In This Week’s Edition:
- USDA Organic Oversight and Enforcement Update
- Final Guidance Available for Policy Regarding N-acetyl-L-cysteine
- USDA Announces Action to Declare Salmonella an Adulterant in Breaded Stuffed Raw Chicken Products
- The Technical Review Process Directive
- FSIS Announces Study of Effect of Increased Poultry Line Speeds on Worker Safety
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
USDA Organic Oversight and Enforcement Update
USDA’s NOP develops and enforces standards for agricultural products labeled organic in the United States. Read their full June 2022 report on the following sections:
- Domestic and Overseas Investigations and Compliance Actions
- Organic Trade Enforcement Interagency Coordination Report
- Report on Enforcement Actions Taken on Organic Imports
Final Guidance Available for Policy Regarding N-acetyl-L-cysteine
FDA announced the availability of a final guidance for industry entitled “Policy Regarding N-acetyl-L-cysteine.” The guidance explains their intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine and are labeled as dietary supplements.
USDA Announces Action to Declare Salmonella an Adulterant in Breaded Stuffed Raw Chicken Products
USDA announced that it will be declaring Salmonella an adulterant in breaded and stuffed raw chicken products. Agricultural Secretary Tom Vilsack made the following statement on the announcement: “Food safety is at the heart of everything FSIS does, that mission will guide us as this important first step launches a broader initiative to reduce Salmonella illnesses associated with poultry in the U.S.”
The Technical Review Process Directive
This directive provides procedures that FSIS headquarters personnel are to follow when an establishment or company submits a request for the Agency to review or evaluate a new technology (including new ingredients and antimicrobials), an on-line reprocessing or off-line reprocessing system, a regulatory waiver request, a protocol requesting to conduct an in-plant trial, or a validation protocol for Agency review before in-plant validation. This revision updates and clarifies the procedural responsibilities of the program offices that participate in the technical review process.
FSIS Announces Study of Effect of Increased Poultry Line Speeds on Worker Safety
USDA has explored various approaches to determining how it can best assess the impact of increased line speeds on worker safety. As part of the process, USDA engaged in discussions with relevant stakeholders, including worker safety advocates and industry. Based on these discussions and our experience with the time-limited trials, FSIS is modifying the NPIS line speed waiver process to facilitate a study on the effects of increased line speeds on worker safety, which will inform future rulemaking. The study will include evaluation of monthly worker safety data submitted by all establishments that receive a modified waiver to continue to operate at up to 175 birds per minute, as well as on-site visits to a subset of establishments by the contracted worker safety experts.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the Cyclospora outbreak in an unidentified vehicle (ref# 1084), the number of cases has increased from 51 to 60 and sample collection and analysis has been initiated.
- A new outbreak has been added to the table: Cyclospora in a not yet identified food (ref #1080). Traceback has been initiated.
- For the Salmonella Paratyphi B var. L(+) tartrate+ outbreak (ref# 1072) in a not identified food, FDA’s investigation status is now closed.
- For the Listeria monocytogenes outbreak (ref# 1070) in a not identified food, the outbreak status has ended and FDA’s investigation status is now closed.
- For the Salmonella Braenderup outbreak (ref #1075), the number of cases has increased from 70 to 74.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include imported products that appear to be misbranded, infant formula due to failure to meet nutrient and labeling requirements, food products due to the presence of salmonella, and more.
FDA Warning Letters
FluxxLab LLC |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Brew City Juice, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
DSP Skin Care LLC |
CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
Transworld International Trading Corp. |
Foreign Supplier Verification Program (FSVP) |
CVM 3, LLC d/b/a Carolina Vapor Mill |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Electrik Smoke LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Boosted LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Walker Trading Co. Inc. d/b/a Vape Dojo |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Ferrum City Liquid |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Gentleman’s Draw LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Cyberliquids, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Five Pawns, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Dongguan Hengtai Biotechnology, Co., Ltd d/b/a Mr. Fog |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Simply Vapour LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Steamist Vape Supply |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Yogi’s Vape |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
LDSD Vapor LLC d/b/a AtascaVapes |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Yogi’s Vape Lounge |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
CVM 3, LLC d/b/a Carolina Vapor Mill |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
CVM 3, LLC d/b/a Carolina Vapor Mill |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Desert Vapors II Inc d/b/a Desert Vapors |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |