FDA Exercises Menu Labeling and Packaged Food Nutrition Labeling Enforcement Discretion
Because of the COVID-19 outbreak, FDA will not take enforcement action against restaurants and manufacturers for selling food that does not bear nutrition labeling. FDA will also not enforce the menu labeling regulations. This enforcement discretion policy will be changed after the COVID-19 public health emergency declared by HHS ends.
FDA Consumer Alert on Fraudulent COVID-19 Products
The consumer update may be found here.
FDA Releases Consumer Information on Food Safety and Availability During COVID-19 Pandemic
The update is available here.
FSIS Releases Notice on Cervid Inspection for Chronic Wasting Disease
The notice provides instructions to inspection program personnel, who perform voluntary inspection of captive cervid animals (i .e., members of the deer family including deer, elk, and reindeer) that have been tested by APHIS for chronic wasting disease.
FDA to Hold Webcast on PFOA in Food
The webcast will be held on Thursday, April 9 at noon. More details here.
AMS Calls for Nominees to National Organic Standards Board
Nominations must be received by June 1.
APHIS Proposes to Allow Fresh Blueberry Imports from Chile
Details here.
FDA Fact Sheet on Safety Distributing Unused Human and Animal Food During COVID-19 Pandemic
The fact sheet is available here.
FSIS to Initiate Rulemaking on U.S. COOL Claims for Meat
FSIS intends to limit the use of certain voluntary labeling claims, such as “Product of USA,” “Made in USA,” and “USA Beef,” to meat products derived from cattle born, raised, and slaughtered in the United States. More details here.
FDA Publishes Fact Sheet on Safely Using Hand Sanitizer
The consumer fact sheet is available here.
FDA Update on Enoki Mushroom Listeria Outbreak
FDA advises consumers to avoid recalled enoki mushrooms from Sun Hong Foods, Inc. and Guan’s Mushroom Co.
FDA Warning on Human Use of Chloroquine Phosphate for Aquarium Fish
Humans should not use Chloroquine Phosphate for aquarium fish as a treatment for COVID-19.
FDA Updates CPG on Post-Detention Sampling of Imports
The CPG is available here.
Bella Fresh Hit with $3 Million PACA Case
Details here.
FDA Releases COVID-19 FAQs
More information here.
APHIS Proposes National List of Reportable Animal Diseases
The agency is proposing to amend the animal disease regulations to provide for a National List of Reportable Animal Diseases, along with reporting responsibilities for animal health professionals that encounter or suspect cases of communicable animal diseases and disease agents.
TTB Modernizes Alcoholic Beverage Labeling Regulations
The final rule provides greater flexibility and will not require industry members to make changes to alcohol beverage labels or advertisements.
APHIS Recommends Removing Port Restrictions for South African Citrus
The proposal will allow South African citrus to be imported in any U.S. port.
Latest FDA Import Alerts
The latest FDA import alerts are available here and include dietary supplements, smoked fish, unapproved colors and more.
Latest FDA Warning Letters:
Posted Date |
Company |
Issuing Office |
Subject |
04/02/2020 |
Gaia’s Whole Healing Essentials, LLC |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
04/02/2020 |
Homeomart Indibuy |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
04/02/2020 |
Health Mastery Systems DBA Pure Plant Essentials |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
04/01/2020 |
NeuroXPF |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
03/31/2020 |
Turkish Trade LLC d/b/a Tarblock, Inc. |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/31/2020 |
TJD Holdings, Inc. d/b/a Venturi |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/31/2020 |
Soniceast LLC |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
03/31/2020 |
Cargill Incorporated |
Division of Human and Animal Food Operations East III |
CGMP/Medicated Feeds/Adulterated |
03/31/2020 |
FICOSOTA LTD |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
03/31/2020 |
Trilogy Laboratories, LLC |
Office of Pharmaceutical Quality Operations, Division II |
CGMP/Finished Pharmaceuticals/Adulterated |
03/31/2020 |
Pharmcore Inc. dba Hallandale Pharmacy |
Office of Pharmaceutical Quality Operations, Division II |
Compounding Pharmacy/Adulterated Drug Products |
03/31/2020 |
Bulletproof 360 Inc |
Division of Human and Animal Food Operations West VI |
CGMP/Dietary Supplement/Adulterated/Misbranded |
03/31/2020 |
Shung Kee Food Co., Ltd. |
Office of Human and Animal Food Operations East Division 1 |
Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
03/31/2020 |
Pfizer Healthcare India Private Limited |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
03/31/2020 |
Bioactive C60/FullerLifeC60 LLC |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
03/31/2020 |
Halosense Inc. |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
03/31/2020 |
JRB Enterprise Group Inc. DBA Anti Aging Bed |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
03/27/2020 |
Corona-cure.com |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
03/27/2020 |
Carahealth |
Center for Drug Evaluation and Research | CDER |
Unapproved Products Related to the 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. |