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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