In This Week’s Edition:
- FDA to Hold Webinar on the New FSMA Laboratory Accreditation for Analyses of Foods Program
- USDA Animal Health’s Risk Designation for Bovine Spongiform Encephalopathy for Ireland
- FDA Guidance on Infant Formula Transition Plan for Exercise of Enforcement Discretion
- Outbreak Investigation of Listeria Monocytogenes: Brie and Camembert Soft Cheese Products
- Report on the Certification of Color Additives: 4th Quarter, Fiscal Year 2022, July 1-September 30
- USDA To Authorize the Importation of Pummelo From Vietnam Into the United States
- USDA Siluriformes Sampling in Domestic Establishments
- USDA GIPSA Proposed Rule: Inclusive Competition and Market Integrity
- FDA to Host Webinar to Discuss Proposed Changes to the Definition of “Healthy”
- 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 to Hold Webinar on the New FSMA Laboratory Accreditation for Analyses of Foods Program
FDA will be holding an informational webinar on Thursday, October 27, 2022, from 1:00 pm-2:30 pm (ET) on the new Laboratory Accreditation for Analyses of Foods program, which establishes a laboratory accreditation program for the testing of food in certain circumstances.
USDA Animal Health’s Risk Designation for Bovine Spongiform Encephalopathy for Ireland
USDA is advising the public of their decision to concur with the World Organization for Animal Health’s (WOAH’s) bovine spongiform encephalopathy (BSE) risk designation for Ireland. The WOAH recognizes Ireland as being of negligible risk for BSE. USDA is taking this action based on its review of information supporting the WOAH’s risk designation for Ireland.
FDA Guidance on Infant Formula Transition Plan for Exercise of Enforcement Discretion
FDA is announcing the availability of a guidance for industry entitled “Infant Formula Transition Plan for Exercise of Enforcement Discretion: Guidance for Industry.” Under the guidance, FDA intends to exercise enforcement discretion until January 6, 2023, for infant formula products that are listed in letters of enforcement discretion that FDA has issued or will issue to specific manufacturers, in response to information provided under FDA’s May 2022 ”Infant Formula Enforcement Discretion Policy: Guidance for Industry,” which remains in effect until November 14, 2022.
Outbreak Investigation of Listeria Monocytogenes: Brie and Camembert Soft Cheese Products
FDA, along with CDC and state and local partners, is investigating a multistate outbreak of Listeria monocytogenes infections linked to Brie and Camembert soft cheese products, including all baked Brie cheeses, manufactured by Old Europe Cheese, Inc. of Benton Harbor, MI, and sold at various retailers under multiple labels and brands.
Report on the Certification of Color Additives: 4th Quarter, Fiscal Year 2022, July 1-September 30
Read the full report on the certification of color additives: 4th quarter, fiscal year 2022, July 1-September 30 here.
USDA To Authorize the Importation of Pummelo From Vietnam Into the United States
USDA is advising the public of their decision to authorize the importation into the United States of fresh pummelo fruit from Vietnam. Based on the findings of a pest risk analysis, which USDA made available to the public for review and comment through a previous notice, USDA has determined that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh pummelo fruit from Vietnam.
USDA Siluriformes Sampling in Domestic Establishments
USDA FSIS has released a revised directive providing inspection program personnel instructions at domestic establishments for collecting raw fish samples of the order Siluriformes (referred from here on as “fish”) for speciation and residue sampling. FSIS is reissuing this directive to remove Salmonella sampling instructions, change speciation sampling to collector-generated sampling if the visual inspection indicates the fish is not a blue catfish, a channel catfish, or a hybrid of the two. This directive is also excluding secondary processor from residue sampling eligibility and providing lotting considerations for wild-caught fish.
USDA GIPSA Proposed Rule: Inclusive Competition and Market Integrity Under the Packers and Stockyards Act
USDA’s AMS is soliciting comments on proposed revisions to the regulations under the Packers and Stockyards Act, 1921. The proposal would prohibit certain prejudices against market-vulnerable individuals that tend to exclude or disadvantage covered producers in those markets. The proposal would identify retaliatory practices that interfere with lawful communications, assertion of rights, and associational participation, among other protected activities, as unjust discrimination prohibited by the law. The proposal would also identify unlawfully deceptive practices that violate the Packers and Stockyards Act with respect to contract formation, contract performance, contract termination, and contract refusal.
FDA to Host Webinar to Discuss Proposed Changes to the Definition of “Healthy”
FDA will host a stakeholder webinar on Friday, October 21, 2022, at 1 p.m. ET to provide an overview of the recently released proposed rule to update the definition of the nutrient content claim “healthy.” The “healthy” claim can act as a quick signal on food package labels to help empower consumers with information to identify foods that will help them build healthy eating patterns. This action is just one part of the agency’s ongoing commitment to reduce diet-related chronic diseases and advance health equity.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the Salmonella Litchfield outbreak in a not yet identified product (reference #1105), the case count has increased from 28 cases to 29 cases.
- For the E. coli O157:H7 outbreak (reference #1081) in a not yet identified product, CDC announced the outbreak is over on 10/4/2022. FDA’s investigation is ongoing.
- For the Listeria monocytogenes outbreak in Brie and Camembert cheese (reference #1106), an Outbreak Advisory was issued on 9/30/2022.
- For the Salmonella Typhimurium outbreak (reference #1095), one additional case was added, and the product linked to illnesses has been changed to cantaloupe. The vehicle of the outbreak was confirmed after the outbreak ended. Given the product(s) were no longer on the market, there was no ongoing risk to public health and no need to avoid eating cantaloupe. Additional information on this outbreak will be forthcoming.
- For the outbreak of Cyclospora cayetanensis in a not yet identified product (reference #1080) the case count has increased from 81 to 84 and the outbreak has ended.
- For the outbreak of Cyclospora cayetanensis in a not yet identified product (reference #1084) the outbreak has ended.
- For Listeria monocytogenes adverse event in a not identified product (reference #1040), the outbreak has ended.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include foods containing illegal/undeclared colors, food products that appear to be misbranded, honey adulteration, and more.
FDA Warning Letters
|EVO Brands, LLC and PVG2, LLC d/b/a Puff Bar |
|Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
|Dell Vapers |
|Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
|Flawless Beauty and Skin |
|Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device |
|Sterling Pharmaceutical Services, LLC |