In This Week’s Edition:
- FSMA Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2023
- Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2023
- Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2023
- USDA and Oregon Sign Cooperative Agreement for State Meat Inspection Program
- USDA Extends Flexibility that’s Helping Manufacturers, States get Formula to WIC Families
- USDA Announces Its Local Food Purchase Assistance Cooperative Agreement with California
- USDA Announces Key Staff Appointments
- 2022 FDA Retail Food Protection Seminar
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
FSMA Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2023
FDA is announcing the fiscal year 2023 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal FD&C Act, as amended by the FDA FSMA. These fees are effective on October 1, 2022 and will remain in effect through September 30, 2023. Read more here.
Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2023
FDA is announcing the fiscal year 2023 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program that is authorized by the Federal FD&C Act, as amended by the FDA FSMA.
Food Safety Modernization Act Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2023
FDA is announcing the fiscal year 2023 annual fee rate for importers approved to participate in the Voluntary Qualified Importer Program that is authorized by the Federal FD&C Act, as amended by the FDA FSMA. Read more here.
USDA and Oregon Sign Cooperative Agreement for State Meat Inspection Program
USDA and FSIS and the state of Oregon have finalized a cooperative agreement, under which the state inspection program may inspect meat products produced for shipment within the state. Under the cooperative agreement, the state inspection program must develop, administer, and enforce requirements “at least equal to” those imposed under the Federal Meat Inspection Act.
USDA Extends Flexibility that’s Helping Manufacturers, States get Formula to WIC Families
USDA is extending a key funding flexibility in the WIC program that has allowed state agencies and their infant formula manufacturers to work together to provide more options for WIC families in need of formula. Under this flexibility – which is now extended through the end of September – USDA is covering the added cost of non-contract formula to make it financially feasible for states to allow WIC participants to purchase alternate sizes, forms, or brands of infant formula.
USDA Announces Its Local Food Purchase Assistance Cooperative Agreement with California
During a visit to the Yolo County Food Bank in Woodland, Calif., Agriculture Secretary Tom Vilsack announced the USDA AMS has signed a cooperative agreement with California under the Local Food Purchase Assistance Cooperative Agreement Program (LFPA). The LFPA is a program authorized through the President’s American Rescue Plan, which invested $400 million to make food more affordable for more Americans and help stabilize agricultural supply chains.
USDA Announces Key Staff Appointments
USDA announced the names of individuals who will hold senior staff positions in Washington, D.C.
- Eric Deeble was appointed Deputy Assistant Secretary for the Office of Congressional Relations
- Bernhard “Bernie” Kluger will serve as Senior Advisor for Management in the Office of the Secretary
- Yeshimebet Abebe was appointed Director of Organizational Management and Cultural Transformation, Farm Production and Conservation Business Center
- Toby Cain was appointed Chief of Staff for the Risk Management Agency
- Anita Adkins will serve as Chief Human Capital Officer
- George Sears will serve as Director of the Office of Small and Disadvantaged Business Utilization
2022 FDA Retail Food Protection Seminar
FDA announced that registration is now open for the 2022 FDA Retail Food Protection Seminar. The Seminar will be held September 19-22, 2022. Registration is free! This event is open to all interested in retail food safety, including all state, local, territorial and tribal regulators, standardized officers, industry and academia. Register here.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the Salmonella Senftenberg outbreak in Peanut Butter (ref# 1067), the outbreak status has ended and the investigation status is now closed.
- A new outbreak has been added to the table: Cyclospora in a not yet identified food (ref #1084).
- For the Salmonella Paratyphi B var. L(+) tartrate+ outbreak (ref# 1072) in a not yet identified food, the outbreak status has ended. FDA’s investigation status is still ongoing.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include heavy metal contamination, imported products that appear to be misbranded, dried fruit due to lead, and more.
FDA Warning Letters
Custom Research Labs Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |
Zhang Medical P.C. dba New Hope Fertility Center |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
Bolive, Inc. |
Foreign Supplier Verification Program (FSVP) |
Bi-Coastal Pharma International |
CGMP/Finished Pharmaceuticals/Adulterated |
Daniel Fred Goodman, M.D./Goodman Eye Center |
Bioresearch Monitoring Program/Institutional Review Board (IRB) |
Blackout Vapors Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
M & K On Cumberland, Inc. dba Big Cloud Vape & Tobacco |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd. |
Refusal to Provide Access to and Copying of Records |
Jose Miguel Gutierrez Salas |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated/Failure to Register and List |
Everyday Import & Export, Inc. dba Everyday Group LLC |
Foreign Supplier Verification Program (FSVP) |
Jost Chemical Co. |
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
Tiger Vapor, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |