In This Week’s Edition:
- FDA Completes First Pre-Market Consultation of a Human Food Made from Cultured Animal Cells
- FDA Releases Draft Amended Environmental Assessment for AquAdvantage Salmon and Announces Virtual Public Meeting
- CFSAN Director Speaks on Infant Formula Issues
- SNAP Rule on Interstate Data Matching Effective Date Extended
- Expansion of FSIS Shiga Toxin-Producing Escherichia coli Testing to Additional Raw Beef Products
- AMS Decreases Assessment Rate for Texas Oranges and Grapefruit
- Vilsack Highlights USDA’s Climate Initiatives and Investments at COP27
- 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 Completes First Pre-Market Consultation of a Human Food Made from Cultured Animal Cells
FDA has announced that they have completed their first pre-market consultation of a human food made from cultured animal cells.
The agency evaluated the information submitted by UPSIDE Foods as part of a pre-market consultation for their food made from cultured chicken cells and has no further questions at this time about the firm’s safety conclusion.
Before this food can enter the market, the facility in which it is made also needs to meet applicable USDA and FDA requirements. In addition to the FDA’s requirements, including facility registration for the cell culture portion, the manufacturing establishment needs a grant of inspection from USDA FSIS for the harvest and post-harvest portions and the product itself requires a USDA mark of inspection.
FDA Releases Draft Amended Environmental Assessment for AquAdvantage Salmon and Announces Virtual Public Meeting
FDA is announcing the availability of a draft amended Environmental Assessment (EA) for an approved application concerning Atlantic salmon with an intentionally altered genome, and a subsequent virtual public meeting to obtain public input on the draft amended EA.
CFSAN Director Speaks on Infant Formula Issues
The comments of Dr. Susan T. Mayne are available here.
SNAP Rule on Interstate Data Matching Effective Date Extended
The Food and Nutrition Service is delaying the effective date for the interim final rule published in the Federal Register on October 3, 2022, Supplemental Nutrition Assistance Program: Requirement for Interstate Data Matching to Prevent Duplicate Issuances. The effective date for the rule published October 3, 2022, at 87 FR 59633 is delayed until December 6, 2022.
Expansion of FSIS Shiga Toxin-Producing Escherichia coli Testing to Additional Raw Beef Products
FSIS is announcing that on February 1, 2023, the Agency will expand its routine verification testing for six Shiga toxin-producing Escherichia coli that are adulterants, in addition to the adulterant Escherichia coli, to ground beef, bench trim, and other raw ground beef components in addition to raw beef manufacturing trimmings in official establishments.
Decrease of Assessment Rate for Texas Oranges and Grapefruit
This proposed rule would implement a recommendation from the Texas Valley Citrus Committee to decrease the assessment rate established for the 2022-23 and subsequent fiscal periods. The proposed assessment rate would remain in effect indefinitely unless modified, suspended, or terminated.
Vilsack Highlights USDA’s Climate Initiatives and Investments at COP27
At the 2022 United Nations Climate Change Conference this week, Secretary of Agriculture Tom Vilsack highlighted USDA’s initiatives and investments in climate-smart agriculture and forestry.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- A new outbreak of Salmonella Typhimurium (reference #1113) in a not yet identified food has been added to the table and traceback has been initiated. There are currently 264 cases. The FDA is working closely with federal, state, and local partners to investigate multiple food items of interest to determine the source of this outbreak and will update the public when more information becomes available.
- For the E. coli O157:H7 outbreak in a not yet identified food (reference #1121), the outbreak status has changed to “Ended”.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include importers who are not in compliance with FSVP, imported foods that appear to be misbranded, and more.
FDA Warning Letters
Vapor Dynasty LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
iwi |
New Drug/Misbranded |
BergaMet North America LLC |
New Drug/Misbranded |
Essential Elements |
New Drug/Misbranded |
Calroy Health Sciences, LLC |
New Drug/Misbranded |
Anabolic Laboratories Inc |
New Drug/Misbranded |
Healthy Trends Worldwide, LLC |
New Drug/Misbranded |
Chambers’ Apothecary |
New Drug/Misbranded |
Smoke N Vape Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Ruthless Vapor Corporation |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Shenzhen Fumot Technology Co., Ltd. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Wizman Limited d/b/a Wizvapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Shenzhen Quawins Technology Co., Ltd |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Moti Global |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
EC Vapor LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
HolleHippos LLC |
Foreign Supplier Verification Program (FSVP) |
Cali Steam, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Lucero Produce II Corp. |
Foreign Supplier Verification Program (FSVP) |
One Stop VAPE Shop #3 – Grove |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |