In This Week’s Edition:
- FSIS Announces Cooperative Agreement on Salmonella Risk Assessments
- Residue Sampling, Testing and Other Verification Procedures under the National Residue Program for Meat and Poultry Products
- Petition Submitted by People for the Ethical Treatment of Animals
- FDA Shares Results on PFAS Testing in Seafood
- FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers
- FDA Finalizes FSMA Guidance on Hazard Analysis and Preventive Controls for Animal Food
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
FSIS Announces Cooperative Agreement on Salmonella Risk Assessments
FSIS announced in October 2021 the development of a stronger and more comprehensive food safety framework for the control of Salmonella in poultry. This week, FSIS has signed a cooperative agreement with the University of Maryland’s Joint Institute for Food Safety and Applied Nutrition, in partnership with EpiX Analytics, to develop two quantitative risk assessments — one for Salmonella in chicken and one for Salmonella in turkey. These risk assessments will provide FSIS with support for the new framework for reducing Salmonella illnesses attributed to poultry consumed in the U.S.
Residue Sampling, Testing and Other Verification Procedures under the National Residue Program for Meat and Poultry Products
This directive provides instructions to inspection program personnel, on conducting verification procedures in accordance with the National Residue Program for meat, and poultry products. FSIS has revised this directive to remove the prescriptive frequency for show animal residue testing and update the definition of a show animal lot.
Petition Submitted by People for the Ethical Treatment of Animals
The petition requests that FSIS initiate rulemaking to no longer allow for FSIS review and approval of animal raising claims on FSIS-regulated products and to rescind the guidelines for the approval of such labels. FSIS has posted a response acknowledging this petition
FDA Shares Results on PFAS Testing in Seafood
FDA made available testing results for per- and polyfluoroalkyl substances (PFAS) in seafood samples collected at retail. The FDA conducted this limited survey as a preliminary step to determine if a more targeted or larger seafood survey should be conducted.
FDA Developing New Framework for Continued, Expanded Access to Infant Formula Options for U.S. Parents and Caregivers
In May 2022, the FDA issued a guidance announcing the agency’s intention to temporarily exercise enforcement discretion, on a case-by-case basis, for certain requirements that apply to infant formula to address the temporary shortage. The FDA’s flexibilities have enabled the agency to help dramatically increase infant formula supplies to address the shortage, while also protecting the health of infants, many of whom rely solely on infant formula during a critical period of growth and development. To date, it has resulted in a total estimated quantity of more than 400 million, 8-ounce bottles worth of formula from nine countries for children in the U.S. The enforcement discretion described in the May guidance is set to remain in effect until Nov. 14, 2022. Read more here.
FDA Finalizes FSMA Guidance on Hazard Analysis and Preventive Controls for Animal Food
FDA finalized Guidance for Industry #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals to help animal food facilities subject to the FDA FSMA Hazard Analysis and Risk-Based Preventive Controls for animal food requirements develop a food safety plan to prevent or significantly minimize hazards that could cause illness or injury to people or animals.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the Salmonella Braenderup outbreak in a not yet identified food (ref# 1075), the case count has increased from 42 to 59 cases.
- For the Listeria monocytogenes outbreak (ref# 1057), a product linked to illnesses is ice cream from Big Olaf Creamery, located in Florida.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include produce from unsanitary conditions, food products that appear to be misbranded, pesticides, and more.
FDA Warning Letters
Vaping Delights LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Ron’s Vapor Station |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Firehouse Vapes LLC d/b/a Zaelynn’s Vape & CBD |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Drive Thru Vapors, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
La Ilusion Fresh Guava Inc. |
Foreign Supplier Verification Program (FSVP) |
Krishna Trading LLC |
Foreign Supplier Verification Program (FSVP) |
Worlds Finest Vape Shop, LLC d/b/a World’s Finest Victory Club |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Herbsens Botanicals |
Finished Pharmaceuticals/Unapproved New Drug |
Klarity Kratom |
Finished Pharmaceuticals/Unapproved New Drug |
Kratom Exchange |
Finished Pharmaceuticals/Unapproved New Drug |
MONQ, LLC |
Finished Pharmaceuticals/Unapproved New Drug |
Export Guatemala Corporation |
Foreign Supplier Verification Program (FSVP) |
Cloudberry Vapors, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Omni Consumer Products LLC d/b/a YoKratom |
Finished Pharmaceuticals/Unapproved New Drug |