In This Week’s Edition:
- USDA Notice of Intent to Reestablish Charter for Fruit and Vegetable Advisory Committee and Call for Nominations
- Update FDA Investigation of Cronobacter Infections: Powdered Infant Formula
- FDA Issues Denies Classifying NAC as Dietary Supplement; Continues Enforcement Discretion
- FNS Adjusts WIC Income Eligibility Guidelines
- Federal Judge Enters Consent Decree Against New Jersey Raw Animal Food Manufacturer for FSMA Violations
- FSIS Listeria Rule Verification Activities Directive Revised
- FSIS Updates Directive on Ready-To-Eat Sampling Program
- AMS Soliciting Comments on Aquaculture Plan
- 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 Notice of Intent to Reestablish Charter for Fruit and Vegetable Advisory Committee and Call for Nominations
USDA announced its intent to reestablish the Charter of the Fruit and Vegetable Industry Advisory Committee, which expires March 16, 2022; its call for nominations to fill up to 25 upcoming vacancies for appointments in 2022, and its call for nominations for a pool of candidates to fill future unexpected vacancies in any position categories should that occur.
Update FDA Investigation of Cronobacter Infections: Powdered Infant Formula
The FDA, along with CDC and state and local partners are investigating consumer complaints and/or reports of infant illness related to products from Abbott Nutrition’s Sturgis, MI facility. The FDA investigators at the Abbott Nutrition facility in Sturgis, MI, collected numerous product and environmental samples:
- Five environmental subsamples collected from the Sturgis, MI, facility were positive for Cronobacter sakazakii; four were detected by the FDA and one was detected through firm-initiated testing. The positive Cronobacter sakazakii environmental samples at the Sturgis, MI, facility have been analyzed using Whole Genome Sequencing, revealing five different strains of Cronobacter sakazakii
- Product samples collected by FDA at the facility were analyzed for Cronobacter by FDA and were found negative.
FDA Denies Petition to Classify NAC as Dietary Supplement; Continues Enforcement Discretion
FDA denied the request in two citizen petitions, from the Council for Responsible Nutrition and the Natural Products Association, asking the agency to determine that products containing N-acetyl-L-cysteine are classified as a dietary supplement under section 201(ff)(3)(B)(i) of the Federal Food, Drug, and Cosmetic Act. FDA however is continuing to exercise enforcement discretion regarding the marketing and sale of NAC as a supplement pending its review of the safety of NAC and its suitability as a dietary supplement.
FNS Adjusts WIC Income Eligibility Guidelines
FNS has announced adjusted income eligibility guidelines to be used by State agencies in determining the income eligibility of persons applying to participate in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).
Federal Judge Enters Consent Decree Against New Jersey Raw Animal Food Manufacturer for FSMA Violations
FDA announced that Bravo Packing, Inc., an animal food manufacturing company of Carney’s Point, New Jersey, has agreed to stop selling, manufacturing and distributing raw pet food and come into compliance with the Federal Food, Drug, and Cosmetic Act. This action marks the first consent decree of permanent injunction against an animal food manufacturer for violating public safety standards under Part 507 (Current Good Manufacturing Practice requirements) of the FSMA Preventive Controls for Animal Food Regulation.
FSIS Listeria Rule Verification Activities Directive Revised
FSIS has revised the directive that provides instructions for inspection program personnel to verify that establishments that produce post-lethality exposed Ready-to-Eat products control Listeria monocytogenes (Lm) through a Hazard Analysis and Critical Control Point plan or prevent Lm through a Sanitation Standard Operating Procedure or other prerequisite program.
FSIS Updates Directive on Ready-To-Eat Sampling Programs
This directive provides instructions to inspection program personnel to collect and submit ready-to-eat meat and poultry product samples to FSIS laboratories and, when appropriate, to take enforcement action in response to positive test results. The directive has been revised to reflect changes to product sampling for Lm and updates to the sampling selection criteria to improve sampling program efficiency.
AMS Soliciting Comments on Aquaculture Plan
The Subcommittee on Aquaculture is extending the comment period on a draft outline of the Strategic Plan for Aquaculture Economic Development, and information on a planned update to the 1983 National Aquaculture Development Plan.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the new adverse events investigation (reference # 1060), the FDA is following up on a series of unconfirmed adverse event reports received from January 2021 to March 2022 that may be associated with an FDA-regulated food product.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include presence of mycotoxins, unsafe food additives, products lacking premarket authorization, and more.
FDA Warning Letters
Vapor Vapes Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Greenway Herbal Products LLC |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Cureganics |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Functional Remedies, LLC D/B/A Synchronicity Hemp Oil |
Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |
UPSY LLC |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Heaven’s Organic LLC |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
CBD Social |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Nature’s Highway |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Medina Baking and Powder Products, Inc. |
Food Labeling/Misbranded |
Dr Retter Ec Wladyslaw Retter |
CGMP/Finished Pharmaceuticals/Adulterated |
Agropharma Laboratories, Inc. |
CGMP/Finished Pharmaceuticals/Adulterated |
Iodine Products Inc |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Applied Biological Laboratories Inc. |
Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) |