In This Week’s Edition:
- FDA Restructuring Human Foods Program
- FDA Announces Qualified Health Claim for Cocoa Flavanols and Reduced Risk of Cardiovascular Disease
- USDA Launches Pilot Cattle Contracts Library
- USDA Food Safety and Inspection Service Foreign Audit Reports Update
- Expansion of FSIS Non-O157 Toxin-producing Escherichia Coli Testing to Additional Raw Beef Products
- California and Imported Kiwifruit; Handling Regulations
- Cloth Sample Collection Method to Replace N60 Excision Sampling for Beef Manufacturing Trimmings and Bench Trim
- 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 Restructuring Human Foods Program
FDA Commisioner Robert M. Califf, M.D. announced a restructuring of the FDA Human Foods Program. The proposal would create a Human Foods Program under a single leader who reports directly to the Commissioner. Under the plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), as well as certain functions of the Office of Regulatory Affairs (ORA) will be unified into a newly envisioned organization called the Human Foods Program. The FDA will conduct a competitive national search for a Deputy Commissioner for Human Foods, who will oversee the Program.
FDA Announces Qualified Health Claim for Cocoa Flavanols and Reduced Risk of Cardiovascular Disease
FDA announced in a letter of enforcement discretion that it does not intend to object to the use of certain qualified health claims regarding the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease for conventional foods, provided that the qualified claim is appropriately worded so as not to mislead consumers and that other factors for the use of the claim are met.
USDA Launches Pilot Cattle Contracts Library
USDA launched its pilot Cattle Contracts Library on the AMS Cattle Contract Library webpage. The Consolidated Appropriations Act of 2022 directed USDA to create a pilot library to increase market transparency for cattle producers. This pilot library will provide new disclosure to the industry and public regarding the key terms, conditions, and volumes under which cattle are contracted.
USDA Food Safety and Inspection Service Foreign Audit Report: Lithuania
FSIS maintains a list of comprehensive audits of foreign country inspection systems to ensure compliance with certain regulatory requirements. Lithuania has been added to this list.
Expansion of FSIS Non-O157 Toxin-producing Escherichia Coli Testing to Additional Raw Beef Products
This notice informs FSIS inspection program personnel at official establishments and official import inspection establishments about the expansion of routine verification testing for six non-O157 Shiga toxin- producing Escherichia coli (STEC) that are adulterants. Currently, FSIS only tests beef manufacturing trimmings for non-O157 STEC. This testing will be expanded to ground beef, bench trim, and other raw ground beef components. FSIS is also merging the individual E. coli O157 and non-O157 STEC reported results into a single “Shiga Toxin-Producing E. coli” reported result.
California and Imported Kiwifruit; Handling Regulations
This final rule implements a recommendation from the Kiwifruit Administrative Committee to modify the handling regulations prescribed under the Federal marketing order for kiwifruit grown in California. This action revises the size and uniformity requirements for all varieties of Actinidia chinensis species kiwifruit, which is commonly known as golden kiwifruit, regulated under the marketing order.
Cloth Sample Collection Method to Replace N60 Excision Sampling for Beef Manufacturing Trimmings and Bench Trim
This notice provides instructions for FSIS inspection program personnel to begin using the cloth sampling technique for routine verification sampling of domestic beef manufacturing trimmings and bench trim beginning February 1, 2023, instead of N60 excision sampling.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- On 1/27/2023, an updated outbreak advisory was issued for the outbreak of Listeria monocytogenes linked to enoki mushrooms (reference #1127) to include additional products.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include heavy metal contamination, foreign suppliers who are not in compliance with FSVP, food products that appear to be misbranded, and more.
FDA Warning Letters
Liquivape |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Switch to Vapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Noble Elements, LLC |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
Organic Heirloom Plants |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
Dr. Green Mom, LLC |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
RightEye, LLC |
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
Urban Electric Power |
CGMP/Drug Products/Adulterated |
Mohawk Laboratories Division of NCH Corporation |
CGMP/Drug Products/Adulterated |
Old Tiles Wallpaper, LLC DBA Old Tiles Decor |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
Monkeypox-treatment.com |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded |