FDA Warns of Chinese-Made Respirators Ineffective for COVID-19
A number of products fail to meet N95 standards.
FDA Requests Label Submissions for Imports
FDA is recommending that product labeling be submitted for all entries in which the agency seeks additional documents to assess whether or not to release the shipment. More information here.
USDA Approves Pandemic EBT for PA, NY, VT, ME, ND and WV
More information here.
USDA Approves NM, CO and NV for Online SNAP
More information:
FDA Updates Interstate Certified Shellfish Shippers List
The list is available here.
Animal Health International Sentenced on Federal Misbranding Charge
Company ordered to pay over $52 million.
FSIS Notice on Microbiological Sampling of Liquid Egg Products
Notice 22-20 is available here.
APHIS Prelimarily Approves Release of Aphelinus hordei for Biological Control of Russian Wheat Aphid
The environmental assessment is available here.
FSIS Revises Directive on Ante-Mortem Livestock Inspection
FSIS is reissuing the directive to incorporate the instructions for verifying the handling of non-ambulatory disabled veal calves, removing the requirement that ante-mortem inspection must be performed in holding pens, and updating the disposition instructions for recumbent cattle. Also, FSIS has updated the directive to provide a definition for “promptly” (as it pertains to euthanasia) and additional instructions about entering the US Suspect tag in the Public Health Information System.
FSIS Notice on Sampling of Fowl Slaughtered Under New Poultry Inspection System as Authorized by Waiver
The notice provides instructions to inspection program personnel for the sampling of fowl carcasses at establishments operating under the New Poultry Inspection System.
FDA Update on Fraudulent COVID-19 Products
FDA is taking enforcement action against a number of companies. More information here.
AMS Renews List of Substances Allowed in Organics
The list is available here.
FSIS Releases Audit of Israel Poultry Inspection System
The audit is available here.
Thailand GSP Trade Status Suspended for Food Products, Tariffs Imposed
Thailand’s duty-free status accorded under the Generalized System of Preferences has been suspended for certain products, including food products. The status was suspended on the basis that Thailand is failing to afford workers internationally-recognized worker rights. More information here.
FDA Consumer Information on Foodborne Illness in Pets
Available here.
USDA Addresses Meat and Poultry Industry on President’s Defense Production Act Moves
The letter from USDA Secretary Perdue is available here.
Color Additve Petition for Spirulina
FDA has filed a petition, submitted by GNT USA, Inc. (GNT), proposing that the color additive regulations be amended to expand the safe use of spirulina (Arthrospira platensis) extract at levels consistent with good manufacturing practice. More information here.
Latest FDA Import Alerts
The latest FDA import alerts are available here and include cilantro, animal feeds, undeclared/unapproved colors, pesticides and more.
Latest FDA Warning Letters:
Posted Date |
Company |
Issuing Office |
Subject |
05/08/2020 |
Chronic Lyme Treatments |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
05/08/2020 |
WashingtonsLastFrontier.Com |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
05/08/2020 |
AgroTerra, Ltd. dba Patriot Hemp Company |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
05/08/2020 |
Sanit Technologies LLC dba Durisan |
Center for Drug Evaluation and Research | CDER |
Unapproved New Drug Products Related to Coronavirus Disease 2019 (COVID-19) |
05/07/2020 |
DrJockers.com, LLC |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
05/07/2020 |
Alive By Nature, Inc. |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
05/07/2020 |
GlutaGenic |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
05/05/2020 |
Philosys Co. Ltd |
Center for Devices and Radiological Health |
Medical Device Reporting/Misbranded |
05/05/2020 |
Bedfont Scientific, Ltd. |
Center for Devices and Radiological Health |
CGMP/QSR/Medical Devices/Adulterated |
05/05/2020 |
University of Kentucky |
Center for Devices and Radiological Health |
Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies |
05/05/2020 |
Tailor Made Compounding LLC |
Division of Pharmaceutical Quality Operations III |
Compounding Pharmacy/Adulterated Drug Products |
05/05/2020 |
Shriram Institute for Industrial Research |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/API/Adulterated |
05/05/2020 |
Global Vitality, Inc. dba Enzyme Process International |
Division of Human and Animal Food Operations West IV |
Unapproved New Drugs/Misbranded |
05/05/2020 |
SeaSnax |
Division of West Coast Imports |
Foreign Supplier Verification Program (FSVP) |
05/05/2020 |
Hawaii Pharm LLC |
Division of Human and Animal Food Operations West V |
CGMP/Dietary Supplement/Adulterated/Misbranded |
05/05/2020 |
Medlife Pharmacy and Compounding, Inc. |
Division of Pharmaceutical Quality Operations IV |
Compounding Pharmacy/Adulterated Drug Products |
05/05/2020 |
Dr. Dhole’s Sushanti Homeopathy Clinic |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
05/05/2020 |
Honey Colony LLC |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
05/01/2020 |
Antroids.com |
Center for Drug Evaluation and Research |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
05/01/2020 |
Foxroids.com |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Please contact Erik Lieberman at elieberman@usfoodimports.com or 202.765.1800 if you have questions or would like additional informati |