FDA Update on Red Onion Salmonella Outbreak
The FDA, along with CDC and state and local partners, is investigating a multistate outbreak of Salmonella Newport infections. FDA’s traceback investigation is ongoing but has identified Thomson International, Inc. of Bakersfield, CA as a likely source of potentially contaminated red onions. Do not eat, sell, or serve recalled onions from Thomson International, Inc. More information here.
FDA Publishes FSMA Fees for FY2021
These rates will be charged to facilities, importers and food facility agents for reinspections. Reinspections may occur when an initial inspection results in an other action indicated (OAI) classification. For FY2021, the hourly rate if domestic travel is required is $263. The hourly rate if foreign travel is required is $310. More details here.
FDA Requests Information on Expansion of List of Produce Exempt from FSMA Produce Safety Rule
These items will join the others on the rarely consumed raw list which are exempt from the FSMA Produce Safety Rule. Receive more information and submit information here.
FSIS Publishes Notice on Use of Results from Non-FSIS Labs
Under certain circumstances, such as during outbreaks or illness investigations, results from non-FSIS laboratories are shared with FSIS. If FSIS decides the results are acceptable, the Agency may take an action (e.g. recommend a recall or detain product). This directive describes the decision-making process FSIS follows to determine appropriate use of the non-FSIS test results. FSIS is reissuing this directive in its entirety to clarify the documentation and information needed by FSIS to complete the review of results provided to FSIS by non-FSIS laboratories.
FDA Issues Final Guidance for Industry on Action Level for Inorganic Arsenic in Infant Rice Cereals
FDA has issued guidance finalizing the 2016 draft guidance for inorganic arsenic in infant rice cereals and identifying the agency’s intended sampling and enforcement approach. The guidance identifies an action level of 100 micrograms per kilogram (µg/kg) or 100 parts per billion (ppb) which protects public health by reducing infants’ dietary exposure to inorganic arsenic and is achievable by industry.
AMS Publishes Proposed Rule with Major Changes to Organic Regulations
The proposed rule will strengthen enforcement of the USDA organic regulations through several actions mandated by the Agriculture Improvement Act of 2018: 1. Reduce the types of uncertified entities in the organic supply chain that operate without USDA oversight–including importers, brokers, and traders of organic products. 2. Require the use of NOP Import Certificates, or equivalent data, for all organic products entering the United States. This proposed change will expand the use of NOP Import Certificates to all organic products imported into the United States. 3. Clarify the NOP’s authority to oversee certification activities, including the authority to act against an agent or office of a certifying agent. Additionally, certifying agents must notify the NOP upon opening a new office.
FDA Updates Interstate Certified Shellfish Shippers List
The list is available here.
FSIS Updates List of Foreign Establishments Eligible to Export to the U.S.
Latest FDA Import Alerts
The latest FDA import alerts are available here and include heavy metals, canned foods, and pesticides among other things.
Latest FDA Warning Letters
Posted Date |
Company |
Issuing Office |
Subject |
08/07/2020 |
Canadian Chaga |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
08/04/2020 |
Pasha Food Distribution USA, Inc. |
Division of West Coast Imports |
Foreign Supplier Verification Program (FSVP) |
08/04/2020 |
New Life International |
Center for Veterinary Medicine |
Unapproved Chloroquine Phosphate Product |
08/04/2020 |
Fishman Chemical of North Carolina, LLC |
Center for Veterinary Medicine |
Unapproved New Animal Drug Products |
08/04/2020 |
ACRX Specialty Pharmacy Inc. |
Center for Drug Evaluation and Research | CDER |
Compounding Pharmacy/Adulterated Drug Products |
08/04/2020 |
Kaymile Trading, Inc. |
Center for Food Safety and Applied Nutrition (CFSAN) |
Foreign Supplier Verification Program (FSVP) |
08/04/2020 |
Ventura Terra Garden Inc. |
Division of West Coast Imports |
Foreign Supplier Verification Program (FSVP) |
08/04/2020 |
MMSTabs.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 information |