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

• · Great to see better, real-time, end-to-end food traceability increasingly becoming the industry standard of care. Food traceability can’t wait. #blockchain #traceability https://www.forbes.com/sites/darrynpollock/2019/08/30/switzerlands-largest-supermarket-chain-follows-the-pack-with-blockchain-food-tracking/#5617c4a05d2c
• · Public meeting on FDA’s New Era of Smarter Food Safety is set for Oct. 21. Mark your calendars now & plan to join us. http://www.thepacker.com/article/fda-talk-about-new-era-food-safety-plan … More info coming soon.

@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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