In This Week’s Edition:
- FDA Allergen Compliance Policy Guide
- IFT Report Recommends Collaboration and Innovation to Advance Food Traceability
- FDA Webinar on Investigational Food Use Authorizations for Genetically Altered Animals
- Animal Welfare Institute Petitions USDA on Carbon Dioxide Stunning of Swine
- National Agricultural Research, Extension, Education, and Economics Advisory Board Meeting
- USDA Funds Projects Aimed at Connecting Families to WIC through Partnership with FRAC
- Importation of Fresh Pumpkin, Squash, and the Hybrid Tetsukabuto From Brazil Into the U.S.
- 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 Allergen Compliance Policy Guide
The compliance guide is available here and addresses cross contact issues among other things. The draft guidance, when finalized, will replace existing guidance for FDA staff on FDA’s enforcement policy regarding major food allergen labeling.
IFT Report Recommends Collaboration and Innovation to Advance Food Traceability
The Institute of Food Technologists (IFT) has released a report commissioned by the U.S. FDA that evaluates food traceability trends based on 90 submissions from teams that participated in FDA’s 2021 Low- or No-Cost Tech-Enabled Traceability Challenge. Read the full report here.
FDA Webinar on Investigational Food Use Authorizations for Genetically Altered Animals
FDA is announcing the availability of a pre-recorded webinar for developers who are interested in learning more about the process of requesting an Investigational Food Use Authorization for animals with investigational intentional genomic alterations (IGAs). IGAs in animals are alterations to the animal’s genome that are made using genome editing or rDNA technologies.
Animal Welfare Institute Petitions USDA on Carbon Dioxide Stunning of Swine
The petition requests that FSIS conduct rulemaking to require swine slaughter establishments that use carbon dioxide stunning to install video cameras inside their stunning areas.
National Agricultural Research, Extension, Education, and Economics Advisory Board Meeting
USDA announced a meeting of the National Agricultural Research, Extension, Education, and Economics Advisory Board on June 6-7.
USDA Funds Projects Aimed at Connecting Families to WIC through Partnership with FRAC
USDA, through a cooperative agreement with USDA’s Food and Nutrition Service and the Food Research & Action Center, has awarded $16 million in subgrants funding from the American Rescue Plan Act of 2021 to 36 projects aimed at testing innovative outreach strategies to increase participation and equity in the Special Supplemental Nutrition Program for Women, Infants, and Children, known as WIC.
Importation of Fresh Pumpkin, Squash, and the Hybrid Tetsukabuto From Brazil Into the U.S.
USDA is advising the public that they have prepared a pest risk analysis that evaluates the risks associated with importation of fresh pumpkin, squash, and the interspecific hybrid tetsukabuto from Brazil into the continental United States. Based on the analysis, USDA has determined that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh pumpkin, squash, and tetsukabuto from Brazil.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the investigation of illnesses linked to morel mushrooms (ref #1152), preliminary information reported by Gallatin City- County Health Department and the Montana Department of Public Health and Human Services (DPHHS) indicates that a food containing imported morel mushrooms consumed at a single restaurant in Montana may be the exposure of concern. Additional information will be provided as it becomes available.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
No new updates this week.
FDA Warning Letters
Drive Thru Vapors, LLC d/b/a Drive Thru Vapors Dallas |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Sea-Long Medical Systems, LLC |
CGMP/QSR/Medical Devices/Adulterated |
EarthLab, Inc., dba Wise Woman Herbals |
Unapproved New Drugs/Misbranded |
Gary’s Cheesecakes & Fine Desserts |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
iSlim, LLC |
Unapproved New Drugs/Misbranded |
Pharmedica USA, LLC |
CGMP/Finished Pharmaceuticals/Adulterated |
Sorcerz.com |
Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet |
Kilo E-Liquid, Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Califa Imports, Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |