Association of Food and Drug Officials

Laws and Regulations Committee Update 11/6 - 11/9, 2017

November 09, 2017 3:43 PM | Amy Bonsell (Administrator)

November 6, 2017


Federal Register

Food and Drug Administration

Rules

Listing of Color Additives Exempt from Certification; Calcium Carbonate

Filed on: 11/06/2017 at 08:45 am Scheduled Pub. Date: 11/07/2017

FR Document: 2017-24194  PDF  16 Pages (129 KB) Permalink

 

Animal and Plant Health Inspection Service

Proposed Rules

Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms; Withdrawal

Filed on: 11/06/2017 at 08:45 am Scheduled Pub. Date: 11/07/2017

FR Document: 2017-24202  PDF  4 Pages (163 KB)  Permalink

 

FDA

FDA Issues Guidance to Allow “Co-Manufacturers” Additional Time to Implement Certain Supply-Chain Program Requirements
Recalls

Date

Brand Name

Product Description

Reason/ Problem

Company

11/03/2017

DSD Merchandisers, Inc.  

Dark Chocolate Almond Products  

Undeclared Milk

DSD Merchandisers, Inc.

 

FSIS

Nov 03, 2017 | PDF

Identifying Regulatory Reform Initiatives at USDA

Update to FSIS Public Health Partners Web Page

 

AskFSIS

Trimming and Washing of Exposed Beef Parts

Noncompliance Record (NR)

Who in FSIS Office of Field Operations Documents Noncompliance?

Number of Noncompliance Records (NR)

 

USDA
USDA to Re-engage Stakeholders on Revisions to Biotechnology Regulations

 

AMS

USDA Files Action Against Olympic Wholesale Produce Inc. in Illinois for Alleged PACA Violations

USDA Files Action Against Huxtable’s Kitchen Inc. in California for Alleged PACA Violations

 

GIPSA
Nebraska Beef, Ltd. Assessed $7,500 Civil Penalty (PDF; 43KB)

Matt Anderson, d/b/a Matt Anderson Cattle Assessed $2,000 Civil Penalty (PDF; 43KB)

 November 7, 2017

FDA

FY 2015 Pesticide Analysis Demonstrates Residue Levels Remain Low

Warning Letters

Letter Issue Date

Company Name

Issuing Office

Subject

Close Out Date

10/31/2017

Stanley Brothers Social Enterprises, LLC

Los Angeles District Office

New Drug/Misbranded/ Cannabidiol(CBD) products

Not Issued *

10/31/2017

Green Roads of Florida LLC

San Juan District Office

New Drug/Misbranded/Cannabidiol(CBD) products

Not Issued *

10/31/2017

Natural Alchemist

Los Angeles District Office

New Drug/Misbranded/Cannabidiol(CBD) products

Not Issued *

10/31/2017

That's Natural

Los Angeles District Office

New Drug/Misbranded/Cannabidiol(CBD) products

Not Issued *

 

 

 

 

 

 

USDA

USDA Files Action Against Olympic Wholesale Produce Inc. in Illinois for Alleged PACA Violations

USDA Files Action Against Huxtable’s Kitchen Inc. in California for Alleged PACA Violations

 

FSIS

Recalls

Product Recalled

Date of Recall

Retail Distribution List

117-2017 CC Kitchens LLC Recalls Meat and Poultry Products Produced Without Benefit of Inspection En Español

Nov 02, 2017

Nov 04, 2017

116-2017 Chelsea Food Services Firm Recalls Pork and Chicken Products Due To Possible Listeria Contamination En Español

Nov 01, 2017

Nov 06, 2017

 

FTC

FTC Releases Draft Strategic Plan for Fiscal Years 2018 to 2022

 

NIH-ODS

Now Available: 2017 ODS Practicum Videos

 November 8, 2017

Federal Register

Food and Drug Administration

Proposed Rules

Guidance: Menu Labeling

Filed on: 11/07/2017 at 11:15 am Scheduled Pub. Date: 11/09/2017

FR Document: 2017-24246  PDF 6 Pages (198 KB)  Permalink

 

Color Additive Petitions: Colorcon, Inc.

Filed on: 11/08/2017 at 08:45 am Scheduled Pub. Date: 11/09/2017

FR Document: 2017-24421  PDF 2 Pages (77.9 KB)  Permalink

  • Ø  Colorcon, Inc., proposed that the color additive regulations be amended by expanding the permitted uses of synthetic iron oxide as a color additive to include use in dietary supplement tablets and capsules

 

Notices

Health and Diet Survey, as Used by Food and Drug Administration

Filed on: 11/08/2017 at 08:45 am Scheduled Pub. Date: 11/09/2017

FR Document: 2017-24409  PDF 4 Pages (86.3 KB)  Permalink

 

Infant Formula Recall Regulations

Filed on: 11/08/2017 at 08:45 am Scheduled Pub. Date: 11/09/2017

FR Document: 2017-24410  PDF 6 Pages (96 KB)  Permalink

 

Federal Trade Commission

Proposed Rules

Energy Labeling

Filed on: 11/08/2017 at 08:45 am Scheduled Pub. Date: 11/09/2017

FR Document: 2017-24381  PDF 27 Pages (698 KB) Permalink

 

FDA

FDA Issues Menu Labeling Guidance, Utilizing Q&A Format and Graphics to Address Concerns, Offer Solutions, and Provide Flexibility

Statement from FDA Commissioner Scott Gottlieb, M.D., on a practical approach to ensuring timely implementation of FDA’s menu labeling rule

Draft Guidance for Industry: Menu Labeling Supplemental Guidance

Warning Letters

Letter Issue Date

Company Name

Issuing Office

Subject

Close Out Date

11/02/2017

Create-A-Pack Foods, Inc.

Minneapolis District Office

CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated

Not Issued *

10/26/2017

Bluegrass Proteins, Inc.

Minneapolis District Office

CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions

Not Issued *

10/25/2017

Finnerty Dairy

Chicago District Office

Illegal Drug Residue

Not Issued *

10/13/2017

Biomin Industries, Inc.

Denver District Office

Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded

Not Issued *

08/18/2017

Threeline Imports, Inc.

New York District Office

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

Not Issued *

Recalls

Date

Brand Name

Product Description

Reason/ Problem

Company

11/07/2017

Nature's Touch  

Frozen Green Beans  

Listeria monocytogenes

Nature's Touch Frozen Foods LLC

 

USDA

USDA Files Action Against Forest City Weingart Produce Co. in Ohio for Alleged PACA Violations

Connecticut Firm Posts $100,000 Employment Bond

 

askFSIS

Slaughter or Processing of Multiple Species in the Same Production Day

 

OEHHA

DARTIC Meeting and Availability of Hazard Identification Materials for Chlorpyrifos and n-Hexane

  • Ø  Chlorpyrifos and n-hexane will be considered for possible listing by the DARTIC at its next meeting. Chlorpyrifos will be considered for possible listing based on the developmental toxicity endpoint.  n-Hexane will be considered for possible listing based on the developmental, male and female reproductive toxicity endpoints. Wed, 11/29/2017 - 10:00am to 5:00pm

 

CSPI

FDA Provides Guidance to Industry on Menu Labeling Compliance

Defense Department Should Not Function as “Alt-FDA”

 

November 9, 2017

Federal Register

Agricultural Marketing Service

Rules

National Organic Program: Organic Livestock and Poultry Practices

Filed on: 11/09/2017 at 08:45 am Scheduled Pub. Date: 11/14/2017

FR Document: 2017-24675  PDF 6 Pages (170 KB)  Permalink

  • Ø  The Organic Livestock and Poultry Practices (OLLP) final rule amends the organic livestock and poultry production requirements of the USDA organic regulations by adding new provisions for livestock handling and transport for slaughter and avian living conditions; and expands and clarifies existing requirements covering livestock care and production practices and mammalian living conditions.  AMS is delaying the effective date of the final rule published in the Federal Register on January 19, 2017 (OLPP final rule), until May 14, 2018.

 

Rules

Food Additives Permitted in Feed and Drinking Water of Animals: Ammonium Formate and Formic Acid

Filed on: 11/09/2017 at 08:45 am Scheduled Pub. Date: 11/13/2017

FR Document: 2017-24366  PDF 8 Pages (110 KB)  Permalink

  • Ø  FDA is amending food additive regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of formic acid and ammonium formate. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination

 

FDA

Canadian Food Inspection Agency and United States Food and Drug Administration sign a Memorandum of Understanding to facilitate sharing of scientific information and collaborative research projects (MOU)

 

FSIS

Recalls

Product Recalled

Date of Recall

Retail Distribution List

118-2017 Nestle Prepared Foods Company Recalls Pork and Beef Products Due To Misbranding and Undeclared Allergens

Nov 08, 2017

Nov 08, 2017

 

askFSIS

Reimbursable ante-mortem inspection activities for poultry destined for Russia

How do I determine if my plant is approved yet?

 

GIPSA

MCCS Livestock, Inc., d/b/a LeFlore County Livestock Auction Assessed $4,400 Civil Penalty (PDF; 43KB)

 

NAD

NAD Recommends Too Faced Cosmetics Discontinue ‘1,944% More Volume’ Claim for Better Than Sex Mascara, Advertiser to Appeal

 

NTP

Board of Scientific Counselors Meeting - December 7-8, 2017

Peer Review of RoC Monograph - January 24, 2018

 

 


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