Laws and Regulations Committee Update 11/21/ 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

  • 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

DateBrandProduct DescriptionReason/ProblemCompany
11/20/2018No brand name; “PACKED BY FIRST SOURCE” printed on back label.Chocolate and Nut TrayUndeclared pecan and cashewFirst Source

Warning Letters

Letter Issue DateCompany NameIssuing OfficeSubjectClose Out Date
11/07/2018Jack B Goods Outlet StoreCenter for Food Safety and Applied NutritionUnapproved New Drugs/MisbrandedNot Issued *
11/07/2018MA Labs LLCCenter for Food Safety and Applied NutritionUnapproved New Drugs/MisbrandedNot Issued *
10/19/20185 Spoke Creamery, LLCCenter for Food Safety and Applied NutritionFood/Prepared Packed or Held Under Insanitary Conditions/AdulteratedNot Issued *
10/19/2018Premier Produce LLCCincinnati District OfficeCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedNot Issued *
10/04/2018Jinher, Inc.San Francisco District OfficeCGMP/Dietary Supplement/Adulterated/MisbrandedNot 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 RecalledDate of RecallRetail Distribution List
116-2018 165368 C. Corporation Recalls Pork Products Due to Possible Listeria ContaminationNov 20, 2018 
113-2018 Majestic Meat Company Recalls Ground Beef Products due to Possible E. coli O157:H7 ContaminationNov 16, 2018No retail sales
112-2018 Jennie-O Turkey Store Sales, LLC Recalls Raw Ground Turkey Products due to Possible Salmonella Reading ContaminationNov 15, 2018Nov 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-FDARIN: 0910-AI03Status: Pending Review
TITLE:Proposed Rule to Revise the Allowable Level of Fluoride Added to Bottled Water
STAGE: Proposed RuleECONOMICALLY SIGNIFICANT: No
** RECEIVED DATE: 11/20/2018LEGAL DEADLINE: None  

National Academies

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

@FDArecalls, @SGottliebFDA, @FDASpox

  • First Source Issues Allergy Alert on Undeclared Pecan and Cashew in Chocolate and Nut Tray http://dlvr.it/QrkpKP
  • #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.
  • “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
  • 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
  • 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
  • #FDA has taken action against another company involved in the outbreak of salmonella contamination in certain kratom products https://go.usa.gov/xPAdB
  • #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