In This Week’s Edition:
- Virtual Public Meeting and Listening Sessions on Strategies on Reducing Added Sugar Consumption in the United States
- FDA Commissioner on Dietary Supplements Program in Proposed FDA Reorganization
- USDA Proposes to Allow Third-Party Testing for Butter Quality
- USDA Finalizes Rule to Allow Chickens with Avian Leukosis in Food Supply; Revises Staff Directive
- FDA Advisory: Do Not Feed Certain Lots of Darwin’s Natural Pet Products for Dogs & Cats Due to Salmonella
- Meeting; Board for International Food and Agricultural Development
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
Virtual Public Meeting and Listening Sessions on Strategies on Reducing Added Sugar Consumption in the United States
The White House Strategy on Hunger, Nutrition, and Health notes that the intake of added sugars for most Americans is higher than what is recommended by the Dietary Guidelines for Americans and calls for FDA, in collaboration with other HHS divisions and USDA, to hold a public meeting regarding future steps that can be taken to reduce added sugars consumption in the United States. FDA will host, in collaboration with other federal partners, a virtual public meeting followed by virtual public listening sessions to discuss strategies for reducing added sugars consumption in the United States. The meeting will be held Nov. 6 and listening sessions on Nov. 7-8.
FDA Commissioner on Dietary Supplements Program in Proposed FDA Reorganization
FDA is embarking on an ambitious plan to transform their current organizational structure in the various foods programs into a unified Human Foods Program. Dr. Robert Califf remarks on FDA’s recap of dietary supplements program under the proposed reorganization.
Plant Records To Include Grade Label Butterfat Testing
USDA invites comments on a proposed amendment to the plant records requirement for the AMS Dairy Grading and Inspection program. The proposal would allow butterfat tests to be performed at an in-house or approved third party laboratory and add a requirement for plants to maintain and make such records available for examination by a USDA inspector.
USDA Finalizes Rule to Allow Chickens with Avian Leukosis in Food Supply; Revises Staff Directive
FSIS is finalizing a rule amending the poultry products inspection regulations to rescind several regulations related to the inspection and condemnation of poultry carcasses affected with any of the forms of avian leukosis complex. This action is in response to the National Chicken Council petition requesting that avian leukosis be considered a trimmable condition instead of a condition requiring the entire carcass to be condemned.
FSIS has published a revised directive for online and offline post-mortem inspection procedures at poultry slaughter establishments operating under the New Poultry Inspection System (NPIS) to reflect the changes made by the final rule.
FDA Advisory: Do Not Feed Certain Lots of Darwin’s Natural Pet Products for Dogs & Cats Due to Salmonella
FDA is cautioning pet owners not to feed their pets certain lots of Darwin’s Natural Pet Products raw cat and dog food, made by Arrow Reliance Inc., after FDA samples from the lots listed below tested positive for Salmonella.
- Darwin’s Natural Pet Products Natural Selections Chicken Recipe with Organic Vegetables for Dogs, Lot 9774, manufactured on Jun 13, 2023.
- Darwin’s Natural Pet Products Natural Selections Chicken Recipe for Cats, Lot 9795, manufactured on Jun 28, 2023.
- Darwin’s Natural Pet Products Natural Selections Chicken Recipe for Cats, Lot 9830, manufactured on Jul 19, 2023.
Meeting; Board for International Food and Agricultural Development
The Board for International Food and Agricultural Development (BIFAD), an advisory committee on food and agriculture issues to the US Agency for International Development (USAID), is hosting a full-day public meeting, Elevating Climate Change Adaptation and Mitigation in USAID’s Agricultural, Nutrition, and Food System Programming to Inform Strategy Implementation: A Discussion of the BIFAD Climate Change Subcommittee Draft Commissioned Report, to address the opportunities and challenges of transformational climate change adaptation and mitigation in USAID’s agricultural, nutrition, and food systems programming. The meeting will be held on September 11.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the outbreak of Listeria monocytogenes (ref #1172) potentially linked to ice cream, an Advisory was issued on 8/10/2023, a recall was initiated, and sample collection and analysis has been initiated.
- For the outbreak of Cyclospora cayetanensis (ref #1171), the case count has increased from 55 to 59 cases. The outbreak has ended, and FDA’s investigation has closed.
- For the outbreak of E.coli O26 (ref #1165), the outbreak has ended, and FDA’s investigation has closed.
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 and foods that appear to be adulterated for economic gain.
FDA Warning Letters
Wise Vice LLC dba Wise Vice Vapors |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Vaper Generation LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Nubilus Vapor, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Denison Pharmaceuticals, LLC |
CGMP/Finished Pharmaceuticals/Adulterated |
Laavo Clean, S.A. de C.V. |
CGMP/Finished Pharmaceuticals/Adulterated |
STPCA Inc. dba Sun Ten Laboratories |
Unapproved New Drugs/Misbranded |
Hekma Center, LLC |
New Drugs/Dietary Supplements/Food Labeling/Misbranded |
AstraZeneca Pharmaceuticals LP |
False & Misleading Claims/Misbranded |
Integra LifeSciences Corporation |
CGMP/QSR/Medical Devices/Adulterated |
CalmCo LLC previously named Ketomi LLC |
Unapproved New Drugs/Misbranded |
ALVA-AMCO Pharmacal Companies, LLC |
Unapproved New Drugs/Misbranded |