In This Week’s Edition:
- FDA Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States
- FDA Investigation of Cronobacter and Salmonella Complaints: Powdered Infant Formula
- Update on FDA’s Continuing Efforts to Understand and Reduce Exposure to PFAS from Foods
- USDA Commits $215 Million to Enhance the American Food Supply Chain
- USDA Grants Additional WIC Flexibilities Amid Abbott Recall of Certain Powder Infant Formula
- 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 Alerts the Public to Potentially Contaminated Products from Family Dollar Stores in Six States
FDA is alerting the public that several categories of FDA-regulated products purchased from Jan. 1, 2021, through the present from Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee may be unsafe for consumers to use. The impacted products originated from the company’s distribution facility in West Memphis, Arkansas, where an FDA inspection found insanitary conditions, including a rodent infestation, that could cause many of the products to become contaminated. The FDA is working with the company to initiate a voluntary recall of the affected products.
FDA Investigation of Cronobacter and Salmonella Complaints: Powdered Infant Formula
The FDA, along with CDC and state and local partners are investigating four consumer complaints of infant illness related to products from Abbott Nutrition’s Sturgis, MI facility received from 9/20/2021 to 1/11/2022. All of the cases are reported to have consumed powdered infant formula (IF) produced from Sturgis, MI facility. These complaints include three reports of Cronobacter sakazakii infections and one report of Salmonella Newport infection in infants. All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case.
Update on FDA’s Continuing Efforts to Understand and Reduce Exposure to PFAS from Foods
FDA issued new test results that are part of our work to better understand and reduce potential exposure to PFAS from foods. They also shared an update on the progress of the voluntary market phase-out of certain short-chain PFAS used in food packaging.
USDA Commits $215 Million to Enhance the American Food Supply Chain
USDA Secretary Tom Vilsack today announced that USDA is making available up to $215 million in grants and other support to expand meat and poultry processing options with the goal of increasing competition in the industry.
USDA Grants Additional WIC Flexibilities Amid Abbott Recall of Certain Powder Infant Formula
USDA announced that it has granted additional flexibilities in response to the impact of the 2022 Abbott recall of certain powder infant formula provided through the Special Supplemental Nutrition Program for Women, Infants, and Children.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- The Enteroinvasive E. coli (EIEC) O143:H26 outbreak (reference #1054) has closed, and the investigation has ended.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include seafood with FSVP, microbiological contamination, nutrient and labeling requirements and more.
FDA Warning Letters
Vape House |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Vapor Proz USA LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
RTP Vapors LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Vapor Corner Inc |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
My Natural Treatment |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Bulldog Vapor LLC dba Bullys Vapor LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Smart Surgical, Inc dba Burst Biologics |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
Extrapharmacy.ru |
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
rxshopmd.com |
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet |
PBDragon LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Freedom Smoke USA International dba Freedom Smoke USA Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
CytoDyn, Inc. |
New Drug/Labeling/Misbranded |
Toxikon Corporation/Labcorp Bedford LLC |
Good Laboratory Practice (GLP) |
Guangdong Sigelei Electronic Technology Co., Ltd. d/b/a Sigelei Vape, Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Patidar Trade, Inc. |
Foreign Supplier Verification Program (FSVP) |
Ulrich Farms |
Illegal Drug Residue Animal Tissue/Adulterated |