AMS Publishes Final Rule on Undue Preferences Under GIPSA
The rule is available here. The four criteria USDA will consider include whether the preference or advantage:
- cannot be justified on the basis of a cost savings related to dealing with different producers, sellers, or growers;
- cannot be justified on the basis of meeting a competitor’s prices;
- cannot be justified on the basis of meeting other terms offered by a competitor; and
- cannot be justified as a reasonable business decision.
FSIS to Prohibit No Nitrate or Nitrite Added, Uncured Claims on Products Using Celery Powder or Other Natural Sources of Nitrates/Nitrites
FSIS indicated this stance in a response to a petition on the matter submitted by the Center for Science in the Public Interest (CSPI). The petition and response are available here.
FDA Issues Final Guidance on Potassium Chloride Labeling
The purpose of the guidance is to advise food manufacturers of FDA’s intent to exercise enforcement discretion for declaration of the name “potassium salt” in the ingredient statement on food labels as an alternative to the common or usual name “potassium chloride.”
FSIS Notice on Raw Pork Products Sampling
The notice indicates that all raw pork samples will continue to be analyzed for Salmonella and for aerobic counts, which will serve as indicator organisms.
FDA Extends Comment Periods on Nutrition Labeling of Sugars Metabolized Differently and Traceability Rules
The comment period on the traceability rule has been extended to February 22, 2021, and the comment period on nutrition labeling of sugars metabolized differently has been extended to February 16, 2021.
FSIS Updated Establishment Directory
Available here.
FSIS Proposes Changes to Accreditation of Non-Federal Analytical Testing Laboratories
FSIS is proposing to change the statistical method it uses to evaluate laboratory proficiency testing sample results to the z score approach for those accreditations that are currently evaluated by Cumulative Summation. FSIS also is proposing to accredit non-Federal laboratories for microbiological indicator organisms and pathogen testing
FSIS Quarterly Sampling Reports to Include Antimicrobial Resistance Information
Details here.
FSIS Publishes 2021 Inspection Rates
The rates are:
Basetime………………………………………… $66.56 Overtime…………………………………………$ 81.72
Holiday…………………………………………. $96.88
Laboratory………………………………………. $84.64
Export Application……………………………….. $4.01 per application
More information here.
FDA Proposes to Eliminate Standard of Identity for Frozen Cherry Pie
The standard regulates the quantity and quality of cherries among other things. Details on the proposed rule to eliminate the standard of identity are available here.
FSIS Uniform Labeling Compliance Date Announced
January 1, 2024, will be the uniform compliance date for new meat and poultry product labeling regulations that will be issued between January 1, 2021, and December 31, 2022.
FSIS Updates List of Foreign Establishments Eligible to Export to the U.S.
Latest FDA Import Alerts
The latest FDA import alerts are available here and include FSVP, salmonella, seafood and mycotoxins.
Latest FDA Warning Letters:
Posted Date |
Company |
Issuing Office |
Subject |
12/16/2020 |
Phoenix Biotechnology, Inc. |
CDER Office of Compliance |
Finished Pharmaceuticals/Unapproved new drug |
12/15/2020 |
JC Ayur Life LLC |
Division of Human and Animal Food Operations West V |
Dietary Supplement/New Drug/Misbranded |
12/15/2020 |
Smoky Mountain Naturals, LLC |
Division of Human and Animal Food Operations East V |
New Drug/Misbranded |
12/15/2020 |
Desert Premium Group, LLC |
Office of Human and Animal Foods Division IV West |
CGMP/Acidified Foods/Adulterated |
12/15/2020 |
Desert Alchemist LLC |
Division of Human and Animal Food Operations West IV |
New Drug/Misbranded |
12/11/2020 |
Heavenly Natural Products |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
12/11/2020 |
Health & Wellness Center International One, L.L.C. dba Hotze Vitamins |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
12/11/2020 |
iThrive.health |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
12/11/2020 |
Indigenous Products |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
12/08/2020 |
Natures Boost LLC |
Division of Human and Animal Food Operations West VI |
New Drug/Misbranded |
12/08/2020 |
Mexi-Land Inc. |
Division of West Coast Imports |
Foreign Supplier Verification Program (FSVP) |
12/08/2020 |
Valentus, Inc. |
Division of Human and Animal Food Operations West I |
New Drug/Misbranded |
12/08/2020 |
Corporativo Bureli S.A. de C.V. |
Center for Drug Evaluation and Research | CDER |
Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
12/08/2020 |
Mushroom Revival, Inc. |
Division of Human and Animal Food Operations East I |
New Drug/Misbranded |
12/08/2020 |
Paradigm RE LLC |
Center for Drug Evaluation and Research | CDER |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
Please contact Erik Lieberman at elieberman@usfoodimports.com for additional information.
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