In This Week’s Edition:
- FDA Issues 2022 Voluntary National Retail Food Regulatory Program Standards
- FDA Posts New FAQs for the FSMA Lab Accreditation for Analyses of Foods Final Rule
- Notice of Availability of Bovine Tuberculosis Status Evaluation of Eight Mexican Regions and Intent To Classify Those Regions for Bovine Tuberculosis
- 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 Issues 2022 Voluntary National Retail Food Regulatory Program Standards
FDA has issued the 2022 edition of the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) to detail the key elements of an effective retail food regulatory program for state, local, tribal and territorial regulatory agencies.
The Retail Program Standards provide recommendations for designing and managing retail food regulatory programs and help regulatory jurisdictions (or other responsible organizations) facilitate more effective inspections, implement foodborne illness prevention strategies, and identify program areas in need of improvement.
The FDA developed these standards with input from federal, state, and local regulatory officials, as well as industry, trade associations, academia, and consumers. The 2022 edition of the Retail Program Standards incorporates changes based on recommendations made during the Conference for Food Protection 2020 Biennial Meeting. Some of these key changes include reformatted curriculum forms and worksheets and the inclusion of alternative sampling methods. To see the complete list of changes, you can view and download a copy of the Summary of Changes.
FDA Posts New FAQs for the FSMA Lab Accreditation for Analyses of Foods Final Rule
FDA posted additional FAQs for stakeholders for the FDA Food Safety Modernization Act final rule on Laboratory Accreditation for Analyses of Foods (LAAF). The LAAF final rule establishes a laboratory accreditation program for the testing of food in certain circumstances. Under the LAAF program, FDA will recognize accreditation bodies that will accredit laboratories to the standards established in the final rule (referred to as LAAF-accredited laboratories). The new FAQs review general requirements for test methods used under the LAAF program; clarify that FDA does not maintain a comprehensive list of test methods performed by LAAF-accredited laboratories; and describe the specific test methods that are required in certain circumstances covered by the LAAF final rule.
After the LAAF final rule is fully implemented, owners and consignees will be required to use a LAAF-accredited laboratory for food testing:
- to support removal from an import alert through successful consecutive testing (e.g., to get a food product or firm removed from the red list);
- to support admission of an imported food (e.g., articles of human or animal food, and U.S. goods returned that are articles of food) detained at the border because it is or appears to be in violation of the Federal Food, Drug, and Cosmetic Act (e.g., products that contain or appear to contain unapproved food additives, including unauthorized food contact substances);
- required by existing FDA food safety regulations, when applied to address an identified or suspected food safety problem (i.e., certain tests related to shell eggs, sprouts, and bottled drinking water);
- required by a directed food laboratory order, a new procedure being implemented in this final rule that will allow FDA to require use of a LAAF-accredited laboratory to address an identified or suspected food safety problem in certain, rare circumstances; and
- conducted in connection with certain administrative processes (e.g., testing submitted in connection with an appeal of an administrative detention order).
Notice of Availability of Bovine Tuberculosis Status Evaluation of Eight Mexican Regions and Intent To Classify Those Regions for Bovine Tuberculosis
USDA is advising the public that they are proposing to classify eight Mexican regions for bovine tuberculosis as follows: The State of Sonora as Level II; the Yucatan Peninsula region (States of Yucatan and Quintana Roo, and part of the State of Campeche), the Huasteca region (parts of the States of Puebla, Veracruz, and Hidalgo), part of the State of Chihuahua, and part of the State of Durango as Level III; and part of the State of Coahuila, part of the State of Nuevo Leon, and the State of Tamaulipas as Level IV.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the outbreaks of Cyclospora in not yet identified products, cases from the Cyclospora outbreak (ref# 1084) have been re-grouped into the other Cyclospora outbreak (ref#1080), based on genomic data provided by the Centers for Disease Control and Prevention. For the outbreak of Cyclospora (ref# 1080), the case count has been adjusted from 6 cases to 70 and for the outbreak of Cyclospora (ref# 1084), the case count has been adjusted from 98 cases to 41 cases.
- For the outbreak of E. coli O157:H7 in a not yet identified food, an on-site inspection has been initiated.
- For the Salmonella Senftenberg outbreak in a not yet identified food (ref# 1087), the case count has increased from 19 to 22 cases and traceback has been initiated.
- For the Salmonella Typhimurium outbreak in a not yet identified food, the case count has increased from 44 to 62 cases and sample collection and analysis has been initiated.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
The latest FDA import alerts include seafood products due to salmonella, honey and blended syrup due to drug residue, dried peppers from Mexico, and more.
FDA Warning Letters
KA Vapes, LLC d/b/a Kickin’ Ash |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Singing Hawk LLC d/b/a Sin City Vapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
ADP Marketing LLC d/b/a Vaporistic |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
BLB7 LLC dba The Vape Mall |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Ridley USA, Inc. dba Hubbard Feeds, Inc. |
CGMP/Animal Food/Adulterated |
Mom and Pop Vapor Shop |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Tramadol US |
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
DNA Distributors, Inc. d/b/a Just Juice |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Top Class Ejuice, Inc. d/b/a The Dollar E-Juice Club |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Wadina Distribution Company LLC d/b/a Gost Vapor |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Adrenaline Vapors LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Rock Drummer Vapors LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |