News Article

Laws and Regulations Committee Update 1/5 - 1/11, 2018

Posted on January 12, 2018

Blog: Association of Food & Drug Officials (AFDO)

January 5, 2018

FDA

Statement from FDA Commissioner Scott Gottlieb, M.D. on FDA Food Safety Modernization Act enforcement discretion guidance

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
01/03/2018	Coconut Tree	Shredded Coconut	Salmonella	Evershing International Trading Company
01/03/2018	Condies Foods	Fruit cup	Undeclared milk and egg	Condies Foods

@FDAFood, @FDA_ORA, @SGottliebFDA

· Evershing International Trading Company Recalls Frozen Shredded Coconut Because of Possible Health Risk http://dlvr.it/Q8sWvR
· Condies Foods Issues Allergy Alert on Undeclared Milk and Egg allergen in Veggie Cup Item# 40781 http://dlvr.it/Q8smDm
· Statement from FDA Commissioner @SGottliebFDA on FDA Food Safety Modernization Act enforcement discretion guidance. https://go.usa.gov/xnytV

FSIS

Hempler Foods Group, LLC Recalls Pepperoni Products due to Possible Extraneous Material Contamination

USDA Offers Food Safety Tips for Areas Affected by East Coast Winter Storm

Recall Updates

Product Recalled	Date of Recall	Retail Distribution List
129-2017 Piller's Fine Foods Recalls Ready-To-Eat Salami and Speck Products due to Possible Salmonella Adulteration \| En Español	Dec 16, 2017	Jan 04, 2018
123-2017 Trafon Group Recalls Chicken and Pork Products Produced Without Benefit of Import Inspection \| En Español	Nov 16, 2017	Jan 03, 2018

FTC

FTC Staff Offers Business Guidance Concerning Multi-Level Marketing

National Academies

Top 10 Reports of 2017

CSPI

Trump Administration Indefinitely Delays Key Food Safety Protections

January 8, 2018

Federal Register

Consumer Product Safety Commission

Notices

Meetings; Sunshine Act

Filed on: 01/05/2018 at 11:15 am Scheduled Pub. Date: 01/09/2018

FR Document: 2018-00229 PDF 2 Pages (72.2 KB) Permalink

FDA

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
01/05/2018	Top's, Purple Cow	Orange Cream Bars	Listeria monocytogenes	Fieldbrook Foods Corporation
01/05/2018	Chao Café	instant coffee	Undeclared milk	Hong Lee Trading, Inc.

@FDAFood, @FDA_ORA, @SGottliebFDA

· @US_FDA issued guidance on areas of #FSMA where #FDA is exercising enforcement discretion to allow more time to consider better approaches, long-term solutions for challenging areas. Our goal? To get a framework that works for the long run: https://go.usa.gov/xnytm
· #FDAORA issues #warningletter to a Honolulu #seafood processing facility for violating federal #foodsafety regulations for seafood: https://go.usa.gov/xnPC9

FSIS

Product Recalled	Date of Recall
002-2018 Crescent City Meats Recalls Ready-To-Eat Tasso Ham Products due to Underprocessing	Jan 05, 2018
001-2018 Hempler Foods Group, LLC Recalls Pepperoni Products due to Possible Extraneous Material Contamination \| En Español	Jan 04, 2018

Jan 05, 2018 | PDF

FSIS Announces Webinar for Posting Individual Salmonella Category Status for Poultry Carcass Establishments
PHIS Export Component Information for Industry Available on FSIS Website

USDA
Report to the President of the United States from the Task Force on Agriculture and Rural Prosperity, Secretary Sonny Perdue, Chair

NTP

ICCVAM Communities of Practice Webinar - January 23

Food and Water Watch

Central Michigan University and William & Mary Win Fifth Annual Tap-a-Palooza

January 9, 2018

Federal Register

Environmental Protection Agency

Notices

Meetings: Environmental Laboratory Advisory Board

Filed on: 01/09/2018 at 08:45 am Scheduled Pub. Date: 01/10/2018

FR Document: 2018-00284 PDF 2 Pages (77.5 KB) Permalink

Food Safety and Inspection Service

Notices

2018 Rate Changes for the Basetime, Overtime, Holiday, and Laboratory Services Rates

Filed on: 01/09/2018 at 08:45 am Scheduled Pub. Date: 01/10/2018

FR Document: 2018-00283 PDF 11 Pages (175 KB) Permalink

OIRA

AGENCY: USDA-FSIS	RIN: 0583-AD62	Status: Concluded
TITLE: Modernization of Swine Slaughter Inspection
STAGE: Proposed Rule	ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/10/2017	LEGAL DEADLINE: None
REVIEW EXTENDED
** COMPLETED: 01/08/2018	COMPLETED ACTION: Consistent with Change

FDA

Learn More about the FSMA Collaborative Training Forum

FSIS

Recalls Updated

Product Recalled	Date of Recall	Retail Distribution List
001-2018 Hempler Foods Group, LLC Recalls Pepperoni Products due to Possible Extraneous Material Contamination \| En Español	Jan 04, 2018	Jan 08, 2018

@FDAFood, @FDA_ORA, @SGottliebFDA

Ø #FDA is committed to making public data easy to access and use. Visit our new data dashboard to see trends in #FDAORA inspections, compliance, enforcement actions: #imports, #recalls http://go.usa.gov/xnmcJ
Ø #TipTuesday: Beware of fraudulent #dietarysupplement products! Some are tainted with drug ingredients that could harm you. LEARN the signs of fraudulent products: https://go.usa.gov/xnR4u #healthfraud

askFSIS

FSIS Overtime, Holiday, and Laboratory Services Rates for 2017

AMS

AMS Town Hall with MRP Under Secretary Ibach – January 11^th

USDA Announces National Honey Board Appointments

Skills Sown in Military Service Grow at USDA

FTC
Electronic Toy Maker VTech Settles FTC Allegations That it Violated Children’s Privacy Law and the FTC Act

Ø The company violated a U.S. children’s privacy law by collecting personal information from children without providing direct notice and obtaining their parent’s consent, and failing to take reasonable steps to secure the data it collected. VTech will pay $650,000 as part of the settlement with the FTC.

NAD

NAD Recommends Dr. Harold Katz Discontinue Health-Performance Claims for Therabreath Rinse, Lozenges; Company to Appeal

January 10, 2018

Federal Register

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 01/10/2018 at 08:45 am Scheduled Pub. Date: 01/11/2018

FR Document: 2018-00334 PDF 5 Pages (95 KB) Permalink

FDA
Reflections on a Landmark Year for Medical Product Innovation and Public Health Advances and Looking Ahead to Policy in 2018

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
08/21/2017	Innovita, LLC	Denver District Office	Unapproved New Drugs/Misbranded	Not Issued *

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
01/09/2018	Various brands: Lucerne, Kroger, Sundae Shoppe.	Orange cream bars and chocolate coated vanilla ice cream bars	Listeria monocytogenes	Fieldbrook Foods Corporation
01/09/2018	Clover Valley®	Iced Oatmeal Cookies	Undeclared milk and tree nuts	Dollar General Corporation

@FDAFood, @FDA_ORA, @SGottliebFDA

· @FDAFood & @USDA are committed to making #FSMA training accessible & comprehensive for the food industry. #FoodSafety https://go.usa.gov/xnp9M
· DID YOU KNOW? #FDAORA serves as the lead office for all FDA inspection and investigational activities. MORE: http://go.usa.gov/xjeKB
· #FDAORA works hard to ensure the food you eat is safe. When there is a #foodborneillness #outbreak, FDA works closely with @CDC & state and local govts to quickly respond. LEARN MORE: http://bit.ly/2BUcCA6

USDA

USDA Announces Proposed Rule to Amend Egg Products Inspection Regulations

Ø Proposed Rule, Egg Products Inspection Regulations

NTP

NTP Update - January 2018 now available

January 11, 2018

Federal Register

Agriculture Department

Proposed Rules

Regulatory Agenda: Semiannual Regulatory Agenda

Filed on: 01/11/2018 at 08:45 am Scheduled Pub. Date: 01/12/2018

FR Document: 2017-28205 PDF 22 Pages (215 KB) Permalink

Consumer Product Safety Commission

Proposed Rules

Regulatory Agenda: Semiannual Regulatory Agenda

Filed on: 01/11/2018 at 08:45 am Scheduled Pub. Date: 01/12/2018

FR Document: 2017-28243 PDF 16 Pages (265 KB) Permalink

Environmental Protection Agency

Proposed Rules

Regulatory Agenda: Semiannual Regulatory Agenda

Filed on: 01/11/2018 at 08:45 am Scheduled Pub. Date: 01/12/2018

FR Document: 2017-28234 PDF 21 Pages (216 KB) Permalink

Health and Human Services Department

Proposed Rules

Regulatory Agenda: Semiannual Regulatory Agenda

Filed on: 01/11/2018 at 08:45 am Scheduled Pub. Date: 01/12/2018

FR Document: 2017-28220 PDF 48 Pages (275 KB) Permalink

FDA

FDA Information about E. coli O157:H7 Outbreak Likely Linked to Leafy Greens

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
01/08/2018	Rely	Dried Longya Lily	Undeclared Sulfites	Wells Collection Inc

@FDAFood, @FDA_ORA, @SGottliebFDA

· FDA continues to work w/CDC, state & local officials on E.coli outbreak likely linked to leafy greens. Last illness was in Dec. suggesting any contaminated product likely no longer on market. Read our update here: http://go.usa.gov/xnpzj
· CDC, FDA investigation continues on E. coli outbreak likely linked to leafy greens. Last illness was in early Dec. which suggests suspect leafy greens linked to this outbreak are likely no longer in the food supply: http://go.usa.gov/xnpzj
· On Tuesday (1/16), we're convening experts to discuss the importance of open data and transparency at the @US_FDA. Hear from @ScottGottliebMD, @drJoshS, Sean Coady (@nih_nhlbi), @cmrherder, @jsross119 and many more. The event will be webcast: http://jhsph.edu/fda-transparency …
· Learn about the members of the #FSMA Collaborative Training Forum, including @Produce_Safety, @IFSH_FSPCA & their work to help the #food industry comply with FSMA rules. https://go.usa.gov/xnp7s
· '@FDAFood & @USDA are committed to making #FSMA training accessible & comprehensive for the food industry. #FoodSafety https://go.usa.gov/xnp9M
· #TBT: An #FDAORA #imports inspector works to keep products made using cocoa beans safe. In the 1960s, FDA seized over 60M lbs of cocoa beans after detecting #salmonella in chocolate candy. MORE: http://bit.ly/2B4Tu5a #keepingyourhotcocoasafe
· #FDAORA ombudsman is “committed to increasing the transparency of our processes, as well as quickly addressing problems that arise.” LEARN MORE about the Ombudsman’s role: https://go.usa.gov/xnRU5