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Laws and Regulations Committee Update - September 3 - 4, 2019

September 06, 2019 9:23 AM | Amy Bonsell (Administrator)

September 3, 2019

Federal Register

Food and Drug Administration

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products

Filed on: 09/03/2019 at 8:45 am Scheduled Pub. Date: 09/04/2019

FR Document: 2019-18987 PDF 8 Pages (113 KB) Permalink

 

FDA

Recalls

Date

Brand

Product Description

Product Type

Reason/Problem

Company

08/30/2019

Hiland

Lemonade

Food & Beverages,

Undeclared Milk

Hiland Dairy

 

FSIS

Aug 30, 2019 | PDF

  • FSIS Enhances Residue Testing
  • Australia Eligible to Export Raw Pork Products to the United States

Ask FSIS

FSIS Microbiology Laboratory Methods Validation Update: Part I

FSIS Microbiology Laboratory Methods Validation Update: Part II

Recalls

Product Recalled

Date of Recall

Retail Distribution List

089-2019 American Beef Packers, Inc. Recalls Raw Beef Products Deemed Unfit for Human Consumption

Aug 31, 2019

N/A (Class II Recall)

088-2019 Heatherfield Foods Inc. Recalls Pork Sausage Products Due to Misbranding

Aug 30, 2019

N/A (Class II Recall)

 

AMS

USDA Restricts PACA Violators in California, New Jersey, Texas and Washington from Operating in the Produce Industry

 

@FrankYiannasFDA

@DrMayneFDAFood

  • ·       Next month, FDA will hold a public meeting to discuss efforts to modernize food standards of identity - sharing ideas for change that could be made across standard food categories, to provide flexibility to develop healthier foods & facilitate innovation. https://go.usa.gov/xVZNt

September 4, 2019

Federal Register

Agricultural Marketing Service

Rules

Establishment of a Milk Donation Reimbursement Program

Filed on: 09/04/2019 at 8:45 am Scheduled Pub. Date: 09/05/2019

FR Document: 2019-19090  PDF 31 Pages (336 KB)  Permalink

 

FDA

ELM Update and Reminder to Firms Exporting Collagen, Gelatin, or Seafood Products to the European Union

Federal judge enters consent decree against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx, for drug, device and dietary supplement violations

Recalls

Date

Brand

Product Description

Product Type

Reason/Problem

Company

09/03/2019

Berkley & Jensen

Pig Ears

Animal & Veterinary,

Potential to be contaminated with Salmonella

Dog Goods USA LLC

Warning Letters

Posted Date

Letter Issue Date

Company

Issuing Office

Subject

09/03/2019

07/30/2019

Pavlos Trifonidis S.A

Center for Food Safety and Applied Nutrition

Seafood HACCP/CGMP for Foods/Adulterated

09/03/2019

08/09/2019

Whitsons Food Service - Bronx, Corp.

Division of Human and Animal Food Operations East I

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

09/03/2019

08/19/2019

Comercial Mares de Chiloe

Center for Food Safety and Applied Nutrition

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

09/03/2019

08/22/2019

Shree Datt Aquaculture Farms

Center for Food Safety and Applied Nutrition

Seafood HACCP/CGMP for Foods/Adulterated

09/03/2019

08/23/2019

Sportron International, Inc.

Office of Human and Animal Food West Division 3

Unapproved New Drugs/Misbranded

09/03/2019

08/26/2019

Absonutrix, LLC

Division of Human and Animal Food Operations East III

Dietary Supplement/Adulterated

GRAS Notices

GRN No.

Substance

859

2'-fucosyllactose

858

Glucosylated steviol glycosides

857

Phospholipase A1 produced by Aspergillus niger

856

Bifidobacterium animalis ssp. lactis strain BB-12

855

Bifidobacterium animalis ssp. lactis strain R0421

854

Inulin from Agave tequilana

853

Lysozyme produced by Trichoderma reesei

852

2’-fucosyllactose

851

Pea protein

850

Shea olein

849

Inulin from artichoke

848

Pea and rice protein fermented by Shitake mycelia

 

FDA OIG

The Food and Drug Administration Did Not Submit Clearance Documents for Any Audit Recommendations During Fiscal Years 2015 and 2016 but Has Since Made Significant Progress 

The Food and Drug Administration Generally Complied With Federal Requirements for the Preparation and Receipt of Select Agent Shipments 

 

FSIS

Petition Submitted by Center for Science in the Public Interest (Aug 29, 2019)

  • ·        The petition requests that FSIS prohibit the statement “No Nitrate or Nitrite Added”  and “Uncured” in the labeling of products that have been processed using any source of nitrate, including non-synthetic sources, such as celery powder.
  • ·        FSIS Response Acknowledging Receipt of Petition (Aug 30, 2019)

 

@FDACommissioner

  • ·        Today, @TheJusticeDept helped FDA take action against two drug, dietary supplement, and device distributors for violating federal law and putting consumer health at risk. https://go.usa.gov/xVkUr
  • ·        When we find products that do not meet FDA standards we will hold the companies & owners accountable. Americans expect products that meet appropriate standards for quality, and we’ll continue taking actions to ensure that these companies & products don't put patients at risk.


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