FDA Issues Warning on CBD Use by Expecting and New Mothers
FDA strongly advises against the use of cannabidiol (CBD), tetrahydrocannabinol (THC), and marijuana in any form during pregnancy or while breastfeeding.
FSIS Issues New Procedure for Submitting Labels for Bison and Other Exotic Species
Establishments may slaughter and process exotic species listed in 9 CFR 352.1(k) (i.e., reindeer, elk, deer, antelope, water buffalo or bison) under the Voluntary Exotic Species Reimbursable Inspection Program. Currently all labels and any modifications to those labels applied to these products must be submitted to FSIS for sketch approval.
FSIS will evaluate certain exotic species labels within a shorter time frame if the label was previously sketch approved by FSIS. Specifically, if an establishment is making a modification to a previously sketch approved label, and that modification is one that would not affect any special claims and would typically qualify for generic approval under 9 CFR 412.2 for meat and poultry products under FSIS jurisdiction and inspection, the label will be handled within a shorter time frame. More information here.
FSIS Posts Updated Data Set on Imports
FSIS has posted the latest dataset on import refusals for products regulated by the agency.
FDA Makes Available List of Records Required Under the Foreign Supplier Verification Program Rule
The list is available here.
Tariff Increase on Products from China Suspended
More information here.
FDA Updates Manufactured Food Regulatory Standards
FDA has revised standards for the state regulatory programs that oversee food facilities that manufacture, process, pack, or hold foods. These regulatory program standards, known as the Manufactured Food Regulatory Program Standards (MFRPS), were first issued by the agency in May 2007 and are updated every three years. The 2019 changes include updates to defined terms, new appendices and job aides, as well as updates to the current standards. More information here.
APHIS Announces Finalized Cervid Chronic Wasting Disease Herd Certification Program Standards
The standards are available here.
FDA Updates Sanitation Compliance and Enforcement Ratings of Interstate Milk Shippers
The list is available here.
APHIS Reminds Importers to Submit Data for Low Value Shipments
Importers and brokers now have the option of using Entry Type 86 when filing Section 321 low-valued shipments in the Automated Commercial Environment (ACE). Section 321 is a type of informal entry designed to speed up the clearance of low value shipments, specifically those valued at $800 or less.
Importers and brokers are reminded that products regulated by the United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) must meet admissibility requirements regardless of value. If importers and brokers do not submit required data or paperwork, shipments may be held at the port of entry or refused entry. More information here.
FSIS Issues Notice on Sampling of Young Chicken Carcasses for Nitrofurans Prior to Chilling
The notice provides instructions to IPP on collecting young chicken carcasses at a point prior to chilling for testing for nitrofurans, including the marker residue semicarbazide (SEM).
APHIS Determinations on Animal Disease Status in Mexico and Singapore
- Singapore recognized as free of foot-and-mouth disease.
- Baja California recognized as free of fever ticks.
APHIS Authorizes Importation of Fresh Guava from Taiwan Into the U.S.
More information here.
AMS Releases Proposed Rule Allowing for New Synthetic Substances to Be Used in Organic Agriculture
The substances include blood meal made with sodium citrate, natamycin and tamarind seed gum.
FSIS Updates Lists of Establishments from Mexico and Israel Eligible to Export to U.S.
Latest FDA Warning Letters
The latest FDA warning letters are:
Date |
Company |
Issuing Office |
Subject |
10/15/2019 |
Vanilla Vapes Limited |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/15/2019 |
JUSTFOG USA YB Sales, Inc. |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/15/2019 |
North Texas Vapor Shop |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/15/2019 |
Freshvaping.com |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/15/2019 |
Westlake IVF, LLC |
Office of Biological Products Operations – Division 2 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
10/15/2019 |
The Skin Atelier, Inc. d.b.a. Skinprint |
Division of Pharmaceutical Quality Operations I |
CGMP/Finished Pharmaceuticals/Adulterated |
10/15/2019 |
Glenmark Pharmaceuticals Limited |
Center for Drug Evaluation and Research |
CGMP/Finished Pharmaceuticals/Adulterated |
10/15/2019 |
Herbal Doctor Remedies |
Division of Pharmaceutical Quality Operations IV |
CGMP/Finished Pharmaceuticals/Adulterated |
10/15/2019 |
Torrent Pharmaceuticals Limited |
Center for Drug Evaluation and Research |
CGMP/Finished Pharmaceuticals/Adulterated |
10/15/2019 |
Coral Pharmaceuticals LTD |
Center for Drug Evaluation and Research |
CGMP/Finished Pharmaceuticals/Adulterated |
10/15/2019 |
Denterprise International, Inc. |
Division of Medical Device and Radiological Health Operations Central |
CGMP/QSR/Medical Devices/Adulterated |
10/15/2019 |
Vanilla Vapes Limited |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/15/2019 |
JUSTFOG USA YB Sales, Inc. |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Please contact Erik Lieberman at elieberman@usfoodimports.com or (202) 765-1800 if you have questions or would like additional information. |