FSIS Seeks Comments on Marler Clark Petition to Declare 31 Salmonella Serotypes as Adulterants
On January 18, 2020, Marler Clark LLP, on behalf of several individuals and consumer advocacy organizations, petitioned FSIS to issue an interpretive rule to declare 31 Salmonella serotypes as adulterants under the Federal Meat Inspection Act (21 U.S.C. 601 et seq.) and the Poultry Products Inspection Act (21 U.S.C. 451 et seq.). The petition requests that FSIS take this action on all 31 serotypes jointly or, if the agency concludes that one or more serotypes do not merit such treatment, on each serotype individually. The Salmonella serotypes identified in the petition have been associated with human illness outbreaks and product recalls. More information here.
Revisions to Federal Seed Act Regulations Proposed
AMS has published a proposed rule revising regulations implementing the Federal Seed Act. The revisions include revisions to seed labeling, testing, and certification requirements. The proposed revisions would add certain seed species to the lists of covered kinds of seed and update the lists to reflect current scientific nomenclature; update regulations related to seed quality, germination and purity standards, and acceptable seed testing methods; and update seed certification and recertification requirements, including new eligibility standards and the recognition of current breeding techniques.
FDA Sampling Frozen Berreis for Hep A and Norovirus
As of September 30, 2019, the FDA has tested 339 domestic samples and 473 import samples of frozen berries. Of the frozen berries sampled, the FDA found genetic material from hepatitis A virus in five samples and genetic material from norovirus in eight samples. More information here.
FDA Center for Tobacco Program Updates
The January 2020 update newsletter is available here.
FSIS Updates List of Establishments from Japan Eligible to Export to the U.S.
Latest FDA Import Alerts
The latest FDA import alerts are available here. They include import alerts on pesticides, salmonella, undeclared colors, shrimp and more.
Latest FDA Warning Letters:
Posted Date |
Company |
Issuing Office |
Subject |
01/31/2020 |
Smart Toothpicks, LLC |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
01/28/2020 |
Yost Foods, Inc |
Cincinnati District Office |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
01/28/2020 |
VapinDash |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
01/28/2020 |
Baja Fur S.A. de C.V. |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
01/28/2020 |
Wave Miami LLC |
Division of Pharmaceutical Quality Operations I |
Unapproved New Drugs/Misbranded |
01/28/2020 |
R & B Medical Group Inc. |
Division of Biological Products Operations II |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
01/28/2020 |
Dental-Kosmetik GmbH & Co. KG |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
01/28/2020 |
Draegar Medical Systems, Inc. |
Office of Medical Device and Radiological Health Operations (Division 1) |
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) |
01/28/2020 |
Cerreta Candy Company, Inc. |
Office of Human and Animal Foods – Division IV West |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
01/28/2020 |
Sunstar Guangzhou Ltd. |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
Please contact Erik Lieberman at elieberman@usfoodimports.com or 202.765.1800 if you have questions or would like additional information.
|