In This Week’s Edition:
- Public Meeting: Modernizing Recalls of FDA-Regulated Commodities
- Process for Establishing Rates for Veterinary Services User Fees
- FDA Seeks Public Comment on Possible Framework for Collecting and Analyzing Data on Antimicrobial Use in Food-Producing Animals
- Adjustments to Mango Board Representation; Withdrawal of Proposed Rule
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
Public Meeting: Modernizing Recalls of FDA-Regulated Commodities
On September 29, 2023, FDA is hosting a hybrid public meeting entitled “Modernizing Food and Drug Administration Recalls Listening Session.” This listening session provides an opportunity for stakeholders to share information and feedback about topics related to recall modernization for FDA-regulated products. Participants are encouraged to address these topics, or any other relevant topics related to recall modernization for FDA-regulated products:
- General recall preparations / contingency planning
- Creating successful recall strategies, including methods to reach underserved communities
- Initiating a recall
- Strategies for public warning, including press releases, social media, and other communication tools
- Increasing efficiency and effectiveness of recall information exchange
- Ensuring effective recalls
- Terminating a recall
- Strategies for reducing recall recurrence for similar situations
Process for Establishing Rates for Veterinary Services User Fees
USDA is revising the regulations concerning user fees that they charge for veterinary diagnostic services and for certain import-related and export-related services for live animals, animal products and byproducts, birds, germplasm, organisms, and vectors. USDA is also removing the tables providing the individual fees from the regulations and posting them on an Animal and Plant Health Inspection Service website.
FDA Seeks Public Comment on Possible Framework for Collecting and Analyzing Data on Antimicrobial Use in Food-Producing Animals
FDA opened a docket to seek public comment on a report outlining a potential framework for establishing a public-private partnership to collect and analyze antimicrobial use data from food-producing animals. The report was prepared for the FDA by the Reagan-Udall Foundation and summarizes the work completed over a multi-year cooperative agreement funded by the FDA. Under this agreement, the Foundation convened a working group to evaluate the feasibility of developing and maintaining a system to collect and report AMU data in the United States.
Adjustments to Mango Board Representation; Withdrawal of Proposed Rule
AMS withdraws a proposed rule recommended by the National Mango Board that would have adjusted the Mango Promotion, Research, and Information Order to allocate the seven foreign producer Board seats to the top five mango exporting countries, based on mango volume exported to the United States, with an additional seat allocated to the top exporting country, and one at-large seat. The rule was withdrawn in response to public comment.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the outbreak of Cyclospora cayetanensis (ref #1171), the case count has increased from 39 to 47 cases.
- For the outbreak of Cyclospora cayetanensis (ref #1163), the case count has increased from 121 to 140 cases.
- For the outbreak of Salmonella Paratyphi B var. L(+) tartrate+ (ref #1157), the case count has increased from 35 to 36 cases.
- For the outbreak of Cyclospora cayetanensis (ref #1159), the case count has increased from 68 to 69 cases.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include foreign establishments refusing FDA inspection, human and animal foods due to pesticides.
FDA Warning Letters
Wise Vice LLC dba Wise Vice Vapors |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Dot Com Vapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Intas Pharmaceuticals Limited |
CGMP/Finished Pharmaceuticals/Adulterated |
RenatiLabs Inc. |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
Avlon Industries, Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |
Centaur Pharmaceuticals Private Ltd. |
CGMP/Finished Pharmaceuticals/Adulterated |
Baxter Healthcare Corporation |
CGMP/Finished Pharmaceuticals/Adulterated |
Medgel Private Limited |
CGMP/Finished Pharmaceuticals/Adulterated |
Iso-Tex Diagnostics, Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |
Jamol Laboratories, Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |
LXR Biotech, LLC |
CGMP/Finished Pharmaceuticals/Adulterated |
Porfirios Italian Foods, Inc. |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
La Yongjia Trade Co. |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
Premier Food Supplies LLC |
Foreign Supplier Verification Program (FSVP) |