In This Week’s Edition:
- New FDA Food Traceability Resources
- Guidance: Canadian Export Certificate Requirement Reminder for Sugar Containing Products of Canada
- APHIS Determines Pioneer Hi-Bred GMO Corn Qualifies for Unregulated Status
- Outbreak Investigation of Salmonella: Cantaloupes
- National Bioengineered Food Disclosure Standard; List of Bioengineered Foods
- Addition of Singapore to the List of Regions Affected by African Swine Fever
- Addition of Bolivia to the List of Regions Affected With Highly Pathogenic Avian Influenza
- Transparency in Poultry Grower Contracting and Tournaments; Final Rule
- Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt
- Outbreak Investigation of Listeria Monocytogenes: Peaches, Plums, & Nectarines
- FDA and Stop Foodborne Illness Co-Host Webinar on Food Safety Culture: Storytelling to Shape, Reinforce and Inspire
- IFSAC Releases Annual Report for 2021 on Sources of Foodborne Illness
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
New FDA Food Traceability Resources
FDA rolled out new tools and FAQs that will continue to inform stakeholders about the Food Traceability Rule and help covered entities come into compliance. Foods subject to the final rule’s requirements appear on the Food Traceability List.
Guidance: Canadian Export Certificate Requirement Reminder for Sugar Containing Products of Canada
Filers are reminded that accessing Canadian sugar containing product requires a Canadian export certificate at entry under the World Trade Organization Agreement and the United States-Mexico-Canada Agreement. Entries made without an authorized Canadian Export Certificate are subject to the high-rate duty. See entry process guidance here.
APHIS Determines Pioneer Hi-Bred GMO Corn Qualifies for Unregulated Status
USDA is advising the public of our determination that DP23211 maize (corn), which has been developed using genetic engineering for insect resistance to western corn rootworm and contains the gene that codes for the phosphinothricin acetyltransferase protein responsible for tolerance to glufosinate-ammonium herbicides, and also the gene that encodes for the phosphomannose isomerase protein as a selectable marker, is no longer considered regulated.
Outbreak Investigation of Salmonella: Cantaloupes
FDA has provided an update on the status of the cantaloupe Salmonella outbreak here.
National Bioengineered Food Disclosure Standard; List of Bioengineered Foods
This final rule updates the National Bioengineered Food Disclosure Standard’s (the Standard) List of Bioengineered (BE) Foods by adding “sugarcane (Bt insect-resistant varieties)” to the List and amending “squash (summer)” to “squash (summer, coat protein mediated virus-resistant varieties).”
Addition of Singapore to the List of Regions Affected by African Swine Fever
USDA is advising the public that they have added Singapore to the APHIS list maintained on the APHIS website of regions considered to be affected with African swine fever (ASF). We have taken this action because of the confirmation of ASF in Singapore.
Addition of Bolivia to the List of Regions Affected With Highly Pathogenic Avian Influenza
USDA is advising the public that they have added Bolivia to the list of regions that the APHIS considers to be affected with highly pathogenic avian influenza (HPAI). This action follows USDA’s imposition of HPAI-related restrictions on the importation of avian commodities originating from or transiting Bolivia as a result of the confirmation of HPAI in that country.
Transparency in Poultry Grower Contracting and Tournaments; Final Rule
This final rule amends the regulations under the Packers and Stockyards Act, 1921, to add disclosures and information that live poultry dealers engaged in the production of broilers must furnish to poultry growers with whom dealers make poultry growing arrangements. The rule also establishes additional disclosure requirements for live poultry dealers engaged in the production of broilers who use poultry grower ranking systems to determine settlement payments for broiler growers.
Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt
FDA is announcing the availability of a guidance for industry entitled “Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt–Small Entity Compliance Guide.” The small entity compliance guide is intended to explain the actions a small entity must take to comply with FDA’s regulations after recent changes made by FDA’s 2021 final rule titled “Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt
Outbreak Investigation of Listeria Monocytogenes: Peaches, Plums, & Nectarines
The FDA and CDC, in collaboration with state and local partners, are investigating a multistate outbreak of Listeria monocytogenes infections linked to peaches, plums, and nectarines.
FDA and Stop Foodborne Illness Co-Host Webinar on Food Safety Culture: Storytelling to Shape, Reinforce and Inspire
FDA announced the ninth in the ongoing series of webinars exploring food safety culture will take place on December 6, 2023, from 12 noon to 1:00 pm ET. The webinar series Collaborating on Culture in the New Era of Smarter Food Safety is in partnership with Stop Foodborne Illness, a non-profit public health organization.
This webinar “Food Safety Culture: Storytelling to Shape, Reinforce, and Inspire” will focus on the importance of storytelling in building and reinforcing a strong food safety culture.
IFSAC Releases Annual Report for 2021 on Sources of Foodborne Illness
The Interagency Food Safety Analytics Collaboration’s (IFSAC) – a collaboration between the FDA, the Centers for Disease Control and Prevention (CDC), and the USDA FSIS – has published its newest annual report, “Foodborne illness source attribution estimates for Salmonella, Escherichia coli O157, and Listeria monocytogenes – United States, 2021.”
IFSAC analyzes foodborne illness outbreak data for priority pathogens and specific foods and food categories responsible for foodborne illnesses in the United States. The data are analyzed by calendar year and released in annual reports as part of ongoing efforts to understand sources of foodborne illness in the United States.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
• For the outbreak of Salmonella Newport (ref # 1201), the case count has increased from 40 cases to 42 cases.
• For the outbreak of Salmonella Sundsvall (ref #1203) linked to cantaloupe, the recall was expanded to include additional retailers and wholesalers who received the recalled melons. See the Outbreak Advisory for additional information.
• For the outbreak of Listeria monocytogenes (ref #989) linked to peaches, plums, and nectarines, the advisory was updated to include additional retailers impacted by this outbreak.
• For the investigation of elevated lead levels in Cinnamon Applesauce Pouches (ref # 1198) the advisory was updated to include additional adverse event reports and advice for consumers.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include imported food products that appear to be misbranded, foreign suppliers who are not in compliance with FSVP, and more.
FDA Warning Letters
HiggyCigs, LLC d/b/a Viral Vapes |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Intas Pharmaceuticals Limited |
CGMP/Finished Pharmaceuticals/Adulterated |
Dr. Berne’s Whole Health Products |
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug |
Shenzhen FreeMax Technology Co., Ltd. d/b/a FreeMaxVape |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Shenzhen IJOY Technology Co., LTD. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Xiamen Wally Bath Manufacture Co., Ltd. |
CGMP/Finished Pharmaceuticals/Adulterated |
Brenntag Great Lakes, LLC |
CGMP/Finished Pharmaceuticals/Adulterated |
Melanie M. Hoppers, M.D./Physicians Quality Care |
Clinical Investigator |
Wan-Gee Foods, Inc. |
CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
National Chemical Laboratories |
CGMP/Finished Pharmaceuticals/Adulterated |
Discover Health, LLC d/b/a Discover CBD and Strain Snobs |
Finished Pharmaceuticals/Unapproved New Drugs/Animal Drugs/Human Foods/Animal Foods/Adulterated/Misbranded |
Cipla Limited |
CGMP/Finished Pharmaceuticals/Adulterated |
Elemental Herbs Inc. d/b/a ALL good |
CGMP/Finished Pharmaceuticals/Adulterated |
Raven Route |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
www.directpharmashop.net |
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
AmLion Toothpaste Mfg. Sdn. Bhd. |
CGMP/Finished Pharmaceuticals/Adulterated |
Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi |
CGMP/Finished Pharmaceuticals/Adulterated |