News Article

Laws and Regulations Committee Update 11/21/ 2018

Posted on November 21, 2018

Blog: Association of Food & Drug Officials (AFDO)

November 21, 2018

Federal Register

Animal and Plant Health Inspection Service

Notices

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

Animal Disease Training

Filed on: 11/21/2018 at 8:45 am Scheduled Pub. Date: 11/23/2018

FR Document: 2018-25462 PDF 4 Pages (95.9 KB) Permalink

 

FDA

FDA warns marketers of products labeled as dietary supplements that contain tianeptine for making unproven claims to treat serious conditions, including opioid use disorder

FDA Takes Action on Products Marketed as Dietary Supplements Containing Tianpetine and Warns Consumers

  • Ø  FDA issued warning letters to two companies whose products marketed as dietary supplements were labeled as containing tianeptine

FDA Extends Comment Period on Use of the Names of Dairy Foods in Labeling Plant-Based Products

 

Recalls

Date

Brand

Product Description

Reason/Problem

Company

11/20/2018

No brand name; “PACKED BY FIRST SOURCE” printed on back label.

Chocolate and Nut Tray

Undeclared pecan and cashew

First Source

 

Warning Letters

Letter Issue Date

Company Name

Issuing Office

Subject

Close Out Date

11/07/2018

Jack B Goods Outlet Store

Center for Food Safety and Applied Nutrition

Unapproved New Drugs/Misbranded

Not Issued *

11/07/2018

MA Labs LLC

Center for Food Safety and Applied Nutrition

Unapproved New Drugs/Misbranded

Not Issued *

10/19/2018

5 Spoke Creamery, LLC

Center for Food Safety and Applied Nutrition

Food/Prepared Packed or Held Under Insanitary Conditions/Adulterated

Not Issued *

10/19/2018

Premier Produce LLC

Cincinnati District Office

CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated

Not Issued *

10/04/2018

Jinher, Inc.

San Francisco District Office

CGMP/Dietary Supplement/Adulterated/Misbranded

Not Issued *

 

 

FSIS

Nov 20, 2018 | PDF

  • FSIS and FDA to Extend Comment Period on Use of Cell Culture Technology To Develop Products Derived From Livestock and Poulty

Docket No. FSIS-2018-0040: Notice of Request for a New Information Collection: Stakeholder Input on Federal Outreach To Control Listeria Monocytogenes at Retail.

 

Recalls

Product Recalled

Date of Recall

Retail Distribution List

116-2018 165368 C. Corporation Recalls Pork Products Due to Possible Listeria Contamination

Nov 20, 2018

 

113-2018 Majestic Meat Company Recalls Ground Beef Products due to Possible E. coli O157:H7 Contamination

Nov 16, 2018

No retail sales

112-2018 Jennie-O Turkey Store Sales, LLC Recalls Raw Ground Turkey Products due to Possible Salmonella Reading Contamination

Nov 15, 2018

Nov 20, 2018

 

AMS

USDA Settles a Case with the Worland Livestock Auction LLC. Resulting in a $3,000 Penalty

USDA Settles a Case with Justin Thompson Resulting in a $1,925 Penalty

USDA Sets Referendum Dates for Proposed Amendments to the Almond Marketing Order

 

OMB

AGENCY: HHS-FDA

RIN: 0910-AI03

Status: Pending Review

TITLE:Proposed Rule to Revise the Allowable Level of Fluoride Added to Bottled Water

STAGE: Proposed Rule

ECONOMICALLY SIGNIFICANT: No

** RECEIVED DATE: 11/20/2018

LEGAL DEADLINE: None  

 

National Academies

The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research

 

@FDArecalls, @SGottliebFDA, @FDASpox

  • Ø  First Source Issues Allergy Alert on Undeclared Pecan and Cashew in Chocolate and Nut Tray http://dlvr.it/QrkpKP
  • Ø  #FDA appreciates the voluntary efforts by any growers, distributors to withdraw romaine supply from the market and urges consumers to heed advice to discard products. We will work hard to provide more specific advice and narrow the source of this outbreak.
  • Ø  “We’re in a position to prevent future cases of human illness. Our first mandate is to protect public health, fully recognizing that this is going to cause extreme hardship for growers and for consumers.” -@SGottliebFDA
  • Ø  Heads up: #FDA today posted warning letters to two companies for illegally marketing products labeled as dietary supplements that contain tianeptine, a chemical compound which is associated with serious adverse events. https://go.usa.gov/xPAeE
  • Ø  Consumers should avoid all products containing tianeptine, especially those claiming to treat opioid use disorder. #FDA issued warning letters to two companies whose products marketed as dietary supplements contain tianeptine http://go.usa.gov/xPAzE
  • Ø  #FDA has taken action against another company involved in the outbreak of salmonella contamination in certain kratom products https://go.usa.gov/xPAdB
  • Ø  #FDA’s investigation showed that more than 50% of kratom products tested were contaminated with salmonella, a level rarely seen in outbreak investigations of this nature. Users of kratom products are at risk of being exposed to salmonella https://go.usa.gov/xP7Wm


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