium (ref # 1234) linked to a not yet identified product has been added to the table. FDA’s investigation is ongoing.
  • 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 and investigation updates. FDA has initiated traceback and an onsite inspection.
  • For the outbreak of Salmonella Typhimurium linked to fresh, organic basil (ref #1218) the outbreak is over and FDA’s investigation is complete.

CORE Investigation Table

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

FDA Import Alerts

The latest FDA import alerts include imported food products that appear to be misbranded, food products due to the presence of salmonella, and more.

FDA Warning Letters

Dollar Tree Inc. 
Adulterated Human Foods 
Landy International 
CGMP/Finished Pharmaceuticals/Adulterated 
McClure’s Lancaster Old Fashioned, LLC 
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated 
Angela D. Ritter, M.D. 
Clinical Investigator (Sponsor) 
VP Global, LLC d/b/a Super Vape Pirates 
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded 
Premier Manufacturing Products, LLC 
Finished Pharmaceuticals/Unapproved New Drug 
Aqualex Co., Ltd. 
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Adulterated
Neobiosis, LLC 
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) 
GFA Production Xiamen Co., Ltd. 
CGMP/Finished Pharmaceuticals/Adulterated 
Chang and Son Enterprises, Inc. 
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes 
J&R Produce, Inc. 
Foreign Supplier Verification Program (FSVP)