Association of Food and Drug Officials

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

November 03, 2017 3:39 PM | Amy Bonsell (Administrator)

October 30, 2017

Federal Register

Food and Drug Administration

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

Filed on: 11/03/2017 at 08:45 am Scheduled Pub. Date: 11/06/2017

FR Document: 2017-24110  PDF 15 Pages (298 KB)  Permalink

 

Formaldehyde, polymer with 1,3-benzenediol, ethers with polyethylene glycol mono-Me ether

Filed on: 11/03/2017 at 08:45 am Scheduled Pub. Date: 11/06/2017

FR Document: 2017-24111  PDF 15 Pages (194 KB)  Permalink

 

Notices

Meetings: New Chemicals Review Program Implementation, etc.

Filed on: 11/03/2017 at 08:45 am Scheduled Pub. Date: 11/06/2017

FR Document: 2017-24112  PDF 10 Pages (158 KB)  Permalink

 

Food and Drug Administration

Rules

Guidance: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food

Filed on: 11/03/2017 at 08:45 am Scheduled Pub. Date: 11/06/2017

FR Document: 2017-24098  PDF 9 Pages (112 KB)  Permalink

 

Notices

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

Filed on: 11/03/2017 at 08:45 am Scheduled Pub. Date: 11/06/2017

FR Document: 2017-24121  PDF 2 Pages (86.6 KB)  Permalink

 

State Petitions for Exemption From Preemption

Filed on: 11/03/2017 at 08:45 am Scheduled Pub. Date: 11/06/2017

FR Document: 2017-24106  PDF 3 Pages (10 KB)  Permalink

 

Substantiation for Dietary Supplement Claims Made Under the Federal Food, Drug, and Cosmetic Act

Filed on: 11/03/2017 at 08:45 am Scheduled Pub. Date: 11/06/2017 FR Document:

2017-24123  PDF 9 Pages (112 KB)  Permalink

 

FDA

Recalls

Date

Brand Name

Product Description

Reason/ Problem

Company

11/02/2017

CVS Gold Emblem, Ocean State Candy, Hannaford Excellent, Market Basket, & Weigels  

Dark Chocolate Products  

Undeclared Milk

New American Food Products, LLC

 

@USFDA

1920s: Illness, death from botulism led to important advances in food processing, oversight & greater safety

 

FSIS

Recalls

Product Recalls

Date of Recall

CC Kitchens LLC Recalls Meat and Poultry Products Produced Without Benefit of Inspection

Nov 02, 2017

 

askFSIS

Pre-shipment Review

What can be done when product arrives with the wrong number stamped on boxes?

Can FSIS Certify Products that have too little Meat or Poultry to be Amenable to FSIS Inspection?

How can I Export other Products (not meat or poultry)?

What is an Import Permit and does FSIS need to see it?

Can I get an Export Certificate Online?

How do I Export Meat or Poultry?

 

NAD

NAD Recommends Schmidt‘s Deodorant Co. Discontinue Certain Claims Challenged by Tom’s of Maine; Finds Schmidt’s Can Support Crowd-Sourced Claim

 

NTP

NTP Update - October 2017 now available

 

CSPI

Sam Clovis Withdraws Nomination to USDA


AFDOSS | CASA | MCAFDO | NCAFDO | NEFDOA | WAFDO

Copyright © 2016 Association of Food and Drug Officials. All Rights Reserved.

Powered by Wild Apricot Membership Software