News Article

Laws and Regulations Committee Update 10/30 - 11/3, 2017

Posted on November 03, 2017

Blog: Association of Food & Drug Officials (AFDO)

October 30, 2017

Federal Register

Notices

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

Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic

Filed on: 10/30/2017 at 08:45 am Scheduled Pub. Date: 10/31/2017

FR Document: 2017-23659 PDF 7 Pages (185 KB) Permalink

FDA

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
10/27/2017	GKI Foods, Shoreline Fruit, Roundy’s	Dark Chocolate Products	Undeclared milk	GKI Foods

FSIS

Oct 27, 2017 | PDF

October is National Cyber Security Awareness Month

FSIS Posts Updated Quarterly Sampling Results

Identifying Regulatory Reform Initiatives at USDA

Recalls

Product Recalled	Date of Recall	Retail Distribution List
115-2017 Taylor Farms Florida Recalls Salad with Chicken Products Due to Misbranding and Undeclared Allergens \| En Español	Oct 28, 2017	N/A (Class II Recall)

AskFSIS

Exotic Animal Inspection

OEHHA

Acceptance of a Request for a Safe Use Determination for Chlorothalonil in Certain Foods Resulting from Pesticidal Use of the Chemical and Opportunity for Public Comment

October 31, 2017

Federal Register

Food and Drug Administration

Proposed Rules

Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease

Filed on: 10/30/2017 at 08:45 am Scheduled Pub. Date:10/31/2017

FR Document: 2017-23629 PDF 90 Pages (432 KB) Permalink

Ø FDA is proposing to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods, based on its review of the totality of publicly available scientific evidence currently available and FDA’s tentative conclusion that such evidence does not support FDA’s previous determination that there is significant scientific agreement among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease.

Proposed Rules

Food Additive Petitions:

DSM Nutritional Products, Inc.; Withdrawal

Filed on: 10/31/2017 at 08:45 am Scheduled Pub. Date:11/01/2017

FR Document: 2017-23728 PDF 2 Pages (156 KB) Permalink

Ø Withdrawal of food additive petition providing for the safe use of ethoxyquin in Vitamin D formulations, including 25-hydroxyvitamin D3 used in animal food.

Filed on: 10/31/2017 at 08:45 am Scheduled Pub. Date:11/01/2017

FR Document:2017-23729 PDF 2 Pages (84.1 KB) Permalink

Ø Withdrawal of food additive petition providing for the safe use of 25-hydroxyvitamin D3 in feed for swine.

FDA

Statement from Susan Mayne, Ph.D., on proposal to revoke health claim that soy protein reduces risk of heart disease

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
10/23/2017	Infantry Labs LLC	Detroit District Office	Unapproved New Drugs/Misbranded	Not Issued *
10/23/2017	Ironmag Labs	Los Angeles District Office	Unapproved New Drugs/Misbranded	Not Issued *
10/23/2017	Panther Sports Nutrition	New Jersey District Office	Unapproved New Drugs/Misbranded	Not Issued *
10/06/2017	Nexagen, LLC	Atlanta District Office	CGMP/Dietary Supplement/Adulterated	Not Issued *
09/25/2017	Demetri's Coffee Service	Cincinnati District Office	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated	Not Issued *
07/18/2017	Pesca Fina, S.A.	Center for Food Safety and Applied Nutrition	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
10/30/2017	Wegmans, Alpine Valley, Circle K and others	Dark Chocolate Products	Undeclared Milk	First Source
10/28/2017	Meijer	Dark Chocolate Products	Undeclared Milk	Meijer
10/27/2017	GKI Foods, Shoreline Fruit, Roundy’s	Dark Chocolate Products	Undeclared milk	GKI Foods

AskFSIS

FSIS Directive 5000.2 - Documenting an MOI

GIPSA

Jon A. Smith Prohibited from Registering for a Period of Three Years Under the Packers and Stockyards Act (PDF; 48KB)

Lynch Livestock, Inc. Settles False Weight Case with GIPSA. Will Pay Restitution to Livestock Sellers (PDF; 39KB)

November 1, 2017

Federal Register

Animal and Plant Health Inspection Service

Rules

Black Stem Rust; Additions of Rust-Resistant Species and Varieties

Filed on: 11/01/2017 at 08:45 am Scheduled Pub. Date: 11/02/2017

FR Document: 2017-23897 PDF 4 Pages (84.8 KB) Permalink

Notices

Environmental Assessments; Availability, etc.: Biological Control of Yellow Toadflax

Filed on: 11/01/2017 at 08:45 am Scheduled Pub. Date: 11/02/2017

FR Document: 2017-23895 PDF 3 Pages (23.6 KB) Permalink

FDA

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
10/31/2017	Toothsome Chocolate Emporium	Dark Chocolate Coffee Beans	Undeclared milk	Rucker’s Makin’ Batch Candies, Inc.
10/31/2017	Uncle Buck’s and Family Choice	Dark Chocolate Peanuts	Undeclared milk	Rucker’s Wholesale and Service Co
10/31/2017	21st Century Snack Foods	Dark Chocolate Almonds	Undeclared Milk	21st Century Snack Foods

FSIS

FSIS Compliance Guideline for Minimizing the Risk of Shiga Toxin-Producing Escherichia coli (STEC) in Raw Beef (including Veal) Processing Operations (2017) – comments due November 6, 2017

Recalls

Product Recalls	Date of Recall	Retail Distribution List
114-2017 Fresh Foods Manufacturing Co. Recalls Chicken Products due to Possible Listeria Contamination \| En Español	Oct 20, 2017	Oct 31, 2017

askFSIS

Deli Product Determination

Neutralizing Buffered Peptone Water (nBPW) in poultry carcass and parts sampling

November 2, 2017

Federal Register

Agriculture Department

Rules

Rules of Practice and Procedure Governing Formal Rulemaking Proceedings Instituted by the Secretary

Filed on: 11/02/2017 at 08:45 am Scheduled Pub. Date: 11/03/2017

FR Document: 2017-23877 PDF 22 Pages (278 KB) Permalink

Food and Drug Administration

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Substances Prohibited From Use in Animal Food or Feed

Filed on: 11/02/2017 at 08:45 am Scheduled Pub. Date: 11/03/2017

FR Document: 2017-23948 PDF 9 Pages (45.2 KB) Permalink

FDA

Agendas Posted for Agricultural Biotechnology Education and Outreach Initiative November 2017 Meetings

FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
11/01/2017	Aurora, AG Supermarkets, Belmont Market, and others	Dark Chocolate Products	Undeclared Milk	Aurora Products, Inc.
11/01/2017	Blue Marble, Roundy's Select, and HyVee	Dark Chocolate Products	Undeclared milk	GKI Foods LLC

USDA

USDA Continues Restrictions of a PACA Violator in Texas from Operating in the Produce Industry

New Infographic Spreads the Word about Butter Grading

FSIS

Recalls

Product Recalls	Date of Recall
116-2017 Chelsea Food Services Firm Recalls Pork and Chicken Products Due To Possible Listeria Contamination	Nov 01, 2017

CSPI

40,000 Urge FDA Not to Delay Updated Nutrition Facts Labels

November 3, 2017

Federal Register

Environmental Protection Agency

Rules

Tolerance Exemptions: Formaldehyde, polymer with 1,3-benzenediol, 2-methyloxirane and oxirane, ethers with polyethylene glycol mono-Me ether