News Article

Laws and Regulations Committee Update 8/14 - 8/18, 2017

Posted on August 18, 2017

Blog: Association of Food & Drug Officials (AFDO)

August 14, 2017

Federal Register

Food and Drug Administration

Rules

Food Additives Permitted in Feed and Drinking Water of Animals: Gamma-Linolenic Acid Safflower Oil

Filed on: 08/14/2017 at 08:45 am Scheduled Pub. Date: 08/15/2017

FR Document: 2017-17214 PDF 8 Pages (111 KB) Permalink

Notices

Guidance: Proposed Method for Adjusting Data on Antimicrobials Sold or Distributed for Use in Food-Producing Animals Using a Biomass Denominator

Filed on: 08/14/2017 at 08:45 am Scheduled Pub. Date: 08/15/2017

FR Document: 2017-17206 PDF 5 Pages (102 KB) Permalink

Animal and Plant Health Inspection Service

Rules

Imports:

Hass Avocados from Colombia

Filed on: 08/14/2017 at 08:45 am Scheduled Pub. Date: 08/15/2017

FR Document: 2017-17211 PDF 16 Pages (136 KB) Permalink

FDA

Guidance for Industry: Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products

FDA to Exercise Enforcement Discretion for the Use and Labeling of Ultrafiltered Milk in Certain Cheeses

FDA warns of potential contamination in multiple brands of drugs, dietary supplements

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
08/11/2017	Madhava	Chocolate Chip Cookie Mix	Undeclared milk	Madhava Natural Sweeteners

OMB-OIRA


AGENCY: HHS-FDA	RIN: 0910-AH43	Status: Pending Review
TITLE: Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease
STAGE: Proposed Rule	ECONOMICALLY SIGNIFICANT: No
** RECEIVED DATE: 08/11/2017	LEGAL DEADLINE: None

AGENCY: HHS-FDA	RIN: 0910-ZA50	Status: Pending Review
TITLE: Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E
STAGE: Proposed Rule	ECONOMICALLY SIGNIFICANT: No
** RECEIVED DATE: 08/11/2017	LEGAL DEADLINE: None

CVM

FDA’s Proposes Biomass Method to Obtain Animal Antimicrobial Sales and Distribution Data based on Animal Species and Weight

FSIS

Luvo Inc. (USA) Recalls Poultry Products Due To Misbranding and Undeclared Allergens

Aug 11, 2017 | PDF

· FSIS Holds a Third Educational Meeting on the Implementation of Siluriformes Inspection
· FSIS Posts Updated Dataset on Imports

AskFSIS

Disposition of Cattle that Become Entrapped in Livestock Handling Areas after Receiving Ante-mortem Inspection

AMS

USDA Cites Hop Hing Produces Inc. in New York for PACA Violations

USDA Lifts PACA Reparation Sanctions on California Produce Business

GIPSA
GIPSA Alleges New Holland Sales Stables, Inc. and David Kolb Violated the Packers and Stockyards Act (PDF; 53KB)

Ozark Regional Stockyards, Inc. Assessed $5,000 Civil Penalty (PDF; 38KB)

Wali Mayar, d/b/a Stockton Livestock Auction Yards Assessed $4,500 Civil Penalty (PDF; 43KB)

GIPSA Alleges Michael Louis Fox Violated The Packers and Stockyards Act (PDF; 51KB)

August 15, 2017

FDA

Guidance for Industry: Clarification on Food Establishment Waiver from Requirements of the Sanitary Transportation of Human and Animal Food Rule

FDA announces Leader Brand, Major Pharmaceuticals, and Rugby Laboratories recall of all liquid products manufactured by PharmaTech due to B. cepacia contamination risk

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
07/06/2017	APS BioGroup, Inc	Los Angeles District Office	Unapproved New Drugs/Misbranded	Not Issued *
07/05/2017	K & B Company, Inc	Denver District Office	CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions	Not Issued *

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
08/14/2017	Dierbergs Kitchen	Flavored Butters	Undeclared Fish, lobster, crab, shrimp, soy and wheat	Dierbergs Markets
08/12/2017	OPA	Ranch Greek Yogurt Dressing	Undeclared	Litehouse Inc.

APHIS

APHIS Publishes Final Rule to Allow Fresh Hass Avocado Fruit from Colombia into the Continental United States.

AMS

Joseph Aiello & Sons Inc. in New York Cited for Operating Without a Valid and Effective PACA License and the Company Satisfies Terms of Consent Decree

USDA Cites Yuqing (Henry) Wang in New York for PACA Violations

August 16, 2017

FDA

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
08/11/2017	California Aloha Mix	California Aloha Mix	Undeclared almonds, walnuts, and cashews	Grand BK Corp

FSIS

Missa Bay, LLC Recalls Chicken Products Due To Misbranding and an Undeclared Allergen

AskFSIS

Questions posted on askFSIS

August 17, 2017

Federal Register

Agricultural Marketing Service

Proposed Rules

Increased Assessment Rates: Hazelnuts Grown in Oregon and Washington

Filed on: 08/17/2017 at 08:45 am Scheduled Pub. Date: 08/18/2017

FR Document: 2017-17488 PDF 17 Pages (259 KB) Permalink

FDA

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
08/15/2017	Seven Sundays	Vanilla Cherry Pecan Muesli	Undeclared Almonds	Seven Sundays, LLC
08/14/2017	Dierbergs Kitchen	Flavored Butters	Undeclared Fish, lobster, crab, shrimp, soy and wheat	Dierbergs Markets