AMS Changes Reporting Requirements for Imports
The final rule changes the reporting requirements for certain Irish potatoes, tomatoes, and onions regulated under section 608e of the Agricultural Marketing Agreement Act of 1937, as amended (section 8e). With this change, importers of those regulated commodities that have been certified by a designated governmental inspection service other than the Federal or Federal-State Inspection Service as meeting section 8e requirements will be required to provide the inspection certificate number and a copy of the certificate to the Agricultural Marketing Service (AMS) (currently, the Canadian Food Inspection Agency is the only entity so designated). In addition, this rule changes the pistachio import regulations to provide for the electronic filing of aflatoxin test results and to eliminate a requirement to report the disposition of reworked or failed lots of pistachios. This rule also changes several of the section 8e regulations by removing or replacing outdated information.
FDA Halts Foreign Inspections
FDA announced it would halt routine foreign inspections for food, drugs and medical devices through April due to COVID-19.
FSIS FOIA Request Report
FSIS has released its latest FOIA request report.
FDA CBD Update
FDA has released an update on their CBD efforts.
FDA Releases Leafy Green Action Plan
FDA has released the 2020 Leafy Greens STEC Action Plan, outlining steps the agency plans to take this year to advance the safety of leafy greens. More information here.
FSIS Recognizes UK for Raw Beef Imports; Updates COVID-19 Website; Announces More Leadership Changes
More information here.
FDA Warning Letters on Fraudulent COVID-19 Cures
Seven companies received warning letters.
CBP Updates Drawback Q&A
The update is available here.
FDA Releases Final Report of Talc-containing Cosmetic Products Tested for Asbestos
The report is available here.
AMS Proposed Rule on Grapefruit and Orange Standards
AMS proposes to revise the U.S. Standards for Grades of Grapefruit (Texas and States other than Florida, California, and Arizona) and the U.S. Standards for Grades of Oranges (Texas and States other than Florida, California, and Arizona). The revision would convert the Acceptable Quality Level (AQL) tables from showing the acceptable number of allowable defective fruit in each grade to showing the percentage of defects permitted in each grade; revise the minimum sample size to 25 fruit; update size classifications; remove references to Temple oranges from the orange standards for grade; and more closely align terminology in both grade standards with Florida and California citrus standards.
FDA Warns Retailers, Manufacturers to Remove Unauthorized E-Cigarette Products from Market
Twenty-two warning letters were issued.
FDA Reopens Comment Period on CBD
The comment period has been extended indefinitely to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
FDA Releases Nutritional Labeling Educational Campaign
The campaign on the new format for nutrition labels is intended for consumers.
APHIS Authorizes Importation of Fresh Jujube from China
More information here.
Latest FDA Import Alerts
The latest FDA import alerts are available here.
Latest FDA Warning Letters
Posted Date |
Company |
Issuing Office |
Subject |
03/10/2020 |
Apollo Future Technology Inc. d/b/a Apollo E Cigs |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/10/2020 |
Whitelightning USA LLC |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/10/2020 |
United Tobacco Vapor Group, Inc. d/b/a Premium Vapes |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/10/2020 |
W3 Markets LLC d/b/a ProSmoke |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/10/2020 |
Global Tobacco LLC d/b/a X2O Vapes |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/10/2020 |
Premiumestore, LLC |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/10/2020 |
Guangzhou Tinci Materials Technology Co., Ltd. |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
03/10/2020 |
Gourmet Catering to Go, LLC |
Office of Human and Animal Foods Operations-East V |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
03/10/2020 |
GuiLin SanYang Dietary Ecological Industry Co.Ltd. |
Center for Food Safety and Applied Nutrition (CFSAN) |
Acidified Foods/Acid Canned Food Regulation |
03/10/2020 |
James R. Corbett, M.D. |
Center for Drug Evaluation and Research | CDER |
Clinical Investigator |
03/10/2020 |
ShiVish International LTD. d/b/a Evapstore |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/06/2020 |
Quinessence Aromatherapy LTD |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
03/06/2020 |
GuruNanda LLC |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
03/06/2020 |
Colloidal Vitality LLC/Vital Silver |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
03/06/2020 |
Xephyr, LLC dba N-Ergetics |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
03/06/2020 |
Vivify Holistic Clinic |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
03/06/2020 |
The Jim Bakker Show |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
03/06/2020 |
Herbal Amy Inc |
Center for Food Safety and Applied Nutrition (CFSAN)eralera |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
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