Kiecker Named FSIS Administrator
Paul Kiecker will be assuming the role following the departure of Administrator Carmen Rottenberg, who is departing federal service. He has been with the agency since 1988. More information here.
APHIS Publishes Final Lacey Act De Minimis Exception Rule
Shipments where the packaging material is the only component subject to the Lacey Act and shipments with 5% or less (by weight) of plant material subject to the Lacey Act (up to 2.9 kg) fall within the exception. The exception does not apply in cases of endangered or threatened species or CITES species.
FDA Voluntary Cosmetic Registration
The February 2020 report is available here.
FDA Announce Public Meeting on International Cooperation on Cosmetics
The public meeting will be held April 14, 2020, from 2:00-4:00 pm to prepare for the International Cooperation on Cosmetics meeting June 8-10 in Brussels.
USDA Files PACA Action Against RRD Produce
The company, operating from California, allegedly failed to make payment promptly to 17 produce sellers in the amount of $174,464 from May 2018 through December 2018.
USDA Requests Comment on Quantifying Greenhouse Gas Emissions
In accordance with Section 2709 of the 2008 Farm Bill, the United States Department of Agriculture (USDA) developed technical guidelines and science-based methods to quantify greenhouse gas sources and sinks from the agriculture and forest sectors at the entity-scale. In the report, Quantifying Greenhouse Gas Fluxes in Agriculture and Forestry: Methods for Entity-Scale Inventory, USDA stated it intends to periodically update the technical guidelines based on newly available data and methodologies, and an update is planned for completion within the next 3 years. As USDA prepares the updated report, the agency is seeking input from the public to ensure that relevant information and data are considered, improve the rigor of the guidelines, and enhance the usability of the methods in the updated technical guidelines.Comments are due by April 20, 2020.
FDA Launches Educational Website on GE Food
The website is available here.
Latest FDA Interstate Certified Shellfish Shippers List
The March 2020 list is available here.
FDA Announces End to Listeria Outbreak Investigation in Hardboiled Eggs
The announcement is available here.
California Kiwi Marketing Order Referendum Announced
The referendum will be conducted among eligible California kiwifruit growers to determine whether they favor continuance of the marketing order regulating the handling of kiwifruit grown in California. The referendum will be conducted from May 18 through May 29, 2020.
Final Rule on Outside Practice Of Law by USDA Lawyers Published
The rule prohibits activities that would conflict with USDA interests.
Latest FDA Import Alerts
The latest FDA import alerts are available here. They include import alerts on Mexican papaya, seafood,illegal color additives and more.
Latest FDA Warning Letters:
Posted Date |
Company |
Issuing Office |
Subject |
03/10/2020 |
Sublime Liquids |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/03/2020 |
Kakushime Matsuda Suisan |
Center for Food Safety and Applied Nutrition (CFSAN) |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
03/03/2020 |
ITL Asia Pacific Sdn Bhd |
“OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, Office of Product Evaluation and Quality” |
CGMP/QSR/Medical Devices/Adulterated/Misbranded |
03/03/2020 |
Silfradent Srl |
“OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, Office of Product Evaluation and Quality” |
CGMP/QSR/Medical Devices/Adulterated/Misbranded |
03/03/2020 |
Reproductive Technologies, Inc. |
Office of Biological Products Operations – Division 2 |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
03/03/2020 |
Zona Health Inc. |
“OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality” |
Premarket Approval/Misbranded/Adulterated |
03/03/2020 |
Luoma Egg Ranch, Inc. |
Office of Human and Animal Foods – West Division 1 |
PHS Act/Shell Egg Regulation/Adulterated |
03/03/2020 |
Jiangsu JDC Medical Devices Co., Ltd. |
“OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices, Office of Product Evaluation and Quality” |
CGMP/QSR/Medical Devices/Adulterated/Misbranded |
03/03/2020 |
Acino Products, LLC |
Division of Pharmaceutical Quality Operations I |
CGMP/Finished Pharmaceuticals/Adulterated |
03/03/2020 |
Lemond Trading Corp |
Division of West Coast Imports |
Foreign Supplier Verification Program (FSVP) |
03/03/2020 |
Chemland Co., Ltd. |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
03/03/2020 |
Yakseon Food Agricultural Co. LTD |
Center for Food Safety and Applied Nutrition (CFSAN) |
Low Acid Canned Food Regulation/Adulterated |
03/03/2020 |
Natures Rx, LLC |
Division of Pharmaceutical Quality Operations IV |
Unapproved New Drugs/Misbranded |
03/03/2020 |
Mikart LLC |
The Office of Prescription Drug Promotion (OPDP) |
False & Misleading Claims/Misbranded |
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